MLリソース：抗ウイルス剤




ヘルペス関連は、次の資料に分離した。
関連●MLリソース：ヘルペス治療剤へ



【日本語版コメント1067】
　一般的にウイルス感染症は、自然治癒するものも多く、一度、感染治癒すると抗体を取得し、その後はかかりにくいものもあります（麻疹（はしか）、風疹（三日ばしか）、ムンプス（おたふく）など）。　一方で、肝炎ウイルス（Ｂ型、Ｃ型）やエイズウイルスのように、長い潜伏期間の後、徐々に増殖、発病するものもある。　また、水疱ウイルスのように、子供の時にかかった水疱（水ほうそう）のウイルスが、大人になって帯状疱疹となって現れるものもある。　また、ごく稀に、日本脳炎、麻疹、インフルエンザ、ヘルペス等のウイルスが脳内に侵入し重い脳炎や脳症を起こすこともある。　エイズ・ヘルペス以外はワクチンで予防可能。
　エンテロウイルス性非特異的発疹症や小型球形ウイルス（SRSV）による胃腸炎（多くは生カキの摂取による冬の集団下痢症）など、特異的な治療方法はなく対症療法を行うものもある。
　抗ウイルス剤が主に使用される対象は、肝炎、ヘルペス、サイトメガロウイルス感染症。

【市場】
　抗ウイルス剤【2000世界市場】Zovirax(=アシクロビル[GSK]) 715億円(￡374百万-7%,[98]￡403百万-27%)、Valtrex(=valaciclovir[GSK]) 462億円(￡242百万+32%,[98]133)、Famvir(=famciclovir[GSK]) 290億円(￡152百万+11%,[98]US$173百万+33%)。　【日本市場】ゾビラックス(=アシクロビル[GSK]) [99]400億円([97]330億円)、アラセナ軟膏(=ビダラビン) [持田]24億円-4%([99]25)、[GSK '99]20億円、デノシン[田辺][99]13億円など。
【インターフェロン2000世界市場】Intron A(=IFN-α-2b[Schering-Plough]) 736億円（Rebetron共$1360百万+21%;[99]1119,[98]719)、Betaferon(=IFN-β1b[Schering AG]692億円(Euro 593百万,[2001]681 +15%,[98]DM720百万)、Roferon A(=IFN-α-2a[Roche]) 205億円（CHF 260百万-9%,[98]>300百万)【インターフェロン2000日本市場】スミフェロン(=IFNα[住友]) 141億円,[99]140,[97]144、フェロン(=IFNβ[第一])122億円,[99]110,[98]134、イントロンＡ(=IFN-α-2b[シェリングプラウ]) 98億円('97)、オーアイエフ(=IFN-α[大塚]) 63億円,[99]68,[98]70、IFNαモチダ/IFNβモチダ([持田]) 52億円+21%,98]41
*インタフェロンαは、Ｃ型肝炎、Ｂ型肝炎と一部のガンの治療薬として販売されている。しかし、一時は1500億円（薬価ベース）近い売り上げに膨らんだため、医療費抑制を図る大蔵省とそれに気おされた厚生省に目の敵とされ、薬価切り下げと使用対象の制限によって、現在、売り上げは600億円まで縮小した。[日経バイオテク（96年７月１日）]


Glaxo SmithKleine
　　　　　　　　　　2001	 2000
　　　　　　　　　　￡m 	 ￡m
★ANTI-VIRALS 　　　2,128[+10]	 1,899[+14]
○HIV 　　　　　　　1,347[+14]	 1,145[+14]
Trizivir　　　　　　  167[>100]	     7[+>100]	abacavir sulfate/ lamivudine/zidovudine
Combivir　　　　　　  606[+ 5]	   562[+21]	lamivudine/zidovudine
Epivir　　　　　　　  302[- 5]	   309[- 7]	lamivudine
Retrovir　　　　　　   55[-11]	    61[-30]	zidovudine
Ziagen　　　　　　　  167[+ 5]	   154[+75]	abacavir sulfate
Agenerase 　　　　　   50[- 7]	    52[+60]	amprenavir
○Herpes　　　　　　  646[+ 5]	   616{+ 5]
Valtrex 　　　　　　  350[+42]	   242[+32]	valacyclovir
Zovirax 　　　　　　  296[-19]	   374[- 7]	aciclovir
Zeffix　　　　　　　  103[+49]	    70[+>100]	lamivudine
Relenza 　　　　　　        ?	    32[+97]	zanamivir

Famvir　　　　　　　        ?	   152[+11]	famciclovir
★売上～日本
(億円)（薬価ベース）    2001
ゾビラックス             270
バルトレックス            80
ゼフィックス              20

Novartis
[2000]
・acquisition of the antivirals Famvir and Vectavir/Denavir from SmithKline Beecham for CHF 2.7 billion
Brands　　　　　　　Sales　               Therapeutic Area
　　　　　　　　　　 2001      2000      1999      CHF millions in local currencies
★[Infections]
Lamisil 　　　　　　 1405(+15) 1278(+12) 1051(+8)  [terbinafine]Fungal infections
Famvir    　　　　　　323(-)    GSK       GSK      [famciclovir]Anti-viral

持田製薬
平成１４年３月期）（単位：億円）
　　　　　　　  02/3     01/3
ＩＦＮαモチダ
ＩＦＮβモチダ　 38(-27)  52(+21) 天然型インターフェロン製剤
アラセナ－Ａ　　 31(+27)  24(+3)  抗ウイルス剤
【開発中の新薬】
　●PhRMA: New Medicines in Development for Infectious Diseases, 2000●Antiviral and HIV Drug and Vaccine Development - Annual Review - 1998等にリスト又は解説。

【解説資料】
■抗ウイルス剤の目次と解説（おくすり１１０番）がおすすめ。　そのほか●インターフェロン(IFN) 　●Project Inform Antiviral Treatment Information ( HIV / AIDS Treatment Information )は抗ウイルス剤療法に関する解説、個別薬剤データ

【疫学資料】
　[●WHO Hepatitis Information]　 慢性Ｂ型肝炎患者は世界で３億５千万人、感染経験者は20億人(http://www.who.int/gpv-dvacc/diseases/hepatitis_b.htm)(Hepatitis B Fact Sheet[98.11])　 慢性Ｃ型肝炎キャリアは世界で１億７千万人。(Hepatitis C Fact Sheet[97.6])　現在、米国ではＣ型肝炎ウイルス（ＨＣＶ）に感染している人が４００万人（人口の２％）、日本では200万人と推定。[Amgen社]
日本でのウイルス肝炎総推計患者数は、38万人［患者調査11年度］

【臨床ガイドライン】
■Primary Care Clinical Practice Guidelines 1や次のところ。Virus Diseases[30種収録]や、Hepatitis, Influenza, Rotavirus, Herpes, HPV, Wartsなど

【ニュース・トピックス】
総説■NIH Guide: MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL STRATEGY[1998]

【オンライン雑誌】
■MedWebPlus: Virus Diseases■MedWebPlus: Virology

【リンク＆リソース】
リソース■MEDLINEplus: Viral Infections■MEDLINEplus: Herpes Simplex■MEDLINEplus: Shingles (Herpes Zoster)
リンク集■日本ウイルス学会　ウイルス関連リンク集■Virus Diseases[www.ohsu.edu]

【主要サイト】
■ISAR :International Society for Antiviral Research[公表資料としては、Antiviral Research[印刷物のみ]、ISAR Newsletters[半年刊]程度]
■American Herpes Foundation[各種ヘルペス情報（一般向け、専門家向け）を提供。　AHF Monitor[季刊]は無料閲覧可]■HRC :Herpes Resource Center[ヘルペス関連の解説資料のWEB発行、リンク頁]■IHMF: International Herpes Management Forum[online雑誌 HERPES[年３回]は全文無料閲覧可。]■HerpesWeb[性器ヘルペス関連情報、診療ガイドラインがある。]








●解説


■抗ウイルス剤の目次と解説（おくすり１１０番）


総目次／感染症治療剤／抗ウイルス剤

1999/07/08(木)　薬事典下書きシリーズ
ご自身の責任において参考にとどめ、医師・薬剤師からの用法用量をお守りください。

目 次
抗ウイルス剤
抗ヘルペスウイルス剤
抗インフルエンザウイルス剤
免疫賦活・抗ウイルス剤
抗HIV剤

＜ 概 説 ＞
ウイルスは、細菌よりも小さく、細胞膜を持たない最も原始的な微生物です。人の細胞の中に侵入してしまうので、薬剤でウイルスを完全に駆除することは困難です。現時点、抗ウイルス剤は、一部のウイルスに対してのみ有効で、その使用は限られています。ウイルスに対しては、今だ、特効的な薬はないと言ってもよいでしょう。むしろ、自然治癒力（免疫）を高めるワクチンなどの予防接種が重要となってきます。

よく知られているウイルスには、インフルエンザ・ウイルス、麻疹ウイルス（はしか）、風疹ウイルス（三日ばしか）、ポリオ、ムンプス（おたふく）、日本脳炎、肝炎ウイルス、ヘルペスウイルス群（水ほうそうウイルス）、サイトメガウイルス、アデノウイルス、エイズウイルス(ヒト免疫不全ウイルス、HIV)などがあります。

一般的にウイルス感染症は、自然治癒するものも多く、一度、感染治癒すると抗体を取得し、その後はかかりにくいものもあります（はしか、風疹、おたふくなど）。一方で、肝炎ウイルス（Ｂ型、Ｃ型）やエイズウイルスのように、長い潜伏期間の後、徐々に増殖、発病するものもあります。また、水疱ウイルスのように、子供の時にかかった水疱（水ほうそう）のウイルスが、大人になっても細胞の中で生き続け、帯状疱疹となって繰り返し現れるものもあります。
また、ごくまれですが、日本脳炎ウイルス、麻疹ウイルス、インフルエンザ・ウイルス、ヘルペスウイルスなどでは、脳内に侵入し重い脳炎や脳症を起こすこともありますから、油断はできません。
目的、用途が異なりますが、多くのウイルスに対するワクチンがありますから、予防接種を受けることも可能です（エイズウイルスなどはありません）。一部は、子供への定期接種となりますが、強制ではなくなり、勧奨接種となっています。

＜ インフルエンザ ＞インフルエンザ・ウイルスは、冬季に必ず流行する感染しやすいウイルスですが、多くは、発病後まもなく自然治癒します。ただし、子供や高齢の人、免疫の落ちている人では、肺炎など２次感染も含め、まれに重症化することもあります。特に子供（乳幼児）では、きわめてまれに、脳内にウイルスが入り込みインフルエンザ脳症を引き起こすこともあります。これは、急激に病状が進行し、予後も好ましくありません。薬物治療における特効薬はなく、対象療法（症状を抑える）が主になります。
予防には、インフルエンザ・ワクチンの接種が最も好ましいと考えられますが、その有効性、副作用などから一部賛否のあるところでもあります。現状では、インフルエンザ・ワクチンを受ける方は、ごく限られていますが、子供や高齢の方は、冬季の流行前に医師と相談されるのもよいでしょう。
そのほか、塩酸アマンタジン（シンメトレル）が、Ａ型インフルエンザウイルスに限り用いられることがあります。Ａ型以外のウイルスには無効です。このお薬は、副作用に留意する必要があるので、一般的ではありませんが、発症後、重症化する恐れのある高齢の人、免疫不全状態の人などに予防的に使用したり、発症後の治療剤として用います。ウイルスの増殖を抑えるものなので、症状が進んでから飲みだしてもあまり効果がないとされています。

＜ 肝炎 ＞肝炎ウイルスのうち、Ａ型は、飲食物より感染することが多く、黄疸など急激な症状が一時的に現れますが、治癒してしまえば慢性化することはありません。やっかいなのは、Ｂ型、Ｃ型です。
肝炎ウイルス（Ｂ型、Ｃ型）は、一般的には感染力は弱く、ふつうの社会的な接触であれば感染することはありません。多くは、輸血など血液を介したり、出産時に赤ちゃんに感染する母子感染によるものです（現在は、輸血はきちんとチェックされ、母子感染もワクチンで予防可能です）。また、準性病ともされ、性行為により感染する場合があります。ただ、それだけでは説明がつかず、昔の集団予防接種での注射針の使い回しが、肝炎を蔓延させた一つの原因ではないかという声も聞かれます（今になって実証するのは、非常に困難ですが、一部裁判も起こされているようです）。
肝炎ウイルス（Ｂ型、Ｃ型）は、慢性化すると、肝硬変に進むこともあり、更に進むと、まれに肝臓がんとなることもあります。
肝炎ウイルスを直接死滅させる特効薬（抗ウイルス剤）はありませんが、インターフェロン（注射）による治療は、大変効果がよく、治療の中心となります。
＜ ヘルペス ＞ヘルペスウイルス群は、水痘・帯状疱疹ウイルスと単純ヘルペスウイルスなどに分類されます。皮膚に水疱（水ぶくれ）を作るのが特徴的です。
このうち、水痘・帯状疱疹ウイルスは、水ほうそうのウイルスです。子供の時にかかった水ほうそうのウイルスが、大人になっても神経細胞に潜んで体の中で共存しています。普段はおとなしくしているのですが、体調をくずしたり、疲れて抵抗力が落ちている時などに、増え出し、神経に添って小さい水疱を作り、ピリピリと耐え難い痛みを伴います。このような症状が帯状疱疹と呼ばれるものです。

一方、単純ヘルペスウイルスで多いのは、かぜを引いたときなどに唇など粘膜に水疱ができたりするものです。また、外陰部に水疱を発生し痛みを伴う性器ヘルペスもしばしば見られます。性器ヘルペスは性行為により感染することもあります。これらは、ふつう自然治癒もしますが、アシクロビル（ゾビラックス）というお薬を早期に使用すれば、症状が軽くて済み、治りも早まります。ただし、ヘルペスウイルスを完全に死滅させることは困難で、人の細胞の中でこっそり生き延び続けるものです。

＜ エイズ ＞後天性免疫不全症候群(エイズ)も、ヒト免疫不全ウイルス（エイズウイルス、HIV）というウイルスによる感染症です。ウイルスが免疫系の細胞に侵入、増殖し、しだいに体の免疫力を弱めていく病気です。国内では血友病の治療に用いる血液製剤から感染した例が多く、いわゆる薬害エイズと呼ばれています。当時、流行が始まっていたアメリカで、エイズウイルス保有者からの売血を原料とした血液の薬が、国内に輸入され、これを使用し続けた多くの血友病の患者様が感染するという悲劇が起こりました。危険が予測されていたにもかかわらず、製薬会社や国の対応が遅れたことの責任が問われています。
エイズウイルス(HIV)は、感染力は弱く、ふつうの社会的な接触であれば感染することはありません。ただし、性行為で、感染する恐れがあります。最近の新たな感染者は、性的接触による感染が大部分です。

アメリカでエイズが流行を始めた頃は、原因も分からず、治療薬もありませんでした。その後、ウイルス感染症であることが明らかになり、逆転写酵素阻害剤のジドブジン（レトロビル、AZT）やプロテアーゼ阻害剤の硫酸インジナビル（クリキシバン）などの抗ウイルス剤が開発されました。現在、これらの抗ウイルス剤を組み合わせる３剤併用療法が試みられるようになり、予後が大変改善されています。

＜ 抗ウイルス剤 ＞内服の抗ウイルス剤は、ごく限られています。ヘルペスウイルスに使用するアシクロビル（ゾビラックス）とエイズの治療に用いる抗HIV剤などがあります。また、塩酸アマンタジン（シンメトレル）は、Ａ型インフルエンザの予防や治療に用いることがあります。肝炎ウイルス（Ｂ型、Ｃ型）には、インターフェロン（注射）による治療が主となります。そのほかのウイルスの感染予防には、各種のワクチンの予防接種が重要となります。

【抗ヘルペスウイルス剤】
水痘・帯状疱疹ウイルス（水ぼうそうの原因ウイルス）と単純ヘルペスウイルスによる感染症に用います。内服では、アシクロビルという一成分が使用されています。このお薬を発病早期に使用することで、症状の悪化を防ぎ、治癒も早まります。唇など皮膚粘膜にできる水疱には軟膏剤が、ヘルペス角膜炎には眼軟膏が使用されます。ほとんど一時的な症状で治癒しますが、免疫の弱っている人では重症化したり、非常にまれに、ヘルペスウイルスが脳に侵入し脳炎を起こすこともあります。このような場合は、注射剤が適応となります。また、注射剤は、肝炎ウイルスに対し応用使用されることもあります。

【抗インフルエンザウイルス剤】
塩酸アマンタジンは、国内では、抗パーキンソン剤などとして、承認されていましたが、９８年１１月にＡ型インフルエンザウイルス感染症にも適応が拡大されました。予防薬や治療薬としますが、副作用も少なくないので安易に使用されるものではありません。インフルエンザワクチンの接種が優先されるべきとされています。このお薬は、ワクチンが使用できない時に限り、重症化する恐れのある高齢の人（特にホームなどで集団感染の恐れの強い場合）や、免疫不全状態の人を対象に補助的に使用するものです。発病後においても同様です。普通の人がＡ型インフルエンザに感染した場合に、むやみに使用するものではありません（人の自然治癒力は捨てたものではありません）。耐性ウイルスの発現を防ぐためにも大切です。尚、Ｂ型インフルエンザには効果がありません。

【免疫賦活・抗ウイルス剤】
イノシンプラノベクスというお薬があります。亜急性硬化性全脳炎の進行を遅らせるお薬です。亜急性硬化性全脳炎は、非常にまれですが麻疹（はしか）のウイルスが脳に侵入・増殖し、脳の働きを悪くする小児の病気で、進行性で予後も好ましくありません。筋肉がこわばったり、けいれんを起こすなど重い症状を伴います。麻疹ワクチンを接種していれば、このような重い症状に至ることはまずありません。

【抗HIV剤】
エイズウイルス(ヒト免疫不全ウイルス、HIV)の増殖を抑えるお薬です。免疫が弱るのを遅らせ、エイズの症状を改善する働きがあります。逆転写酵素阻害剤と、プロテアーゼ阻害剤の２系統に分類されます。レトロビル（ジドブジン、AZT）を基本に、２種類の逆転写酵素阻害剤と１種類のプロテアーゼ阻害剤による３剤併用療法も試みられています。これらは、効果も高いお薬ですが、副作用も多いので、事前に医師から十分な説明を受け薬の性質を理解した上で使用するようにしましょう。

＜ 関連薬剤 ＞
【インターフェロン（α、β）】
インターフェロンは、免疫を高める物質の一種で、肝炎（Ｂ型、Ｃ型）の治療にかかせない注射剤です。相当によい治療効果がありますが、全ての人が完治する訳ではありません。一時的にウイルスが消えたかに見えても、再発することが少なくありません。また、副作用も多い方ですから、使用前に医師から十分な説明を受け薬の性質を理解した上で治療に入るようにしましょう。【免疫グロブリン】血液製剤の一種で、細菌やウイルスに対する抗体が含まれます。各種感染症の症状軽減に使用します。

【ワクチン類】
ウイルスに直接作用する抗ウイルス剤は種類も少なく、その効果にも限界があるので、事前に予防接種を受け各種ウイルスに対する免疫力を高めておくことが重要です。感染しても重症化することが少なくなります。かつて、ポリオが大流行をしたさい、女性パワーに屈し、政府が旧ソ連からポリオワクチンを超法規的に緊急輸入し、成果を上げたことはよく知られています。予防接種には、赤ちゃんや子供の定期接種（勧奨接種）のほか、任意の接種のものもあります。現在、定期接種は強制接種ではなくなりましたが、接種による副反応（副作用）と、受けなかった場合の感染時の重症化のリスクを比べた場合、はるかに予防接種を受けた場合の方が有利と言えます（一方で、インフルエンザワクチンなど、その効果を疑問視する向きも一部にないこともありませんが・・）。主に、以下のようなワクチンがあります。尚、ＢＣＧや３種混合ワクチン、コレラワクチンは、ウイルスではなく、細菌による感染症を予防するものです。

    ポリオワクチン．．．ポリオウイルスによる急性灰白髄炎（小児まひ）の予防。乳児。
麻疹ワクチン．．．麻疹ウイルスによる麻疹（はしか）の予防。乳幼児。
風疹ワクチン．．．風疹ウイルスによる風疹（３日ばしか）の予防。乳幼児、（小学、中学）。
日本脳炎ワクチン．．．日本脳炎ウイルスによる日本脳炎の予防。幼児。
ＢＣＧワクチン．．．結核菌による結核症を予防。幼児、小学、中学。
３種混合ワクチン．．．百日咳菌（防御抗原）、ジフテリア菌（トキソイド）、破傷風菌（トキソイド）。乳幼児。
おたふくワクチン．．．おたふくウイルスによるおたふくかぜ（流行性耳下腺炎）の予防。乳幼児（任意。副反応、副作用やや多い）。
水痘ワクチン．．．水痘ウイルスによる水痘（水ぼうそう）の予防。（任意～ハイリスクの人）。
インフルエンザワクチン．．．インフルエンザウイルスによるインフルエンザの予防。（任意～ハイリスクの人）。
Ａ型肝炎ワクチン．．．Ａ型肝炎ウイルスによる肝炎の予防。（任意～ハイリスクの人、流行地域への渡航者等）。
Ｂ型肝炎ワクチン．．．Ｂ型肝炎ウイルスによる肝炎の予防。（母子感染の防止、任意～ハイリスクの人。） コレラワクチン．．．コレラ菌によるコレラ（腸内感染）の予防。（流行地域への渡航者等）。


各 薬 品
　
【抗ヘルペスウイルス剤】

    
アシクロビル
区分　 ： 感染症治療剤／抗ウイルス剤／抗ヘルペスウイルス剤／アシクロビル
製品例： ゾビラックス錠200~400、ゾビラックス顆粒40%（住友/グラクソ）
アシクロビル（外皮用）
区分　 ： 感染症治療剤／抗ウイルス剤／抗ヘルペスウイルス剤／アシクロビル（外皮用）
製品例： ゾビラックス軟膏5%（住友/グラクソ）
アシクロビル（眼軟膏）
区分　 ： 感染症治療剤／抗ウイルス剤／抗ヘルペスウイルス剤／アシクロビル（眼軟膏）
製品例： ゾビラックス眼軟膏（住友/グラクソ）
ビダラビン
区分　 ： 感染症治療剤／抗ウイルス剤／抗ヘルペスウイルス剤／ビダラビン
製品例： アラセナ－Ａ軟膏（持田/ＳＢＳ） 


　
【抗インフルエンザウイルス剤】

    
塩酸アマンタジン
区分　 ： 感染症治療剤／抗ウイルス剤／抗インフルエンザウイルス剤／塩酸アマンタジン
製品例： シンメトレル錠50mg~100mg、シンメトレル細粒（ノバルティス） 


　
【免疫賦活・抗ウイルス剤】

    
イノシンプラノベクス
区分　 ： 感染症治療剤／抗ウイルス剤／免疫賦活・抗ウイルス剤／イノシンプラノベクス
製品例： イソプリノシン錠（持田） 


　
【抗HIV剤】

    
アジドチミジン
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／逆転写酵素阻害剤／アジドチミジン（ジドブジン）(AZT)
製品例： レトロビルカプセル（グラクソ）
サニルブジン
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／逆転写酵素阻害剤／サニルブジン
製品例： ゼリットカプセル15（BMS/吉富）
ザルシタビン
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／逆転写酵素阻害剤／ザルシタビン
製品例： ハイビッド錠0.375（ロシュ）
ジダノシン
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／逆転写酵素阻害剤／ジダノシン
製品例： ヴァイデックス錠25~50~100、ヴァイデックスドライシロップ167~250（ＢＭＳ）
ラミブジン
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／逆転写酵素阻害剤／ラミブジン
製品例： エピビル錠（グラクソ）
メシル酸サキナビル
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／プロテアーゼ阻害剤／メシル酸サキナビル
製品例： インビラーゼカプセル（日本ロシュ）
メシル酸ネルフィナビル
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／プロテアーゼ阻害剤／メシル酸ネルフィナビル
製品例： ビラセプト錠（JT/日本ロシュ）
リトナビル
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／プロテアーゼ阻害剤／リトナビル
製品例： ノービア・カプセル100mg、ノービア・リキッド（ダイナボット/大日本）
硫酸インジナビル
区分　 ： 感染症治療剤／抗ウイルス剤／抗HIV剤／プロテアーゼ阻害剤／硫酸インジナビル
製品例： クリキシバンカプセル（萬有） 

おくすり１１０番



●インターフェロン(IFN)


元々、インターフェロンは1986年に、白血病を治療するために認可を受け、遺伝子工学的に生産された。これは天然物質として生体内に微量見い出された蛋白質の複製である。
それは1991年2月25日にFDA食品医薬品局よりC型肝炎への使用が認められた。
アルファインターフェロン製剤は、およそ 毎年15万人のアメリカ人に影響を及ぼすこの種類の肝炎に対する最初の効果的な治療法である。

C型肝炎治療にインターフェロンを投与するのを目的とした、薬品会社（シェーリング・プラウ社）の文献によると：週3回300万単位のインターフェロン投与は、約25％の治療効果がある。

harily 細胞型の白血病とC型肝炎の他に、αインターフェロンはカポジー肉腫や生殖器腫瘍に関連したAIDSの治療としても認可されている。シェーリングプラウ社は、商標名イントロン-Aとして製品を市場に出していて、肝炎治療の製品としての認可を受けた。

インターフェロンは、C型肝炎に認可されてきた。患者は症状のあるなしよりも、持続的な肝機能異常（血液検査）を基に治療される。軽度のC型肝炎患者に何をすべきかというのは、よく知られてはおらず、軽度でも一部は悪化して肝硬変になる可能性があるので、インターフェロンでの治療が通常勧められる。そのような患者は肝疾患に詳しい専門家（胃腸科医／肝臓専門医）に診てもらうことを勧める。-『ウイルス性肝炎の予防、診断、マネージメント』、AMAより引用

インターフェロンでの治療を受けた約半数の患者が、血液検査と肝生検において良好な反応を示す。再発した半数の患者は一度インターフェロン投与を中止される。-『ウイルス性肝炎の予防、診断、マネージメント』、AMAより引用

αインターフェロンは、感染直後に投与されると効き目がかなりあるようだ。しかしC型肝炎の多くのケースにおいて、治療を止めると症状は再び悪化する。ある研究では、αインターフェロンで反応があった半数の C型肝炎患者は、治療停止後6ヵ月内に再発がみられた。このように25％のHCV患者のみが、再発なしに順調な反応を示している。

週3回、6ヵ月間の投与は高額なものである（週に75ドルかかる）。多くの患者に風邪様症状や、白血球数の減少、血小板数の減少のような副作用があらわれる。

インターフェロンの反応性に最も関連している因子は：

肝生検で線維化や肝硬変がない
C型肝炎ウイルスの遺伝子型が1bでない
ウイルス量が少ないこと（PCR-RNAでたとえば200万個/ml以下）
感染してから期間が短い（感染がいつなのかはほとんど判らない！）
では、インターフェロンに反応も、逆に再発もしない患者はどうか？医師や科学者は重複治療への研究を始めている。抗ウイルス薬などの他の薬剤とインターフェロンを組み合わせることで、臨床治験では確かな結果が示された。この研究についての情報は、こちらをクリックしてください。

BまたはC型肝炎患者は、腹部に水がたまったり（腹水）、拡張した食道の静脈（食道静脈瘤）から出血したり、または精神錯乱（脳症）を示したり、それらの人々は臨床治験でのみ治療されるべきである（訳者注：インターフェロンの適応でないということ）。インターフェロン治療の適応でない他の人々には、重篤な心・肺・腎疾患患者、ヒト免疫不全ウイルス(HIV)感染者、又は副腎皮質ホルモン服用中の臓器移植患者、シクロスポリンやFK-506（などの免疫抑制薬、抗癌剤）、抗うつ薬の服用患者や自殺未遂経験者などの人々である。インターフェロンは、妊娠する可能性のある女性にも、父親となる予定の人にも投与すべきではない。薬物乱用の患者（アルコールや非合法麻薬）に対しては、この治療は行うべきではない。-『B,C型肝炎に対するインターフェロン治療の現状』アメリカ肝臓基金より引用

日本でのインターフェロン使用の通達
--------------------------------------------------------------------------------
1994 "Drug Information for the health care professional"からの引用 (異なるタイプの インターフェロン）
*αインターフェロン:
Alferon N----interferon alfa-n3 Intron A-----interferon alfa-2b Roferon-A----interferon alfa-2a Wellferon----interferon alfa-n
*source:
Roferon-A.....遺伝子組み替え型大腸菌によって合成される。これは２３の位置にリジンを持っており、唯一のαインターフェロンサブタイプを含んでいる。
Intron-A....遺伝子組み替え型大腸菌によって合成される。これは２３の位置にアルギニングループを持っており、唯一のαインターフェロンサブタイプを含んでいる。
Alferon....１4の天然型ヒトαインターフェロンサブタイプに高度に純化された混合物。プールされた人の白血球からつくられ、interferon alfa-n3をつく る。鳥のウイルスによる不完全感染によって誘導される。
Wellferon...天然のヒトαインターフェロンの高度に純化された混合物。これは人の幼若化リンパ球から得られ、センダイウイルスで誘導される。

これはアミジェン（カゼインの酵素分解産物）溶液のインターフェロンと一致するものは含まれていないので、この両者は遺伝子内にインターフェロンの遺伝子を持った細菌からできている。細菌を大量に培養して、インターフェロンを抽出する。他の2種類は細菌の刺激によってインターフェロンを産生するように誘導されたヒト細胞培養で育てられたものである。その後インターフェロンが抽出される。
--------------------------------------------------------------------------------
原文を読む
--------------------------------------------------------------------------------
1997.8.30更新、10.8更新、1998.4.29更新



■Project Inform Antiviral Treatment Information ( HIV / AIDS Treatment Information )

Project Inform
Antiviral Treatment Information
Below are the materials related to antiviral treatments. Be aware that each of the treatments have differing degrees of effectiveness. Some antivirals are approved by the FDA while others are undergoing clinical trials; some may be available through buyer's clubs and others may be supported by limited scientific evidence. When starting a new medication, always be aware of possible side effects and potential drug interactions.
Materials which are listed but are not available online can be obtained by contacting the Project Inform Hotline. The Hotline will address any questions you may have.
Antivirals Treatments
Main Antiviral Fact Sheet●ファクトシート
Antiviral Strategies

FDA Approved Treatments●医薬品データ
3TC
Abacavir / GW1592 Fact Sheet also Available in PDF Format
Acyclovir
Amprenavir
AZT
d4T
ddc
ddI
Delavirdine Fact Shee
Indinavir
Nelfinavir Fact Sheet also Available in PDF Format
Nevirapine - Available in PDF Format
New Antiviral Therapies - 4/99※
Protease Inhibitors※
Ritonavir (Norvir(R))
Saquinavir (Fortovase(R), Invirase(R))

●Discussions of treatments in clinical trials
Adefovir (Preveon(R))
Hydroxyurea
Gene Therapy
Efavirenz / DMP266/ Sustiva)

New Antiviral Therapies - 4/99
Protease Inhibitors
Vaccines
Treatments with limited research backing
Alternative / Holistic

●Related articles　関連記事
Adherence to HAART (Maintaining)
Diagnostic TestsDrug Dosing Chart (in Antiviral
Strategies Fact Sheet) - also in PDF Forma
Drug Interactions
Drug Side Effects
Drug Resistant HIV
Federal Guidelines (non PI Links)
Guidelines for the Use of Antiretroviral Agents in HIV Infected Adults and Adolescents 
Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
Lipodystrophy (Protease Inhibitor side effect)
Pulsed Therapy Quick Sheet
Second & Third Line Therapy Options Quick Sheet
Understanding Antiviral Resistance
=======================================================

■Project Inform's New Antiviral Therapies Quick Sheet [ HIV / AIDS Treatement Information ]

Information, Inspiration and Advocacy for People  Living with HIV/AIDS
New Antiviral Therapies
Quick Sheet
Date: 4/99 reprinted from PI Perspective 27, April 1999

●Table of Contents
New Antiviral Therapies 
Abbott Laboratories Study of ABT-387
T-20: A New Therapy for the Third Line
●New Antiviral Therapies
reprinted from PI Perspective #27, April 1999
The widespread availability of the next generation of new anti-HIV therapies is still at least a year or more off. However, most of them are currently in, or will soon be in, small studies. A few are already moving into large-scale studies.


●Abbott Laboratories Study of ABT-378
One new drug under study is Abbott Laboratories' new protease inhibitor (PI), ABT-378.
Preliminary results show ABT-378 is very potent and well tolerated, at least as first line therapy. In the main study reported so far, 101 people who had never received prior anti-HIV therapies participated. They were given a combination of ABT-378 and a small amount of ritonavir (Norvir(R)). ABT-378 will always be combined with some dose of ritonavir because ritonavir helps keep high amounts of ABT-378 active in the body for longer periods.
Volunteers began the study with an average viral load of about 70,000 copies HIV RNA and an average CD4+ cell count of about 350. Three different doses of ABT-378/ritonavir (Norvir(R)) were used (200/100mg, 400/100mg and 400/200mg), all of which were taken twice a day in combination with d4T (stavudine, Zerit(R)) + 3TC (lamivudine, Epivir(R)).

After 24 weeks, the drug combination suppressed viral load to less than 400 HIV RNA copies in about 85% of the participants. The ultrasensitive viral load test was performed in a smaller group of participants; and among that group, 89% had less than 50 copies HIV RNA. No one has dropped out of the study because of side effects. Most side effects noted to date have been mild to moderate in severity, with abnormal stools (less than three loose stools per day) and diarrhea (more than three loose stools per day) being the most commonly reported.

Abbott had high hopes for ABT-378, thinking it would be effective for people who have experienced renewed viral activity or breakthroughs despite using numerous protease inhibitors. More recently, they have become more realistic about how this drug will fare in the multi-protease resistant population. However, Abbott is starting new studies, including some for people who developed resistance to a single protease inhibitor.

Planned studies will test the drug in people who are resistant to several available protease inhibitors but who have not yet taken a non-nucleoside reverse transcriptase inhibitor. A committee of activists is working with Abbott to propose other study designs for third line use. Together, these studies will help determine where and how to best use the ABT-378/ritonavir combination. For now, it looks like the best-proven use will be as first line therapy.


●T-20: A New Therapy for the Third Line
The only new therapy on the immediate horizon that has a new mechanism of slowing HIV replication is called T-20 (pentafuside), the first of a class of drugs known as fusion inhibitors. T-20 inhibits HIV by blocking the virus from fusing with an immune cell.

The drug was studied in a group of 78 people with an average viral load of 100,000 copies HIV RNA and an average CD4+ cell count of 100. Most importantly, study participants had previously used an average of nine different drugs. Most had used three or more currently available protease inhibitors and many had already used up all three classes of anti-HIV drugs. This was truly a difficult population in which to test a new drug—a true examination of third line therapy.

People received one of six different doses of T-20. Participants had been either off all anti-HIV medications for at least two weeks before starting T-20 or they could add T-20 to their existing regimen. Consequently, many people used T-20 as single drug therapy, something that would rarely if ever be done in people with such advanced disease. In this short-term study, those receiving the highest two doses, 50mg and 100mg twice daily by subcutaneous (subQ, under the skin) injections (total daily doses of 100mg and 200mg respectively) had the best anti-HIV responses. At the end of the 28-day study, people receiving the 50mg subQ twice daily dose had a viral load reduction of 0.6 logs (four-fold change) in HIV RNA while the 100mg subQ twice daily dose group had a 0.7 logs reduction (five-fold change). However, all but the people who received the very lowest dose still achieved some degree of anti-HIV activity.

While on the surface these results may not seem impressive, the majority of study participants had failed all available therapies and were taking T-20 alone. In this context, it is somewhat remarkable that the drug worked at all, since almost any other known therapy would likely have failed altogether. Further, these results showed that people who entered the study with lower HIV levels (below 100,000 copies HIV RNA) had better anti-HIV responses [0.8 and 1.4 log reductions in HIV RNA levels (6 and 25 fold) on the 50mg and 100mg subQ dose respectively]. People with pre-study HIV levels of over 100,000 copies HIV RNA had a 0.3 and 0.4 log reduction in HIV RNA levels (2 and 2.5 fold reduction) on the 50mg subQ dose and 100mg subQ dose respectively.

Most importantly, the drug appears to be active even in people who had developed resistance to all other currently available therapies. This is exactly the kind of response needed if we are to find a successful third line treatment. The results also suggest that, although T-20 is active against HIV in people who have developed resistance to the currently available drugs, it should be used in combination with other drugs, preferably ones that are new to the individual. As additional new drugs become available, it is likely that the potency of regimens containing T-20 may improve.

A significant drawback to T-20 is that the drug will never exist in pill form. Today, it requires simple, twice daily injections, similar to those that diabetics take. Some people may find this troublesome, but others, such as those who are tired of taking large handfuls of pills every day, may welcome the change in administration methods. Other means of administration are being explored.
At least two other fusion inhibitor drugs are under development. The manufacturer of T-20 is developing a second fusion inhibitor, reported to be many times more potent than T-20.



■ウイルス肝炎 (Kitasato Univ. Electronic Textbook:内科診断検査アクセス)




■■Handbook of Ocular Disease Management - Viral Conjunctivitis

Viral Conjunctivitis
(Pharyngoconjunctival Fever & Epidemic Keratoconjunctivitis)
A Pseudomembrane in EKC
Severe Follicular Reaction

SIGNS AND SYMPTOMS
Most viral infections produce a mild, self-limiting conjunctivitis, but some have the potential to produce severe, disabling visual difficulties. The two most common self-limiting forms of viral conjunctivitis are epidemic keratoconjunctivitis and pharyngoconjunctival fever.
Pharyngoconjunc-tival fever (PCF) is characterized by fever, sore throat and follicular conjunctivitis. It may be unilateral or bilateral. It is caused regularly by adenovirus 3 and occasionally 4 or 7. Corneal infiltrates are rare. The disorder varies in severity but usually persists for four days to two weeks. While the virus is shed from the conjunctiva within 14 days, it remains in fecal matter for 30 days.
Epidemic Keratoconjunctivitis (EKC) often presents as a bilateral, inferior, palpebral, follicular conjunctivitis, with epithelial and stromal keratitis. Subepithelial corneal infiltrates are much more common in EKC than in PCF and are typically concentrated in the central cornea. EKC is regularly caused by adenovirus types 8 and 19.
The key clinical signs of both conditions include: conjunctival injection, tearing, serous discharge, edematous eyelids, pinpoint subconjunctival hemorrhages, pseudomembrane formation and palpable preauricular lymph nodes. In severe cases, conjunctival desiccation causes scarring and symblepharon formation (adherence of the bulbar and palpebral conjunctivas).
Both conditions are highly contagious. Patients will usually report recent contact with someone who had either red eyes or an upper respiratory infection. Both forms tend to start in one eye, then spread to the other eye within a few days. In rare cases, the focal subconjunctival hemorrhages can evolve into acute hemorrhagic conjunctivitis.

PATHOPHYSIOLOGY
Viral conjunctival infections are thought to be caused by airborne respiratory droplets or direct transfer from one's fingers to the conjunctival surface of the eyelids. After an incubation period of five to 12 days, the disease enters the acute phase, causing watery discharge, conjunctival hyperemia and follicle formation. Lymphoid follicles are elevated, with avascular lesions ranging from 0.2 to 2mm in size. They have lymphoid germinal centers that have responded to an infectious agent.
Adenovirus type 8 can proliferate in the corneal epithelial tissues, producing the characteristic keratitis and subepithelial infiltrates. This, along with the immune response to viral antigens, causes lymphocytes to collect in the shallow anterior stroma, just beneath the epithelium. Sometimes, a conjunctival membrane will form. These are made up of fibrin and leukocytes, and in prolonged cases, of fibroblast and collagen deposits. “Pseudomembranes” are much easier to remove than “true” membranes.

MANAGEMENT
Because EKC and PCF are contagious and self-limiting, the primary treatment once again is patient education. Instruct patients to stay home from work or school until there is absolutely no discharge. Also instruct them not to share utensils, glasses, linens or wash cloths with others.
Medical management can range from cold compresses and artificial tears to topical vasoconstrictors (e.g., naphazoline) and steroids (Vexol, Flarex, Pred Forte) two to four times daily. If a membrane is present, peel it off with a wet, cotton-tipped applicator or forceps. After removal, prescribe a topical antibiotic-steroid combination such as Tobradex or Maxitrol q.i.d. Anti-viral drugs such as Viroptic are ineffective against adenovirus.
Recently, there has been a breakthrough in the management of adenoviral keratoconjunctivitis. Cidofovir (Vistide), an anti-viral drug used intravenously to treat cytomegalovirus retinitis, appears to be effective in adenoviral keratoconjunctivitis. The topical form creates a faulty viral DNA structure. Twice daily instillation is recommended. This topical anti-viral is also possibly effective against herpes simplex and zoster, and Epstein-Barr virus.

CLINICAL PEARLS
Keep your equipment, instruments and chair area meticulously clean to avoid contaminating your patients and staff.
Most practitioners reserve topical steroidal therapy for severe cases (if the infection is on the visual axis and affecting acuity, for example), or recalcitrant cases. EKC infiltrates resolve without scarring the cornea.
Tell patients to expect the symptoms to get worse for about seven to 10 days before getting better, and that the infection won't completely go away for three to six weeks. Remember to always taper steroids slowly as the condition recedes.
Other reports in this section
Allergic Conjunctivitis &Vernal Keratoconjunctivitis
Viral Conjunctivitis
Bacterial Conjunctivitis
Chlamydial & Gonococcal Conjunctivitis
Conjunctival Laceration
Episcleritis
Scleritis
Pingueculitis
Pterygium
Superior Limbic Keratoconjunctivitis (SLK of Theodore)
Toxic Conjunctivitis
Conjunctivitis with Pseudomembrane
Giant Papillary Conjunctivitis
Eyelids & Eyelashes | Conjunctiva & Sclera | Cornea
Uvea | Vitreous & Retina | Optic Nerve & Brain | Oculosystemic Disease
Handbook Main Page






●データ


●市場調査レポート

Antivirals - Technologies, Trends, and Market Opportunities[2001.9]

Strategic Perspectives 2001: The Antiviral Market - A Market For Expanding Indications[2001.7]
 - http://www.the-infoshop.com/study/dc8144_antiviral.html


●市場レビユー
Antiviral market overview[2002.1]
 - http://www.nature.com/cgi-taf/DynaPage.taf?file=/nrd/journal/v1/n1/full/nrd709_r.html
 Nature Reviews Drug Discovery 1, 11-12 (2002) 
[pdf]


●専門サイト
http://www.herpes.org/
New Zealand Herpes Foundation

●製品サイト
Famvir
http://www.genitalherpes.com
DenavirR - Treatment for cold sores
http://www.denavir.com

●解説
口唇ヘルペスってどんな病気？
 - http://www.glaxosmithkline.co.jp/herpes/


医薬・医療・診断分野の新リポート

医薬・医療・診断分野の既刊リポート[★フロスト＆サリバン] 
World Infectious Disease Vaccine Markets
ワクチン市場（世界）
Ｂ型肝炎ワクチン，Ｃ型肝炎ワクチン，ＨＳＶ（単純ヘルペスウイルス）ワクチン，ＨＰＶ（ヒトパピローマウイルス）ワクチン，その他ＳＴＤ（性感染症）ワクチン，インフルエンザワクチン（米，欧，日）
ﾘﾎﾟｰﾄ番号：5722， 199ﾍﾟｰｼﾞ， 1999年2月， $3,450 + S/H
U.S. Clinical Laboratory Markets: End-User Study
クリニカルラボ市場（米）：エンドユーザーサーベイ
臨床化学アナライザーと検査，血液学アナライザーと検査，イムノアッセーアナライザーと検査，アナリストの見解と意見
ﾘﾎﾟｰﾄ番号：5403， 179ﾍﾟｰｼﾞ， 1999年2月， $4,450 + S/H



■PhRMA: New Medicines in Development for Infectious Diseases, 2000

 --- Oct 2000; 16p ; Antivirals 22

Product Name	 Company	 Indication	 Development Status

adefovir dipivoxil	 Gilead Sciences	 hepatitis B	 Phase III
Alferon N Inj.	Interferon Sciences 	chronic hepatitis C infections 	Phase III
(interferon alfa-n3 (human leukocyte derived)	hepatitis C and HIV co-infection	Phase II
Ampligen HemispheRx 	Biopharma 	chronic fatigue immune dysfunction syndrome	Phase III
Coviracil(R) 	Triangle Pharmaceuticals 	hepatitis B 	Phase III
entecavir(BMS 200475)	 Bristol-Myers Squibb	 hepatitis B	 Phase II
★carbocyclic 2'-deoxyguanosine nucleoside
Epivir(R)-HBV(TM)	BioChem Pharma Laval	 chronic hepatitis B	 application submitted
(lamivudine)		/Glaxo Wellcome
Famvir(R) 	SmithKline Beecham	 suppression of genital herpes	 Phase III
(famciclovir) 		hepatitis B
GV118819	 Glaxo Wellcome	 community-acquired bacterial infections	 Phase II
(oral trinem)
Heptazyme(TM)	Ribozyme 	hepatitis C 	Phase I completed
Intron A(R)	 Enzon	 hepatitis C (PEG-Intron A(R) )	 Application submitted
(interferon alfa-2b) -----------------------------------------------------
(recombinant) 	/Schering-Plough	 hepatitis C (PEG-Intron A(R) /	 Phase III
					Rebetrol(Tm)combination)
ISIS 14803 	Isis Pharmaceuticals 	hepatitis C 	Phase II
L-dT       	Novirio Pharmaceuticals 	hepatitis B 	Phase II
Maxamine(R) 	Maxim Pharmaceuticals 	hepatitis C 	Phase II
(histamine dihydrochloride)
MEDI-493	 MedImmune	 treatment of RSV disease in adult	 Phase III
				 bone marrow transplant patients
pleconaril 	Sanofi Synthelabo	 viral meningitis	 Phase III
(SR 63843) 	/ViroPharma		viral respiratory infection
RWJ 270201 	R.W. Johnson 	treatment and prevention of 	Phase III
(neuraminidase inhibitor) 	influenza A and B
Tamiflu	 Gilead Sciences	prevention of influenza	 申請済み
(oseltamivir)		type A and B	neviraminidase inhibitor
(GS4104/RO64-0796)	/ Hoffmann-La Roche
valganciclovir	 Hoffmann-La Roche	 treatment and prevention of CMV retinitis	 Phase III
Valtrex(R) 	Glaxo Wellcome	 CMV suppression/prevention	 Phase III
(valacyclovir)
Veldona(R) 	Amarillo Biosciences 	treatment of human papillomavirus- Phase II
(interferon-alpha lozenges)	 induced oral warts related to HIV infection
VX-497 	Vertex Pharmaceuticals 	hepatitis C 	Phase II
Zorex(TM)	Meditech Pharmaceuticals 	herpes viroplex 	Phase II completed


●1998年版収録===============================================================
ABT-606 	Abbott Laboratories	 herpes zoster	 Phase II
　註)http://www.informagen.com/Resource_Informagen/Full/2368.html;(97/11) preclinical data on ABT 606 (antiviral compound licensed from Medivir - M114) showed greater protection significance vs aciclovir or control re: HSV-1 infection. ;http://www.medivir.se/projects.htm ;CF.MIV-606
FTC	 Triangle Pharmaceuticals	 hepatitis B	 Phase I★=BW524W91
lobucavir	 Bristol-Myers Squibb	 hepatitis B	 Phase III★A-69992; Cyclobut-G ; C-Oxt-G; (+-)Cyclobut-G; C-Oxetanocin-G 
					herpes simplex (recurrent and suppressive)
					herpes zoster
					-----------------------------------------
					cytomegalovirus (CMV) prevention in HIV	 Phase II
					and transplantation
penciclovir 	SmithKline Beecham	 herpes infections	 application submitted
(IV and topical)
Rebetron(TM)	Schering-Plough	 hepatitis C (naive patients-not previously	 application submitted
(Intron(R) A and 			 treated with interferon)
Rebetrol(TM) combination therapy)
Wellferon 	Glaxo Wellcome	 hepatitis C	 Phase III
(alpha interferon)
GR121167	 Glaxo Wellcome	 influenza	 Phase III
(neuraminidase inhibitor)
AccuSite(TM)	Matrix Pharmaceutical	 genital warts	 application submitted
(fluorouracil/epinephrine injectable gel)
Ampligen	 HemispheRx Biopharma	 chronic fatigue immune dysfunction syndrome	 Phase III
HNK20	 OraVax	 respiratory syncytial virus (RSV)	 Phase III
Lidakol(R)	 LIDAK Pharmaceuticals	 herpes labialis	 application submitted
(n-docosanol)
Malarone	 Glaxo Wellcome	 malaria treatment and prophylaxis	 Phase III
Mepron 		Glaxo Wellcome 	Pneumocystis carinii pneumonia (PCP)	 Phase III
(atovaquone) 			 prophylaxis
Ostavir(TM)	Protein Design Labs	 chronic hepatitis B treatment	 Phase II
(human anti-hepatitis B antibody (OST-577))
PEN203 		Pentose Pharmaceuticals 	human papillomavirus infections	 Phase I/II
Vitravene(TM)	Isis Pharmaceuticals	 CMV retinitis in AIDS patients	 application submitted
(fomivirsen)

●Viral Infections
・ More than 95 percent of Americans gets chickenpox (caused by varicella-zoster virus) by adulthood. About 4
million cases occur in the United States each year, resulting in some 5,000-9,000 hospitalizations and 100 deaths.3
・ In the United States, as many as 95 percent of adults between ages 35-40 have been infected with Epstein-Barr
virus. When infection occurs during adolescence or young adulthood, it causes infectious mononucleosis 35-50 percent of the time.3
・ An estimated 77,000 cases of sexually transmitted hepatitis B infection occur annually in the United States and about 750,000 people are living with it.1
・ Between 5 percent and 10 percent of the estimated 320,000 new hepatitis B virus (HBV) infections in the United States each year become chronic infections. Annually, chronic HBV infection kills as many as 6,000 people.1
� Of the nearly 4 million Americans who have been infected with the hepatitis C virus (HCV), 85 percent will remain chronically infected. HCV is a major cause of chronic liver disease and is responsible for a third of all U.S. cases of cirrhosis and liver cancer, half of all liver transplants, and 8,000 to 10,000 deaths a year.1
� About one in five people in the United States over age 12 approximately 45 million people are infected with herpes simplex virus-2 (HSV-2), the virus that causes genital herpes. Up to 1 million new HSV-2 infections may be transmitted each year.1
� An estimated 20 million people in the United States are infected with human papillomavirus (HPV), and as many as 5.5 million new infections occur each year. Genital warts, caused by HPV, infect an estimated 1 million Americans each year. Cervical infection with oncogenic types of HPV is associated with more than 80 percent of cases of invasive cervical cancer, which killed nearly 5,000 American women in 1998.1
� Each year, 35-50 million Americans contract influenza, and more than 20,000 people die. The rate in children is two to 10 times that in adults, but more than 90 percent of influenza-associated deaths occur in people age 65 and older. During an outbreak of flu, 20-50 percent of a population may be affected.1
� By age 3, more than 80 percent of children have had at least one episode of otitis media (ear infection), and nearly half have had three or more episodes.1
� Pneumonias account for about 15 percent of all hospital-associated (nosocomial) infections and are the second most common type of nosocomial infection after those of the urinary tract.3
� During their first respiratory syncytial virus (RSV) infection, between 25 percent to 40 percent of infants and children have signs or symptoms of bronchiolitis or pneumonia, and 0.5 percent to 2 percent require hospitalization.
The majority of children hospitalized are under 6 months of age.3
� Rotavirus, the most common cause of severe diarrhea among children, results in the hospitalization of approximately 55,000 children each year in the United States and the deaths of more than 600,000 children annually worldwide. Most U.S. children are infected by age 2, and about 1 in 40 children with rotavirus gastroenteritis will require hospitalization for intravenous fluids.3
� Approximately 90 percent of viral meningitis cases are due to a group of common intestinal viruses called enteroviruses. Most people are exposed to these viruses at some time in their lives, but fewer than 1 in 1,000 people infected actually develops meningitis.4



●WHO Hepatitis Information

   ●Hepatitis information and documents
Hepatitis C Fact Sheet
Global surveillance and control of hepatitis C". ; Journal of Viral Hepatitis, Vol. 6, 1999
Hepatitis C: global prevalence".  Weekly Epidemiological Record,Vol. 72, 46, 1997
"Hepatitis C":  Weekly Epidemiological Record, Vol.72, 10, 1997
Hepatitis B Fact Sheet
   ●WHO Press releases
No scientific justification to suspend hepatitis B immunization  WHO Press Release, 2 October 1998
Hepatitis C: 170 million affected worldwide and still no vaccine  WHO Press Release, 1 May 1998



■患者数

[日本]●平成１１年患者調査の概況

●平成11年 閲覧第９７表　総患者数，傷病基本分類別～全１３９表
　(単位：千人)
[1] 　Ａ60　　肛門性器ヘルペスウイルス[単純ヘルペス]感染症
  1 　　Ａ60.0　　性器及び尿路性器のヘルペスウイルス感染症
    　　Ａ60.1　　肛門周囲皮膚及び直腸のヘルペスウイルス感染症
    　　Ａ60.9　　肛門性器ヘルペスウイルス感染症,詳細不明
[2] 　Ａ63　　主として性的伝播様式をとるその他の感染症,他に分類されないもの
  2 　　Ａ63.0　　肛門性器(性病性)いぼ<疣><疣贅>
    　　Ａ63.8　　主として性的伝播様式をとるその他の明示された感染症

[19]　Ｂ00　　ヘルペスウイルス[単純ヘルペス]感染症
    　　Ｂ00.0　　疱疹性湿疹
  9 　　Ｂ00.1　　ヘルペスウイルス(性)小水疱性皮膚炎
  1 　　Ｂ00.2　　ヘルペスウイルス(性)歯肉口内炎及び咽頭扁桃炎
    　　Ｂ00.3+ 　ヘルペスウイルス(性)髄膜炎(Ｇ02.0*)
    　　Ｂ00.4+ 　ヘルペスウイルス(性)脳炎(Ｇ05.1*)
  7 　　Ｂ00.5+ 　ヘルペスウイルス(性)眼疾患
    　　Ｂ00.7　　播種性ヘルペスウイルス疾患
    　　Ｂ00.8　　その他の型のヘルペスウイルス感染症
  2 　　Ｂ00.9　　ヘルペスウイルス感染症,詳細不明

[34]　Ｂ02　　帯状疱疹[帯状ヘルペス]
    　　Ｂ02.0+ 　帯状疱疹(性)脳炎(Ｇ05.1*)
    　　Ｂ02.1+ 　帯状疱疹(性)髄膜炎(Ｇ02.0*)
  7 　　Ｂ02.2+ 　帯状疱疹,その他の神経系合併症を伴うもの
    　　Ｂ02.3+ 　帯状疱疹(性)眼疾患
    　　Ｂ02.7　　播種性帯状疱疹
    　　Ｂ02.8　　帯状疱疹,その他の合併症を伴うもの
 27 　　Ｂ02.9　　帯状疱疹,合併症を伴わないもの
    　
109 　Ｂ07　　ウイルス(性)いぼ<疣><疣贅>
[13]　Ｂ08　　皮膚及び粘膜病変を特徴とするその他のウイルス感染症,他に分類されないもの
    　　Ｂ08.0　　その他のオルソポックスウイルス感染症
  9 　　Ｂ08.1　　伝染性軟属腫
  2 　　Ｂ08.2　　突発性発疹[第６病]
  0 　　Ｂ08.3　　伝染性紅斑[第５病]
  1 　　Ｂ08.4　　発疹を伴うエンテロウイルス性水疱性口内炎
  1 　　Ｂ08.5　　エンテロウイルス性水疱性咽頭炎
    　　Ｂ08.8　　皮膚及び粘膜病変を特徴とするその他の明示されたウイルス感染症
    　Ｂ09　　詳細不明の皮膚及び粘膜病変を特徴とするウイルス感染症

    　ウイルス肝炎(Ｂ15－Ｂ19)
[1] 　Ｂ15　　急性Ａ型肝炎
    　　Ｂ15.0　　急性Ａ型肝炎,肝性昏睡を伴うもの
  1 　　Ｂ15.9　　急性Ａ型肝炎,肝性昏睡を伴わないもの
[18]　Ｂ16　　急性Ｂ型肝炎
    　　Ｂ16.0　　急性Ｂ型肝炎,デルタ因子(重複感染)及び肝性昏睡を伴うもの
    　　Ｂ16.1　　急性Ｂ型肝炎,デルタ因子(重複感染)を伴い,肝性昏睡を伴わないもの
    　　Ｂ16.2　　急性Ｂ型肝炎,デルタ因子を伴わず,肝性昏睡を伴うもの
 18 　　Ｂ16.9　　急性Ｂ型肝炎,デルタ因子及び肝性昏睡を伴わないもの
[49]　Ｂ17　　その他の急性ウイルス肝炎
    　　Ｂ17.0　　Ｂ型肝炎キャリア<病原体保有者>の急性デルタ(重)感染症
 49 　　Ｂ17.1　　急性Ｃ型肝炎
    　　Ｂ17.2　　急性Ｅ型肝炎
    　　Ｂ17.8　　その他の明示された急性ウイルス肝炎
[309] Ｂ18　　慢性ウイルス肝炎
  2 　　Ｂ18.0　　慢性Ｂ型ウイルス肝炎,デルタ因子(重複感染)を伴うもの
 41 　　Ｂ18.1　　慢性Ｂ型ウイルス肝炎,デルタ因子(重複感染)を伴わないもの
258 　　Ｂ18.2　　慢性Ｃ型ウイルス肝炎
  2 　　Ｂ18.8　　その他の慢性ウイルス肝炎
  6 　　Ｂ18.9　　慢性ウイルス肝炎,詳細不明
[3] 　Ｂ19　　詳細不明のウイルス肝炎
    　　Ｂ19.0　　詳細不明のウイルス肝炎,昏睡を伴うもの
  3 　　Ｂ19.9　　詳細不明のウイルス肝炎,昏睡を伴わないもの

    　ヒト免疫不全ウイルス[ＨＩＶ]病(Ｂ20－Ｂ24)
    　Ｂ20　　感染症及び寄生虫症を起こしたヒト免疫不全ウイルス[ＨＩＶ]病
    　　Ｂ20.0　　マイコバクテリア感染症を起こしたＨＩＶ病
    　　Ｂ20.1　　その他の細菌感染症を起こしたＨＩＶ病
    　　Ｂ20.2　　サイトメガロウイルス病を起こしたＨＩＶ病
    　　Ｂ20.3　　その他のウイルス感染症を起こしたＨＩＶ病
    　　Ｂ20.4　　カンジダ症を起こしたＨＩＶ病
    　　Ｂ20.5　　その他の真菌症を起こしたＨＩＶ病
    　　Ｂ20.6　　カリニ肺炎を起こしたＨＩＶ病
    　　Ｂ20.7　　複合感染症を起こしたＨＩＶ病
    　　Ｂ20.8　　その他の感染症及び寄生虫症を起こしたＨＩＶ病
    　　Ｂ20.9　　詳細不明の感染症又は寄生虫症を起こしたＨＩＶ病
    　Ｂ21　　悪性新生物を起こしたヒト免疫不全ウイルス[ＨＩＶ]病
    　　Ｂ21.0　　カポジ肉腫を起こしたＨＩＶ病
    　　Ｂ21.1　　バーキットリンパ腫を起こしたＨＩＶ病
    　　Ｂ21.2　　その他の型の非ホジキンリンパ腫を起こしたＨＩＶ病
    　　Ｂ21.3　　リンパ組織,造血組織及び関連組織のその他の悪性新生物を起こした
    　　　　　　　ＨＩＶ病
    　　Ｂ21.7　　多発悪性新生物を起こしたＨＩＶ病
    　　Ｂ21.8　　その他の悪性新生物を起こしたＨＩＶ病
    　　Ｂ21.9　　詳細不明の悪性新生物を起こしたＨＩＶ病
    　Ｂ22　　その他の明示された疾患を起こしたヒト免疫不全ウイルス[ＨＩＶ]病
    　　Ｂ22.0　　脳症を起こしたＨＩＶ病
    　　Ｂ22.1　　リンパ性間質性肺臓炎を起こしたＨＩＶ病
    　　Ｂ22.2　　消耗症候群を起こしたＨＩＶ病
    　　Ｂ22.7　　他に分類される多発疾患を起こしたＨＩＶ病
    　Ｂ23　　その他の病態を起こしたヒト免疫不全ウイルス[ＨＩＶ]病
    　　Ｂ23.0　　急性ＨＩＶ感染症候群
    　　Ｂ23.1　　(遷延性)全身性リンパ節症を起こしたＨＩＶ病
    　　Ｂ23.2　　血液学的及び免疫学的異常を起こしたＨＩＶ病,他に分類されないもの
    　　Ｂ23.8　　その他の明示された病態を起こしたＨＩＶ病
  2 　Ｂ24　　詳細不明のヒト免疫不全ウイルス[ＨＩＶ]病
    　その他のウイルス疾患(Ｂ25－Ｂ34)
    　Ｂ25　　サイトメガロウイルス病
    　　Ｂ25.0+ 　サイトメガロウイルス(性)肺臓炎(Ｊ17.1*)
    　　Ｂ25.1+ 　サイトメガロウイルス(性)肝炎(Ｋ77.0*)
    　　Ｂ25.2+ 　サイトメガロウイルス(性)膵炎(Ｋ87.1*)
    　　Ｂ25.8　　その他のサイトメガロウイルス病
    　　Ｂ25.9　　サイトメガロウイルス病,詳細不明
[3] 　Ｂ26　　ムンプス
    　　Ｂ26.0+ 　ムンプス精巣<睾丸>炎(Ｎ51.1*)
    　　Ｂ26.1+ 　ムンプス髄膜炎(Ｇ02.0*)
    　　Ｂ26.2+ 　ムンプス脳炎(Ｇ05.1*)
    　　Ｂ26.3+ 　ムンプス膵炎(Ｋ87.1*)
    　　Ｂ26.8　　ムンプス,その他の合併症を伴うもの
  3 　　Ｂ26.9　　ムンプス,合併症を伴わないもの
[1] 　Ｂ27　　伝染性単核症
    　　Ｂ27.0　　ガンマヘルペスウイルス(性)単核症
    　　Ｂ27.1　　サイトメガロウイルス(性)単核症
    　　Ｂ27.8　　その他の伝染性単核症
  1 　　Ｂ27.9　　伝染性単核症,詳細不明
[5] 　Ｂ30　　ウイルス(性)結膜炎
  5 　　Ｂ30.0+ 　アデノウイルスによる角結膜炎(Ｈ19.2*)
    　　Ｂ30.1+ 　アデノウイルスによる結膜炎(Ｈ13.1*)
    　　Ｂ30.2　　ウイルス(性)咽頭結膜炎
    　　Ｂ30.3+ 　急性流行性出血性結膜炎(エンテロウイルス性)(Ｈ13.1*)
    　　Ｂ30.8+ 　その他のウイルス(性)結膜炎(Ｈ13.1*)
    　　Ｂ30.9　　ウイルス(性)結膜炎,詳細不明
    　Ｂ33　　その他のウイルス疾患,他に分類されないもの
    　　Ｂ33.0　　流行性筋痛(症)
    　　Ｂ33.1　　ロスリバー疾患<病>
    　　Ｂ33.2　　ウイルス性心炎
    　　Ｂ33.3　　レトロウイルス感染症,他に分類されないもの
    　　Ｂ33.8　　その他の明示されたウイルス疾患
[1] 　Ｂ34　　部位不明のウイルス感染症
    　　Ｂ34.0　　アデノウイルス感染症,詳細不明
    　　Ｂ34.1　　エンテロウイルス感染症,詳細不明
    　　Ｂ34.2　　コロナウイルス感染症,詳細不明
    　　Ｂ34.3　　パルボウイルス感染症,詳細不明
    　　Ｂ34.4　　パポーバウイルス感染症,詳細不明
    　　Ｂ34.8　　部位不明のその他のウイルス感染症
  1 　　Ｂ34.9　　ウイルス感染症,詳細不明
　註)Emerging viral Infections関連は除いた






●臨床ガイドラインなど


■Primary Care Clinical Practice Guidelines 1

 1 - ID - Infectious diseases

2002 May 2,9,10,15, Aug 1
UCSF -Department of Medicine


■National Guideline Clearinghouse - Virus Diseases-106guidelines

Related Sub-concepts:
Arbovirus Infections-8guidelines
Central Nervous System Viral Diseases-8guidelines
DNA Virus Infections-27guidelines
Encephalitis, Viral-1guideline
Eye Infections, Viral-1guideline
Fatigue Syndrome, Chronic-1guideline
Hepatitis, Viral, Human-20guidelines
Opportunistic Infections-5guidelines
Pneumonia, Viral-1guideline
RNA Virus Infections-59guidelines
Sexually Transmitted Diseases-49guidelines
Skin Diseases, Viral-9guidelines
Slow Virus Diseases-17guidelines

© 2002 National Guideline Clearinghouse






●総説記事・文献


■NIH Press Release -Antiviral Drug Sharply Reduces Return of Herpes of the Eye-7/29/98


NATIONAL INSTITUTES OF HEALTH |National Eye Institute

EMBARGOED FOR RELEASE
Wednesday, July 29, 1998
6:00 PM Eastern Time

Judith Stein or Michael Coogan
301-496-5248
jas@nei.nih.gov
mjc@.nei.nih.gov

Antiviral Drug Sharply Reduces Return of Herpes of the Eye

Researchers have found that an antiviral drug, often used to suppress genital herpes, also decreases the recurrence of herpes of the eye. A paper detailing these findings is published in the July 30, 1998 issue of The New England Journal of Medicine.

Scientists found that the drug acyclovir, taken by mouth, reduced by 41 percent the probability that any form of herpes of the eye would return in patients who had the infection in the previous year. Importantly, researchers noted a 50 percent reduction in the rate of return of the more severe form of the disease - stromal keratitis - among patients who had this infection during the past year. Stromal keratitis causes scarring of the cornea, which can lead to loss of vision and possibly blindness. Recurring episodes of stromal keratitis can often result in the need for a corneal transplant.

"This drug is the first treatment that helps prevent herpes of the eye from returning," said Dr. Carl Kupfer, director of the National Eye Institute (NEI), part of the Federal government's National Institutes of Health (NIH) and the agency that supported the clinical trial. "The results of this study should change medical practice."

Herpes of the eye, or ocular herpes, is caused by the herpes simplex virus. This infection can produce a painful sore on the eyelid or surface of the eye and cause inflammation of the cornea, the transparent tissue that covers the front of the eye. The less severe forms of ocular herpes include blepharitis, conjunctivitis, and epithelial keratitis. The more severe form of ocular herpes is stromal keratitis, which causes the body's immune system to attack and destroy an inner layer of the cornea. Stromal keratitis is more difficult to treat than less severe ocular herpes infections.

An estimated 400,000 Americans have had some form of ocular herpes. Previous studies show that once people develop ocular herpes, they have up to a 50 percent chance of having a recurrence. This second flare-up could come weeks or even years after the initial occurrence. Each year, nearly 50,000 new and recurring cases are diagnosed in the United States, with the more serious stromal keratitis accounting for about 25 percent.

The clinical trial - called the Acyclovir Prevention Trial (APT) - followed 703 patients who had herpes of the eye during the preceding year, but did not currently have an active case of the disease. Of this number, 357 received acyclovir by mouth, and 346 received a placebo. Researchers discovered that the probability of a recurrence of any form of ocular herpes during the treatment period was significantly lower in the acyclovir group (19 percent) than in the placebo group (32 percent). This represents a reduction by 41 percent between the two groups.

Among the 703 patients, researchers examined 337 patients with a prior history of the more serious stromal keratitis. Acyclovir reduced the rate of recurrences of stromal keratitis from 28 percent to 14 percent, a difference of 50 percent between the two groups. The study medication caused no serious side effects.

"The study clearly shows that acyclovir therapy can benefit people with all forms of ocular herpes," said Dr. Kirk Wilhelmus, professor in the Department of Ophthalmology at the Baylor College of Medicine and chairman of the APT clinical trial. "Ocular herpes can be painful, chronic, and disabling. This new treatment will improve people's quality of life. Those who have had the more serious stromal keratitis will benefit the most."

Dr. Wilhelmus noted that not all patients had the same benefit from taking acyclovir. "Patients should consult with their eye care professionals to see if prolonged use of acyclovir is right for them," he said.

Researchers also found that oral acyclovir reduced the risk of herpes infections in other parts of the body, particularly the mouth and face, by 43 percent. During the 12-month treatment period, 20 percent of patients in the group receiving acyclovir had at least one herpes infection affecting the mouth or face, as compared with 35 percent of patients in the placebo group.

Once treatment stopped, the rate of ocular herpes or herpes affecting the mouth and face did not increase, according to Dr. Wilhelmus. "During the six months after treatment ended, the percentages of herpes recurrences affecting the eye or the mouth and face was the same in both the treatment and placebo groups," he said.
The Acyclovir Prevention Trial is part of a larger study - called the Herpetic Eye Disease Study - that is supported through cooperative agreements with the NEI. The APT was conducted at 74 university and community-based clinical sites nationwide, reporting to eight regional centers. See list of regional centers.

Background
The Acyclovir Prevention Trial

Ocular Herpes
Like other herpetic infections, herpes of the eye remains a controllable, but incurable, problem. In one large, unrelated study, researchers found that recurrence rate of ocular herpes was 10 percent within one year, 23 percent within two years, and 63 percent within 20 years. Some factors believed to be associated with recurrence include fever, stress, sunlight, and eye injury.
The less severe forms of ocular herpes include epithelial keratitis, conjunctivitis, and blepharitis. The more severe form of ocular herpes - stromal keratitis - can lead to corneal scarring and can be associated with secondary glaucoma and cataract. Standard treatment with antiviral eyedrops or ointment helps to stop the herpes virus from multiplying. However, until the APT, there was still no known effective method for reducing the frequency of ocular herpes recurrence.

★The APT Protocol
The Acyclovir Prevention Trial (APT) is a multicenter randomized clinical trial designed to determine if the antiviral drug acyclovir, given orally, would prevent herpes simplex virus infection from recurring in the eyes of patients who had the infection in the past.
To be eligible for participation, patients must have experienced a form of ocular herpes in one or both eyes during the preceding year. This infection had to be inactive and untreated for at least the previous 30 days before enrollment. About 29 percent of the enrolled patients had experienced one previous episode of ocular herpes; 71 percent experienced multiple previous recurrences. The most common types of prior ocular herpes were epithelial keratitis (47 percent), stromal keratitis (16 percent), and both epithelial keratitis and stromal keratitis (32 percent). About 49 percent of patients had a history of fever blisters or other previous symptoms of herpes of the mouth and/or face.

Of the 703 patients, 357 were randomly assigned to the acyclovir group, and 346 to the placebo group. All patients were followed for all forms of ocular and nonocular recurrences during a 12-month treatment period, followed by a six-month observation period. The acyclovir group received oral acyclovir 400 mg twice daily for 12 months. The other group received placebo capsules that were identical in appearance and taste to the acyclovir capsules. Study medication (acyclovir or placebo) was continued for the full 12 months regardless of whether a recurrence occurred.
Herpes recurrences were classified as either superficial ocular infections (blepharitis, conjunctivitis, and/or epithelial keratitis); stromal keratitis; or iritis. When patients had a recurrence of ocular herpes, they were treated with standard topical medication, but continued to receive the oral acyclovir or placebo for the entire 365-day period.
Only four percent of patients in the acyclovir group and five percent in the placebo group stopped treatment because of side effects. One-half of these side effects were due to gastrointestinal upset; some patients may have had intolerance to the lactose contained in the study capsules (Treatment medication that does not contain lactose is now available).
Glaxo Wellcome supplied to APT investigators over a half million free capsules of its brand name acyclovir, called Zovirax(R).
Secondary Findings
In addition to the main findings, doctors also noted that:
During the 12 months of treatment, oral acyclovir reduced the incidence of epithelial keratitis from 11 percent to nine percent, and the incidence of stromal keratitis from 13 percent to eight percent.
During the 12-month treatment period, four percent of patients in the acyclovir group and nine percent in the placebo group had more than one recurrence.
「以下略」


■NIH Guide: MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL STRATEGY

MOLECULAR AND STRUCTURAL APPROACHES TO ANTIVIRAL STRATEGY
Release Date: March 20, 1998
PA NUMBER: PA-98-045
P.T.
National Institute of Allergy and Infectious Diseases

PURPOSE
The Division of Microbiology and Infectious Diseases (DMID), National Institute
of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH),
invites applications proposing innovative basic research projects on selective
antiviral strategies. The important areas include, but are not limited to: (1)
novel molecular and structural approaches (chemical or biological) to rational
drug design and discovery that utilize an understanding of viral genetics,
replication, and pathogenesis; (2) novel drug discovery through knowledge-based
screening of combinatorial libraries and natural products; and (3) novel
molecular approaches to drug delivery. The virus targeted for intervention
should be a human pathogen or one that serves as a model for a human pathogen,
except for human immunodeficiency virus (HIV) and/or other lentiviruses.

HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas. This PA, Molecular and Structural
Approaches to Antiviral Strategy, is related to the priority areas of maternal
and infant health, sexually transmitted diseases, immunization, chronic diseases
and infectious diseases. Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock
No. 017-001-00473-1) through the Superintendent of Documents, Government Printing
Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY
Applications may be submitted by domestic and foreign, for-profit and non-profi
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT
Traditional research project grant (R01) applications may be submitted in
response to this program announcement. Applications for R01 grants may reques
up to five years of support. Responsibility for the planning, direction, and
execution of the proposed research will be solely that of the applicant.

RESEARCH OBJECTIVES

Background
The discovery and development of effective and safe antiviral therapies for the
treatment of human viral infections are among major scientific interests of the
DMID. In 1988, the DMID issued a Request For Application (RFA) to solici
applications proposing research on the design of antiviral agents that will
specifically inhibit a viral (or viral-induced) function and not interact with
cellular components. This RFA was recompeted in 1994 and 11 Cooperative
Agreements (U01s) were awarded. These awards will expire July 1999. In
recognition of the future need for new antiviral agents and recent advances in
chemistry and biology, this Program Announcement (PA) expands the goals of the
RFA to include other important basic antiviral research areas. The goal of this
PA is to solicit investigator-initiated applications that address critical areas
or new opportunities in antiviral research.

Viral infections are significant causes of human mortality, morbidity, and
economic loss. Although there are a limited number of antiviral therapeutic
agents available for the treatment of viral infections, the majority of viral
infections are impossible to treat effectively, and many are serious health
concerns. Currently, only fifteen antiviral therapeutic agents (idoxuridine,
trifluridine, acyclovir, valacyclovir, famciclovir, vidarabine, ganciclovir,
foscarnet, cidofovir, podofilox, amantadine, rimantadine, ribavirin, RSVIGIV, and
interferon) have been approved by the FDA for the treatment of a small number of
non-HIV viral diseases. However, in many cases, their utility is limited by
toxicity or the emergence of resistant mutants. Because many of these drugs have
the same mechanism of action, a simple mutation can result in cross-resistance
to a whole family of the drugs. For example, emergence of thymidine kinase
deficient mutants of herpes simplex virus in immunocompromised patients renders
the three acyclic nucleosides for herpes simplex infections ineffective for the
treatment of these infected patients. Amantadine and rimantadine share a common
mechanism of action, and influenza virus quickly develops resistance to both
drugs even in immunocompetent patients. In addition to development of viral
resistance, cidofovir, ganciclovir and foscarnet, the three drugs approved for
CMV retinitis in AIDS patients, have significant toxicity. Therefore, the
development of clinically effective and safe antiviral agents is essential for
the control of viral infections.

Viruses are intracellular pathogens sharing many of the nutritional requirements
and synthetic pathways of the host cells they infect. Therefore, an ideal
antiviral agent will be one that effectively interdicts viral infection as a
consequence of interaction with a target that is unique to the virus, and hence
of little or no concern to the uninfected host tissues. In principle, such
selective antiviral activity can be achieved by directing drugs toward virus-
specific genes, enzymes, or cellular receptors. Selectivity may also be possible
by interfering with virus replication via host mechanisms. For example,
amantadine's anti-influenza activity is a consequence of its causing altered pH
in endocytotic vesicles.

Although most of the currently approved antivirals were discovered by random
screening, recent advances in the knowledge of the molecular details of virion
structures and viral replication have provided evidence that one can logically
apply such information for rational design and discover selective antiviral
drugs. A recent dramatic example is the design of clinically effective
inhibitors based on the crystal structure of the HIV protease. Recent
preliminary clinical trials have also shown encouraging results with inhibitors
of influenza neuraminidase and picornavirus capsid-binding interactions,
respectively. Antisense oligonucleotides targeting specific viral mRNA sequences
of HIV, human cytomegalovirus (HCMV), or human papillomavirus (HPV) are also now
in clinical trials.

Recent developments in chemistry and biology suggest molecules generated from
combinatorial libraries, isolated from natural products, and collected in
chemical databases represent a series of rich sources of novel diversified
chemical entities ready for drug discovery. Knowledge-based searches of such
sources could lead to the discovery of active compounds with unanticipated
structures.

It is known that many potentially effective antivirals are intrinsically active
but associated with unacceptable systemic toxicity. By employing novel
controlled delivery systems, one could achieve optimum therapeutic responses,
prolonged efficacy, and decreased toxicity by, predictably and reproducibly,
transporting and releasing the drug to the specific target environment.
The antiviral agents designed and discovered by investigators supported by this
PA can be further evaluated by DMID-supported contractors who engage in
preclinical evaluation of potential antiviral compounds. The contractors provide
in vitro screens to test compounds' cytotoxicity and activities in cell culture
systems against a variety of viruses. These include herpes viruses (herpes
simplex virus types 1 and 2, varicella zoster virus, human and murine
cytomegaloviruses, and Epstein-Barr virus), respiratory viruses (influenza virus
types A and B, respiratory syncytial virus, parainfluenza virus type 3, measles
virus, and adenovirus type 5), and hepatitis B virus. Active compounds
identified in the in vitro screens can be further studied in the DMID-supported
animal models, which examine compounds' in vivo efficacy and toxicity and limited
pharmacokinetics. These models mimic human viral diseases caused by herpes
simplex virus, cytomegalovirus, papillomavirus, influenza, parainfluenza,
measles, and hepatitis B virus. The information obtained from the in vivo
experiments serve to guide the design of clinical trial protocols.

Research Objectives and Scope
The purpose of this PA is to stimulate research in the development of novel
molecularly targeted approaches to antiviral therapy. This includes, but is no
limited to, strategies for the rational design and discovery of new agents with
novel mechanisms of action and development of methods for selective drug
delivery. The strategies proposed should involve a molecular rationale for
anticipated antiviral activity without significant concomitant cellular and/or
organism toxicity.

Viral-specific or virus-induced events in viral replication, pathogenesis, and
host interaction pathways could provide appropriate targets for selective
antiviral agents. Important or new targets would then be utilized for new lead
generation and optimization. The strategies include, but are not limited to:
molecular modeling and de novo design, quantitative structure-activity
relationships, computer-assisted structural searching, mechanism-based design,
and/or transport and receptor-based design. Drug discovery may also be achieved
through exploiting molecular diversity generated from structure-based
combinatorial libraries (chemical or biological) and natural products coupled
with smart screening strategies. Targeted approaches to drug delivery are also
encouraged since drug toxicity often results from effects on uninfected cells.
Collaborations between different scientific disciplines, such as chemistry and
virology, as well as collaborations between industrial and academic investigators
are encouraged. Virus systems should be those (except HIV and related
lentiviruses) that provide a model for a clinically important human viral
infection. The preferential choices include hepatitis C virus, hepatitis B
virus, papillomavirus, cytomegalovirus, influenza viruses, respiratory syncytial
virus, parainfluenza virus, dengue, coronavirus, rhinovirus, enterovirus, and
calicivirus.

It is possible that research proposals will involve the use of clinical
specimens. If so, the issues discussed below in the section STUDY POPULATIONS
should be addressed regarding the populations from which the specimens are
obtained. Proposals to conduct clinical trials will not be considered for this
PA.
「以下略」



■WHO: Progress in development and use of antiviral drugs and interferon. Report of aninformal consultation. Geneva, Switzerland, 13-15 March 1995

Progress in development and use of antiviral drugs and interferon. Report of an informal consultation. Geneva, Switzerland, 13-15 March 1995
WHO/EMC/LTS/95.1

* List of contents: English
* HTML: not yet available
* PDF:
English 1752k
Download the free
* How to order 

* ●Progress in development and use of antiviral drugs and interferon. Report of an informal consultation. Geneva, Switzerland, 13-15 March 1995

Introduction
Human Immunodeficiency Virus (HIV)
Human Papillomaviruses (HPV)
Herpesvirus infections
Varicella-zoster (VZV) virus
Cytomegalovirus infections (CMV)
Epstein-Barr virus infections (EBV)
Acute respiratory virus infections
Chronic viral hepatitis
Arboviruses and haemorrhagic fevers
Conclusions
Recommendations
Last updated 19-Nov-1998



■WHO: 11. APPENDIX E: ANTI-VIRAL DRUGS SUMMARY

11. ANNEX E: ANTI-VIRAL DRUGS

QUICK SUMMARY
In vitro test results of the anti-influenza drug amantadine with human and most avian influenza virus sub-types indicate that any future pandemic strain would also be sensitive to this drug and its derivative rimantadine (Oxford, 1996). These compounds have been shown to be clinically effective in preventing illness, when taken throughout the period of exposure to virus in a normal epidemic or outbreak situation. They also can reduce the severity and duration of illness, when taken early after onset. In the latter situation, they may select for resistant variants, which can spread to close contacts but are unlikely to spread further.
Other anti-influenza drugs with a different mode of action to amantadine and rimantadine appear promising in laboratory and clinical trials. However, policies are needed about the roles of these drugs in a pandemic situation, when they may for a time be the only specific measures with which to combat a new virus. Cost and supply problems make it unrealistic to consider them for widespread prophylactic use.
Nevertheless, as part of pandemic planning, it would be appropriate, as a precaution, to ensure that mechanisms exist to import, license and use those drugs already approved in some countries, and to maintain a supply adequate for critical needs which might arise, such as protection of health care staff and laboratory workers who may be exposed to a new virus. Of the two currently used drugs, rimantadine has the better safety profile.
The availability of anti-viral drugs will normally precede the availability of vaccine to a new strain. Nevertheless, issues related to anti-viral drugs are similar to those for vaccines: target groups and equity of distribution, dose, availability, (im)possibility to respond to a sudden increase of demand, and safety.
Currently there are two anti-influenza drugs that are licensed in some
countries: amantadine and rimantadine. Their effectiveness is similar, but rimantadine has a better record of safety. Specifically, amantadine is excreted renally, and can cause significant neurological side effects, particularly in those with diminished kidney function, including generally healthy elderly persons. This does not appear to be a problem for rimantadine.
Both drugs interfere with the replicative cycle of influenza A but not B viruses, through blocking the function of a membrane spanning protein synthesized in influenza-infected cells. Each has been found to be >70% effective in preventing illness caused by influenza A virus (Dolin, 1982).
WHO recommends either drug for use in the elderly and high risk people, when influenza A viruses threaten high risk residents of institutions, and vaccine is not yet available or has only just been administered (WHO, 1985).
The recommended dose of amantadine for prophylaxis and therapy is:
200 mg daily for adults
100 mg for 10-15 years and over 65 years
2-4 mg/kg for children 1-9 years

Doses must also be reduced in case of decreased renal function. Occasional resistance to amantadine and rimantadine can develop in viruses present in persons using the drugs to treat symptoms (Belshe, 1989), and such drug-resistant viruses may be transmitted to contacts (Hayden, 1989). The long-term epidemiological significance of drug-resistant viruses is not yet known, but no rationale or evidence has been found as to why such resistant mutants would have a biological advantage and spread.
Recently two closely related compounds have been developed that bind to the active site in a minor protein found on the surface of influenza viruses, the enzyme neuraminidase. The binding appears extremely strong, and, in laboratory tests and human clinical studies, inhibits virus replication to a high degree, and provides protection similar to amantadine and rimantadine. Resistance may be less frequent than with amantadine and rimantadine. Presently, the compounds are undergoing large-scale human clinical trials to support applications for licensure. If approved, and found to have a good safety profile, either drug would offer the advantage, during inter-pandemic situations, of being useful regardless of the virus type. Having anti-influenza drugs available, which act on different viral targets, may permit application with less concern about resistance, and possibly will provide opportunities for use in situations such as the early stages of primary viral pneumonia.

REFERENCES
Belshe RB, Burk B, Newman F, Cerruti RL and Sim IS. Resistance of influenza A virus to amantadine and rimantadine: results of one decade of surveillance. J Infect Dis 1989; 159: 430-435.
Dolin R, Reichman RC, Madore HP, Maynard R, Linton PM and Webber-Jones J. A controlled trial of amantadine and rimantadine in the prophylaxis of influenza A infection. N Engl J Med 1982; 307: 580-584.
Hayden FG, Belshe RB, Clover RD, Hay AJ, Oakes MG and Soo W. Emergence and apparent transmission of rimantadine-resistant influenza A virus in families. N Engl J Med 1989; 321: 1696-1702.
Oxford J and Al-Jabri A. Specific antiviral therapy of respiratory viruses. In: viral and other infections of the human respiratory tract 1. Ed. S. Myint and D. Taylor-Robinson. Pub: Chapman and Hall 1996: 397-420.
WHO. Current status of amantadine and rimantadine as anti-influenza A agents: memorandum from a WHO meeting. Bull WHO 1985; 63: 51-56.






●ニュース・トピックス


●インターフェロン効能追加

平成11年3月17日効能追加のお知らせ
　持田製薬株式会社（社長：持田 直幸）は、３月１２日付けで、下記２品目について効能追加の承認を受けましたので、お知らせします。
記
１．天然型インターフェロン－α(BALL-１)製剤
(1)　「ＩＦＮαﾓﾁﾀﾞ250」「ＩＦＮαﾓﾁﾀﾞ500」「ＩＦＮαﾓﾁﾀﾞ1000」
Ｃ型慢性肝炎におけるウイルス血症の改善(血中ＨＣＶ ＲＮＡ量が高い場合を除く)
(2)　「ＩＦＮαﾓﾁﾀﾞ250」「ＩＦＮαﾓﾁﾀﾞ500」
慢性骨髄性白血病

２．天然型インターフェロン－β製剤
「ＩＦＮβﾓﾁﾀﾞ」
亜急性硬化性全脳炎患者におけるイノシン プラノベクスとの併用による臨床症状の進展抑制
＊ イノシン プラノベクス：イソプリノシン錠（持田製薬製造販売）
＊ 「ＩＦＮβﾓﾁﾀﾞ」は大日本製薬株式会社との並行販売をしております。
以　上
〈リリースに関するお問い合わせ先〉
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「スミフェロン３００」に亜急性硬化性全脳炎の効能追加 【住友製薬】

薬事日報データベース 記事日付：99/03/19 
　住友製薬は、天然型インターフェロン‐α製剤「スミフェロン３００」に亜
急性硬化性全脳炎（ＳＳＰＥ）の効能が１２日付で追加承認されたと発表し
た。
　ＳＳＰＥは、麻疹ウイルスの変異株、ＳＳＰＥウイルスによる慢性進行性脳
炎。乳幼児期に麻疹に罹患したあと、数年の潜伏期間を経て小児期に発症す
る。知能低下が徐々に起こり、痙攣発作が現れ、大脳皮質機能の喪失へと増悪
し、予後は不良。発症は極めて稀で、現在の患者数は国内で百数十例と推定さ
れるという。
　ＳＳＰＥに対する医薬品としてこれまで承認されていたのは、生存期間延長
の効能を持ったイノシンプラノベクスだけで、より効果の高い治療方法が切望
されていた。
　今回追加された効能は「ＳＳＰＥにおけるイノシンプラノベクスとの併用に
おける臨床症状の進展抑制」。同社は平成５年から稀少疾病用医薬品の指定を
受け開発を進めていた。






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●Latest News
Tourists Beware: Monkeys Can Carry Nasty Virus (09/12/2002, Reuters Health)

●From the National Institutes of Health
Microbes in Sickness and in Health (National Institute of Allergy and Infectious Diseases)

●General/Overviews
Virus or Bacterium? (American Society for Microbiology)
Also available in:  Spanish

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ClinicalTrials.gov: Virus Diseases (National Institutes of Health)

●Prevention/Screening
10 Tips for Preventing the Spread of Infection (Association for Professionals in Infection Control and Epidemiology)
Handwashing (University of Utah, Health Sciences Center)
Also available in:  Spanish
Why is Handwashing Important? (Centers for Disease Control and Prevention)

●Research
Herpes Virus Hijacks Cell's Own Transportation System (National Institute of General Medical Sciences)

●Specific Conditions/Aspects
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Molluscum Contagiosum (American Academy of Dermatology)
Non-Polio Enterovirus Infections (National Center for Infectious Diseases)
Rotavirus Vaccine (National Immunization Program)
Also available in:  Spanish
Viral Gastroenteritis (National Center for Infectious Diseases)
Yellow Fever (World Health Organization)
Yellow Fever - Disease and Vaccine Information (National Center for Infectious Diseases)

●Organizations
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●Statistics
Respiratory Syncytial Virus Regional Trends (National Center for Infectious Diseases)

●Children
Adenovirus (Nemours Foundation)
Arctic Investigations Program: Respiratory Syncytial Virus (National Center for Infectious Diseases)
Coxsackie Viruses (Nemours Foundation)
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Hand, Foot, & Mouth Disease (National Center for Infectious Diseases)
Human Parainfluenza Viruses (National Center for Infectious Diseases)
Respiratory Syncytial Virus (Centers for Disease Control and Prevention)
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関連■
MEDLINEplus: Herpes Simplex
関連■MEDLINEplus: Shingles (Herpes Zoster)





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★Related Categories:
Science > Biology > Microbiology > Virology(45)
Science > Biology > Flora and Fauna > Viruses(4)

★Web Pages
All the Virology on the WWW-http://www.virology.net/garryfavwebindex.html
 Directory of virus related web sites that includes information about specific viruses.

Harvard School of Public Health Mosquito-Borne Viruses-http://www.hsph.harvard.edu/mosquito/
 Research of mosquito-borne viruses that focuses primarily on West Nile encephalitis, Eastern Equine encephalitis, St. Louis encephalitis, and LaCrosse encephalitis. Includes mosquito facts, suggestions for mosquito control, and links to HSPH research and various outside resources.

Respiratory Tract Infection Alert-http://www.rtialert.com/
 The RTI alert will warn consumers and health care professionals to track new cases of respiratory tract infections nationwide. It can forecast the likelihood of an outbreak of infections and predict when they are expected to peak in a given area. RTI alert is updated each week.

Smallpox-http://www.whale.to/vaccines/smallpox.html
 By Whale: A look at this diseases severity and infectiousness, vaccine damage and failures and links to articles.

How Stuff Works: Human Viruses-http://www.howstuffworks.com/virus-human.htm
 Enlightening description of how human viruses grow and spread, with many related links.
The Stealth Virus Support Group-http://www.groups.yahoo.com/group/TheStealthVirusSupportGroup
 Describes the group which is for researchers, scientists, and patients who are interested in the research, development, and treatment protocols for this Herpes family Virus. Join, post and read mail.






●主要サイト


■日本ウイルス学会　ホームページ

---現在、学会誌、欧文誌の抄録onlineデータ公開。
[ Home ] [ 更新履歴 ] [ 学会案内 ] [ 入会のご案内 ] [ 学会の組織 ] [ 活動内容 ] [ Virus News ] [ 会員へのお知らせ ] 

--------------------------------------------------
学会誌「ウイルス」[半年刊] - 2001.12～抄録公開
 - バックナンバーコンテンツ[目次]
 - MICROBIOLOGY and IMMUNOLOGY[日本ウイルス学会] --- 英文誌。　全文記事公開(PDF)

日本ウイルス学会　支部
学術集会の案内
第50回日本ウイルス学会学術集会案内(2002年　札幌)
 [http://kwarin.net/congress/virus50th/]
第51回日本ウイルス学会学術集会案内(2003年　京都)
ウイルス関連リンク集



●ウイルス関連リンク集



All the virology on the WWW
http://www.tulane.edu/~dmsander/garryfavweb.html
American Society for Virology
http://www.mcw.edu/asv/
Bioinformatics Group
http://life.anu.edu.au/
CDC
http://www.cdc.gov/
Cytokine Web
http://www.psynix.co.uk/cytweb/
Cytomegalovirus research
http://www.kc.lth.se/immun/texter/CMV.html
DNA vaccine Web
http://www.genweb.com/Dnavax/main.html
Entrez
http://www3.ncbi.nlm.nih.gov/Entrez/
The Garry Lab Virology Servers
http://www.tulane.edu/~dmsander/garryfavweb.html
HIV Web Dictionary　厚生省エイズ治療薬研究班
http://www.iijnet.or.jp/aidsdrugmhw/
Influenza Sequence Database
http://www.flu.lanl.gov/
Institute for Molecular Virology
http://www.bocklabs.wisc.edu/Welcome.html
Journal of General Virology
http://www.socgenmicrobiol.org.uk/vir_main.htm
Journal of Virology
http://intl-jvi.asm.org/
NIH
http://web.fie.com/fedix/nih.html
NIH AIDS Reagent Program　(PDF File)
http://www.aidsreagent.org/docs/register.pdf
OIE, the World Organisation for Animal Health
http://www.oie.int/
Outbreak
http://www.outbreak.org/cgi-unreg/dynaserve.exe/index.html
ProMed
http://www.healthnet.org/programs/promed.html
USDA, Animal and plant health inspection service
http://www.aphis.usda.gov/
Vector data base
http://vectordb.atcg.com/
Virology
http://fai.idealibrary.com:80/cgi-bin/www.idealibrary.com_8011/xlogin/guest/ideal
Virus data base on line
http://life.anu.edu.au/viruses/welcome.htm
Virus Reference Laboratory, Irland
http://www.ucd.ie/~virusref/vrlhome.html
WHO
http://www.who.int/
WHO Center for Health Development in Kobe
http://www.who.or.jp/
WWW Server for Virology
http://www.bocklabs.wisc.edu/Welcome.html
インフルエンザ研究者交流の会
http://wwwsoc.nacsis.ac.jp/jsci/
家畜衛生試験場
http://ss.niah.affrc.go.jp/NIAH/hoge-s.html
日本神経ウイルス研究会
http://ils.t.soka.ac.jp/nevi/
連続講座　人獣共通感染症
http://wwwsoc.nacsis.ac.jp/jsvs/prion.html
ウイルス性下痢症研究会
http://web.sapmed.ac.jp/viralge/



■ISAR :International Society for Antiviral Research

　公表資料としては、Antiviral Research[印刷物のみ]、ISAR Newsletters[半年刊]程度
 The names and affiliations of all officers and committee members of ISAR are listed. 
Membership Information
ISAR Officers and Committees
A program summary from Kirk Field can be found here.
 Listed are times and sites for the next three ICAR conferences.
ISAR Corporate Sponsors
A list of corporate sponsors of the International Society for Antiviral Research is located here.
ISAR Newsletters★半年刊
The latest ISAR newsletter is currently from July, 1999 . It contains information on current events happening with the Society.
15th ICAR Final Program
15th ICAR Second Announcement
14th ICAR Contributors
14th ICAR Summary
Future ICAR Conferences
The International Society for Antiviral Research (ISAR) was formally established on May 14, 1987.


■[CliniWeb International] Virus Diseases[www.ohsu.edu]

http://www.ohsu.edu/cliniweb/C2/C2.html

●Arbovirus Infections [10 more specific term/s, 246 more link/s]
Search PUBMED for Arbovirus Infections:
All | Review | Therapy | Diagnosis 

●Bronchiolitis, Viral
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Radiology: Pediatric Chest: Viral Bronchiolitis: Med Connect 

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Herpes Encephalitis - Histology: Virtual Hospital, U. of Iowa
Herpes Encephalitis - Pathologic Brain Photo: Virtual Hospital, U. of Iowa
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Herpes Simplex Encephalitis - Histology: Virtual Hospital, U. of Iowa
Herpes Simplex Encephalitis - Histology: Virtual Hospital, U. of Iowa
Herpes Simplex Encephalitis: Virtual Hospital, U. of Iowa
Herpesvirus: Vanderbilt U.
Rabies Encephalitis - Electron Micrograph: Virtual Hospital, U. of Iowa
Rabies Encephalitis - Histology: Virtual Hospital, U. of Iowa
Rabies Encephalitis - Histology: Virtual Hospital, U. of Iowa
Rabies Encephalitis, Central Nervous System, Negri Body - Pathologic Photomicrograph 

●Eye Infections, Viral [4 more specific term/s, 37 more link/s]
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Chronic Fatigue Syndrome Defined: CDC
Chronic Fatigue Syndrome: Brain Perfusion Scan: Harvard U.
Chronic Fatigue, Sarcoidosis, and ACE
Common Treatments for CFS: CDC
Infectious Mononucleosis in the Child Care Setting: CDC 

●Hepatitis, Viral, Animal [2 more specific term/s, 2 more link/s]
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Acute Viral Hepatitis - Clinical Case Definition - 1995: MMWR
Acute Viral Hepatitis - Clinical Case Definition - 1996: MMWR
Apoptosis, viral hepatitis, microscopic: U. of Utah Webpath
Protection Against Viral Hepatitis - ACIP Recommendations - 1990: CDC
Viral hepatitis with collapse, liver, Trichrome stain, microscopic: U. of Utah Webpath
Viral hepatitis, liver, gross: U. of Utah Webpath
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1997 Guidelines for Prevention of Opportunistic Infections in Persons with HIV
Opportunistic Infections in the HIV-Positive Patient: U. of Iowa
Prophylaxis of Opportunistic Infections (1996, Louisiana State Univ Med Ctr)
Sporozoa: Isospora belli & hominis: Thomas Jefferson U. 

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Viral Pneumonias: CDC 

●RNA Virus Infections [17 more specific term/s, 3 more link/s]
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●Sexually Transmitted Diseases [1 more specific term/s, 0 more link/s]
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1998 Guidelines for Treatment of Sexually Transmitted Diseases
CDC Travel Health: sexually transmitted diseases
Cervical Cancer Screeing for Women Who Attend STD Clinics or Who Have a History of STDs: CDC
Chlamydia and Gonorrhea, Chpt 39: The Virtual Hospital, U. of Iowa
Counseling - Sexually Transmitted Diseases and HIV Infection (Chpt 58): Virtual Hospital, U. of Iowa
Counseling - Sexually Transmitted Diseases and HIV Infections (Chpt 22): Virtual Hospital, U. of Iowa
Diseases Characterized by Vaginal Discharge: CDC
Female Urinary Tract Infections: U. of Iowa
Figures Showing National Rates of STDs: CDC
Figures Showing Rates of Other Sexually Transmitted Diseases (PID, Chancroid, Herpes, Nonspecific Urethritis, and Trichomal Infections): CDC
Figures Showing Rates of STDs in Adolescents and Young Adults: CDC
Figures Showing Rates of STDs in Minorities: CDC
Figures Showing Rates of STDs in Women and Infants: CDC
Figures Showing Rates of STDs in the South: CDC
HIV Infection, Chpt 39: The Virtual Hospital, U. of Iowa
HIV Prevention Through Early Detection and Treatment of other STDs (MMRW Jul 31, 1998): JAMA HIV/AIDS Info Center
Health Education and Risk Reduction Activities for HIV/STD and TB: CDC
JAMA Women's Health STD Information Center - Screening Adolescents for Sexually Transmitted Infections...[Fulltext, Aug 12 JAMA. 1998;280:564-565] (c) AMA 1998
Other Sexually Transmitted Diseases: 1993 (PID, Chancroid, Herpes, Nonspecific Urethritis, and Trichomal Infections): CDC
Other Sexually Transmitted Diseases: 1994 (PID, Chancroid, Herpes, Nonspecific Urethritis, and Trichomal Infections): CDC
STD Classification: Cornell U.
STD Introduction and Epidemiology: Cornell U.
STD Prevention Links for Health Providers: John Hopkins University
STD Treatment Guidelines: Special Populations (Pregnant, Children, HIV Patients): CDC
STDs and HIV Treatment Guidelines: CDC
STDs and HIV, Chpt 39: The Virtual Hospital, U. of Iowa
STDs in Adolescents and Young Adults: 1993: CDC
STDs in Adolescents and Young Adults: 1994: CDC
STDs in Developing Nations: HealthCare Communications Group
STDs in Minorities: 1993: CDC
STDs in Minorities: 1994: CDC
STDs in Women and Infants: 1993: CDC
STDs in Women and Infants: 1994: CDC
STDs in the South: 1994: CDC
STDs: Diseases Characterized by Genital Ulcers: CDC
Sexual Assault and STDs: Adults and Adolescents: CDC
Sexual Assault and STDs: CDC
Sexual Assault or Abuse of Children: CDC
Sexually Transmitted Diseases: Social Networks and the Core Theory
Sexually Transmitted Diseases: U. of Iowa
Sexually Transmitted Diseases: WHO
Syphilis, Chpt 39: The Virtual Hospital, U. of Iowa
The Virtual Navy Hospital: General Medical Officer Manual: Genital Ulcer Disease
The Virtual Navy Hospital: General Medical Officer Manual: Sexually Transmitted Diseases
Vaginitis and STDs (1998, Louisiana State Univ Med Ctr)
Vaginitis and STDs Treatment (1996, Louisiana State Univ Med Ctr) 

●Skin Diseases, Viral [5 more specific term/s, 53 more link/s]
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Herpetic Whitlow - Index Finger, Periungual: U. of Iowa
Skin Infections: U. of Iowa 

●Slow Virus Diseases [11 more specific term/s, 156 more link/s]
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●Tumor Virus Infections [6 more specific term/s, 12 more link/s]
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Human Papillomavirus Infections in Nonmelanoma Skin Cancers From Renal Transplant Recipients and Nonimmunosuppressed Patients: NCI
JAMA Contempo Issue: Obstetrics and Gynecology : AMA 

●Viremia
Search PUBMED for Viremia:
All | Review | Therapy | Diagnosis 

●Zoonoses
Search PUBMED for Zoonoses:
All | Review | Therapy | Diagnosis
Other Zoonoses: U. of Iowa
Zoonoses - 1995: Medical Sciences Bulletin
Zoonoses: cats, fleas, and bacteria - 1994: Medical Sciences Bulletin



■American Social Health Association[ASHA]

Facts & Answers About STDs
ASHA and CDC Hotlines
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●Facts & Answers About STDs



Introduction to STDs
STD Glossary
How to Use a Condom
STD Statistics
Links

	-AIDS and HIV
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	-Crabs
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	-HPV
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	-Contagiosum
	-NGU
	-PID
	-Syphilis
	-Vaginitis 



●ASHA and CDC Hotlines



Hotline Information
CDC National STD and AIDS Hotlines
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North Carolina Family Health Resource Line



●Programs and Resource Centers



Introduction
ASHA Research Fund 
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●Herpes Resource Center



  以下のほかニュース掲載
Herpes: Get the Facts
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Links



■Antiviral Agents Bulletin Home

Ordering information - Subscriptions are $350 for 12 monthly issues (32 pages each).
 ($410 for non-North American subscribers, issues sent by air mail).

News -- 公開
WO Pub
US Patents



■Bock Laboratories at UW-Madison

the Robert M. Bock Laboratories UW-Madison, USA
www.bocklabs.wisc.edu
Institute for Molecular Virology
Laboratory of Molecular Biology

CMB Cellular and Molecular Biology Graduate Program 
LOCI
 - Laboratory for Optical and Computational Instrumentation



●Institute for Molecular Virology



What's new
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Eradication of poliovirus
about this virus
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Join the virus of the month club

Rhinovirus
about this virus
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●Virology-related News and Journal Articles



 Hepatitis C info on the Web 
Global Programme on AIDS Newsletter
Influenza Activity During 1994-1995 Season as of 25 October 1994
 The Life and Times of the Hantaviruses
(from The Scientist, Jul. 11, 1994)
 AIDS Research Progress Stymied By Narrow Focus, Critics Charge
(from The Scientist, Jul. 11, 1994)
 HIV and AIDS [letter]
(from The Scientist, Jul. 11, 1994)
One Year Later, The Hantavirus Investigation Continues
(from The Scientist, Jul. 25, 1994).
Scene is Set for Destruction of Smallpox Virus (WHO/65)
Tuberculosis, HIV on Collision Course in Asia (WHO/63)
Technical Advisory Meeting on Implications of The Newly Identified HIV-1 Subtype O Viruses for HIV Diagnosis (WHO/50)
Oral Vaccines Against Canine Rabies: WHO Announces World's First Field Tests (WHO/49)
Emerging and Re-Emerging Infectious Diseases: WHO Responds to a Global Threat (WHO/37)
"HIV Vaccine Development at Crossroads", Says WHO Director of AIDS Research (WHO/30)
Poliomyelitis Eradication: 141 Polio-Free Countries Reported in 1993 (WHO/29)
Communicating Information about Virus Structure and Biology Via the World Wide Web (from the Advance Proceedings of the Second International World Wide Web Conference, 1994)
© 1994-1997











[965,1143]●製品valacyclovir (Valtrex [GSK])


　日本語版註）valacyclovir HCl(Valtrex [GSK])　塩酸バラシクロビル
　【別名】256U87; BW-256U ;ValACV　【開発元】GSK　 [DBR_ID]42048
　【化学名】L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride.
　【承認】FDA申請=、FDA承認=23-JUN-95[Herpes Zoster], 15-DEC-95[Genital herpes], 9-Sept-2002[Cold Sores (Herpes Labialis)];【製剤】Caplets -500mg, or 1g　【適応】1)Herpes Zoster: VALTREX is indicated for the treatment of herpes zoster (shingles). 2)Genital Herpes: VALTREX is indicated for the treatment) or suppression of genital herpes. 3)Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores(herpes labialis).　【製品情報】http://www.valtrex.com/　【添付文書】http://us.gsk.com/products/assets/us_valtrex.pdf　【日本】バルトレックス錠=承認2000.7.3,薬価,発売2000.10.6[帯状疱疹]；顆粒=承認2001.7.17,薬価2002.6.14,発売2002.7.10[帯状疱疹]；単純疱疹効能追加2002.9.26　【その他】the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir

バルトレックス錠500 日本標準商品分類番号 =87625 効能又は効果追加承認年月（最新）=2002年9月 国際誕生年月=1994年12月 薬効分類名=抗ウイルス化学療法剤 薬価基準収載年月=2000年8月 販売開始年月=2000年10月 成分・含量=1錠中に塩酸バラシクロビル556mg（バラシクロビルとして500mg 一般的名称=塩酸バラシクロビル /Valaciclovir hydrochloride 効能又は効果=**単純疱疹、帯状疱疹 用法及び用量= **単純疱疹 =通常、成人にはバラシクロビルとして1回500mgを1日2回経口投与する。 帯状疱疹 =通常、成人にはバラシクロビルとして1回1000mgを1日3回経口投与する。 バルトレックス顆粒50% 効能又は効果追加承認年月（最新）=2002年9月 価基準収載年月=2002年6月 販売開始年月=2002年7月 成分・含量=1g中に塩酸バラシクロビル556mg(バラシクロビルとして500mg) 効能又は効果／用法及び用量 *単純疱疹 =通常、成人にはバラシクロビルとして1回500mgを1日2回経口投与する。 帯状疱疹=通常、成人にはバラシクロビルとして1回1000mgを1日3回経口投与する

【日本語版コメント】
　バラシクロビルは、世界売上トップのヘルペス治療薬。米国では1995年に帯状疱疹、性器ヘルペスの適応で承認され、2002年9月9日に口唇ヘルペス[cold sores(herpes labialis)]の適応が認められた。　日本でも、帯状疱疹治療薬としてバルトレックス錠が2000年10月6日に薬価収載&発売、顆粒も今年7月発売、そして単純疱疹の追加適応が2002.9.26承認。　適応症の表現に日米の表現差があるが。 
＜日本語版コメント用要約＞
・経口バラシクロビルが新たに口唇ヘルペスの治療薬として承認された。
・投与は1日2回、1日間のみと簡便である。
・臨床試験では、初発症状発現時に投与を開始すれば治癒時間が短縮されることが示された。
・アシクロビルと同様に忍容性はよい。

　→詳細は参考資料●リソース：抗ウイルス剤|リソース：ヘルペス治療剤に纏めた。




●承認データ：FDA



	
情報ソース●DDPA June 1995
20-487     VALTREX                 BURROUGHS WELLC         VALACYCLOVIR
                                                           HYDROCHLORIDE
23-JUN-95  (TABLET)                RES TRIANGLE PK, NC     EQ 500MG BASE
(2 S)                              27709                   EQ 1GM BASE*
                                                           (ANTIVIRAL)
                                                           [TREATMENT OF HERPES 
                                                           ZOSTER
                                                           (SHINGLES) IN
                                                           IMMUNOCOMPETENT
                                                           ADULTS]


	
情報ソース●DDPA December 1995
20-550     VALTREX                 GLAXO WELLCOME     VALACYCLOVIR HYDROCHLORIDE
15-DEC-95  (TABLET)                RES TRIANGLE PK, NC     EQ 500MG BASE
(6 S)                              27709                   EQ 1GM BASE*
                                                      (ANTIVIRAL)
                                                      [EPISODIC TREATMENT OF
                                                      RECURRENT GENITAL HERPES
                                                      IN IMMUNOCOMPETENT ADULTS]

	
情報ソース●Drug Approvals October 1996
Application #: 020550 Efficacy Supplement #: 001 
Type: SE1 to Original New Drug Application 
Approval Date: 04-OCT-96 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 
Efficacy Claim: Treatment of initial episode genital herpes

	
情報ソース●Drug Approvals January 1997
Application #:020487　LabelingSupplement#: 004 To Original New Drug Application 
Approval Date: 13-JAN-97 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 

	
情報ソース●Drug Approvals for April 1997
Application #:020550Labeling Supplement#:004 
To Original New Drug Application 
Approval Date: 30-APR-97 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX

	
情報ソース●Drug Approvals for September 1997
Application #: 020550 Efficacy Supplement#: 003 
Type: SE1 to Original New Drug Application 
Approval Date: 26-SEP-97 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 
Efficacy Claim: For the suppression of recurrent episodes of genital herpes in i
mmunocompetent adults 

	
情報ソース●FDA Drug Approvals List June 2001
Application #: 020550 Labeling Supplement#: 013 
To Original New Drug Application 
Approval Date: 25-JUN-01 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 

Application #: 020550 Labeling Supplement#: 010 
To Original New Drug Application 
Approval Date: 25-JUN-01 
Trade Name: VALTREX 
Dosage Form: TABLET 
Applicant: GLAXO WELLCOME INC 
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 

	
情報ソース●FDA Drug Approvals List July 2001
Application #: 020550 Efficacy Supplement #: 012 
Type: SE2 to Original New Drug Application 
Approval Date: 25-JUN-01 
Trade Name: VALTREX 
Dosage Form: CAPSULE 
Applicant: GLAXOSMITHKLINE 
Active Ingredient(s):VALACYCLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 
Efficacy Claim: For the treatment of recurrent episodes of genital herpes 


	
情報ソース●FDA Drug Approvals - V
Valtrex (valacyclovir hydrochloride), Rx GlaxoSmithKline
Application #=NDA 20-550/S16
Approval Date=9/9/02
Letter Posted=9/11/02
Label Posted =
Review Posted=

Valtrex (valacyclovir hydrochloride), Rx GlaxoSmithKline
Application #=NDA 20-550S12
Approval Date=7/13/01
Letter Posted=11/6/01
Label Posted =11/6/01
Review Posted=

Valtrex (valacyclovir hydrochloride) Caplets, 500 mg, Rx GlaxoSmithKline 
Application #=NDA 20-550
Approval Date=6/25/01
Letter Posted=
Label Posted =
Review Posted=



●FDAその他



●総説
Genital Herpes: A Hidden Epidemic
[FDA Consumer magazine March-April 2002]




●GlaxoSmithKlein



 - http://www.gsk.com/index.htm
●Product
Valtrex -US
Valtrex -UK

●Media Room -Press release
New study evaluates the effectiveness of VALTREXR caplets for suppression of genital herpes
 in HIV-infected persons[2002.10.25]
New study evaluates suppressive therapy with VALTREXR tablets for the reduction of
 transmission of genital herpes[2002.9.27]

Studies show ValtrexR (valacyclovir hcl) caplets shorten duration of a cold sore outbreak[2002.8.1]
 - cold soreの適応追加申請中
FDA approves first one-day, oral antiviral treatment of cold sores[2002.9.10]
 - １日１回投与
PEOPLE WITH HIV CAN STAY FREE OF GENITAL HERPES[1997.5.21]
 - Valtrex was first introduced in 1995 for the treatment of herpes zoster infec
tions (shingles) and herpes simplex infections (including genital herpes).
PREVENTION OF GENITAL HERPES RECURRENCES WITH ONCE DAILY VALTREX[1996.3.21]
 - Valtrex was first launched in the UK in January 1995 for the treatment of her
pes zoster and was first launched for the treatment of genital herpes in the UK 
in November 1995. Regulatory submissions for Valtrex? for this new indication ar
e planned during 1996. Valtrex? is now approved in over 25 countries worldwide, 
including the US and major European countries. 


★http://www.valtrex.com/





●[日本]ニュースリリース



グラクソ・スミスクラインのバルトレックス錠により性器ヘルペスのウイルス感染率が
有意に抑制される-第42回インターサイエンス(ICAAC)学会より-[2002.10.16]
グラクソ・スミスクライン株式会社、ヘルペス感染症治療薬「バルトレックス」単純疱疹
の効能追加取得[2002.9.30]
 - 2002年9月26日付けで取得。[効能・効果]:単純疱疹、帯状疱疹。錠500、顆粒50%
　 GSK独自調査によると、口唇ヘルペスの患者さんは、年間のべおよそ800万人と推計さ
　れますが、その内、抗ウイルス薬の治療を受けているのは、約10%に過ぎず、いまだ治
　療を受けてない多くの患者さんが、この感染症に苦しんでいます。また、2000年にGSK
　が行った"口唇ヘルペス"についての認知度調査では、70%の人々が、疾病に関して詳し
　く知らない事が明らかになりました。バルトレックスの服薬投与回数、1回1錠、1日2回
　投与という簡便さから、口唇ヘルペスの治療に大いに貢献するものと考えられます。
　バルトレックスは、すでに欧州、米国を含む世界85ヶ国以上で使用

グラクソ・スミスクライン株式会社、「バルトレックス顆粒50%」明日発売、患者さんの
服薬改善につながる顆粒[2002.7.9]
 - 2001年7月17日に剤型追加承認され、本年6月14日に薬価収載

ヘルペスウイルス感染症の実態について-国際性感染症学会において疫学調査結果が発表される[2001.7.5]
 --- http://www.glaxosmithkline.co.jp/corp/press/2001_07/P1000013.html; 2001.7.13
小児におけるＢ型慢性肝炎の治療に大きな進展 グラクソ･スミスクラインのB型慢性肝炎
治療薬｢ゼフィックス｣の小児における高い有効性と安全性が証明される[2001.6.15]
 --- http://www.glaxosmithkline.co.jp/corp/press/2001_1_6/20010615.html;
グラクソ・スミスクライン2001『口唇ヘルペス』疾患啓発キャンペーン[2001.6.1]
 --- http://www.glaxosmithkline.co.jp/corp/press/2001_1_6/20010601.html ; 

グラクソ・ウエルカムヘルペス感染症治療薬「バルトレックス錠500」を発売‐１日３回
の服用で帯状疱疹治療がより簡便に‐[2000.10.6]
 --- http://www.glaxosmithkline.co.jp/corp/press/2000/20001006.html; 2000.10.6
１０月６日、新規の帯状疱疹治療薬「バルトレックス錠500」（一般名：塩酸バラシクロビル）を発売しました
グラクソ・ウエルカムヘルペス感染症治療薬「バルトレックス錠500」の承認取得[2000.7.3]
 --- http://www.glaxosmithkline.co.jp/corp/press/2000/20000703_2.html ; 
７月３日付で厚生省より、帯状疱疹治療薬として抗ウイルス化学療法剤「バルトレックス
錠500」（一般名：塩酸バラシクロビル）の承認を取得しました。

●GSK:口唇ヘルペス
 - http://www.glaxosmithkline.co.jp/herpes/






●製品: Viroptic(R) Ophthalmic Solution (trifluridine)


　日本語版註）trifluridine (Viroptic(R) Ophthalmic Solution [King Pharm])
　【別名】trifluorothymidine,F3TdR,F3T,　【開発元】GSK　 [DBR_ID] 18296(TC=1310)
　【化学名】α,α,α-trifluorothymidine
　【承認】FDA申請=、FDA承認=3-Feb-1998 ;Distributed by: Monarch Pharmaceuticals, Inc.,/Manufactured by: Catalytica Pharmaceuticals, Inc.【製剤】Ophthalmic solution - 1%　【適応】for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2　【製品情報】　【添付文書】http://www.kingpharm.com/uploads/pdf_inserts/Viroptic_PI.pdf　【日本】　【その他】カナダではは、GSKはTheramed社にライセンス









●承認データ：FDA



	
情報ソース●FDA Drug Approvals - V
Viroptic (trifluridine ophthalmic solution) 1% Sterile Monarch Pharmaceuticals, Inc. 
Application #=NDA 18-299S-014 
Approval Date=2/20/02
Letter Posted=2/21/02
Label Posted =
Review Posted=












■メーカーサイト




●King Pharmaceuticals




 - http://www.kingpharm.com/default_king.htm

●売上
($million)  2001
Altace       284.7 (+76%) ramipril (ACEI)
Levoxyl      105.1 (+81)  levothyroxine sodium
-------------------------------
　純売上計   825.5

●Products
Viroptic
●News
●Annual Report









●Catalytica Pharmaceuticals Announces Manufacturing Agreement With Monarch Pharmaceuticals



MOUNTAIN VIEW, CA February 9, 1998 - Catalytica Pharmaceuticals, Inc., a subsidiary of Catalytica, Inc. (Nasdaq: CTAL), today announced a new contract with Monarch Pharmaceuticals, Inc., a subsidiary of King Pharmaceuticals, Inc., to continue to produce two Monarch drugs at its Greenville, North Carolina development and manufacturing facilities. 


Under the contract, Catalytica Pharmaceuticals will manufacture eye and ear preparations for adult and pediatric use. Monarch acquired the Cortisporinｮ and Viropticｮ product lines, among others, from Glaxo Wellcome in 1997 and has entered into the current three-year manufacturing agreement with Catalytica to ensure their continued production. The products have been manufactured at the Greenville facility for both Glaxo Wellcome and Burroughs Wellcome in the past. 


James A. Cusumano, Chairman of Catalytica, Inc. and Chief Executive Officer of Catalytica Pharmaceuticals, called the latest agreement with Monarch an important step toward fulfillment of the company's long-term growth strategy. "Within six months of acquiring the Greenville facility, Catalytica Pharmaceuticals has completed several important pharmaceutical contracts and partnerships, including our newest relationship with Monarch. The increasing use of outsourcing by the pharmaceutical industry, combined with our unique position as a preferred one-stop supplier, is providing mounting evidence that our growth strategy is on solid ground." 


Monarch becomes the latest healthcare product company to sign a manufacturing agreement with Catalytica since its acquisition of the Greenville facility from Glaxo Wellcome Inc. As part of the agreement to acquire the Greenville facility, Catalytica negotiated a five-year outsourcing agreement to manufacture certain Glaxo Wellcome products formerly produced at the facility. In addition, Amgen Inc. and Pfizer Inc. have recently committed to producing sterile products and chemical intermediates, respectively, at the North Carolina facility. 


Monarch Pharmaceuticals, Inc. is a wholly-owned subsidiary of King Pharmaceuticals, Inc., and is based in Bristol, Tennessee. Monarch markets and sells prescription brand-name pharmaceuticals including, among others, Cortisporinｮ, Viropticｮ, Septraｮ and prescription formulations of Neosporinｮ and Polysporinｮ. King Pharmaceuticals is a full-service, fully integrated pharmaceutical developer, manufacturer, marketer, sales and distribution company. King currently manufactures a variety of pharmaceutical products which include injectables, tablets, capsules, liquids, suspensions, creams, ointments, suppositories and other ethical drug products for human and animal health. 


Catalytica, Inc., through its subsidiaries, provides technologies and advanced products that allow its customers and business partners to streamline and reduce the cost of bringing their products and services to market. Catalytica Pharmaceuticals, Inc., a majority-owned subsidiary, provides process and formulation development and manufacturing for business partners in the pharmaceutical and biotech industry. Find Catalytica on the World Wide Web at www.catalytica-inc.com. 


This news release contains forward-looking statements regarding Catalytica's future operation of the Greenville facility and Catalytica's competitive position in its markets. These statements involve risks and uncertainty, including without limitation, the ability to operate the facility efficiently, the ability to perform cost-effectively and in a timely manner, the ability to obtain contracts with new customers, product development delays, changes in the company's competitive position, and the impact of FDA and other regulations on fine chemical manufacturing. Investors are encouraged to review Catalytica's Form 10-K/A for the year ending December 31, 1996 (Part II, Item 7) and Form 10-Q for the period ending September 30, 1997, and the Proxy Statement dated July 16, 1997 for a more complete discussion of factors that could affect Catalytica's future performance. 








●FDA Approves Pediatric Use For Viroptic 



BRISTOL, TN -- February 3, 1998 -- The United States Food and Drug Administration has granted approval for the expanded use of King Pharmaceuticals, Inc.'s Viroptic(R) Ophthalmic Solution (trifluridine) 1%, to include pediatric patients, ages six and above.


Viroptic is indicated for the treatment of inflammation of the cornea of the eye caused by the herpes simplex virus. The product contains an antiviral agent (trifluridine), which is effective against both types of the herpes simplex virus, types 1 and 2 and vacciniavirus. Viroptic Ophthalmic Solution is supplied in a 7.5 ml dispenser bottle 

● King Pharmaceuticals, Inc. - http://www.kingpharm.com
















●製品: シドフォビル cidofovir (Vistide, HPMPC) Gilead Sciences, Inc.




　日本語版註）シドフォビル cidofovir (Vistide, HPMPC) Gilead Sciences, Inc.

　【別名】HPMPC　【開発元】Gilead Science社[www.gilead.com]　 [DBR_ID]28017

　【化学名】

　【承認】FDA申請=、FDA承認=96.6.26、発売96.6 ;EU承認=1997.5; 米国外販売元=Pharmacia　【製剤】　【適応】CMV retinitis　【製品情報】　【添付文書】　【日本】未開発　【その他】米国外はPharmacia社にライセンス











●承認データ：FDA



	
情報ソース●FDA Drug Approvals - V
Vistide (cidofovir injection) 75 mg/mL
Application #=NDA 20-638
Approval Date=3/9/99
Letter Posted=
Label Posted =
Review Posted=
Vistide Indications:
 For the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.




●Eudra-EPAR: Vistide INN:Cidofovir (Rev. 5)



 - http://www.eudra.org/humandocs/humans/epar/vistide/vistide.htm
Revision 5 - 1/2/02
Vistide [Pharmacia & Upjohn SA]
Therapeutic indication
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome 
(AIDS) and without renal dysfunction 












●Gilead Science




 - http://www.gilead.com/wt/home
Vistide
 - http://www.gilead.com/wt/sec/vistide
News
Investors - Annual Reports等

FDA Grants Marketing Clearance of Gilead's VISTIDE for the Treatment of CMV Retinitis in Patients with AIDS[1996.6.27]
 - 同社初の製品。





















●製品: Vitravene (fomivirsen sodium intravitreal injectable)=ISIS 2922




　日本語版註）Vitravene (fomivirsen sodium intravitreal injectable)[ISIS]

　【別名】ISIS 2922　【開発元】Isis Pharmaceuticals(www.isip.com)が創製　 [DBR_ID]45122

　【化学名】

　【承認】FDA申請=98.4.9、FDA承認=98.8.26、発売[米国]=98.11.8　全世界販売CIBA Vision (http://www.cibavision.com/) /EU申請=1998.4、EU承認=1999.7.29,市場回収=2002.5.23;【製剤】　【適応】　【製品情報】http://www.vitravene.com/　【添付文書】　【日本】　【その他】 VitraveneはCibaVisionの商標












●承認データ：FDA



	
情報ソース●FDA Drug Approvals - V
Vitravene Injection (fomivirsen sodium intravitreal injectable), 6.6mg, Rx
Isis Pharmaceuticals
Application #=NDA 20-961
Approval Date=8/26/98
Letter Posted=8/28/98
Label Posted =8/28/98
Review Posted=4/10/02
Vitravene Indications:
 Vitravene Injection for the local treatment of cytomegalovirus (CMV) retinitis 
in patients with acquired immunodeficiency syndrome (AIDS) who are intolerant of
 or have a contraindication to other treatment(s) for CMV retinitis or who were 
 insufficiently responsive to previous treatment(s) for CMV retinitis.



●Consumer drug Information: Vitravene



 - http://www.fda.gov/cder/consumerinfo/druginfo/vitravene.htm




  
Vitravene

  
Brand Name:Vitravene

  
Active Ingredient:  fomivirsen sodium

  
Strength(s): 6.6mg

  
Dosage Form(s):  Intravitreal (eye) injection

  
Company Name:   Isis Pharmaceuticals, Inc.

  
Availability: Prescription only

  
*Date Approved by the FDA:  August 26, 1998

  
*Approval by FDA does not mean that the drug is available for consumers at this time.






  
What is Vitravene used for? Vitravene is used to treat a virus called cytomegalovirus (CMV). CMV can affect one or both eyes in patients with acquired immunodeficiency syndrome (AIDS) who cannot take other treatment(s) for CMV retinitis or who did not respond to other treatments for CMV retinitis. The diagnosis should be made after a comprehensive eye exam, including indirect ophthalmoscopy.

 Warning(s) with Vitravene: 
    
   
  • Vitravene only works in the eye in which it is injected and does not treat CMV elsewhere in the body. Because CMV may be in other parts of your body and not only in your treated eye, your doctor will monitor you for CMV in the untreated eye or CMV elsewhere in your body (e.g. pneumonitis, colitis).
    • 
   
  • Vitravene is not recommended if you have been treated within the last 2-4 weeks with cidofivir (Vistide) because of the increased risk of eye inflammation.
    • 
 

 
General Precautions with Vitravene: 
    
   
  • Vitravene is for eye(s) only. 
    • 
   
  • Vitravene is not a cure for CMV retinitis. CMV retinitis in some patients may get worse during or following Vitravene treatment. You should have regular eye exams by your ophthalmologist.
    • 
   
  • Inflammation of the eye (uveitis) occurs in approximately one out of four patients being treated with Vitravene. This type of reaction is most common when starting treatment with Vitravene. Your doctor may prescribe medication to treat the inflammation and may interrupt Vitravene treatment until the inflammation stops.
    • 
   
  • Increased pressure in the eye has been reported as another common side effect of Vitravene injections. Your doctor should monitor the pressure in your eye(s) during each visit and treat the increase in pressure if necessary.
    • 
   
  • If you are receiving Vitravene, you should have regular follow-up eye exams. 
    • 
   
  • HIV-infected patients should continue taking their prescribed antiretroviral medications, unless their doctor tells them otherwise.
    • 
 

 
What should I tell my doctor or health care provider? 

 
Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding. 

 
What are some possible side effects of Vitravene? (This is NOT a complete list of side effects reported with Vitravene. Your health care provider can discuss with you a more complete list of side effects.)   

 
The most common side effect is eye inflammation. This reaction is most common when starting Vitravene and may be treated by your health care provider (See General Precautions). 

 
Other side effects that may relate to the eye(s) are:
    
   
  • Abnormal vision
    • 
   
  • Swelling around the eye
    • 
   
  • Blurred vision
    • 
   
  • Cataract
    • 
   
  • Bleeding in and around the eye
    • 
   
  • Decreased visual sharpness, clearness, 
    • 
   
  • Reduced color vision
    • 
   
  • Eye pain
    • 
   
  • Objects in the field of vision (floaters)
    • 
   
  • Increased eye pressure
    • 
   
  • Sensitivity to light
    • 
   
  • Retinal detachment
    • 
   
  • Swelling of the retina
    • 
   
  • Bleeding of the retina
    • 
   
  • Color changes of the retina
    • 
 

 
Additional non-eye related side effects might include:
    
   
  • Stomach pain
    • 
   
  • Low blood count
    • 
   
  • Weakness
    • 
   
  • Diarrhea
    • 
   
  • Fever
    • 
   
  • Headache
    • 
   
  • Infection
    • 
   
  • Nausea
    • 
   
  • Pneumonia
    • 
   
  • Rash
    • 
   
  • Inflammation of the sinuses
    • 
   
  • Vomiting
    • 
   
  • Liver or kidney problems
    • 
   
  • Dehydration
    • 
   
  • Sweating
    • 
   
  • Flu-like symptoms
    • 
   
  • Cough
    • 
   
  • Chest pain
    • 
 

 
For more detailed information about Vitravene, ask your health care provider.

 
Vitravene Approved Label
 
Date Posted: 10/5/98

 Revised: 7/25/00







●Eudra-EPAR: Vitravene INN:Fomivirsen



 - http://www.emea.eu.int/pdfs/human/press/pus/1238202en.pdf

●Public Statement - Market Authorisation withdrawn (6/8/02)
 - 1999.7.29 EUでの承認をCiba Visionに与えたが、2002.5.23に商業的理由から市場回
収された。　EU内ではスイスのみ供給を続けている。











■メーカーサイト




●ISIS Pharmaceuticals




 - http://www.isip.com/
●News
European Approval of VitraveneTM Triggers $2.5 MM Milestone for Isis[1999.8.4]
Isis Pharmaceuticals Reports its Financial Results and Highlights for the Year 2001
 - Company Outlines 2002 Goals[2002.2.7]

●Products
Vitravene - http://www.vitravene.com/
 VitraveneはCibaVisionの商標
●Investor Relations -Annual Reports









●Vitravene:



 - http://www.vitravene.com/
 First Drug with Antisense Mechanism
First Antisense research focused on treatment of AIDS-related CMV retinitis. Bre
akthrough technology fights blindness at DNA level. Disease background. Progress updates.

Reimbursement | Press Releases | Abstracts | References | Glossary







●Ciba Vision




 - http://www.cibavision.com/

●Press Release
06/5/2000
CIBA VISION’S VITRAVENE? DRUG TREATMENT FOR CMV RETINITIS RECOGNIZED AS ONE
 OF THE MOST INNOVATIVE PHARMACEUTICAL PRODUCTS IN 2000

06/5/2000
CIBA VISION’S VITRAVENE? DRUG TREATMENT FOR CMV RETINITIS RECOGNIZED AS ONE OF
 THE MOST INNOVATIVE PHARMACEUTICAL PRODUCTS IN 2000

●Vitravene - http://www.vitravene.com/









●Novartis




 - http://www.novartis.com/





















●製品：その他





■valganciclovir Valcyte[Roche]




　日本語版註）valganciclovir HCl (Valcyte[Roche]) (VAL-site)

　【別名】ganciclovir L-valyl ester; RO 107-9070　【開発元】Roche　 [DBR_ID]x

　【化学名】L-Valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-3-hydroxypropyl ester, monohydrochloride

　【承認】FDA申請=、FDA承認=29-MAR-01 ;【製剤】Tablets -450mg　【適応】For the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS)　【製品情報】　【添付文書】www.rocheusa.com/products/valcyte/ppi.html　【日本】　【その他】Valcyte (valganciclovir HCl tablets) contains valganciclovir hydrochloride (valganciclovir HCl), a hydrochloride salt of the L-valyl ester of ganciclovir that exists as a mixture of two diastereomers. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).








●承認データ：FDA



	
情報ソース●FDA Drug Approvals List March 2001

Original Application #: 021304 
Approval Date: 29-MAR-01 
Trade Name: VALCYTE 
Chemical Type: 2 
Therapeutic Potential: P 
Dosage Form: TABLET 
Applicant: SYNTEX (USA) INC LLC 
Active Ingredient(s): VALGANCICLOVIR HYDROCHLORIDE 
OTC/RX Status: RX 
Indication(s): For the treatment of cytomegalovirus (CMV) retinitis in patients 
with acquired immunodeficiency syndrome (AIDS) 


	
情報ソース●Drug Approvals - V
Valcyte (valganciclovir HCI) Tablets,450 mg, Rx Roche
Application #=NDA 21-304
Approval Date=3/29/01
Letter Posted=4/13/2001
Label Posted =4/13/2001
Review Posted=
Valcyte Indications: Treatment of cytomegalovirus (CMV) retinitis in patients wi
th acquired  immunodeficiency syndrome (AIDS).



●メーカーサイト




●製品サイト:Roche US Pharmaceuticals : Our Products : Valcyte
 --- www.rocheusa.com/products/valcyte/

VALCYTE Information
 --- www.rocheusa.com/products/valcyte/ppi.html












●メーカーニュース




Valcyte receives US approval for treatment of AIDS-related CMV retinitis Oral drug with IV potency[2001.4.2]
 --- http://www.roche.com/inv-news-detail-2001?id=606&media-language=e
Valcyte receives first European regulatory approval for treatment of AIDS-related CMV retinitis[2001.9.27]
 --- http://www.roche.com/inv-news-detail-2001?id=698&media-language=e
 Pan-European approval for oral CMV treatment expected mid-2002

 --- 



















●製品: インターフェロン








■FDA CBER Index


FDA/Center for Biologics Evaluation and Research
Hepatitis A Vaccine, Inactivated (VAQTA)
Hepatitis B Immune Globulin (Human) (Nabi-HB)
Hepatitis B Vaccine (Recombinant) (Engerix-B)
Hepatitis B Vaccine (Recombinant) (Recombivax)
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) (CHIRON RIBA HCV 3.0 Strip Immunoblot)

Infergen (Interferon alfacon-1)
Interferon alfa-2b (Intron A)
Intron A (Interferon alfa-2b)
Interferon alfa-n1, Lymphoblastoid (Wellferon)
Interferon alfacon-1 (Infergen)
Interferon beta-1a (Avonex)
Last Updated: 11/12/99




●Interferon alfa-2b, Schering Corp.



FDA/Center for Biologics Evaluation and Research
Product Approval Information - Licensing Action

Proper name: Interferon alfa-2b
Tradename: Intron A
Manufacturer: Schering Corp., Kenilworth, NJ, License #0994
Indication for Use: Use in conjunction with chemotherapy in patients with follicular lymphoma.
Approval Date: 11/6/97
Type of submission: Biologics license supplement

Approval Letter (Text)
Clinical Review (PDF)
Labeling (PDF)
Last Updated: 7/14/99




●●Interferon alfa-n1, Lymphoblastoid, Wellcome Foundation Ltd Wellcome Research L



U.S. Food and Drug Administration

FDA/Center for Biologics Evaluation and Research
Product Approval Information - Licensing Action

Proper name: Interferon alfa-n1, Lymphoblastoid
Tradename: Wellferon
Manufacturer: Wellcome Foundation Limited Wellcome Research Laboratories, Beckenham, Kent, UK, License #0129
Indication for Use: For the treatment of chronic hepatitis C in patients 18 years of age or older without decompensated liver disease.
Approval Date: 3/25/99
Type of submission: Product license application

Approval Letter (PDF)
Label (PDF)
Last Updated: 5/28/99




●Interferon alfacon-1 - Amgen, Inc.



FDA/Center for Biologics Evaluation and Research
Product Approval Information - Licensing Action

Proper name: Interferon alfacon-1
Tradename: Infergen
Manufacturer: Amgen, Inc., Thousand Oaks, CA, License #1080
Indication for Use: Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA
Approval Date: 10/6/97
Type of submission: Biologics license application

Approval Letter (PDF)
Label   (PDF) 
Last Updated: 3/30/99




●Interferon beta-1a, Biogen, Inc.



FDA/Center for Biologics Evaluation and Research
Product Approval Information - Licensing Action

Proper name: Interferon beta-1a
Tradename: Avonex
Manufacturer: Biogen, Inc., Cambridge, MA, License #1204 
Indication for Use: Treatment of relapsing forms of multiple sclerosis to slow t
he accumulation of physical disability and decrease the frequency of clinical exacerbations.
Approval Date: 5/17/96
Type of submission: Product license application
Approval Letter (PDF)
Label (PDF)
SBA (PDF)
Last Updated: 12/9/98












■製品: ALFERON N Injection(R) [Interferon alfa-n3 (human leukocyte derived)] 



　日本語版註）

　【別名】　【開発元】　 [DBR_ID]

　【化学名】

　【承認】FDA申請=、FDA承認= ;【製剤】　【適応】　【製品情報】　【添付文書】　【日本】　【その他】









●Alferon for Recurrent Genital Warts - Package Insert



ALFERON N Injection(R) 

The Company's ALFERON N Injection(R) [Interferon alfa-n3 (human leukocyte derived)] product has been approved by the U.S. Food and Drug Administration for the treatment of certain types of genital warts and is being studied for the potential treatment of HIV, hepatitis C and other indications. 


ALFERON N Gel(R) 

ALFERON N Gel(R) is the Company's registered trademark for its topical (dermatological) Natural Alpha Interferon preparation in a hydrophilic gel base.

In January 1998, the Company announced the start of an investigator-sponsored, Phase 2 clinical trial in women with intravaginal warts, a condition caused by the human papillomavirus (HPV). This study will evaluate the effectiveness of ALFERON N Gel in treating the warts and eliminating the HPV in these patients.


ALFERON LDO(R) 

ALFERON LDO(R) is the Company's registered trademark for its low-dose, oral liquid formulation of Natural Alpha Interferon. 

The Company has completed two Phase 2 clinical trials using ALFERON LDO for the treatment of HIV-infected patients. In addition, a National Institute of Allergy and Infectious Disease (NIAID) sponsored Phase 3 trial in HIV-infected patients has been concluded in which ALFERON LDO was included as one of the treatments. The NIAID will analyze and publish the results of the completed patients when available.

The Company also has other Natural Alpha Interferon formulations in various stages of development for the potential treatment of viral and immune system diseases.

●Interferon Sciences : http://www.interferonsciences.com/








株式会社メドレット
			Medlet Japan KK

〒103-0024 東京都中央区日本橋小舟町１２－１０共同ビル（掘留）５Ｆ　久永&Co気付
  tel.03-3664-2020  fax.03-3666-3188　URL:www.medmk.com/mm/ 　E-Mail: support@medmk.com


	
一覧へ戻る。

	
ホームへ戻る。
	
関連●MLリソース：ヘルペス治療剤へ
	
関連●MLリソース：肝炎へ
	
関連●MLリソース：C型肝炎治療剤へ
	
関連●ML:抗ウイルス薬：インフルエンザ[1063_ADD]へ
	
●2002-------------------------------------------
	
★★1143★18/23★02.11.11★095★口唇ヘルペス治療薬バラシクロビル（Valtrex）/2p●MLリソース：抗ウイルス剤|MLリソース：ヘルペス治療剤
	
●2001-------------------------------------------
	
★★1113★17/19★01.09.17★081★インフルエンザ予防2001-2002/2p●MLリソース：インフルエンザ|MLリソース:抗ウイルス薬(インフルエンザ)[1063_ad2]
	
●2000-------------------------------------------
	
★★1092★16/24★00.11.13★108★再発性口唇ヘルペス治療薬ドコサノール・クリーム(Abreva)/1p●MLリソース：ヘルペス治療剤
	
●1999-------------------------------------------
	
1053★15/11★99.05.21★050★ロタウイルスワクチン/1p●1053追加メモ[42KB]
	
★1063★15/21★99.10.08★091★インフルエンザ治療用：二つのノイラミニダーゼ阻害剤[ザナミビル,オセルタミビル]/2p●MLリソース:インフルエンザ|●MLリソース:抗ウイルス薬(インフルエンザ)[1063_ad2]
	
★1067★15/25★99.12.03★113★非HIVウイルス感染症治療薬/8p●MLリソース：抗ウイルス剤
	
●1997-------------------------------------------
	
1003★13/13★97.06.20★057★口唇ヘルペスに対する局所用ペンシクロビル
	
1006★13/16★97.08.01★069★非ＨＩＶウィルス感染症に対する薬剤/8p
	
●1996-------------------------------------------
	
0965★12/01★96.01.05★003★バラシクロビル
	
-------------------------------------------------
	
作成：2000.1.11　最終更新:2000.1.11/2002.12.16　小菅博之


          
The Medical Letter日本語版
●追加メモ

On Drugs and Therapeutics



	
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