Protease inhibitor consensus statement. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023. NLM AIDSLINE Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

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Protease inhibitor consensus statement. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Treat News. 1995 Mar 24;(no 219):7. Unique Identifier : AIDSLINE AIDS/95700358

Abstract: The Protease Consensus Coalition has developed the Consensus Statement on the Accelerated Approval of Protease Inhibitors. The statement has been signed by 61 organizations, as well as over 100 individuals. According to the statement, access to protease inhibitor drugs now in development represents the best hope for delaying disease progression for many people living with HIV and AIDS who have exhausted the limited benefit from currently approved antiviral therapies. The inhibitors have demonstrated both lower levels of toxicity and significantly increased levels of antiviral activity, even in people with advanced disease. A limitation of the compounds may be drug resistance. The statement demands that both sponsors and the Food and Drug Administration (FDA) make use of compassionate access programs to make these drugs available, prior to accelerated approval, for those people who have failed existing therapies and risk near-term danger of death or life-threatening infections. In addition, protease inhibitor compounds should be licensed for accelerated approval as soon as possible. The statement also requests meaningful data on the speed and levels of resistance encountered, degree of cross-resistance found with other protease inhibitor compounds, the interaction of the compound with other commonly used anti-HIV medications, and bioavailability. Organizations and individuals can obtain a copy of or sign the statement by sending a fax to the Linda Grinberg Foundation, (310) 471-4565.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Consensus Development Conferences Drug Approval Drug Interactions Drug Resistance, Microbial Human HIV Infections HIV Protease Inhibitors/*THERAPEUTIC USE NEWSLETTER ARTICLE

KWDacquiredimmunodeficiencysyndrome/KWDdrugtherapyconsensusdevelopmentconferencesdrugapprovaldruginteractionsdrugresistance,microbialhumanhivinfectionshivproteaseinhibitors/KWDtherapeuticusenewsletterarticle
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