Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women.

Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women. Research Abstract Details 

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Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women. Abstract Text:

Risa M Hoffman,Obiamiwe C Umeh,Cindy Garris,Naomi Givens,Judith S Currier,Risa M Hoffman,Obiamiwe C Umeh,Cindy Garris,Naomi Givens,Judith S Currier,Risa M Hoffman,Obiamiwe C Umeh,Cindy Garris,Naomi Givens,Judith S Currier,

Purpose: Recent studies focusing on HIV-1-infected women have suggested the existence of sex-related differences in natural history, antiretroviral pharmacokinetics, efficacy, and tolerability. This article analyzes three pivotal trials of the protease inhibitor (PI) fosamprenavir (FPV) with a view to providing a better understanding of potential sex differences in efficacy and safety. Method: A post hoc, descriptive analysis was performed on data from 700 subjects (26% women) in three trials of FPV to evaluate sex differences with regard to efficacy, rates of discontinuation, and treatment-related adverse events. Results: No major sex differences were found. Men and women had similarly good antiviral responses, with greater than 60% of treatment-naïve subjects achieving virologic suppression (<400 copies/mL) at 48 weeks. PI-experienced women in CONTEXT receiving once-daily FPV/r experienced the highest rates of discontinuations due to virologic failure (29% in women vs. 8% in men). Women generally had slightly lower rates of liver enzyme elevations and fewer abnormalities of total cholesterol and triglycerides. Conclusion: The absence of major sex differences provides reassurance, but the small number of women in these trials limited the ability to draw conclusions. Future trials should be specifically powered to detect sex differences in safety and efficacy. Key words: antiretroviral efficacy, antiretroviral safety, fosamprenavir, sex differences.

Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women. Publishing Authors By Initials

RM Hoffman,OC Umeh,C Garris,N Givens,JS Currier,RM Hoffman,OC Umeh,C Garris,N Givens,JS Currier,RM Hoffman,OC Umeh,C Garris,N Givens,JS Currier,

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Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: HIV clinical trials

VOLUME: 8

Page Numbers: 371-80

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ISSN: 1528-4336

DAY: 28

MONTH: 11

YEAR: 2007

Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women. Information

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LANGUAGE: eng

NlmUniqueID: 100936377

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AFFILIATION: Division of Infectious Diseases and Center for Clinical AIDS Research Education, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.

Country: United States

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MEDLINETA: HIV Clin Trials

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