Document Detail

Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention.
MedLine Citation:
PMID:  22333749     Owner:  NLM     Status:  MEDLINE    
Although the balance of recent evidence supports the efficacy of antiretroviral (ARV)-based pre-exposure prophylaxis (PrEP) against HIV-1 infection, recent negative trial results are perplexing. Of seven trials with available HIV endpoints, three different products have been tested: tenofovir 1% vaginal gel, oral tenofovir disoproxil fumarate (TDF) tablets, and TDF/emtricitabine tablets. Six of these trials were conducted exclusively in sub-Saharan Africa; all found the products to be well tolerated, and four demonstrated effectiveness. Furthermore, the HIV Prevention Trial Network (HPTN) 052 trial recently confirmed that antiretroviral treatment leads to 96% reduction in transmission to HIV-negative partners in HIV-serodiscordant couples. These results, along with human and animal data, provide substantial evidence for the efficacy of antiretroviral-based HIV prevention. Yet assessment of oral TDF/emtricitabine in the FEM-PrEP study and of oral and vaginal tenofovir in the Microbicide Trial Network (MTN)-003 trial (VOICE) was stopped for futility. How do we make sense of these discrepant results? We believe that adherence is a key factor, although it cannot be the only factor. Expanding upon a recent editorial in the Lancet, we discuss the impact of suboptimal product adherence on PrEP efficacy in the context of variable drug concentration at the exposure site, integrity of the vaginal epithelium, and the role of acute infection.
Ariane van der Straten; Lut Van Damme; Jessica E Haberer; David R Bangsberg
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  AIDS (London, England)     Volume:  26     ISSN:  1473-5571     ISO Abbreviation:  AIDS     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-04-13     Completed Date:  2012-07-30     Revised Date:  2012-11-01    
Medline Journal Info:
Nlm Unique ID:  8710219     Medline TA:  AIDS     Country:  England    
Other Details:
Languages:  eng     Pagination:  F13-9     Citation Subset:  IM; X    
Women's Global Health Imperative, RTI International, Department of Medicine, University of California San Francisco, USA.
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MeSH Terms
Adenine / analogs & derivatives,  therapeutic use
Administration, Oral
Anti-HIV Agents / administration & dosage,  therapeutic use*
Antiviral Agents / therapeutic use
Clinical Trials as Topic*
Deoxycytidine / analogs & derivatives,  therapeutic use
HIV Infections / prevention & control*,  transmission
HIV-1 / drug effects*
Patient Compliance
Phosphonic Acids / therapeutic use
Risk Factors
Treatment Outcome
Vaginal Creams, Foams, and Jellies / therapeutic use
Grant Support
Reg. No./Substance:
0/Anti-HIV Agents; 0/Antiviral Agents; 0/Phosphonic Acids; 0/Vaginal Creams, Foams, and Jellies; 0/emtricitabine; 0/tenofovir disoproxil; 107021-12-5/tenofovir; 73-24-5/Adenine; 951-77-9/Deoxycytidine

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