VOICE

Recent Results and Implications for the Field

The VOICE Study – Vaginal and Oral Interventions to Control the Epidemic – was designed to evaluate the safety and effectiveness of two antiretroviral (ARV)-based approaches for preventing sexual transmission of HIV in women as well as determining which of these women are more likely to follow: applying vaginal gel daily or taking an ARV tablet once a day.

Researchers announced that none of the interventions tested—daily oral tenofovir, daily oral TDF/FTC (Truvada), and daily 1% vaginal tenofovir gel—provided additional protection against HIV in the study, likely because few of the women in the trial used the products as directed. This low adherence explains the lack of benefit and is consistent with data from other trials that found a correlation between higher levels of adherence and protection from HIV.

Results from VOICE provide an urgent reminder that products must meet the needs of the people using them. While disappointing, the results lend new urgency and direction to the search for additional safe and effective HIV prevention options for women.

Read more from a recent Huffington Post piece by AVAC director Mitchell Warren, Listening to Women's Voices on HIV Prevention.

Summary documents

• Webinar with VOICE investigators -- recording, slides and write-up available here
• Watch the presentation of the data at CROI
• Click here to read a summary of reactions from the IRMA listserv
• Microbicides Trial Network — Understanding the results of VOICE
• Microbicides Trial Network — VOICE Questions & Answers
  
  

Statements on Trial Results

• Microbicides Trial Network — Daily HIV prevention approaches didn't work for African women in the VOICE study
• US National Institutes of Health — Daily-use HIV prevention approaches prove ineffective among women in NIH study
• AVAC — VOICE trial results underscore need to accelerate development of additional HIV prevention options for women
• Bill & Melinda Gates Foundation — Understanding the VOICE trial results
• CAPRISA — Women have to use tenofovir-containing tablets and gels to show that they prevent HIV infection
• US Centers for Disease Control and Prevention — In wake of latest trial results, CDC stresses that consistent use is imperative when using pre-exposure prophylaxis to prevent HIV infection
• HIV Prevention Trials Network — HPTN applauds study effort and urges continued research
• iPrEx — Results of a major HIV prevention study in African women confirms that pre-exposure prophylaxis is effective only when used consistently
• IRMA - Rectal Microbicide Advocacy — Statement on VOICE results
• NHVMAS — Statement on VOICE results
• USAID — VOICE HIV prevention trial releases findings

Working Group on US Women and PrEP

The US Women and PrEP Working Group, a coalition of more than 50 women from leading AIDS and women’s health organizations, calls on US government agencies to coordinate a national agenda that will quickly and accurately answer questions about how the antiretroviral (ARV) drug Truvada can best be made available as an HIV prevention option for women at risk of HIV infection.

More information:

• Coalition of US Women’s Health and HIV Advocates Call for Accelerated US Government Plan for Demonstrating Feasibility of PrEP for Women
• Working Group on US Women and PrEP Statement
• US Women and PrEP Working Group Position Statement: Key points

To join the Working Group, or learn more, e-mail avac@avac.org.

Further Resources:

• VOICE (MTN-003)
  Microbicide Trials Network Page
• NAM-AVAC Microbicides Webinar
  Examines the current state of research into topical microbicides
• PrEP and Women
  More information including a new statement on action needed in the US