Dear MTN Friends and Family We are writing to you today to share information about changes in the VOICE trial resulting from the DSMB review of the study on September 16, 2011. The DSMB for VOICE has conducted three reviews of safety data and two reviews of efficacy. Based on this most recent review, the DSMB recommended that VOICE participants randomized to the oral tenofovir arm discontinue their use of the study product because of futility. What this means is that the VOICE study was not able to demonstrate that oral tenofovir is effective in preventing HIV in our study population. The DSMB made clear in its recommendation that it had no concerns about the safety of oral tenofovir and that VOICE should continue to evaluate the safety and effectiveness of tenofovir gel and the oral Truvada tablet. We are all asking ourselves why oral tenofovir was not effective in preventing HIV in the diverse group of young women in VOICE. The simple answer at this point is that we do not know. Oral tenofovir was very effective in the women enrolled in the Partners PrEP Study. But it is important to recognize that the women in the Partners PrEP Study are very different than the women enrolled in VOICE. They are older overall, and importantly all are in a committed relationship with a partner known to have HIV. If there’s one thing we’ve learned over the years it’s that unmarried women in their 20s are in a very different place in their lives than married women in their 30s. People in different circumstances will make different choices about their use of condoms, their choice of partners and whether or not to use a biomedical prevention product. As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir, and even when we have more information available to us, understanding what exactly happened (or not) will not be simple. Studies are designed to answer questions, and the VOICE team and our communities of participants have helped us understand that daily use of oral tenofovir was not an effective approach for our participants living in communities where HIV incidence is very high. While we are disappointed in this outcome, we believe that these results will be of great importance as decisions are made regarding which populations might most benefit from oral tenofovir pre-exposure prophylaxis as part of a prevention package. We are working to implement the changes recommended by the DSMB, which will not be without its challenges. Thankfully, we have a stellar team, supportive communities and committed participants. They have brought us this far in VOICE, and they will carry us forward as well. So, please join us in thanking the sites, the participants, communities, the labs, the data management teams, Kaila Gomez and the many talented staff at FHI 360 and VOICE protocol co-chairs Mike Chirenje and Jeanne Marrazzo for their tireless dedication to this study. Finally, we would like to thank our funders at NIH and acknowledge the support of both Gilead and CONRAD who have worked closely with our teams. As we continue our efforts to complete VOICE, we look forward to seeing many of you in October at our regional meeting in Cape Town. We have much work to do. Sincerely Sharon Hillier and Ian McGowan SeeMicrobicide Trials Network Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women Questions and Answers Regarding the Decision to Modify VOICE NIAID Statement
