Dear MTN Friends and Family
We are writing to you today to share some new information about changes in the VOICE trial resulting from the DSMB review of the study on November 17, 2011. The DSMB for VOICE has conducted four reviews of safety data and three reviews of efficacy. As you know, the DSMB review in September resulted in the discontinuation of the oral tenofovir tablet arm for futility. After reviewing additional efficacy and safety data on November 17, the DSMB recommended that VOICE participants randomized to 1% tenofovir gel and placebo gel arms discontinue their use of the study product because of futility. The incidence of HIV was no different in the tenofovir gel group than it was in the placebo gel group. What this means is that the VOICE study did not confirm the 39% protective benefit of tenofovir gel which was reported from the CAPRISA 004 study. The DSMB made clear that it had no concerns about the safety of tenofovir gel and that VOICE should continue to evaluate the safety and effectiveness of the oral Truvada tablet.
As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir and tenofovir gel, and even when we have more information available to us, understanding why our results differed from the CAPRISA results may not be clear. For now, the study will continue and we will work to complete the remaining visits for the women continuing in the study. All women in the study will be informed of the closure of the gel arm. The women enrolled in the gel arms will discontinue use of their assigned product at their next scheduled visit and will then return for a final follow-up visits 8 weeks later. Women enrolled in the oral Truvada or oral placebo groups will continue their planned follow-up visits as originally planned. We estimate that the final visits on oral drugs will be completed before June 2012. Although we are all eager to understand whether adherence, our daily dosing strategy, inflammation, or other factors could explain the lack of oral and vaginal tenofovir effectiveness in VOICE, we will not likely have all of the assays completed until later next year.
While we are disappointed and surprised by these results, we are grateful that we successfully answered the question of whether daily use of tenofovir gel could prevent HIV. As you know, we have several planned and ongoing studies of tenofovir gel and the future of these studies is being discussed with our colleagues at NIH and CONRAD. In the meantime, please join us in thanking the sites, the participants, and communities for their critical contributions, Kaila Gomez and the entire team at FHI360, SCHARP, and our VOICE protocol co-chairs Mike Chirenje and Jeanne Marrazzo for their leadership of 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.
December 2 is World AIDS Day, and it is a good opportunity to remember that prevention of HIV has been a difficult challenge. The past year has brought both amazing victories and tremendous disappointments. The women enrolled in the gel arms of VOICE had a 6% annual sero-incidence rate of HIV, a level of infection which is astonishingly high 30 years into this epidemic. We must continue our efforts to identify methods which can reliably reduce the rates of new infections for people worldwide.
Sincerely,
Sharon Hillier and Ian McGowan
Please see attached the MTN statement and a comprehensive Questions and Answers document, or go to http://www.mtnstopshiv.org/news/studies/mtn003
| Description | Date | Size |
|---|---|---|
| MTN Statement on Decision to Discontinue Use of Tenofovir Gel | 2011-Nov-25 | 321.1 KB |
| Questions and Answers on Decision to Modify VOICE, Outcome of November 17 DSMB Review | 2011-Nov-25 | 658.45 KB |
