Two Pivotal Studies Show Oral Antiretroviral Drugs Substantially Reduce Risk of HIV Infection in Men and Women

Confirms the power of ARVs to prevent HIV transmission

Statement from Dr. Zeda Rosenberg, CEO, International Partnership for Microbicides

SILVER SPRING, Md. (July 13, 2011) — In a major step forward in the fight against HIV/AIDS, important results from two studies, Partners PrEP and TDF2, show that taking an oral antiretroviral (ARV) tablet once a day — in the form of either tenofovir or Truvada® (tenofovir with emtricitabine) — significantly reduces the risk of becoming infected with HIV in heterosexual men and women. IPM congratulates the research teams from both studies and all the study volunteers for their important contributions to HIV prevention efforts that could one day save millions of lives.

Partners PrEP is a Phase III trial led by the University of Washington that enrolled 4,758 serodiscordant couples (in which one partner is HIV-positive and the other is not) at nine research sites in Kenya and Uganda. The trial examined the efficacy of two different ARVs, tenofovir and Truvada, to prevent HIV infection compared with a placebo. On July 10, 2011, the Partners PrEP Data Safety and Monitoring Board (DSMB) determined that, due to the significant HIV prevention effect of the products being tested, the results of the trial should be made public and the placebo arm of the study be discontinued. Results showed that participants who received daily tenofovir tablets had an average of 62 percent fewer HIV infections than the placebo arm, and participants who received daily Truvada tablets had an average of 73 percent fewer infections. All participants received comprehensive HIV prevention services. The DSMB also recommended that the study continue, but with participants originally randomized to the placebo arm to now receive tenofovir or Truvada.

TDF2 is a Phase II trial led by the US Centers for Disease Control that enrolled 1,200 heterosexual men and women in Botswana to receive a daily dose of either Truvada or a placebo along with comprehensive HIV prevention services. Overall, Truvada was found to be approximately 63 percent effective at preventing HIV infection.

These two studies are significant achievements in the fight against HIV. Researchers will continue to examine data from these studies and explore the different findings reported by the recent FEM-PrEP trial, which looked at the efficacy of oral Truvada in heterosexual women and was stopped early when it was determined to be highly unlikely that the product would demonstrate effectiveness in that population. The study sponsor, FHI 360, is conducting additional analyses to determine if there were differences in adherence to the study product or other factors.

Today’s news alongside recent studies showing the great potential of ARV-based prevention for HIV —including last year’s landmark CAPRISA 004 study showing proof-of-concept for ARV-based vaginal microbicides as well the recent iPrEx and HPTN 052 studies — all demonstrate the enormous potential for ARV-based technologies to revolutionize the world’s approach to preventing HIV. A number of additional studies are currently underway to confirm or expand on the CAPRISA, Partners PrEP and TDF2 results, and help the global community identify how to best ensure that safe and effective ARV-based prevention tools are made available to those who need them most.

Today’s announcements strengthen our efforts to build on this research and explore additional, long-acting ARV-based prevention strategies that could potentially improve adherence and effectiveness. In addition, given the disparate impact of the epidemic on women, the need for new, women-initiated tools for HIV prevention has never been more urgent. In sub-Saharan Africa, young women ages 15 to 24 are more than twice as likely as young men to be HIV-positive yet lack HIV prevention methods that they can use to protect themselves. Products such as vaginal rings and gels could expand the range of practical prevention methods available to women. The microbicide ring also has the potential to deliver combinations of ARV drugs with a contraceptive, allowing women to preserve their HIV prevention and reproductive choices.

The promise of ARV-based prevention will only be realized if people can obtain these new technologies easily and affordably, and use them effectively once they are available. Thanks to the dedication of both study teams and all the volunteers who made today’s announcement possible, we have made a great leap forward in that direction.

For more information about the Partners PrEP study, visit: http://depts.washington.edu/uwicrc/research/studies/files/PrEP_PressRelease-UW_13Jul2011.pdf

http://depts.washington.edu/uwicrc/research/studies/files/PrEP_FAQ.pdf

For more information about the TDF2 study, visit: http://www.cdc.gov/nchhstp/newsroom/PrEPHeterosexuals.html

For more information about the FEM-PrEP study, visit:

http://www.fhi.org/en/Research/Projects/FEM-PrEP.htm

About IPM: IPM is a nonprofit product development partnership dedicated to developing new HIV prevention technologies and making them available to women in developing countries. IPM has offices in the United States, South Africa and Belgium. To learn more, please visit www.IPMglobal.org.

Contacts:

IPM US and Europe: Holly Seltzer, hseltzer@IPMglobal.org, +1.301.608.4277

IPM Africa: Leonard Solai, lsolai@IPMglobal.org, +27.84.660.6776