Joint Statement by the International Partnership for Microbicides and the Microbicide Trials Network on the FACTS 001 Study Results
February 24, 2015 — Although today’s announcement that tenofovir gel was not effective in preventing HIV when used before and after sex in the FACTS 001 study is disappointing, the study has provided important insight into how we can address the urgent need for prevention products women can and will use. Indeed, one of the key messages is that long-acting products, some of which are in clinical trials, may be more practical options for young women in Africa at high risk for HIV.
We applaud the dedication and efforts of the women who participated in the study, the true heroes in the quest to find effective, female-initiated prevention tools. We also commend both the FACTS 001 research team (the Follow-on African Consortium for Tenofovir Studies) and CONRAD, the study’s sponsor, for leading a well-run trial of the highest scientific caliber and ethical standards.
Each clinical study builds on previous efforts, and it is only through the persistence and commitment of researchers, volunteers and their communities that we will find the new tools that match women’s needs and fit into their lives. It is essential to maintain that tenacious commitment to prevention research for women, who, in many parts of the world, bear the brunt of the epidemic.
As the FACTS researchers further analyze the data to help better understand today’s result, we can focus on what we do know:
- Women urgently need self-initiated prevention tools. Women are biologically more vulnerable to HIV infection than men during heterosexual sex, yet gender inequities and other obstacles too often restrict their ability to protect themselves. Young women are particularly at risk. In some parts of Africa, women ages 15-24 are up to five times more likely than young men to be infected.
- Antiretroviral (ARV) drugs can prevent HIV when used consistently. Several studies show that ARVs are highly effective in preventing HIV. At the same time, other studies indicate that for young, high-risk women in Africa, ARVs delivered as a vaginal gel or as a tablet are not practical methods.
- Researchers have a responsibility to find products that women are able to use consistently. To that end, The Ring Study and ASPIRE are two Phase III studies being conducted in Africa in which we are evaluating a new product, a monthly vaginal ring that provides sustained-release of an ARV called dapivirine.
These two pivotal sister studies of the dapivirine ring — The Ring Study, being led by the International Partnership for Microbicides (IPM), and ASPIRE, being led by the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) — are designed to tell us whether the ring is safe and effective against HIV infection. The ring, which women insert and leave in place for one month, was developed by IPM, and is the first product of its kind to be studied for HIV prevention.
We are hopeful that the challenges women have faced using the gel will be fewer with the ring. Efficacy results of both trials are expected later this year or in early 2016. If the results support the ring’s efficacy and long-term safety, IPM will submit the product to global and national regulatory agencies for approval next year.
Because there will be no single solution to stopping HIV, we also have great hope for a number of products in earlier phase testing such as long-acting injectable ARVs, products that combine ARVs with a contraceptive, new vaginal and rectal products, and vaccines.
It is the responsibility of researchers, advocates and donors to make certain that all promising approaches are explored. New tools that match women’s needs will give them the power to protect their health, and bring us all closer to ending the epidemic.
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Additional information about FACTS 001 and tenofovir gel is available from the FACTS team at http://www.facts-consortium.co.za and CONRAD, the study’s sponsor, at http://www.conrad.org/news-pressreleases-107.html.
About dapivirine: Dapivirine belongs to a class of ARVs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that prevent HIV from making copies of itself. IPM acquired dapivirine in 2004 for development as a microbicide through a public-private collaboration with Janssen Sciences Ireland UC, a Janssen pharmaceutical company of Johnson & Johnson.
About IPM: The International Partnership for Microbicides (IPM) is a nonprofit organization dedicated to developing new HIV prevention tools and other sexual and reproductive health technologies for women, and making them available in developing countries. IPM partners with clinical trial networks and research centers around the world, and has offices in the United States and South Africa. Please visit www.IPMglobal.org.
About MTN: The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally. More information can be found at www.mtnstopshiv.org.