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GLOBAL INTEREST IN MICROBICIDES
In 2011, the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that 34 million people were infected with HIV worldwide. In sub-Saharan Africa, almost 60 percent of infected individuals are women. Despite their great risk, many women find it difficult to protect themselves from HIV infection through negotiating delay of sexual debut, partner reduction and condom use. Therefore, a need exists for HIV prevention methods that women can initiate themselves. As an agency committed to international development and a key partner in the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the U.S. Agency for International Development (USAID) supports the development of microbicides (products that can be applied vaginally to prevent sexual transmission of HIV) as one of several methods to address this urgent and yet unmet need for protecting women in developing countries against HIV and AIDS.
For more than a decade, USAID has been a global leader in microbicide research and development. Since 2000, USAID has collaborated with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to develop and implement strategic HIV prevention research. USAID is committed to supporting the development of safe, effective, acceptable and affordable microbicide products that are suitable for use in developing country public sector programs.
ADVANCING MICROBICIDE RESEARCH
The Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 trial was completed in 2010 in South Africa. Results from the trial provided the first-ever proof of a concept that a vaginal microbicide could safely and effectively reduce the risk of heterosexual transmission of HIV from men to vulnerable women. The use of 1% tenofovir gel in a pericoital (before and after sex) dosing regimen by 889 women at high risk of HIV infection proved the method to be 39 percent effective in reducing a woman’s risk of becoming HIV infected. Importantly, the gel was more effective in women who were highly adherent (based on levels of tenofovir) and was associated with an 80 percent reduced risk of HIV transmission in this group.
Since USAID is committed to providing new HIV prevention options to vulnerable women and girls across the world, particularly those in low-resource settings, the Agency jumpstarted a confirmatory trial to bring the product one step closer to licensure.
The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) through USAID, the Bill & Melinda Gates Foundation and the Government of South Africa collaboratively supported a confirmatory trial of 1% tenofovir gel used before and after sex. This confirmatory trial, called FACTS 001 (Follow-on African Consortium for Tenofovir Studies), was conducted by a newly created South African-initiated and -led consortium established to develop and conduct follow-on research on whether tenofovir gel can protect women against HIV infection as well as infection with herpes. Enrollment in FACTS 001 began in October 2011, and results were released in February 2015 at the Conference on Retroviruses and Opportunistic Infections.
Although FACTS 001 was designed to confirm and replicate CAPRISA 004 on a larger scale, FACTS 001 did not confirm the results of CAPRISA 004. Overall, adherence in the study population may have been too low to confirm tenofovir gel effectiveness for HIV prevention in women. Moving forward, USAID will focus predominantly on less user-dependent delivery systems, such as vaginal rings and long-acting topical and systemic dosage forms. These methods may prove to be more suitable for women whose circumstances do not favor daily or pericoital dosing regimens.
USAID believes this trial reflects the larger cooperation between the United States and South Africa on addressing the AIDS epidemic. This partnership is also a prime example of successful country ownership and South Africa’s prioritization of donor-supported activities within the context of its own goals for global health.
As part of USAID’s continuing leadership in the microbicide field and pioneering role as a development agency, the Administrator has developed a high priority strategic plan for microbicide introduction. The shared vision emphasizes USAID’s commitment to move aggressively in pursuing these objectives. USAID is using its experience in introductory studies, distribution, logistics management, service delivery, provider training and social marketing to ensure these products are available once regulatory approval is received.
A woman holds a vaginal ring.
Additionally USAID is contributing to the first-ever efficacy study for an antiretroviral drug-based monthly vaginal ring. The sustained release dapivirine ring is intended to provide women with a long-acting method for protection from HIV. The Ring Study began enrolling in April 2012 and is being conducted by the International Partnership for Microbicides. Results of this Phase III study are anticipated in late 2015.
USAID also continues to fund several novel microbicide leads and delivery methods to ensure that women will have a variety of options for protection from HIV in the future.
- Read Administrator Shah’s Statement on the results of CAPRISA 004.
- Read Administrator Shah’s Statement on the Announcement of FACTS 001.
- Proposal for a Shared Vision and Strategic Plan for Microbicide Introduction [PDF, 180KB]
- Read USAID’s Question and Answer Fact Sheet on the results of FACTS 001 [PDF, 576KB]
Last updated: February 24, 2015