WHO and UNAIDS welcome ground breaking proof of concept study results for vaginal gel showing reduced risk of HIV infections in women
First time results from a South African study show that a gel containing an antiretroviral drug—when used as a vaginal microbicide—was found to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex.
VIENNA, 19 July 2010—The results announced today at the XVIII International AIDS conference in Vienna showed a significant reduction in risk of HIV infection in women who used a new generation of microbicide gels, one that contains the antiretroviral drug tenofovir. It also showed a significant reduction in genital herpes, a common viral sexually transmitted infection, which itself increases the risk of acquiring HIV infection.
This landmark proof of concept study was completed by the Centre for the AIDS Programme of Research in South Africa (CAPRISA). The gel was found to be both safe and acceptable when used once in the 12 hours before sex and once in the 12 hours after sex by women aged 18 to 40 years. Use of the gel reduced HIV infection by 39% and herpes simplex virus-2 infection by 51%.
“We are giving hope to women. For the first time we have seen results for a woman initiated and controlled HIV prevention option,” said Mr Michel Sidibé, Executive Director, UNAIDS. “If confirmed, a microbicide will be a powerful option for the prevention revolution and help us break the trajectory of the AIDS epidemic.”
Nearly 20 years of research have gone into microbicides that can be controlled by a woman, independent of her partner. This microbicide study could open new possibilities for HIV prevention.
"We welcome the findings of the CAPRISA study. All new advances in HIV prevention, particularly for women are exciting. We look forward in seeing these results confirmed. Once they have been shown to be safe and effective, WHO will work with countries and partners to accelerate access to these products", said Dr Margaret Chan, Director-General of WHO.
WHO and UNAIDS congratulate CAPRISA, a designated UNAIDS Collaborating Centre for HIV Prevention Research, on the successful completion of the study.
About half of the people living with HIV in the world are women. In sub-Saharan Africa more women are infected than men. HIV is a major cause of maternal mortality.
Given high levels of ongoing HIV transmission to young women in high prevalence settings, it is urgent now to confirm these results so that a safe and effective tenofovir gel can rapidly be made available to women who want it.
In addition to rapidly moving to additional trials to confirm results, key issues that need to be addressed include: determining requirements for the approval by national drug regulatory authorities of this new indication for tenofovir; operations research on how to deliver and sustain product supplies within combination prevention programmes; determining the frequency of HIV testing; and accelerated studies to expand knowledge on the safety of the product particularly in young women (below 18 years of age) and pregnant women.
To stimulate and prioritize rapid action, WHO and UNAIDS will convene an expert consultation in August with women’s health and HIV prevention advocates, scientists, microbicide research teams and product developers, and public health experts to discuss the next steps with the product. Given the important contribution and leadership role of the women who participated in the study, South African scientists, advocates and policy makers in implementing the study of tenofovir gel, the consultation will be held in South Africa.