NIH [to 27 February 2016]
http://www.nih.gov/news/releases.htm
February 22, 2016
Vaginal ring provides partial protection from HIV in large multinational trial
— NIH-funded study finds protective effect strongest in women over age 25.
A ring that continuously releases an experimental antiretroviral drug in the vagina safely provided a modest level of protection against HIV infection in women, a large clinical trial in four sub-Saharan African countries has found. The ring reduced the risk of HIV infection by 27 percent in the study population overall and by 61 percent among women ages 25 years and older, who used the ring most consistently.
These results were announced today at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston and simultaneously published online in the New England Journal of Medicine.

“Women need a discreet, long-acting form of HIV prevention that they control and want to use,” said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the primary funder of the trial. “This study found that a vaginal ring containing a sustained-release antiretroviral drug confers partial protection against HIV among women in sub-Saharan Africa. Further research is needed to understand the age-related disparities in the observed level of protection.”…

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UNAIDS [to 27 February 2016]
http://www.unaids.org/en/resources/presscentre/
23 February 2016
More investment needed in developing female-controlled HIV prevention options
Results from two recent studies of a monthly vaginal ring show modest protection from HIV infection for women
GENEVA, 23 February 2016—Results from two large-scale studies of a vaginal ring that releases the antiretroviral medicine dapivirine to prevent HIV among women have shown protection of around 30% against HIV. The results are encouraging and show the urgent need to expand investment in research and development for female-controlled methods of HIV prevention.

Although less effective than hoped for, the results are the first to show that a sustained release mechanism for antiretroviral medicine is feasible, safe and partially effective in preventing HIV infection among women. Follow-up studies are needed to build on these results and there is a need to better understand how to optimize the HIV prevention effect and support adherence.

“Women urgently need better options for HIV prevention, especially options that allow them greater control,” said Luiz Loures, Deputy Executive Director, UNAIDS. “The path to an effective microbicide has been a long one. The important results from these two studies take us one step closer towards an HIV prevention product that could protect millions of women worldwide.”

The two studies, presented on 22 February 2016 at the annual Conference on Retroviruses and Opportunistic Infections, being held in Boston, United States of America, were carried out across four African countries and recruited more than 4500 women. Each participant was randomly assigned to use either an active ring that slowly released the antiretroviral medicine dapivirine over the course of one month or to receive an inactive placebo ring containing no medicine. The risk of HIV infection was compared between women using the active rings and women using the placebo rings after two to four years of follow-up.

The ASPIRE/MTN-020 trial was carried out by the Microbicide Trials Network and the Ring Study/IPM 027 trial was carried out by the International Partnership for Microbicides. As the two trials were independent, it is encouraging that they achieved similar results (27% protection in ASPIRE and 31% protection in the Ring Study). Despite the high levels of adherence to the ring (82% in ASPIRE and 73% in the Ring Study), the results are lower than hoped for.

Another important finding from both studies was that there was little protection against HIV for women aged 21 years and below, with better protection for women 22 years and above. At least part of this difference was explained by better adherence in the older age group.

Young women in sub-Saharan Africa remain most affected by HIV. Around 79% of all women living with HIV (aged 15 years and older) live in the region. The results from this, and previous studies into female-controlled HIV prevention methods, reinforce the urgent need to find better HIV prevention methods that offer more choices for women…

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IAVI International AIDS Vaccine Initiative [to 27 February 2016]
http://www.iavi.org/press-releases/2016
February 22, 2016
IAVI Welcomes New Data from Dapivirine Ring Studies
The International AIDS Vaccine Initiative (IAVI) welcomes new data from two late-stage clinical studies indicating that vaginal rings containing the antiretroviral drug dapivirine can safely help protect vulnerable women in Sub-Saharan Africa from HIV infection.

Results of the ASPIRE and The Ring studies, announced Monday at the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, indicate that, when used consistently, the ring reduced the risk of HIV infection by approximately 30 percent in study participants overall (the study enrolled HIV-negative women aged 18-45). The results also indicate higher efficacy in women 21 and older, who also appeared to use the ring more consistently. Lower to no protection was found among participants 18 to 21 years of age.
The studies confirmed the very high-incident HIV infection rates among women in Sub-Saharan Africa, and found rates even higher than anticipated among some groups of younger participants.

“These results represent a significant step in advancing biomedical research of effective approaches to preventing HIV infection in women, and provide important insights into both opportunities and challenges to developing innovations capable of protecting those at greatest risk of infection in Sub-Saharan Africa,” said Mark Feinberg, MD, PhD, IAVI President and CEO.

“The data also underscore yet again the critical need for choices in HIV prevention – and the power to exercise those choices – for women in low-income countries who bear the brunt of this epidemic. We must ensure that all those living with HIV get access to antiretroviral treatment, that all biomedical prevention strategies with demonstrated efficacy are available to those who need them, and that research efforts to develop new highly effective prevention modalities are redoubled and sustained,” said Feinberg. “The sponsors, investigators and participants in the studies announced today all deserve tremendous recognition for their dedication and efforts to ensure the successful conduct of these important studies.”