“Game changer” in fight to protect women from HIV
22 February 2016
A vaginal ring that contains an anti-HIV drug to protect women could transform the response to the AIDS epidemic.
We welcome the results released today from two new clinical trials showing that a monthly vaginal microbicide ring that provides sustained delivery of the antiretroviral drug (ARV) dapivirine, reduces overall HIV infections among women by about 30%. This is the first time Phase III studies have confirmed statistically significant efficacy for a microbicide to prevent HIV.
The two studies — The Ring Study and ASPIRE — tested the efficacy of the ring. ASPIRE (MTN 020) was launched by the Microbicide Trials Network (MTN) and enrolled 2,629 women in Malawi, South Africa, Uganda and Zimbabwe; and The Ring Study (IPM 027) was sponsored by the International Partnership for Microbicides (IPM) and enrolled 1,950 women at sites in Uganda and South Africa.
Women have been waiting
Divya Bajpai, senior advisor for sexual and reproductive health and rights said: “Women have been waiting for this. The options we currently have are just too limited. The trial results show that we can provide women with a means of protecting themselves from HIV, ways that don’t require the active participation of their male partner. This is potentially groundbreaking.”
“In addition, the ring is already used for contraception and could be integrated into existing sexual and reproductive health services. We also understand that efforts will be made to make the ring affordable, which is vital for women in low and middle income countries who are most affected by HIV.”
For women over 25 years the trials showed promising levels of effectiveness – for example, the ASPIRE study showed that the ring reduced HIV risk by 60%. However, the results of the trials for 18-21 year old women were less encouraging, with the ring providing ‘little or no protection’ probably due to lack of adherence.
“We need to explore the ring’s potential for young women and adolescent girls who, crucially, are less able to negotiate condom use, an important factor driving the need for discreet and long-acting solutions like the dapivirine ring,” said Ms Bajpai.
“Ultimately the potential for the ring is huge. We want every woman to have the right to choose freely which HIV prevention methods work for her.”
Contribution to a growing HIV ‘toolbox’
Whilst these results are significant, no single biomedical tool will prevent HIV infections among women. The Alliance’s approach to HIV prevention is strongly rooted in a combination approach where biomedical interventions (such as the ring) must be combined with other interventions that promote an enabling environment and safe behaviour.
In planning for access to the ring, product developers, the donor community and governments must ensure that women are empowered to make informed choices.
There are still several steps to go before the ring can be submitted for approval by regulators – estimated to be early 2017. Next is the Open Label Extension (OLE) follow-on study which will make the dapivirine ring available to all Ring Study participants. This involves providing placebo participants with active rings to provide further insight into how women would use the ring once they are aware it can help offer protection.
An additional challenge is the reality of shrinking health budgets and falling donor support. Governments and donors will need to discuss and understand what level of financial resources they can dedicate to the roll-out of this product.
For years, women have been driving the microbicides agenda – and we congratulate the efforts of the 4500+ women who participated in these two trials, the researchers who have worked on the study and the advocates who have been championing women’s HIV prevention and sexual and reproductive health over the years.
We also acknowledge the continuing role that women living with HIV, their communities and the organisations that support them will play in supporting the next steps towards getting this new technology approved and rolled out, including ensuring that women know about the ring and how to use it.
- The full results will be presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts on Wednesday 24 February and can be viewed within 24 hours at http://www.croiconference.org
- Download our media statement here.