April 23, 2015
Manju Chatani-Gadi is an AVAC staff member.
Disappointed but not defeated – reflected the mood of many microbicides advocates at the recently concluded AVAC 2015 Partners Forum. At CROI 2015, results were announced from the FACTS 001 study that involved over 2000 mostly young women in South Africa. It found no effect for vaginal tenofovir gel overall in the trial. A month later, at the Partners Forum, many long-time microbicides advocates were still smarting from the results – having put a lot of heart and work into preparing for the results and hoping for success. In that context, participants in a breakout session to discuss the dapivirine vaginal rings studies were a little cautious in discussing how to best prepare for the trial results.
Earlier discussions at the Forum focused on the importance of advocating for women’s access to oral PrEP as a proven intervention. However, the need for a wide array of tools and options for women remains important and the group gathered for this breakout were also interested in non-systemic options for women like vaginal microbicides.
At the breakout session, an IPM colleague shared updates on the ASPIRE (MTN 020) and the RING (IPM 027) studies, reviewed the timeline for study results and plans for follow on trials. Both trials are studying a vaginal ring containing the antiretroviral drug dapivirine that is designed to be inserted into the vagina and remain there for roughly a month. Together, the two ongoing efficacy trials have enrolled over 4500 participants in Malawi, South Africa, Uganda and Zimbabwe. Results are expected in late 2015 or early 2016.
The research teams are planning for success, actively engaging regulators in each country as well as at the global level to discuss the timeline and requirements for licensure, should the results be positive. There are also plans for open-label extension trials to provide former study participants access to the dapivirine ring while it is undergoing regulatory review.
The open-label trials are still research studies that would seek to understand more about the safety and women’s use of the ring, issues important for broader implementation of the ring should it be approved. IPM is also collaborating with key partners to help ensure the ring would then be made available to women in developing countries at a low cost and as soon as possible. The earliest possible regulatory decision would be in 2017 or 2018.
Some participants at the breakout session were interested to know what kinds of adherence measures were being used in the Ring studies. Previous microbicide and PrEP trials – including FACTS 001, VOICE and FEM-PrEP – reported difficulties in participants adhering to trial dosing regimens. They were curious if the Ring study teams were talking to other researchers to learn about how to address adherence issues found in earlier trials. Several participants were concerned on what it would mean for the field if the ring trials did not show positive results, and a few talked about fatigue to disappointing results.
There was animated discussion about whose role it was to prepare for results with policy makers, media and community groups. “Are we doing the work of the trial teams?” one participant asked, “Why aren’t they preparing better?”, “Are we giving false hope?”, and “What if it doesn’t work?” One view that helped to rally the room is that advocates need to be poised to respond to the results – if positive, to advocate for quick passage to licensure and then into the hands of those who most need prevention tools; and if not – to ensure the urgent need for more tools for women does not fall off the radar.
In discussing how to prepare for the ring results expected late 2015 or early 2016, many in the room pointed to existing platforms that could be built on: the in-country mechanisms through which groups prepared for the FACTS 001 results; the ad-hoc groups brought together for the Ring consultations conducted last year by IPM, MTN, AVAC and country partners; and AVAC’s materials and ongoing processes to help prepare advocates for results.
There was a clear call for early planning and for materials that were specific to each country’s context. The group called on the research teams and AVAC to help ensure that advocates had a good understanding of the research to be able to react, and to develop materials and messages. They also called for simple information on results from past trials to be able to refer to. Many advocates in the room committed to have meetings when they got back home to develop more detailed plans.
Cautiously optimistic, advocates and allies left the room still discussing what they learned and felt from FACTS 001 – and how to re-energize for the Ring results.