Dear MTN Friends and Family,

Greetings from Boston and the Conference on Retroviruses and Opportunistic Infections (CROI), where just a short time ago results of ASPIRE and The Ring Study, were released in the opening press conference. The bottom line: both studies showed a similar and statistically significant reduction in new HIV infections with use of the dapivirine ring, the first sustained delivery method for prevention of HIV.

One of the greatest challenges in HIV prevention research has been the lack of replication of results across studies. We had great optimism after the HPTN-035 study showed a reduction in HIV among women assigned to the PRO 2000 gel group, but the reduction in HIV was not confirmed in the MDP-301 study. Similarly, the CAPRISA 004 study demonstrated a 39% reduction in HIV in women assigned to tenofovir gel, while in FACTS-001 there was no significant reduction in HIV in women asked to use the gel before and after sex. Even for oral PrEP we saw widely divergent results with Partners PrEP and iPrEx reporting significant reductions in HIV for people receiving tenofovir-based regimens, but in VOICE and Fem-PrEP which were conducted predominantly in young women, there was no significant reduction in new infections.

The results of ASPIRE were published online in the New England Journal of Medicine today, at the same time the results of both ASPIRE and The Ring study were announced at the CROI press conference.  Although the results of both studies found a 30% reduction in new infections overall, both studies showed that adherence continues to be a significant challenge for the youngest women in our trials. In women over 25 years of age, there was a 61% reduction in HIV infections. Additional age-stratified analyses showed that the ring reduced infections in women older than 21 years of age by 56%. That’s good news! But clearly, innovative new strategies will be needed to improve product adherence in the youngest women who were the least likely to use the rings. The Ring Study similarly showed a trend toward lower efficacy in the youngest women, with lower adherence to ring use in women younger than 21.

There are many questions about next steps for the dapivirine ring. For the MTN, the National Institute of Allergy and Infectious Diseases plans to convene a panel on March 9 to advise on areas of highest priority for next studies of the dapivirine ring. Meanwhile, The Ring Study is ongoing, but women who are on the study and who were assigned to the placebo ring will be offered rings containing dapivirine.

We want to congratulate the ASPIRE and The Ring Study teams for their monumental efforts in delivering two high quality trials. Our colleagues from the International Partnership for Microbicides (IPM), who developed the dapivirine ring, will be assembling the data from both studies into an integrated safety and efficacy summary so that the combined strength of the two studies can be understood. We are thrilled to have played a role as one of two sister studies. We are galvanized by these results

Please join us in thanking and acknowledging the study teams whose work was recognized today at CROI, as well as the participants and the NIH which supported ASPIRE. We are privileged to do this work. And please join us in also recognizing the many significant contributions made by you, the MTN.  The road ahead will be full of challenges and opportunities to provide new tools for HV prevention that can change the trajectory of the epidemic in young women.

Sincerely,

Sharon L. Hillier, PhD / Ian McGowan, MD, PhD, FRCP