February 26, 2016
Anna Miti, a 2015 AVAC fellow and Zimbabwean broadcast journalist, writes in her blog about the dapivirine vaginal ring results. She talks about next steps for the ring and how there is a need now to advocate for all stakeholders to call for the expedition of the process to make the ring available to those who need it.
I have to admit that the last few weeks have been a bit stressful, waiting anxiously for the results of a microbicide ring study- meant to prove its efficacy in HIV prevention. Well, finally the results are here! This is probably one of the biggest breakthroughs we have had in HIV prevention specifically for women in a while. Significant because we know women are more vulnerable to HIV infection than their male counterparts. I am glad to say that after the disappointing results of previous microbicides trials in Africa, the world has some news to share. And it is good news- well, mostly. The results of two phase 3 trials, ASPIRE study and Ring study, showed efficacy rates ranging from 27 to 61 percent. The trials showed that a monthly vaginal ring containing the antiretroviral drug (ARV) dapivirine can safely help prevent HIV infection in women. The Ring Study showed that the monthly dapivirine ring safely reduced HIV infection overall by 31 percent compared to a placebo. Similar results were seen in ASPIRE, which found that the ring safely reduced infection by 27 percent overall. The factors leading to the differences in efficacy are by age and consistency of ring use, or adherence, where older women (aged 25 and above) and those with the best adherence having the best protection. ASPIRE showed that the ring reduced HIV risk by 61 percent in women older than age 25, and 56 percent in women older than 21 (in a post-hoc analysis), who also appeared to use the ring more consistently. The Ring Study also showed higher efficacy (37 percent) for women over 21. However, little to no protection was seen in women ages 18-21 across both studies — 15 percent in The Ring Study and no protection in ASPIRE.
The good news is that the ring has the potential to prevent new HIV infections in one out of three women at worst and one out of two women at best, if used correctly and with high adherence. Besides pre-exposure prophylaxis and the male and female condom, the ring can be used as an additional tool for women to protect themselves from HIV infection. Significantly the Ring, when available, would be the only tool that women can use overtly or covertly for HIV prevention, removing the need to negotiate for safer sex. Negotiations for safer sex are not always successful as women find themselves vulnerable due to various socio-economic issues and therefore powerless to protect themselves from HIV by insisting on condom use or refusal to have sex.
The not-so-good-news is that this trial once again proved low levels of adherence in young women and subsequently low levels of protection for adolescent girls and young women, who are the most vulnerable to HIV infection. However some schools of thought suggest that other factors, such as biological differences might have played a role in low levels of protection in younger women.
The Ring Study enrolled 1,959 HIV-negative women ages 18-45 at seven sites in South Africa and Uganda, and ASPIRE enrolled 2,629 HIV-negative women ages 18-45 at 15 sites in Malawi, South Africa, Uganda and Zimbabwe. ASPIRE began in 2012 and ended in 2015. The Ring Study also began in 2012 and is reporting results early after its independent data safety and monitoring board recommended the study proceed to final analysis.
What Now
After all has been said and done the results of these two studies are positive. The microbicide ring is an additional tool that women can use to protect themselves from HIV. It can be used as part of a basket of HIV prevention methods including Pre-Exposure prophylaxis and the condom. There is need now to advocate for all stakeholders to call for the expedition of the process to make this ring available to those who need it. If we can prevent half of potential new HIV infections as proven by the two studies, then we have the potential to halt or reverse the HIV trajectory. The impact of such an occurrence would be phenomenal. Imagine the saving to public health if we stop new infections,which put a strain on health system in terms of costs, not to mention the impact on human development. On the other hand more needs to be done to investigate how to overcome barriers to HIV prevention for the youngest women. Efforts are already underway for studies to understand how ring use, and potential biological and other factors that may have influenced the different levels of protection seen by age in these studies. There is need to study what works for young women, and how we can further make HIV prevention tools work for them. We need to investigate barriers to adherence in young women, beyond the factors we already know such as low HIV risk perception.
The Future
There are still lots of potential to increase options for women, anchored on the success of the microbicides trials. Efforts are already underway to develop multi-purpose prevention technologies, which are basically products which will not only protect a woman from HIV, but protect her from pregnancy as well.
Conclusion
I believe that the swift move towards starting demonstration studies for the ring and the commencing of licensure processes can make HIV prevention in women happen faster. This will expedite the progress towards ending AIDS by 2030. Finally, as I finish this blog, I cannot pen off without thanking and appreciating the work done by research participants. These women are s/heroes and their dedication to the study will be beneficial to generations of women worldwide — WELL DONE!!