The next generation of drugs and preventive treatments for HIV / AIDS still looks promising. New research released Tuesday suggests that people can safely wear a vaginal ring-based treatment designed to prevent HIV infection for up to three months. A monthly version of the same drug is already being weighed for approval in African countries and elsewhere.
The treatment is called dapivirine. Like other antiretroviral drugs, it inhibits HIV’s ability to multiply in cells. Since 2014, the International Partnership for Microbicides (IPM) – a non-profit organization dedicated to developing HIV prophylactics for women in lower-income countries – owns the rights to dapivirine and is trying to be the first of its kind intravaginal ring to lower a person’s risk of infection. This would make the drug a form of it pre-exposure prophylaxis, or (PrEP). Currently, the only available form of PrEP is a pill that must be taken daily.
At the end of 2019, after the completion of two phase III studies in Africa, a monthly formulation of dapivirine was submitted to the European Medicines Agency (EMA) for approval. Last year, the EMA gave a positive review of the clinical trial data, which found that women taking dapivirine were about 27% to 35% less likely to contract HIV than those in the control group. Earlier this January, the World Health Organization recommended dapivirine as a treatment to be included as one of several HIV prevention options. The IPM has said they are seeking approval of dapivirine in several countries in sub-Saharan Africa, where the HIV rate among women is still very high. Last week too applied for the drug’s approval from the U.S. Food and Drug Administration.
While this process was underway, the IPM, in partnership with the U.S. National Institutes of Health, has been testing whether a longer-lasting version of the ring might be better for women to use once it is likely to be available to the public. Their preliminary results, detailed Tuesday on the (virtual) Conference on Retroviruses and Opportunistic Infections, seem to point in that direction.
The phase I study included 49 healthy HIV-negative women and subjects who were given female sex at birth in the US. Two groups of volunteers wore either a 100 milligram or 200 milligram dapivirine ring for 90 days, while a third wore the monthly ring containing 25 milligrams dapivirine for the same time. They were then monitored for 13 weeks.
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All three groups seem to tolerate their rings well, with no serious health risks identified during the study. But those who wore the 90-day version had higher levels of dapivirine in their blood and cervix tissue. This indicates that the drug could be more powerful and effective in preventing HIV when used in this longer-term form.
The results are still preliminary, it should be noted. And Phase I studies are expressly designed to test the safety of an experimental treatment, not its effectiveness. But if the monthly form of the dapivirine ring is approved as expected later this year, it wouldn’t be much of a hurdle to eventually bring a 90-day version to the public, assuming this research remains promising. The IPM is also testing a version of the ring that would contain dapivirine and a long-term contraceptive.
“Regulatory approval of the monthly ring would be an incredible milestone for women who have been the face of the HIV epidemic in much of the world and need and deserve a range of safe and effective methods. Hopefully, an extended-duration dapivirine ring that women replace every three months could be another option available to women in the not-too-distant future, ”said study author Albert Liu, clinical research director at the San Francisco Department of Public Health. a pronunciation released by the Microbicide Trials Network, a project funded by the U.S. National Institutes of Health to study and help develop preventive treatments for sexually transmitted diseases such as HIV.
There has been a lot of encouraging news in the world of HIV research lately. Aside from the vaginal ring approach, work is underway to develop other, longer-lasting versions of PrEP, taken as a injection or a pill, for people at higher risk of infection. And in February was the first long-term HIV treatment – a series of two injections, taken monthly – approved by the FDA, called Cabenuva. Recent research has since then suggested that Cabenuva can only be taken six times a year, and the drug’s maker, VIVi Healthcare, has now filed for updated approval for its bi-monthly version.