The next generation of HIV / AIDS drugs and preventive treatments continues to look promising. New research released on Tuesday suggests that people can safely use a vaginal ring 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 works by inhibiting HIV’s ability to replicate inside cells. Since 2014, the International Partnership for Microbicides (IPM) – a non-profit organization focused on the development of HIV prophylactics for women in low-income countries – has owned the rights to dapivirine and has tried to secure approval of the drug as the first of its type of intravaginal ring that can reduce a person’s risk of infection. This would make the drug a way of pre-exposure prophylaxis, or (PrEP). Currently, the only form of PrEP available is a pill that must be taken daily.
In late 2019, after the completion of two Phase III trials in Africa, a monthly formulation of dapivirine was submitted for approval by the European Medicines Agency (EMA). Last year, the EMA did 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. In early January, the World Health Organization recommended dapivirine as a treatment that should be included as one of several options for HIV prevention. IPM said it is applying for the approval of dapivirine in several countries in sub-Saharan Africa, where HIV rates among women remain very high. Last week, they also applied for the approval of the drug by the US Food and Drug Administration.
While this process was underway, IPM, in partnership with the United States National Institutes of Health, tested whether a longer-lasting version of the ring would be better for women to wear, as it is likely to be made available to the public. Your preliminary results, detailed Tuesday at (virtual) Conference on Retroviruses and Opportunistic Infections, seem to point in that direction.
The Phase I study involved 49 healthy HIV-negative women and women at birth in the United States. Two groups of volunteers used a ring containing 100 milligrams or 200 milligrams of dapivirine for 90 days, while a third group wore the monthly form of the ring, which contained 25 milligrams of dapivirine, for the same period of time. Then, they were observed for 13 weeks.
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All three groups appear to tolerate their rings well, with no serious health risks found during the study. But those who used the 90-day version had higher levels of dapivirine in their blood and cervical tissue. This indicates that the drug could be more potent and effective in preventing HIV when used in this more lasting way.
The results are still preliminary, it should be noted. And Phase I tests 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 would not be a major hurdle to bring a 90-day version to the public eventually, assuming that this research continues to show promise. 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 faced the HIV epidemic in much of the world and need and deserve to have a variety of safe and effective methods. Hopefully, an extended-lasting dapivirine ring that women replace every three months may be another option available to women in the not-too-distant future, ”said study author Albert Liu, director of clinical research at the Department of Public Health of San Francisco, in a demonstration launched by the Microbicide Trials Network, a project funded by the United States National Institute of Health to study and help develop preventive treatments for sexually transmitted diseases like HIV.
Recently, there has been a lot of encouraging news in the world of HIV research. In addition to the vaginal ring approach, work is underway on the development of other, longer-lasting versions of PrEP injection or one compressed, for people at higher risk of infection. And in February, the first long-term HIV treatment – a series of two injections, taken monthly – was okay by the FDA, called Cabenuva. Recent research has since suggested that Cabenuva can be taken only six times a year, and that the manufacturer of the drug, VIVi Healthcare, has already applied for an updated approval in the bimonthly version.