The next generation of preventive drugs and treatments for HIV / AIDS continues to look promising. New research published Tuesday suggests that people can safely use a vaginal ring-based treatment intended to prevent HIV infection for up to three months. A monthly version of the same drug is already being evaluated for approval in African countries and elsewhere.
The treatment is called dapivirine. Like other antiretroviral drugs, it works by inhibiting the ability of HIV to replicate within cells. Since 2014, the International Microbicide Association (IPM), a non-profit organization focused on developing HIV prophylactics for women in low-income countries, owns the rights to dapivirine and has been seeking approval from the medication as the first option. -Itravaginal ring of this type that can reduce a person’s risk of infection. This would turn the drug into a form of pre-exposure prophylaxisor (PrEP). Currently, the only available form of PrEP is a pill that must be taken daily.
In late 2019, following 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 gave a positive review of clinical trial data, which found that women taking dapivirine were 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 to be included as one of several HIV prevention options. The IPM has said they are seeking approval for dapivirine in several countries in sub-Saharan Africa, where HIV rates among women remain very high. Last week, too applied for drug approval by the US Food and Drug Administration.
While this process is taking place, the IPM, in partnership with the US National Institutes of Health, has been testing whether a more durable version of the ring might be better for women once it is available to the public. Their preliminary results, detailed on Tuesday in the (virtual) Conference on Retroviruses and Opportunistic Infections, they seem to point in that direction.
The Phase I study involved 49 healthy HIV-negative women and individuals assigned to the female sex at birth in the U.S. Two groups of volunteers wore a ring containing 100 milligrams or 200 milligrams of dapivirine for 90 days, while a third He used the monthly form of the ring, which contained 25 milligrams of dapivirine, for the same time period. They were then observed for 13 weeks.
All three groups appear to tolerate their rings well, and no serious health risks were 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 may be more powerful and effective in preventing HIV when used for longer periods of time.
The results are still preliminary, it should be noted. And phase I trials are expressly designed to test the safety of an experimental treatment, not its efficacy. But if the monthly form of the dapivirine ring is approved as expected later this year, it wouldn’t be a huge hurdle to bring a 90-day version to the public eventually, assuming this research continues to show promise. The IPM is also testing a version of the ring that would contain dapivirine and a long-acting 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 variety of safe and effective methods. Hopefully, a long-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. from San Francisco, in a statement published by the Microbicide Trials Network, a project funded by the US National Institutes 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, other longer duration versions of PrEP are being developed, taken as a injection or a pill, for people at higher risk of infection. And in February, the first longest-lasting HIV treatment was given, a series of two monthly injections. approved by the FDA, called Cabenuva. Recent research has He suggested that Cabenuva can be taken as little as six times a year, and the drug’s maker, VIVi Healthcare, has now requested updated approval in the bi-monthly version.