The next generation of drugs and preventive treatments for HIV / AIDS continues to look promising. New research launched on Tuesday suggests that people can safely wear a vaginal ring treatment designed to prevent HIV infection for three months. A monthly version of the same drug is already weighed 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 inside cells. Since 2014, the International Partnership for Microbicides (IPM) – a nonprofit organization focused on developing HIV prophylaxis for women in lower-income countries – has rights to dapivirine and is seeking approval for the drug as its first intravaginal ring that can reduce the risk. infecting a person. This would make the drug a form of pre-exposure prophylaxisor (PrEP). Currently, the only available form of PrEP is a pill that should 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 for approval by the European Medicines Agency (EMA). Last year, the EMA did a positive analysis of clinical trial data, which found that women receiving 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. The IPM said it was calling for dapivirine to be approved in several countries in sub-Saharan Africa, where HIV rates among women remain very high. Last week, too applied for approval of the drug by the US Food and Drug Administration.
While this process is underway, IPM, in partnership with the US National Institutes of Health, has tested whether a more durable version of the ring could be better for women to use, once it is likely to be made available to the public. Their preliminary results, detailed on Tuesday at (virtual) Conference on Retroviruses and Opportunistic Infections, they seem to point in that direction.
The Phase I study involved 49 HIV-negative healthy women and individuals who were assigned female birth rates in the United States. Two groups of volunteers wore either a ring containing 100 milligrams or 200 milligrams of dapivirine for 90 days, while a third wore the monthly ring shape, which contained 25 milligrams of dapivirine, for the same period of time. They were then followed 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 wearing the 90-day version had higher levels of dapivirine in their blood and cervical tissue. This indicates that the drug may be stronger and more effective in preventing HIV when used in this longer-lasting form.
The results are still preliminary, it should be noted. And phase I studies are specifically designed to test the safety of an experimental treatment, not its effectiveness. But if the monthly shape of the dapivirine ring is approved as expected later this year, it would not be an obstacle to finally bring a 90-day version to the public, assuming that this research continues to look promising. IPM is also testing a version of the ring that would contain dapivirine and a long-acting contraceptive.
The regulatory approval of the monthly ring would be an incredible milestone for women, who have been facing the HIV epidemic in much of the world and need and deserve to have a number of safe and effective methods. We hope that 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. A statement launched by the Microbicide Trials Network, a project funded by the US National Institutes of Health to study and contribute to the development of preventive treatments for sexually transmitted diseases such as HIV.
Recently, there has been a lot of encouraging news in the world of HIV research. In addition to the vaginal ring approach, there is ongoing work to develop other long-term versions of PrEP, taken as a injection or a pill, for people at higher risk of infection. And in February, the first more sustainable HIV treatment – a series of two injections, taken monthly – was approved by the FDA, called Cabenuva. Recent research has since suggested that Cabenuva can be taken six times a year, and the drug manufacturer, VIVi Healthcare, has now requested an updated approval for the bi-monthly version.