The next generation of medicines and preventive treatments for HIV / Aids still looks promising. New research released Tuesday suggests that people can safely wear a treatment on the vaginal ring for three months to prevent HIV infection. A monthly version of the same remedy is already being weighed in African countries and elsewhere for approval.
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 non-profit organization aimed at developing HIV contraceptives for women in low-income countries – has had the rights to dapivirine and seeks the approval of the drug as a first its kind of intravaginal ring that can lower the risk of infection of a person. This will give the drug a form of prophylaxis before exposure, or (PrEP). Currently, the only available form of PrEP is a pill to be taken daily.
At the end of 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 the clinical trial data, which found that women with dapivirine were approximately 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 the various options for HIV prevention. The IPM said it was applying for dapivirine approval in several countries in sub-Saharan Africa, where the percentage of HIV among women is still very high. Last week they also applied for the approval of the drug by the U.S. Food and Drug Administration.
While this process was underway, the IPM, in partnership with the U.S. National Institutes of Health, tested whether a long-lasting version of the ring was better for women to use once it was likely to be made available to the public. Their preliminary results, Tuesday on the (virtual) Conference on retroviruses and opportunistic infections, seems to point in that direction.
The Phase I study covers 49 healthy HIV-negative women and individuals who were assigned female sex during childbirth. Two groups of volunteers wore a ring containing 100 mg or 200 mg of dapivirine for 90 days, while a third carried the monthly form of ring containing 25 milligrams of dapivirine for the same period. Then they were watched for 13 weeks.
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All three groups appear to tolerate their rings well, while no serious health risks were found during the study. But those who wore the 90-day version had higher levels of dapivirine in their blood and cervical tissue. This suggests that the drug may be more potent and effective in preventing HIV when used in this long-term form.
The results are still preliminary, it should be noted. And Phase I trials are explicitly designed to test the safety of an experimental treatment, not its effectiveness. But if the monthly form of the dapivirine ring is approved later this year, it would not be much of an obstacle to finally bring a 90-day version to the public, assuming this research still shows promise. The IPM is also testing a version of the ring that contains dapivirine and a long-acting contraceptive.
‘The approval of the monthly regulation will be an incredible milestone by the regulations for women who have faced the HIV epidemic in most of the world and who need and deserve a range of safe and effective methods. Hopefully, an extended-duration dapivirine ring that replaces women every three months could be another option available to women in the not-too-distant future, ‘said author Albert Liu, clinical research director at the San Francisco Department of Public Health. said a statement released by the Microbicide Trials Network, a project funded by the U.S. National Institutes of Health to study preventative treatments for sexually transmitted diseases such as HIV.
There has been a lot of encouraging news in the world of HIV research recently. Apart from the approach to the vaginal ring, work is constantly underway to develop other long-lasting versions of PrEP injection of a pill, for people with a 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 suggested that Cabenuva can be taken as little as six times a year, and the drug’s manufacturer, VIVi Healthcare, has now applied for an updated approval for the bi-monthly version.