The US Food and Drug Administration (FDA) has approved the antiretroviral medication fostemavir (Rukobia) for adults living with HIV, whose infection cannot be successfully treated with other therapies.
Heavily treatment-experienced adults with high levels of HIV-RNA in their blood, despite being on antiretrovirals participated in a clinical trial (n=371) to receive either fostemavir or placebo twice daily for eight days, in addition to their current medication. Most participants (71%) had been treated for HIV for more than 15 years, and had been exposed to at least five different HIV treatment regimens.
On the eighth day, participants treated with fostemavir had a significantly greater decrease in levels of circulating HIV-RNA compared to those taking placebo. After eight days, all participants received fostemavir with other antiretroviral drugs.
After 24 weeks of fostemavir treatment plus other antiretrovirals, 53 per cent of participants achieved RNA suppression, which rose to 60 per cent at 96 weeks.
Comment on the decision, Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research said: “This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options."