The US Food and Drug Administration has approved ViiV Healthcare’s fostemsavir (Rukobia), as a new type of oral antiretroviral medication for adults living with drug-resistant HIV-1 infection.
Fostemsavir can be used in patients who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” said Jeff Murray, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.
Fostemsavir is a first-in-class HIV-1 attachment inhibitor that works by binding directly to the glycoprotein 120 (gp120) subunit on the surface of the virus. By binding to this location on the virus, the drug blocks the HIV virus from attaching to the host immune system CD4+ T-cells and other immune cells, thereby preventing HIV from infecting those cells and multiplying.
The drug was evaluated in a clinical trial of 371 heavily treatment-experienced adult participants who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs against placebo, both taken twice daily. Most participants had been treated for HIV for more than 15 years (71 per cent), had been exposed to five or more different HIV treatment regimens before entering the trial (85 per cent) and/or had a history of AIDS (86 per cent).
On 8th day fostemsavir showed a significantly greater decrease in levels of HIV-RNA in their blood compared to those taking the placebo. After the eighth day, all participants received fostemsavir with other antiretroviral drugs.
After 24 weeks of combined drug intake, 53 per cent of participants achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable. After 96 weeks, 60 per cent of participants continued to have HIV RNA suppression, revealed the company.