Heavily treatment-experienced HIV patients who failed on other antiretrovirals have a new option, as the FDA approved fostemsavir (Rukobia), a new type of antiretroviral therapy (ART) for patients who have previously tried multiple other therapies, the agency announced on Thursday.
The approval of fostemsavir (ViiV Healthcare) is specifically for adults living with HIV whose infection cannot be successfully treated with other therapies due to “resistance, intolerance or safety considerations,” the FDA announced in a press release.
“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives,” said Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a statement.
Murray added that fostemsavir may benefit patients “who have run out of HIV treatment options.”
Fostemsavir is a gp120 attachment inhibitor. The NIH website, AIDSInfo, describes the drug as attaching to the gp120 protein on the outer surface of the virus, and blocking HIV from infecting immune cells. It is a prodrug that converts to temsavir once inside the body.
The trial that led to approval involved 371 heavily treatment-experienced patients and showed that after 24 weeks of fostemsavir plus another ART, 53% of participants achieved HIV RNA suppression, and 60% had continued suppression after 96 weeks.
Patients in the study had high levels of HIV RNA, despite being on ART. Most had received treatment for more than 15 years, and a large majority had been exposed to five or more different HIV treatment regimens. Participants received either fostemsavir or placebo twice a day for 8 days, with the fostemsavir group reporting a significantly greater decrease in HIV RNA versus placebo.
Nausea was the most common adverse reaction, though patients co-infected with hepatitis B or C also reported elevations in liver enzymes and changes in the immune system.
Approval of fostemsavir was sped along through the regulatory process via the FDA’s Fast Track, Priority Review, and Breakthrough Therapy designations, the agency said.
Last Updated July 02, 2020