FDA Approves Fostemsavir for HIV Treatment

Officials with the FDA have approved fostemsavir (Rukobia, ViiV Healthcare) as a novel inhibitor for the treatment of HIV-1 infection in heavily treatment experienced (HTE) adults with a multidrug resistant HIV-1 infection or who cannot use other medications out of safety concerns, according to the FDA.¹

In most patients, HIV is considered to be a manageable lifelong condition. However, approximately 6% of adult patients are HTE.² This means that they have very little to no options left due to safety concerns, tolerability or resistance. Patients with HTE HIV are at a risk of progressing to AIDS and death, according to Viiv Healthcare.²

The approval was supported by the phase 3 BRIGHTE study, which is a partially-randomized, double-blind, placebo-controlled study comprised of 371 patients with HTE. The majority of participants, 71%, had been treated for HIV for more than 15 years. Fostemsavir was distributed to participants twice a day, orally.¹

According to the FDA, after 24 weeks of fostemsavir and other antiretroviral drugs, 53% of participants achieved HIV RNA suppression. After 96 weeks, 60% of participants had HIV RNA suppression.²

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” CEO of ViiV Healthcare Deborah Waterhouse said, in a press release. ²

The most common adverse effect was nausea, fatigue and diarrhea.¹ At week 96, 7% of participants had discontinued fostemsavir due to an adverse event. According to the press release, the most common adverse event was infection which occurred in 3% of the study population. Serious drug reactions occurred in an additional 3%.²

REFERENCE

• FDA Approves New HIV Treatment for Patients With Limited Treatment Options [news Release]. White Oak, MD; July 2, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-treatment-patients-limited-treatment-options Accessed July 2020
• ViiV Healthcare announces US FDA approval for Rukobia (fostemsavir), a first-in-class treatment for HIV in adults with few treatment options available [news release]. London, GB; July 2, 2020: ViiV Healthcare. Accessed July 2020