July 20, 2020Regulatory
The FDA has approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
The safety and efficacy of Rukobia, taken twice daily by mouth, were 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.
Two hundred seventy-two participants were treated in the main trial arm, and an additional 99 participants received Rukobia in a different arm of the trial. Most participants had been treated for HIV for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens before entering the trial (85%) and/or had a history of AIDS (86%). Participants in the main cohort of the trial received either Rukobia or a placebo twice daily for eight days, in addition to their failing antiretroviral regimen. On the eighth day, participants treated with Rukobia had 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 Rukobia with other antiretroviral drugs. After 24 weeks of Rukobia plus other antiretroviral drugs, 53% of participants achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable. After 96 weeks, 60% of participants continued to have HIV RNA suppression.
The most common adverse reaction to Rukobia was nausea. Severe adverse reactions included elevations in liver enzymes among participants also infected with hepatitis B or C virus, and changes in the immune system (immune reconstitution syndrome).
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations.
The FDA granted approval of Rukobia to ViiV Healthcare.