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A new type of antiretroviral medication, Rukobia (fostemsavir), has been approved for people with HIV who have not had success with other therapies, the U.S. Food and Drug Administration announced Thursday.
Rukobia, 600 mg extended-release tablets that are taken twice daily, is part of a new class of antiretroviral treatments for those with multidrug-resistant HIV due to resistance, intolerance, or safety considerations.
The approval was based on data from the phase III BRIGHTE study of 371 heavily treatment-experienced adults with high levels of HIV despite treatment with antiretroviral drugs, 71 percent of whom had received treatment for HIV for at least 15 years. Before enrolling in the trial, 85 percent of the patients had been exposed to five or more different HIV regimens and 86 percent had a history of AIDS.
In the main arm of the trial, patients received Rukobia or placebo for eight days plus their current antiretroviral treatment. On the eighth day, HIV-RNA levels decreased significantly more among the patients who received Rukobia versus placebo (decline of 0.79 versus 0.17 log10 copies/mL). All patients then received Rukobia with other antiretroviral drugs, and after 24 weeks, 53 percent of patients achieved HIV-RNA suppression. At 96 weeks, 60 percent of patients maintained suppression.
The most commonly reported adverse reaction was nausea. Reported severe adverse reactions were liver enzyme elevation in patients also infected with hepatitis B or C and immune reconstitution syndrome.
Approval was granted to ViiV Healthcare.
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