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TUESDAY, July 7, 2020 (HealthDay News)<\/p>\n
A new type of antiretroviral medication, Rukobia (fostemsavir), has been approved for people with HIV<\/a> who have not had success with other therapies, the U.S. Food and Drug Administration announced Thursday.<\/p>\n 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<\/a> due to resistance, intolerance, or safety considerations.<\/p>\n The approval was based on data from the phase III BRIGHTE study of 371 heavily treatment-experienced adults with high levels of HIV<\/a> despite treatment with antiretroviral drugs<\/a>, 71 percent of whom had received treatment for HIV<\/a> for at least 15 years. Before enrolling in the trial, 85 percent of the patients had been exposed to five or more different HIV<\/a> regimens and 86 percent had a history of AIDS<\/a>.<\/p>\n 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<\/a>-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<\/a>, and after 24 weeks, 53 percent of patients achieved HIV-RNA suppression. At 96 weeks, 60 percent of patients maintained suppression.<\/p>\n The most commonly reported adverse reaction was nausea<\/a>. Reported severe adverse reactions were liver<\/a> enzyme elevation in patients also infected with hepatitis B<\/a> or C and immune reconstitution syndrome.<\/p>\n Approval was granted to ViiV Healthcare.<\/p>\n
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