Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and possess the known or suspected M184V/I resistance mutation, a prevalent form of treatment resistance that affects up to 63% of patients with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs).
This new authorization was bolstered by data from a Phase III study demonstrating efficacy, safety, and tolerability, which successfully met its primary endpoint of reducing the number of detectable HIV RNA copies. Biktarvy’s single-tablet regimen achieved viral suppression in 89% of participants with the M184V/I mutation by week 48, while maintaining a safety profile consistent with previous observations in patients without a history of antiretroviral treatment.
This FDA approval underscores Gilead’s commitment to addressing the complex challenges of HIV treatment resistance and providing effective therapies for patients in need.- Flcube.com
