FOSTER CITY, Calif. - Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Biktarvy, a single-tablet regimen for the treatment of HIV. This approval allows the use of Biktarvy in individuals with HIV who are virologically suppressed and have the M184V/I resistance mutation. This mutation is one of the most common forms of resistance in people with HIV, affecting those with a history of treatment resistance to nucleoside reverse transcriptase inhibitors (NRTIs).
The approval is based on a study, known as Study 4030, which evaluated the efficacy, safety, and tolerability of Biktarvy in a diverse population of adults with HIV-1, including those with pre-existing NRTI resistance. Results showed that 89% of participants with the M184V/I mutation maintained viral suppression, with no cases of treatment-emergent resistance to Biktarvy observed.
Biktarvy, which combines bictegravir, emtricitabine, and tenofovir alafenamide, is now the only FDA-approved and DHHS guideline-recommended integrase strand transfer inhibitor (INSTI)-based single-tablet regimen for this particular patient group. The high barrier to resistance offered by Biktarvy is critical in managing treatment for people with HIV, as resistance can lead to treatment failure and limit future options.
The study's findings are crucial for healthcare providers, offering a new option for patients with certain forms of pre-existing resistance or a history of past treatment failure. Gilead Sciences emphasized the importance of continuing to address public health needs and maximizing long-term outcomes for people with HIV through scientific innovations.
While this expanded label provides a new treatment avenue, it is important to note that there is no cure for HIV or AIDS. The safety profile of Biktarvy in Study 4030 was consistent with that observed in other studies with participants who had no antiretroviral treatment history.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.