Gilead Sciences gets USFDA nod for new Biktarvy indication for people with HIV who are treatment experienced, restarting antiretroviral treatment
Foster City: Gilead Sciences, Inc. has announced that it has received new approval from the U.S. Food and Drug Administration (FDA) for a novel indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).
This new indication expands Biktarvy’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. The approval of this supplemental New Drug Application (sNDA) will help bridge an unmet public health need in PWH who are viremic and restarting ART given the limited treatment options approved by the FDA for this population to date.
“Continuous scientific discoveries and person-centric advances in HIV care have helped transform the treatment landscape,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “At the same time, not everyone is achieving long-term HIV treatment success, especially when someone experiences an interruption in their HIV care. With this new indication, Biktarvy can now support an even broader range of PWH in reaching their long-term treatment goals, including those who are not virologically suppressed and who are restarting treatment. We are proud to take another step toward fulfilling Gilead’s commitment to end the HIV epidemic through a person-centered approach to treatment research that seeks to expand choices and enhance outcomes for those with HIV.”
In the United States, this new indication for Biktarvy helps address a critical unmet need. Currently only 65% of PWH are estimated to be virally suppressed at any point in time, and many interrupt and later need to restart treatment. Research has shown that HIV transmission is highest among those who are not engaged in care or virally suppressed. Gaps in care account for nearly 80% of new HIV diagnoses, underscoring the need to focus on re-engagement in care and restarting treatment to help reduce the potential transmission of HIV. According to the U.S. Department of Health and Human Services, when PWH take their treatment as prescribed, and achieve and maintain an undetectable viral load for at least six months, it prevents sexual transmission of HIV to their partners.
“For PWH who have stopped treatment or fallen out of care and are not virally suppressed, re-engagement and restarting treatment are crucial for preventing the spread of the virus and supporting individual long-term outcomes,” said Paul E. Sax, MD, Clinical Director of the Division of Infectious Diseases, Brigham and Women’s Hospital. “This expanded indication can now help healthcare providers more confidently support an even broader range of PWH, including PWH who are not virologically suppressed and are restarting HIV treatment.”
FDA granted this new indication based on a scientific justification supported by the strength of evidence for Biktarvy from treatment naïve studies 1489 and 1490 which demonstrated rapid and durable viral suppression, an established long-term safety and tolerability profile and zero cases of treatment-emergent resistance to Biktarvy through five years.
BIKTARVY is indicated in U.S. as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
