The U.S. Food and Drug Administration has approved a supplemental New Drug Application expanding Biktarvy's indication to include treatment-experienced people with HIV who are not virologically suppressed and restarting antiretroviral therapy. Gilead Sciences announced the approval on July 30, 2025, marking a significant expansion of treatment options for a vulnerable patient population.
The new indication specifically covers people with HIV who have an antiretroviral treatment history but are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir. This approval addresses what Gilead describes as "an unmet public health need" given the limited FDA-approved treatment options for this population.
Addressing Critical Treatment Gaps
The expanded indication targets a substantial clinical challenge in HIV care. Currently, only 65% of people with HIV in the United States are estimated to be virally suppressed at any point in time, with many patients interrupting and later needing to restart treatment. Research demonstrates that HIV transmission rates are highest among those 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 announcement. The U.S. Department of Health and Human Services notes that when people with HIV maintain an undetectable viral load for at least six months, it prevents sexual transmission to their partners.
Dr. Paul E. Sax, Clinical Director of the Division of Infectious Diseases at Brigham and Women's Hospital, emphasized the clinical significance: "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."
Scientific Foundation for Approval
The FDA granted the new indication based on scientific justification supported by evidence from treatment-naïve studies 1489 and 1490. These studies 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 of follow-up.
Dr. Jared Baeten, Senior Vice President and Virology Therapeutic Area Head at Gilead, stated: "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."
Treatment Profile and Administration
Biktarvy combines three components: bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg in a single tablet. The drug is described as the smallest 3-drug, integrase strand transfer inhibitor-based single-tablet regimen available, offering once-daily dosing with or without food, limited drug interaction potential, and a high barrier to resistance.
For adult and pediatric patients weighing 25 kg or more, the standard dose is one tablet daily. Pediatric patients weighing 14 kg to less than 25 kg receive a lower-strength formulation containing 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide.
Safety Considerations
The most common adverse reactions in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). The drug carries a boxed warning regarding post-treatment acute exacerbation of hepatitis B in patients co-infected with HIV and hepatitis B virus.
Biktarvy is contraindicated with dofetilide or rifampin due to drug interactions. The medication is not recommended for patients with severe hepatic impairment or those with creatinine clearance below 30 mL/min, with specific exceptions for certain patient populations.
Broader HIV Treatment Landscape
Gilead has developed 13 HIV medications over more than 35 years, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis, and the first long-acting injectable HIV treatment administered twice-yearly. The company states its commitment to ending the HIV epidemic through continued scientific innovation and expanded access initiatives.
The expanded Biktarvy indication represents another step in addressing the complex needs of people with HIV, particularly those who have experienced treatment interruptions and require re-engagement with care.
