FDA Approves Expanded Indication for HIV Therapy


The new indication for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF (Biktarvy) is for patients with suppressed viral loads, pre-existing resistance.

The FDA has approved a new, expanded indication for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF (Biktarvy) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance.

“This label update builds on the established high resistance barrier of Biktarvy by showing that it’s effective in PWH who may have certain forms of pre-existing resistance or a history of past treatment failure,” Paul E. Sax, MD, Clinical Director, Division of Infectious Diseases, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, said.

Biktarvy is manufactured by Gilead and it is a HIV treatment that combines 3 therapies to form an integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available.

What the Data Showed

The expanded label is based on week 48 data from Study 4030, a phase 3 randomized, double-blinded study of virologically suppressed adults with HIV on a baseline regimen of dolutegravir (DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF).

Study participants were randomized 1:1 to switch to Biktarvy (n=284) or DTG+F/TAF (n=281). To be included, participants must have been stably suppressed (HIV RNA < 50 copies/mL) with current baseline regimen for at least six months if NRTI resistance was documented or suspected, or at least three months if NRTI resistance was not documented or suspected prior to trial entry.

Of the participants receiving Biktarvy, 47 had HIV-1 with pre-existing M184V/I resistance substitutions. The primary endpoint was the proportion of participants with HIV RNA ≥ 50 copies/mL at Week 48. Eighty-nine percent (42/47) of participants with M184V/I remained suppressed (HIV-1 RNA < 50 copies/mL) and 11% (5/47 participants) did not have virologic data at the Week 48 timepoint.

No participants with M184V/I who received Biktarvy and had virologic data had HIV RNA ≥ 50 copies/mL at Week 48. Additionally, at Week 48 the proportion of subjects with HIV RNA ≥ 50 copies/mL was 0.4% (1/284) in the Biktarvy group and 1.1% (3/281) in the DTG+F/TAF group (difference -0.7% [95% CI: -2.8%, 1.0%]). There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

“Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of PWH,” Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences, said in a statement.

Overall, the safety profile in virologically suppressed adults in the study was similar to that in participants in other Biktarvy studies with no antiretroviral treatment history.

The Challenge of Treatment Resistance

For those with treatment resistance, it can lead to less-than-optimal outcomes include severe illness, cross-resistance, and mortality. And not only can it affect individuals themselves, but create the potential for transmission of treatment-resistant HIV within communities.

“Treatment failure in HIV must be avoided whenever possible, so a high barrier to resistance should be standard of care to maximize the chances of durable virologic suppression,” Sax said.

“Thanks to decades of therapeutic improvements, PWH may live longer, healthier lives, but treatment needs remain. Treatment resistance is one such area,” Baeten said. “We are committed to a person-centered approach to HIV treatment research that not only advances continuous scientific innovations to help address public health needs, but also maximizes long-term outcomes for PWH.”


U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance. Gilead press release. February 26, 2024. Accessed February 26, 2024.

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