Additionally, at Week 48 the proportion of subjects with HIV-1 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% ).

No participants with M184V/I who received Biktarvy and had virologic data had 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. The primary endpoint was the proportion of participants with HIV RNA ≥ 50 copies/mL at Week 48. Of the participants receiving Biktarvy, 47 had HIV-1 with pre-existing M184V/I resistance substitutions. Study participants must have been stably suppressed (HIV-1 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. Participants were randomized 1:1 to switch to Biktarvy (n=284) or DTG+F/TAF (n=281). 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-1 on a baseline regimen of dolutegravir (DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF). 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.” “Thanks to decades of therapeutic improvements, PWH may live longer, healthier lives, but treatment needs remain. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of PWH,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.

Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. Biktarvy Is a Long-Term Treatment Option with a High Barrier to Resistance for a Broad Range of Individuals. M184V/I One of the Most Common Forms of Resistance Among People with HIV. Biktarvy Now First and Only INSTI-Based Single-Tablet Regimen That is FDA Approved and DHHS Guideline Recommended for People Who are Virologically Suppressed with M184V/I Resistance. FDA Approves Expanded Indication for Gilead’s Biktarvy ® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

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