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U.S. FDA Approves Expanded Indication for Gilead's Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance
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• 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 –
• M184V/I One of the Most Common Forms of Resistance Among People with HIV --
• Biktarvy Is a Long-Term Treatment Option with a High Barrier to Resistance for a Broad Range of Individuals --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. 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. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. 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. 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. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.
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). Participants were randomized 1:1 to switch to Biktarvy (n=284) or DTG+F/TAF (n=281). 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. 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-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% [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. Overall, the safety profile in virologically suppressed adults in Study 4030 was similar to that in participants in other studies of Biktarvy with no antiretroviral treatment history.
Please see below for U.S. Indications and Important Safety Information for Biktarvy, including Boxed Warning.
There is no cure for HIV or AIDS.
https://www.gilead.com/news-and-press/press-room/press-releases/2024/2/us-fda-approves-expanded-indication-for-gileads-biktarvy-to-treat-people-with-hiv-with-suppressed-viral-loads-preexisting-resistance
Please click here to view the full Prescribing Information for Biktarvy, including Boxed Warning.
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