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29 Feb 2024
Admin
News Article

Gilead’s Biktarvy Gets Approval for Expanded Indication

US FDA approves expanded indication for Gilead’s Biktarvy to treat people with HIV with suppressed viral loads, pre-existing resistance

Overview

Gilead Sciences, Inc. announced the US 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.

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.

Study 4030 (Safety study for Biktarvy)

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 US Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.
Gilead Sciences on Biktarvy’s effectiveness
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,” said Jared Baeten, MD, PhD, vice president, HIV clinical development, Gilead Sciences.
Thanks to decades of therapeutic improvements, PWH may live longer, healthier lives, but treatment needs remain.
Treatment resistance is one such area. We are committed to a person-centred 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.

Trial Response Behind Label

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.

HIV Drug Resistance

Once someone with HIV has developed resistance to a treatment, it will persist for the rest of their life. Reducing the risk of drug resistance is a key goal in HIV therapy.
HIV drug resistance continues to receive clinical and public health attention because it may hinder the ability of HIV medicines to suppress and block replication of the virus over the course of an individual’s life.
Resistance may lead to treatment failure in individuals, while also creating the potential for transmission of treatment-resistant HIV within communities.

Words from Doctors

“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,” said Paul E. Sax, MD, Clinical Director, Division of Infectious Diseases, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School.
“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.”

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance.
Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.
Biktarvy is a complete STR and should not be taken with other HIV medicines.
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history 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.

Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.