Gilead’s Biktarvy gains FDA expanded indication approval for HIV

27 Feb 2024
www.pharmaceutical-technology.com
Phase 3Drug ApprovalClinical Result
Gilead’s Biktarvy gains FDA expanded indication approval for HIV
Preview
Source: Pharmaceutical Technology
Gilead’s Biktarvy offers the convenience of once-daily dosing and has a high barrier to resistance with limited drug interaction potential. Credit: Andreas Marquardt / Shutterstock.com.
Gilead Sciences has received approval from the US Food and Drug Administration (FDA) for an expanded indication for Biktarvy to treat HIV patients with M184V/I resistance mutations.
This marks Biktarvy as the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen recommended for people with HIV-1 (known as PWH) with resistance mutations.
Biktarvy combines bictegravir, emtricitabine and tenofovir alafenamide into the smallest available INSTI-based single-tablet regimen.
It offers the convenience of once-daily dosing and has a high barrier to resistance with limited drug interaction potential.
A complete treatment regimen, Biktarvy should not be combined with other HIV medications.
See Also:MHRA streamlines approval process for established medicines
Gilead’s Biktarvy gains FDA expanded indication approval for HIV
Preview
Source: Pharmaceutical Technology
Beyond approval: Patients pursue alternate paths to get rare disease treatments
Gilead’s Biktarvy gains FDA expanded indication approval for HIV
Preview
Source: Pharmaceutical Technology
The challenge of HIV treatment resistance, which is permanent and can limit future treatment options, is underscored by the prevalence of the M184V/I mutation in between 22% and 63% of patients with prior resistance to nucleoside reverse transcriptase inhibitorsnucleoside reverse transcriptase inhibitors.
The FDA’s latest approval is supported by data from the Study 4030 Phase III clinical trial, which assessed Biktarvy’s safety, efficacy and tolerability across a diverse HIV-1 population, including those with M184V/I resistance.
Biktarvy’s expanded indication is based on week 48 outcomes from Study 4030, which involved virologically suppressed adults with HIV-1.
The safety profile of Biktarvy in the trial was in line with previous studies in subjects without a history of antiretroviral treatment.
Gilead Sciences HIV clinical development vice-president Jared Baeten stated: “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.”
The latest development comes after Gilead and Biocytogen entered an antibody deal to leverage the discovery and development of new antibody therapeutics.
The agreement gives Gilead a three-year nomination period to select targets of interest and evaluate the antibodies, with the option of acquiring them for worldwide therapeutic development.
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