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.
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.
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.
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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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