Gilead Sciences, Inc. has announced the FDA’s approval of an expanded indication for Biktarvy® to treat people with HIV (PWH) who are virologically suppressed but have known or suspected resistance to M184V/I, a common form of treatment resistance. This resistance can limit future treatment options, making this approval particularly significant for management of HIV in individuals confronting such challenges.
Biktarvy is the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen approved for PWH with M184V/I resistance, a mutation found in 22-63% of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs).
The label update is based on Week 48 data from Study 4030, which assessed the efficacy, safety, and tolerability of Biktarvy in a diverse population of virologically suppressed individuals, including those with the M184V/I resistance mutation. The study showed a high percentage of participants with M184V/I resistance maintained viral suppression after switching to Biktarvy, with no participants who had virologic data showing HIV RNA levels greater than or equal to 50 copies/mL at Week 48.
Jared Baeten, MD, PhD, Vice President of HIV Clinical Development at Gilead Sciences, emphasized Biktarvy’s established role as a long-term HIV treatment and noted the label update enhances healthcare providers’ understanding of its efficacy for a patient segment with specific treatment needs.
The FDA’s approval recognizes Biktarvy’s efficacy in this patient population, underscoring Gilead Sciences’ dedication to advancing HIV treatment options that address public health needs and optimizing long-term outcomes for those living with HIV.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
