Gilead’s Biktarvy receives FDA OK for expanded indication

Gilead Sciences received the Food and Drug Administration’s approval for 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, the company said. 

[Read more: Gilead gets FDA nod for new indication for Veklury]

“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, vice president of HIV Clinical Development at 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-centered 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.”

Once someone with HIV has developed resistance to 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 the replication of the virus throughout 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, the company noted.

[Read more: Gilead’s Trodelvy receives FDA nod for new indication]

“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 Sax, clinical director of the division of infectious diseases at Brigham and Women’s Hospital, professor of medicine at 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.”