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The FDA Says This Group Can Now Use Biktarvy Safely

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The once-daily regimen for those with HIV can now be prescribed to those with a common treatment resistance.

Good news for those living with HIV — the federal Food and Drug Administration announced this week that Gilead Sciences’s Biktarvy can be used by PLWH struggling with M184V/I resistance, a common form of treatment resistance.

Biktarvy, a once-daily pill to treat HIV, can now be used by people with suppressed viral loads but also dealing with M184/I resistance. The M184V/I resistance mutation has been found to be present in a range of PLWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors.

“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,” Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences, said in a statement. “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.”

Treatment resistance is a serious problem; once someone with HIV develops such resistance, it’s permanent and irreversible. HIV drug resistance could lead to one’s regimen failing to stop the replication of the virus, as well as potentially leading to transmission of HIV to others if the resistance leads to a person’s viral load no longer being suppressed.

“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.”

Relatedly, it was announced last year that Biktarvy is also safe for use by pregnant individuals.

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