FDA Expands Indication for Gilead’s Biktarvy for HIV With Suppressed Viral Loads, Pre-Existing Resistance

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Gilead Sciences has announced that the FDA has approved a new, expanded indication for Biktarvy, according to a company press release.¹ The label update expands the therapy’s ability to now treat people with human immunodeficiency virus (HIV) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance.

According to the Centers for Disease Control and Prevention, an estimated 1.2 million people in the United States had HIV at the end of 2021. In the same year, 36,136 people received an HIV diagnosis in the United States. However, the annual number of new diagnoses decreased by 7 percent from 2017 to 2021.²

“Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of people with HIV. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of people with HIV,” said Jared Baeten, MD, PhD, vice president, HIV clinical development, Gilead Sciences in the press release. “Thanks to decades of therapeutic improvements, people with HIV 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 people with HIV.”

According to the press release, the expanded label is based on data from a Phase III randomized, double-blinded study of virologically suppressed adults with HIV-1 on a baseline regimen of dolutegravir (DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF). Of the participants receiving Biktarvy, 47 had HIV-1 with pre-existing M184V/I resistance substitutions. The study met its primary endpoint with 89 percent of participants with M184V/I remaining 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 in the press release. “This label update builds on the established high resistance barrier of Biktarvy by showing that it’s effective in people with HIV who may have certain forms of pre-existing resistance or a history of past treatment failure.”

References

1. U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance. News release. February 26, 2024. Accessed February 26, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/2/us-fda-approves-expanded-indication-for-gileads-biktarvy-to-treat-people-with-hiv-with-suppressed-viral-loads-preexisting-resistance
2. HIV Basics. Centers for Disease Control and Prevention. Reviewed May 22, 2023. Accessed February 26, 2024. https://www.cdc.gov/hiv/basics/statistics.html