FDA Approves Expanded Indication for Biktarvy for HIV Treatment

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The new indication includes individuals with HIV who have suppressed viral loads with known or suspected M184V/I resistance.

The FDA approved a new and expanded indication for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF; Biktarvy and Gilead Sciences Inc) to treat those with HIV who have suppressed viral loads with known or suspected M184V/I resistance, which is a common form of resistance, according to a press release from the company.

HIV positive blood sample | Image Credit: jarun011 - stock.adobe.com

Image Credit: jarun011 - stock.adobe.com

HIV treatment resistance is permanent and irreversible, according to the press release, which could jeopardize future treatment options for the patient population. M184V/I resistance has been found in a range of 22% to 63% of individuals with HIV who have pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTI) in various HIV subtypes. The approval makes the drug the first and only integrase strand transfer inhibitor-based single tablet approved by the FDA and DHHS guideline recommendations for the patient population, according to the press release.

“Clinical data have established [B/F/TAF] as a long-term HIV treatment option for a broad range of [those with HIV]. With this label update, health care providers have a better understanding of the efficacy of [B/F/TAF] in an underserved segment of [those with HIV],” Jared Baeten, MD, PhD, vice president of HIV Clinical Development at Gilead Sciences, said in the press release. “Thanks to decades of therapeutic improvements, [individuals with HIV] may live longer, healthier lives, but treatment needs remain. Treatment resistance is one such area.”

About Study 4030

Trial Name: Switching to a Fixed Dose Combination of Bictegravir/​Emtricitabine/​Tenofovir Alafenamide (B/​F/​TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

ClinicalTrial.gov ID: NCT03110380

Sponsor: Gilead Sciences

Completion Date (Actual): February 2021

The updated label is supported by data from Study 4030, evaluating the efficacy, safety, and tolerability of B/F/TAF in a broad range of individuals with HIV, including with or without pre-existing NRTI resistance and M184V/I resistance. Study 4030 is a phase 3 randomized, double-blinded trial of virologically suppressed adults with HIV on a baseline regimen of dolutegravir (DTG) and either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate, according to the press release. The treatment was randomized 1 to 1 where individuals received either B/F/TAF or DTG+F/TAF.

The data showed that, out of those receiving B/F/TAF, 47 had HIV with pre-existing M184V/I resistance. The primary endpoint included the proportion of individuals with HIV RNA greater or equal to 50 copies per mL at week 48, according to the press release. Approximately 89% remained suppressed and 11% did not have virologic data at week 48, according to the results. Additionally, no individuals with M184V/I who received B/F/TAF and had virologic data had HIV RNA of 50 or greater copies per mL at this time point.

Furthermore, the results showed that at the same time point, only 0.4% in the B/F/TAF group had HIV-1 RNA greater than or equal to 50 copies per mL compared to 1.1% in the DTG+F/TAF group. There were also no cases of treatment-emergent resistance to B/F/TAF, regardless of known or suspected pre-existing M184V/I resistance in the final analysis population, according to the press release.

“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,” Paul E. Sax, MD, clinical director of the Division of Infectious Diseases, at Brigham and Women’s Hospital, said in the press release. “This label update builds on the established high resistance barrier of [B/F/TAF] by showing that it’s effective in [individuals with HIV] who may have certain forms of pre-existing resistance or a history of past treatment failure.”

The safety data was similar to individuals in other studies of B/F/TAF with no antiretroviral treatment history, according to the press release.

Reference

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance. News release. Gilead Sciences. 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

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