FDA approves expanded indication of Vicata Ruby for HIV treatment

FDA has approved a new indication expansion for bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (B/F/TAF; Biktarvy and Gilead Sciences Inc) for the treatment of HIV-infected individuals with known or suspected M184V. Acknowledged. According to the company's press release, /I resistance is a common form of resistance.

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According to a press release, HIV treatment resistance is persistent and irreversible, potentially threatening future treatment options for this patient population. M184V/I resistance has been found in a range of 22% to 63% of HIV-infected individuals with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) of various HIV subtypes. According to a press release, this approval makes the drug the first and only integrase strand transfer inhibitor-based single tablet approved by FDA and HHS guideline recommendations for the patient population.

“Clinical data is well established [B/F/TAF] As a long-term option for broad-based HIV treatment [those with HIV]. This label update allows healthcare providers to: [B/F/TAF] in underserved segments [those with HIV],” Jared Baeten, MD, vice president of HIV clinical development at Gilead Sciences, said in a press release. “Thanks to decades of improved treatments, [individuals with HIV] You may live a longer, healthier life, but the need for treatment remains. Treatment resistance is one such area. ”

The updated label is supported by data from Study 4030, which evaluated the efficacy, safety, and tolerability of B/F/TAF in a wide range of HIV-infected individuals, including those with and without preexisting NRTI resistance and M184V/I resistance. Masu. According to a press release, Study 4030 showed that patients with baseline regimens of dolutegravir (DTG) and either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate were virologically suppressed. This is a phase 3, randomized, double-blind trial in HIV-infected adults. . Treatment was randomized 1:1 to receive either B/F/TAF or DTG+F/TAF.

Data showed that 47 of those who received B/F/TAF were infected with HIV and were already resistant to M184V/I. Primary endpoints included the proportion of individuals with 50 or more copies of HIV RNA per mL at week 48, according to a press release. Approximately 89% remained suppressed, and 11% had no virologic data at 48 weeks, according to the results. Furthermore, her M184V/I patient who underwent B/F/TAF and had virological data had no HIV RNA more than 50 copies per mL at this time.

Additionally, the results showed that at the same time point, only 0.4% of the B/F/TAF group had 50 or more copies of HIV-1 RNA per mL compared to 1.1% of the DTG+F/TAF group. It was shown that there was. According to the press release, no cases of resistance to B/F/TAF developed during treatment, regardless of the presence or absence of known or pre-existing M184V/I resistance in the final analysis population.

“HIV treatment failure should be avoided whenever possible, so high barriers to resistance should be the standard of care to maximize the chances of sustained viral suppression,” Brigham University. said Paul E. Sachs, MD, Clinical Director of the Division of Infectious Diseases. said Women's Hospital in a press release. “This label update builds on the established high resistance barrier. [B/F/TAF] By showing that it is effective, [individuals with HIV] There may be some type of pre-existing resistance or history of past treatment failure. ”

According to a press release, safety data were similar to subjects in other studies of B/F/TAF without prior antiretroviral therapy.

reference

The U.S. FDA has approved an expanded indication for Gilead's Biktarvy to treat people with HIV who have suppressed viral loads and 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-hiv Suppress and treat resistant viral load in