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FDA Expands Indication for Biktarvy for Those with Resistant HIV

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Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.

The FDA has approved an expanded indication for Gilead’s Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets). It is now approved to treat people with HIV who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance.

Between 22% and 63% of people with HIV with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes have the M184V/I mutation.

Biktarvy is currently indicated as a treatment for people with HIV-1 infection in adults and pediatric patients weighing at least 14 kg. For the full year 2023, Biktarvy generated $11.9 billion in worldwide revenue, a 14% increase over 2022. Company officials said in a press release that this is a result of higher demand and higher average realized price.

The list price of Biktarvy is $3,981 per month. Patients with commercial insurance may pay as little as $0 per month with the Gilead Advancing Access copay coupon with a limit of $9,600 annually. The company notes it may limit support for patients with plans that have accumulator adjustment programs that exclude copay support from annual deductibles. Gilead also offers patient assistance for those without insurance

The new approval is supported by the phase 3 Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. In the study, 565 patients were randomized to switch to Biktarvy or dolutegravir plus either Descovy (emtricitabine/tenofovir alafenamide) or Truvada (emtricitabine/tenofovir disoproxil fumarate).

Of the patients receiving Biktarvy, 47 had HIV-1 with preexisting M184V/I resistance substitutions. Of these patients, 89% remained suppressed at Week 48. There were also no cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

In October 2023, Gilead reported data from a three-year outcomes study of Biktarvy. The BICSTaR study collected data from people with HIV who were enrolled in Canada, France, and Germany. Overall, Biktarvy was found to be highly effective for trial participants after three years of follow-up, with 97% of treatment-naïve and 97% of treatment-experienced patients virologically suppressed. Additionally, there were no reports of treatment-emergent resistance.

The most common drug-related adverse events were weight change and depression. Rates of mental health conditions are higher among people with HIV compared with the general population. Mental health impairments can further increase the risk of negative health outcomes at every stage of the HIV care continuum.

Additionally, researchers have evaluated the results of a pooled analysis of nine phase 3 randomized studies in treatment-naïve and virologically suppressed people with HIV who were restarting treatment with Biktarvy after experiencing virologic rebound. Out of the total 3,772 patients, 2.5% experienced virologic rebound, resulting in 110 virologic rebound events. The study found that the majority of participants who experienced virologic rebound achieved viral resuppression within 30 days after regaining virologic control.

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