The FDA has approved an expanded indication for Gilead’s Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets).1 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.
Key Takeaways
- The FDA has approved an expanded indication for Gilead's Biktarvy to treat people with HIV who have suppressed viral loads and known or suspected M184V/I resistance, a common form of treatment resistance.
- The approval is supported by phase 3 Study 4030, where patients with M184V/I resistance receiving Biktarvy showed 89% remaining suppressed at Week 48. The study demonstrated Biktarvy's efficacy and safety in individuals with or without pre-existing NRTI resistance.
- In 2023, Biktarvy generated $11.9 billion in worldwide revenue. The list price is $3,981 per month, and Gilead offers copay coupons and patient assistance programs to enhance accessibility.
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.2
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.
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In October 2023, Gilead reported data from a three-year outcomes study of Biktarvy.3 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.
READ MORE: HIV Resource Center
This article originally appeared on Managed Healthcare Executive.
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. Gilead. February 26, 2024. Accessed February 27, 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. Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results. News Release. Gilead. February 6, 2024. Accessed February 27, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/2/gilead-sciences-announces-fourth-quarter-and-full-year-2023-financial-results
3. Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities. News Release. Gilead. October 19, 2023. Accessed February 27, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2023/10/real-world-evidence-reinforces-biktarvy-as-a-long-term-treatment-option-with-a-high-barrier-to-resistance-for-people-with-hiv-and-a-range-of-comorbid
