Five-year long-term data of the HIV-1 drug Biktarvy (ingredient name bictegravir/emtricitabine/tenofovir alafenamide, B/F/TAF) was added to the approval requirements.
Gilead Sciences Korea announced on the 27th that the Ministry of Food and Drug Safety on January 30th added clinical information on 5-year long-term data conducted on adults infected with HIV-1 after initial treatment.
The clinical trial information reflected in the approval was a randomized, double-blind, active trial that evaluated the efficacy and safety of Biktarvy in 634 HIV-1-infected people without previous Anti-Retroviral Therapy (ART) experience. These are the results of 5-year long-term follow-up of two controlled phase 3 clinical trials (Study 1489 and Study 1490).
Both clinical trials were evaluated in a double-blind manner from the first dose to 144 weeks, followed by additional open-label administration of Biktarvy for 96 weeks, an optional extension phase.
When analyzed with Missing=Excluded (M=E), the primary efficacy evaluation variable of the two clinical trials, the virus level suppression effect at week 48 (HIV-1 RNA less than 50 copies/mL), was more than 99% in the Biktarvy monotherapy group. appeared high.
Afterwards, despite the virus suppression effect at week 240, which is the secondary efficacy evaluation variable, it achieved and maintained a non-detection level of more than 98%, and in both clinical trials, no case of treatment failure due to resistance was observed among the Biktarvy monotherapy groups.
By week 240, the median change in CD4+ cell count was 313 cells/μL in Study 1489 and 331 cells/μL in Study 1490.1 The CD4+ cell count remained stable for 5 years.
In both clinical trials, the rate of treatment-related adverse events of grade 3-4 or higher during 240 weeks was low at 1 and 2 patients, respectively, and the rate of discontinuation of treatment due to treatment-related adverse events in the Biktarvy monotherapy group was less than 1%.
Lee Seung-woo, CEO of Gilead Sciences Korea, said, “As the importance of long-term management of HIV infection is gradually emerging, we are delighted to be able to deliver additional news on the approval of long-term data for 5 years of initial treatment.” We will continue to work hard to develop and supply innovative drugs that can be taken without worry.”
