5-year long-term data clinical trial information added to Gilead’s HIV-1 treatment ‘Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablet, B/F/TAF)’ Safety has been proven once more.
Gilead Sciences Korea (CEO Lee Seung-woo) announced on the 27th that the clinical trial information among Biktarvy’s approvals from the Ministry of Food and Drug Safety has been changed.
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 adults 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 by 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. It was high.
Afterwards, despite the virus suppression effect at the 240th week, which is the secondary efficacy evaluation variable, the virus-free level of 98% or more was achieved and maintained steadily. In addition, in both clinical trials, no cases of treatment failure due to resistance were observed among the Biktarvy monotherapy groups. The median change in CD4+ cell count by week 240 was 313 cells/μL in Study 1489 and 331 cells/μL in Study 1490. CD4+ cell counts remained stable for 5 years.
In both clinical trials, the most common adverse reactions in the Biktarvy monotherapy group were headache (5%), diarrhea (5%), and nausea (4%). 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%.
CEO Lee Seung-woo said, “HIV infection has long been in the realm of chronic disease through one-a-day treatment. We will continue to strive to develop and supply innovative drugs that can do the same.”
Meanwhile, according to the US Department of Health and Human Services (DHHS) guidelines, Biktarvy is recommended as an initial ART therapy for most HIV-infected people, with the AI level having the highest level of recommendation and evidence.
