Cumulative five-year results from two Phase III studies (Study 1489 and Study 1490) of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) were announced on Friday by US biotech major Gilead Sciences (Nasdaq: GILD).
The new, long-term data further demonstrate the sustained efficacy and safety profile and lack of treatment failure due to resistance in the final resistance analysis population associated with Biktarvy for the treatment of HIV-1 in treatment-naïve adults. The data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).
In both studies, ≥98% of participants who initiated treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through five years of follow-up (Week 240, 1489 n=208/213, 1490: n=218/219, missing equals excluded analysis). Through five years of analysis, zero cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies, further demonstrating the efficacy and tolerability profile of Biktarvy for the treatment of HIV-1 in treatment-naïve adults.
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