Gilead Sciences has reported that new long-term data from open-label extensions (OLE) of two Phase III studies (Study 1489 and 1490) of Biktarvy showed sustained efficacy and safety profile for treating treatment-naïve adults with HIV-1.
In the Phase III, randomised, double-blind, active-controlled studies, subjects were blinded to receive either Biktarvy or a dolutegravir-containing triple therapy for 144 weeks.
At week 144, treatment outcomes were analysed and subjects in both groups had undetectable viral load, with no treatment-emergent resistance.
After week 144, subjects were able to receive Biktarvy in an active OLE phase for up to 96 weeks.
According to the latest data, more than 98% of subjects who began Biktarvy treatment and remained in the study achieved and maintained an undetectable viral load through four years of follow-up in both studies.
Increased efficacy and durable viral suppression were noted in subjects switching to Biktarvy from a dolutegravir-containing triple therapy for the 48-week OLE periods.
Furthermore, no treatment-emergent resistance to any components of Biktarvy was observed in subjects receiving Biktarvy.
Gilead Sciences Virology Therapeutic Area senior vice-president Diana Brainard said: “Gilead is committed to developing innovative HIV treatments, like Biktarvy, that help to address the unmet needs of people living with HIV today, including achieving and maintaining an undetectable viral load over the long-term.
“These data reinforce that Biktarvy provides durable viral suppression, strong efficacy and a high barrier to resistance in both adults that are new to HIV therapy and those replacing their existing treatment.”
In a subgroup analysis of subjects with transmitted-drug resistance (TDR), Biktarvy also achieved comparably increased levels of durable viral suppression up to 144 weeks among those with and without TDR.