Saturday, September 18, 2021

Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy

Gilead Sciences has revealed new, four-year data from two Phase III studies evaluating Biktarvy for the treatment of HIV-1 in treatment-naïve adults.

In the two studies – Study 1489 and Study 1490 – 98% of participants who started treatment with Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) achieved and maintained an undetectable viral load through four years of follow-up.

High efficacy and durable viral suppression were also observed in participants who switched to Biktarvy from dolutegravir-containing triple therapy for the 48-week open-label extension periods.

Gilead also presented additional data for Biktarvy which included findings from a 144-week analysis of the same Phase III studies.

This demonstrated that people living with HIV who received initial therapy with Biktarvy reached and maintained an undetectable viral load with no-treatment emergent resistance through 144 weeks.

A subgroup analysis of participants with transmitted-drug resistance (TDR) – based on a retrospective sequencing of baseline samples – found that Biktarvy achieved comparably high levels of durable viral suppression through 144 weeks among participants with and without TDR.

“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,” said Diana Brainard, senior vice president, virology therapeutic area, Gilead Sciences.

“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,” she added.

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