Gilead’s experimental HIV treatment meets main goal in late-stage trial

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Dec 15 (Reuters) – Gilead Sciences said on Monday its experimental HIV treatment met the main goal and was found to be statistically non-inferior to its top-selling drug Biktarvy in a late-stage trial.

The treatment regimen could expand treatment options and help people with HIV maintain long-term control of the virus, the company said.

Shares of the Foster City, California-based company were up 2% in premarket trading.

In the study, a once-daily, single-tablet combination of bictegravir and lenacapavir was as effective as Gilead’s existing HIV pill Biktarvy in patients whose virus was already suppressed.

The trial randomized patients two-to-one to either switch to the experimental tablet or stay on their existing regimen with Biktarvy.

The combination was generally well tolerated, with no significant or new safety concerns identified, Gilead said.

Bictegravir is a widely recommended HIV drug known as an integrase strand transfer inhibitor and is used only in combination with other antiretroviral medicines, which are used to stop reproduction of the virus.

HIV-1 is the most common strain of the retrovirus that causes acquired immunodeficiency syndrome, commonly known as AIDS.

Lenacapavir is the active ingredient in Gilead’s long-acting HIV treatment Sunlenca and Yeztugo, its twice-yearly injection for preventing HIV infection in adults and adolescents.

In a previous late-stage trial, the experimental tablet regimen was found to be statistically non-inferior to multi-tablet antiretroviral regimens.

The company will share full data from the two late-stage trials next year and plans to submit them for regulatory approval.

(Reporting by Sriparna Roy in Bengaluru; Editing by Tasim Zahid)