Gilead's experimental HIV treatment non-inferior to blockbuster drug in trial
By Sriparna Roy
Dec 15 (Reuters) - Gilead Sciences GILD.O said on Monday its experimental HIV treatment was found to be statistically non-inferior to its top-selling drug Biktarvy in a late-stage trial.
The experimental regimen could expand treatment options and help people with HIV maintain long-term control of the virus, the company said.
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 regimen will have the biggest impact in the virologically suppressed population and be a convenient option for patients that switch regimens, said Needham analyst Joseph Stringer.
The combination was generally well tolerated, with no significant or new safety concerns identified, Gilead said.
We view it as a nice expansion of the HIV portfolio and another step towards solidifying protection from the patent expiration of Biktarvy in 2036, Stringer added.
Gilead recorded Biktarvy sales of $13.4 billion in 2024.
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 treatments Sunlenca and Yeztugo, which is 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.
Related Articles
Elon Musk’s SpaceX Poised for Record-Breaking IPO: How Can Retail Investors Get In on the Action of Starlink Stock?
TradingKey - Elon Musk's rocket manufacturer SpaceX is expected to launch an IPO in 2026, with a target IPO valuation projected to reach $1.5 trillion. However, prior to its listing, the stock can only be traded in the private market, characterized by low information transparency and high capital ba
Musk’s Next Ambition: Building a Space-Based AI Data Center
TradingKey - Musk has long resisted the idea of taking SpaceX public. After the Tesla take-private drama and the resulting SEC penalties (which cost him the chairmanship), he’s been wary of public market entanglements. But something’s changed—and fast.
Japan Central Bank Rate Hike To Three-Decade High Imminent, How Will The Market Go? Which Assets Most Affected?
As global monetary policy divergence enters a critical phase, the Bank of Japan (BoJ) is anticipated to raise its benchmark interest rate at the monetary policy meeting on December 19, 2025, by 25 basis points to 0.75% , marking its highest level in nearly 30 years.
Gold Price Steady Climb and the Sudden Surge of Silver and Copper: Will Their Bull Run Extend Into 2026?
Dow Jones Market Data shows this marks the first time since 1980all three metals—gold, silver, and copper—simultaneously refreshed their all-time highs in the same year. Will this rally extend into 2026?
