Gilead set to present 96-week data for novel long-acting combination treatment in HIV at EACS 2025. Credit: Sundry Photography /Shutterstock.com.
Gilead Sciences will present long-term data on a novel long-acting oral combination treatment for HIV at a major upcoming conference.
According to Gilead, the findings demonstrate a sustained two-year viral suppression in people living with HIV (human immunodeficiency virus) who switched to the novel two-drug combination.
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The company plans to present results from an ongoing open-label Phase II study (NCT05052996) investigating a once-weekly oral combination regimen of its drug lenacapavir with islatravir, which is being developed by Merck & Co (MSD).
The late-breaking abstract shows that 88.5% (46/52) and 100% (46/46) of adults treated with islatravir and lenacapavir maintained undetectable viral load (HIV-1 RNA <50 copies/mL) at week 96, when based on Missing = Failure and Missing = Excluded analyses, respectively. These findings will be presented at the 20th European AIDS (acquired immunodeficiency syndrome) Conference (EACS), which is being held in Paris, France from 15 to 18 October 2025.
This novel treatment regimen is currently under investigation in two Phase III trials (NCT06630286 and NCT06630299), testing the safety and efficacy of switching to the once weekly tablet compared to continuing with standard of care (SoC) treatment. Primary completion dates for both trials are expected in April 2026, as per ClinicalTrials.gov.
If approved, the combination could become the first weekly oral treatment option for HIV. This would be welcome news for patients, offering a simpler and more convenient alternative to the SoC that could help improve adherence and quality of life.
Lenacapavir was approved under the name Sunlenca in the US and EU back in 2022 for heavily treatment-experienced adults with multidrug resistant HIV-1 infection whose current treatment has failed.
Since then, the treatment has evolved to become one of Gilead’s star assets, following its approval as the first twice-yearly pre-exposure prophylaxis (PrEP) in June 2025, sold under the brand name Yeztugo. This milestone is set to establish lenacapavir as a blockbuster asset, with forecasting by Globaldata, parent company of Clinical Trials Arena, predicting annual sales of over $5bn in 2031.
MSD strengthens standing in the HIV disease space
Meanwhile, outside of investigation in combination with Gilead’s lenacapavir, MSD’s islatravir is currently under review by the FDA for approval in combination with doravirine for adults with virologically suppressed HIV. The two-drug regimen has been given a Prescription Drug User Fee Act (PDUFA) target date of 28 April 2026.
MSD is also currently recruiting for a Phase III study investigating the potential of MK-8527, a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), as a once-monthly oral PrEP (NCT07044297).
In addition, MSD is set to initiate Phase III testing of MK-8527 in women and adolescent girls in sub-Saharan Africa in the EXPrESSIVE-10 trial, announced in July 2025.
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