Weekly HIV pill matches daily therapy in phase 3 trial

A phase 3 clinical trial found that a once-weekly oral HIV regimen combining islatravir and lenacapavir performed as well as standard once-daily, three-drug therapies in keeping virus levels suppressed. Researchers said the weekly approach met the study’s predefined noninferiority benchmark when compared with established daily options.

The results come from 607 participants enrolled across 12 countries. All participants had already achieved viral suppression before entering the study and were monitored for 48 weeks, according to the trial findings.

48-week outcomes for viral suppression Across the overall 48-week outcomes for viral suppression Across the overall study population Across the overall study population, 93% of participants maintained viral suppression through week 48, researchers reported. They also said there were no instances of virological failure in the group receiving the once-weekly regimen during the trial period. Measures of immune function stayed stable over follow-up. Researchers described the stability as comparable between people taking the weekly regimen and those assigned to daily therapies. Safety results and serious adverse events The study reported broadly similar overall safety outcomes between the two trial arms. However, the trial summary did not provide detailed descriptions of serious adverse events. Serious adverse events were reported in 5.3% of participants receiving the once-weekly regimen and 4.6% of those assigned to daily therapies. Researchers framed the overall safety profile as broadly comparable between the groups based on the findings presented. Boundaries on how far the findings can be applied Officials cautioned that the study’s design sets clear limits on interpretation. Because eligibility was restricted to people who were already virally suppressed at baseline, the results may not directly translate to patients who are not yet controlled on treatment or who have difficulty taking therapy consistently. Officials also pointed to the 48-week duration as Officials also pointed to the 48-week duration as a key constraint. They said longer-term monitoring is still needed to determine whether any risks emerge beyond the follow-up window covered by the trial, a factor that can weigh on clinical decision-making and regulatory review.

Hepatitis B screening consideration

According to the study description, the islatravir-lenacapavir regimen does not have activity against hepatitis B. Officials said this would require clinicians to account for hepatitis B status in screening and treatment selection, particularly in settings where co-infection is a concern.

Treatment simplification as the central aim

Researchers presented the findings as part of wider efforts to simplify HIV treatment while preserving strong viral control and maintaining a manageable safety profile. At the same time, they emphasized that the inclusion criteria and the 48-week length leave open questions about performance and safety in people outside the trial’s eligibility rules and over longer periods than the study captured.