Merck-Gilead’s Combined HIV Treatment Sunlenca Shows Positive Results in Mid-Phase Clinical Trial

A mid-phase trial featuring Gilead Sciences and Merck & Co.’s once-weekly HIV combination therapy has successfully met its primary 24-week endpoint and surpassed expectations by suppressing the virus at the 48-week mark.
The trial in question took place in March and looked at over 100 virologically suppressed adults, in whom the collaborators’ combination treatment was pitted against Gilead’s once-daily Biktarvy, the control treatment. The combination treatment features Gilead’s lenacapavir, sold under the name Sunlenca, and Merck’s islatravir, which together, after 24 weeks of once-weekly dosing, were able to keep HIV-1 RNA below 50 copies/mL in 98% of patients. In contrast, the control treatment was able to keep HIV-1 RNA below 50 copies/mL in 100% of the patients after 24 weeks.

Follow-up data was tracked up to the 48-week mark, at which point the rates of HIV suppression in the combination and Biktarvy arms were 94.2% and 92.3%, respectively. Gilead and Merck presented this data during an oral session at IDWeek 2024. At 24 weeks, the rate of HIV suppression for both groups in the trial was measured to be close to 94%.
Regarding the milestone for the once-weekly HIV combination therapy, Elizabeth Rhee, vice president of global clinical development at Merck Research Laboratories, said, “Daily single-tablet regimens have helped to transform HIV care but can be challenging for some people to maintain. Novel HIV treatment options that allow for less frequent oral dosing have the potential to help support adherence and address the stigma faced by some individuals taking daily oral therapy.”
Given these positive results, a new phase 3 trial for the combination therapy is in the works, with Gilead starting two randomized trials consisting of 600 virologically suppressed adults each, who will either be given the once-weekly combination or the once-daily Biktarvy. Observing the proportion of participants with HIV-1 RNA of 50 copies/mL or fewer at Week 48 is the primary endpoint of the trials.
Despite Merck’s previous efforts to make islatravir the primary candidate among the new generation of HIV therapies, the company has encountered a number of hurdles. Only a few years ago, in 2021, the drugmaker had to pause enrollment in studies of the molecule due to drops in total lymphocyte and CD4+ T-cell counts.

Up until the 48-week mark in the phase 2 trial, in both the combination therapy and Biktarvy cohorts, there had been no major differences between CD4+ T-cell counts or absolute lymphocyte counts. In no instance did participants have to discontinue their regimen due to a decrease in CD4+ T-cell or lymphocyte counts.

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