HealthDay News — Patients with multidrug-resistant HIV-1 infection receiving the capsid inhibitor lenacapavir have a greater reduction in viral load than those receiving placebo, according to a study published in the May 12 issue of the New England Journal of Medicine.
Sorana Segal-Maurer, M.D., from NewYork/Presbyterian Queens in Flushing, and colleagues enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to the change in the plasma HIV-1 RNA level between screening and cohort-selection visits in a phase 3 trial. In cohort 1, patients were first randomly assigned to receive oral lenacapavir or placebo for 14 days; the lenacapavir group then received subcutaneous lenacapavir once every six months, while the placebo group received oral lenacapavir followed by subcutaneous lenacapavir; both groups also received optimized background therapy. In cohort 2, all patients received open-label oral lenacapavir on days 1 through 14 with optimized background therapy, then received subcutaneous lenacapavir. Seventy-two patients were enrolled: 36 in each cohort.
The researchers observed a decrease of at least 0.5 log10 copies/mL in the viral load by day 15 in 88 and 17% of patients in the lenacapavir and placebo groups, respectively, in cohort 1. At week 26, 81 and 83% of patients in cohorts 1 and 2, respectively, reported a viral load of less than 50 copies/mL, with a least-squares mean increase of 75 and 104 cells/mm3 in the CD4+ count, respectively. There were no serious adverse events related to lenacapavir reported.
“Lenacapavir led to a significant decrease in viral load as functional monotherapy,” the authors write.
The study was funded by Gilead Sciences, the manufacturer of lenacapavir.