Incidence of HIV Lower With Twice-Yearly Subcutaneous Lenacapavir

TUESDAY, Dec. 3, 2024 (HealthDay News) — In a population of cisgender men, transgender women, transgender men, and gender-nonbinary persons, the incidence of HIV is lower with receipt of twice-yearly subcutaneous lenacapavir compared with daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), according to a study published online Nov. 27 in the New England Journal Medicine.

Colleen F. Kelley, M.D., M.P.H., from the Hope Clinic of the Emory University School of Medicine in Decatur, Georgia, and colleagues randomly assigned cisgender men, transgender women, transgender men, and gender-nonbinary persons to receive subcutaneous lenacapavir every 26 weeks or daily oral F/TDF in a 2:1 ratio in a phase 3 trial.

The modified intention-to-treat analysis included 3,265 participants: 2,183 were assigned to lenacapavir and 1,088 to F/TDF. The researchers found that HIV infections occurred in two and nine participants in the lenacapavir and F/TDF groups, respectively (0.10 and 0.93, respectively, per 100 person-years). In the screened population (4,634 participants), the background incidence was 2.37 per 100 person-years. In the lenacapavir group, the incidence of HIV infection was significantly lower than the background incidence and the incidence in the F/TDF group (incidence rate ratios, 0.04 and 0.11, respectively). There were no safety concerns reported. Overall, 1.2 and 0.3 percent of the lenacapavir and F/TDF groups, respectively, discontinued the trial regimen due to injection site reactions.

“Twice-yearly lenacapavir offers an efficacious choice for prevention of HIV infection, which may increase preexposure prophylaxis uptake,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures lenacapavir and funded the study.

Abstract/Full Text (subscription or payment may be required)