HIV/AIDS > )HIV/AIDS– PURPOSE 2 trial affirms advantages formerly shown in cisgender ladies
by Crystal Phend, Contributing Editor, MedPage Today November 27, 2024
Twice-yearly lenacapavir (Sunlenca) considerably minimized HIV infection when utilized for preexposure prophylaxis (PrEP) in cisgender males and transgender or gender-nonbinary individuals in the critical PURPOSE 2 trial.
Injections every 26 weeks cut the rate of HIV infections by a relative 89% compared to everyday oral emtricitabine-tenofovir disoproxil fumarate (F/TDF, Truvada), with rates of 0.10 versus 0.93 per 100 person-years (occurrence rate ratio 0.11, 95% CI 0.02-0.51, P=0.002).
There was likewise a 96% decrease in danger compared to background HIV occurrence of 2.37 per 100 person-years amongst people evaluated for registration with no PrEP or HIV evaluating in the previous 3 months (IRR 0.04, 95% CI 0.01-0.18, P(0.001).
And no security issues developed, scientists led by Moupali Das, MD, MPH, of drug maker Gilead Sciences in Foster City, California, reported in the New England Journal of Medicine
“Twice-yearly lenacapavir uses an effective option for avoidance of HIV infection, which might increase PrEP uptake,” the group concluded.
The findings followed those of the PURPOSE 1 trial that revealed a comparable benefit to twice-yearly lenacapavir amongst cisgender females in high-risk nations. Before being stopped early for effectiveness, the trial discovered a 100% decrease in HIV occurrence compared to day-to-day F/TDF or background HIV occurrence (P(0.001 for both).
While low-cost PrEP with F/TDF has actually been offered, adherence with a day-to-day medication has actually been viewed as adding to development infections. In PURPOSE 2, the day-to-day oral PrEP adherence started high (82% taking a minimum of 4 tablets a week at week 8) however decreased to 67% at week 26 and 62% at week 52. The advancement infections were related to low adherence to F/TDF.
The stage III trial gone for registration of people age 16 and older from “market subpopulations that are disproportionately impacted by HIV and have actually traditionally been underrepresented in HIV scientific trials”– cisgender gay, bisexual, and other guys, transgender females, transgender guys, and gender nonbinary individuals who have condomless responsive anal sex with partners designated male at birth.
Trial websites remained in locations with proof of significant continuous HIV transmission, many in the United States (61 ), together with 9 in Brazil, 7 in Thailand, 6 in South Africa, 5 in Peru, 3 in Argentina, and one in Mexico.
In general, 3,265 individuals were randomized 2:1 to double-blind treatment with lenacapavir or F/TDF and consisted of in the customized intention-to-treat analysis that left out individuals adjudicated as having HIV infection at randomization. The trial was stopped early after an interim analysis recommended exceptional effectiveness of lenacapavir.
2 cases of HIV infection in the lenacapavir group took place throughout the trial duration and had introduction of capsid resistance arising from lenacapavir monotherapy.
“We’re at a crossroads in the HIV upsurge,