Injectable PReP Better Than Daily Pills, Study Finds
A new study reveals that two yearly injections of the drug lenacapavir is more effective at preventing HIV than a daily pill regimen.
A recent study has found that lenacapavir, an injectable medication administered twice a year, is more effective at preventing HIV among gay, bisexual, and transgender people than a daily regimen of Truvada, taken orally, as a form of pre-exposure prophylaxis.
The study examined cisgender men, transgender men and women, and nonbinary individuals who have sex with partners assigned male at birth. The participants hailed from Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.
Participants in the trial were randomized to either receive lenacapavir or Truvada on a placebo-controlled, double-blind basis — meaning that neither they nor the researchers were aware of who was getting which drug.
An analysis of the trial results found that only two out of 2,180 participants who had received lenacapavir seroconverted, meaning they acquired HIV during the trial, compared to 9 of the 1,087 people who received Truvada.
For the former group, this represented an 89% lower HIV infection rate than those in the Truvada group, and what Gilead estimated was a 96% lower infection rate than what would be expected had participants received neither HIV prevention drug.
Given the statistical superiority of lenacapavir over Truvada, researchers will end the trial’s blinded phase several months early.
They will then inform participants of which drug they received and offer all participants the option of receiving lenacapavir as a form of PrEP.
Jen Kates, the director of global health and HIV policy at the health policy research nonprofit KFF, called the results “nothing short of amazing.”
The findings come on the heels of a separate study concluding that lenacapavir demonstrated 100% efficacy among cisgender women in sub-Saharan Africa, and was more effective than Truvada as PrEP or a once-daily regimen of the HIV prevention medication Descovy. That treatment was so effective that the participants were also offered the option of taking lenacapavir to avoid acquiring HIV.
“With such remarkable outcomes across two Phase 3 studies, lenacapavir has demonstrated the potential to transform the prevention of HIV and help to end the epidemic,” Daniel O’Day, the chairman and CEO of Gilead, said in a statement. “Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide.”
Additional trials testing the efficacy of lenacapavir among cisgender women in the United States and among intravenous drug users remain ongoing.
The results of the studies so far have led some experts to speculate that lenacapavir could be a game-changer in stemming the spread of HIV.
While taking daily Truvada as PrEP has been hailed as a significant development in HIV prevention — being 99% effective at preventing HIV — the drug’s effectiveness can be impeded if patients do not routinely take the medication on a daily basis.
Additionally, gay and bisexual black men — the group with the highest incidence of HIV — have shown low adherence rates in past studies examining Truvada as PrEP, which creates inequities in terms of the drug’s effectiveness among different racial or income-based groups.
Unfortunately, as NBC News reports, lenacapavir carries a hefty price-tag of $3,450 per month, putting it out of reach for the very same people at risk of acquiring HIV.
A similar injectable HIV prevention medication, ViiV Healthcare’s Apretude, which is administered every eight weeks, costs a $1,965 per month and has failed to gain traction in the United States.
Gilead Sciences, the manufacturer of lenacapavir — as well as Truvada and Descovy — plans to submit the drug for approval for use as a form of PrEP by the end of the year, meaning it could be available as a treatment option by mid-to-late 2025.
The drug is considered safe and well-tolerated, with no major safety concerns, according to Gilead. One side effect is that the subcutaneous injection of the drug in the abdominal area leaves a small deposit that can be visible among individuals with low body fat — something that could discourage some potential users from pursuing treatment.
Medical experts look at injectables as something that would be easier to administer, and more likely to ensure adherence, than relying on a pill regimen.
“Right now, the challenge is having people take a pill every day to prevent something that they don’t have,” Dr. Hansel Tookes, a professor in the infectious diseases division at the University of Miami Miller School of Medicine, told NBC News. “Having to get an injection twice a year is an easier sell.”
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