A recent study of injectable pre-exposure prophylaxis found that twice-yearly injections of lenacapavir — marketed as Yeztugo by Gilead Sciences — do not have clinically significant interactions with gender-affirming hormone therapy.
“In the most gender-diverse Phase III PrEP trial conducted to date, lenacapavir had no clinically significant impact on feminizing or masculinizing gender-affirming therapy concentrations,” the study’s researchers concluded, as reported by POZ.
The study, led by Dr. Jill Blumenthal of the University of California San Diego, examined whether lenacapavir interacts with gender-affirming hormone therapy, including estradiol (a form of estrogen) and testosterone. Because those hormones are metabolized by enzymes such as CYP3A4 — which lenacapavir can inhibit — the researchers analyzed whether the drug altered hormone levels.
Researchers collected blood samples from a subset of participants using gender-affirming hormones while receiving injectable PrEP, measuring plasma levels of estradiol, testosterone, and dihydrotestosterone — an active metabolite — over the course of a year.
Among the more than 2,000 participants, 14% identified as trans women, 1% as trans men, and 6% as nonbinary — most of whom were assigned female at birth. About 253 participants — roughly 60% of non-cisgender participants — reported receiving gender-affirming hormones while receiving lenacapavir injections.
In the study, 115 participants taking estradiol showed comparable hormone concentrations before and after receiving the PrEP injections. Similarly, testosterone and dihydrotestosterone levels generally did not change before or after injections among 25 participants using masculinizing hormones.
Those findings aligned with an earlier study showing that blood levels of lenacapavir did not change after hormone therapy. The researchers said that those results, combined with their own, support the use of twice-yearly lenacapavir injections in gender-diverse individuals, “addressing a key barrier to PrEP uptake and adherence in a population that is disproportionately vulnerable to HIV acquisition.”
Lenacapavir, found to be more effective than oral pills at preventing HIV infection, was approved by the Food and Drug Administration in June. The six-month window of protection it provides improves on existing options, including GlaxoSmithKline’s injectable PrEP drug cabotegravir, marketed as Apretude, which must be administered every two months, and daily oral PrEP regimens such as Truvada.
As of 2023, 45% of gay and bisexual men in the United States who are at high risk for HIV had used some form of PrEP, according to a CDC report issued last year. HIV prevention advocates say that greater PrEP adherence will help curb transmission rates and argue that injectables may offer better adherence than daily oral medication.
Transgender, gender-nonconforming, and nonbinary people face a higher risk of HIV acquisition and are more likely to be living with the virus than the population at large. Despite making up approximately 1% of the U.S. population, gender-diverse individuals — primarily trans women — accounted for 2% of new HIV diagnoses as recently as 2019, according to the Centers for Disease Control and Prevention.
Past studies have found that some transgender individuals are hesitant to take antiretrovirals for PrEP or HIV treatment due to concerns about potential impacts on hormone therapy. According to POZ, estimates suggest that about 20% of gender-diverse people have used PrEP, and adherence rates among that population can be as low as 30%. Researchers hope that a long-acting alternative to daily oral medication may encourage more trans and gender-diverse people to pursue PrEP and improve adherence.
Lenacapavir injections are also currently more affordable than other forms of PrEP, costing about $60 annually, compared to six annual Apretude injections, which together cost approximately $160, and daily oral PrEP, which can cost hundreds of dollars per year, even with health insurance.
Federal Judge Victoria Calvert has permanently blocked a portion of Georgia’s law banning prisoners from receiving gender-affirming care, ruling on Dec. 3 that the state’s blanket ban on hormone therapy violates the Eighth Amendment’s prohibition on cruel and unusual punishment.
Signed by Gov. Brian Kemp in May and implemented in July, the law bars prisoners from receiving hormone therapy or other treatment for gender dysphoria -- even when a doctor deems it medically necessary. It prohibits the state from funding such care and blocks transgender inmates from paying for it themselves. Non-transgender prisoners, however, may still receive hormone therapy and other gender-affirming treatments so long as the care is not related to gender transition.
The U.S. House of Representatives voted largely along party lines to advance a bill that would imprison doctors for providing gender-affirming care to transgender minors and punish parents who consent to their child’s treatment.
The bill, introduced by U.S. Rep. Marjorie Taylor Greene (R-Ga.), would impose prison sentences of up to 10 years on medical providers who recommend or prescribe puberty blockers, hormone therapy, or surgery to transgender patients under 18. It would also criminalize parents who consent to their child’s treatment or transport them across state lines to obtain such care.
Congressional lawmakers have approved a measure that would bar Medicaid -- the federal health insurance program for low-income Americans -- from covering gender-affirming care, including hormonal and surgical interventions, for minors.
The "Do No Harm in Medicaid Act," sponsored by U.S. Rep. Dan Crenshaw (R-Texas), is the third in a series of Republican-backed efforts to block people under 18 from accessing medical treatments that assist in a gender transition.
The measure passed by a 215-201 vote, with four Democrats -- Reps. Henry Cuellar (Texas), Vicente Gonzalez (Texas), Don Davis (N.C.) and Marie Gluesenkamp Perez (Wash.) -- joining Republicans in support of the ban.
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