Lenacapavir, the new long-acting HIV prevention medication that hit the United States market with a price tag of over $28,000 per patient per year, will be made available for around $40 for 120 low- and middle-income countries and territories. That price puts it on par with other pre-exposure prophylaxis (PrEP) medications, but it will be restricted to places included in voluntary generic licensing agreement set by manufacturer Gilead Sciences.
Through a deal struck by the Clinton Health Access Initiative, Unitaid and Wits RHI with a pharmaceutical manufacturer in India, and a separate deal between the Gates Foundation and a second manufacturer in India, generic versions of lenacapavir are expected to enter the global market in 2027. Funders announced the news September 24.
Lenacapavir entered the domestic market in June under brand name Yeztugo, following its approval by the Food and Drug Administration. As an injectable that only has to be administered twice a year, it’s by far the longest-acting PrEP medication. It’s been widely heralded as a unprecedented breakthrough for HIV prevention—or rather, it could be, if people at risk could access it.
“While an HIV vaccine remains elusive, lenacapavir is the next best thing,” World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said in July.
In one study that included 5,338 at-risk participants assigned female at birth, lenacapavir was 100-percent effective in preventing HIV acquisition after one year—none of the 2,134 people who received lenacapavir contracted HIV. In another comparably sized study of primarily male participants, the medication was 96-percent effective after one year.
For now, the cost in the US remains over $14,000 per dose.
On September 18, the Centers for Disease Control and Prevention issued new HIV prevention guidance, stating in an open letter that “on the basis of a high certainty of evidence for its efficacy and safety” the agency “strongly recommends lenacapavir.”
While the CDC recommendation doesn’t have a direct bearing on medication access the way FDA approval does, its value is that it may persuade insurers to cover it. For now, its cost in the US remains over $14,000 per dose.
In late August, Reuters reported that CVS would not add Yeztugo to its drug coverage lists. Pharmacy benefit manager CVS Caremark controls the drug-pricing in more than one-quarter of the US pharmaceutical market.
“We’re in the process now of attaining insurance coverage for lenacapavir,” Daniel O’Day, chairman and CEO of Gilead Sciences, said at a September press conference. “It’s going as planned. We expect within six months of launch to have around 75 percent of insurers covering lenacapavir and about 90 percent in 12 months. And that plan is very actively underway right now for Americans.”
At that press conference, the Trump administration unveiled an agreement with Gilead to cover the cost of Yeztugo for 2 million people internationally over the next three years. This is focused only on preventing mother-to-child transmission; however, State Department senior official Jeremy P. Lewin said that “there’s no formal restriction” as to how countries allocate the doses.
Gilead had already voluntarily licensed the medication to generics manufacturers by the time lenacapavir received FDA approval, which appears to be the first such arrangement of its kind.
No PrEP medication is FDA-approved for HIV risk associated with injection drug use; only with sexual contact.
Three other PrEP medications have previously been approved by the FDA, and appear in the CDC’s clinical guidance. Truvada, which was already an established HIV treatment medication, received FDA approval for PrEP in 2012. Descovy followed in 2016, and Apretude, the first injectable form, was approved in 2021. While Truvada and Descovy are pills meant to be taken once a day, Apretude requires only one injection every two months.
None of the four medications are FDA-approved for the prevention of HIV transmission associated with injection drug use (IDU); only with sexual contact. However, the CDC guidance states that Truvada is “recommended to prevent HIV among all people with sex or injection drug use risk factors,” and medical experts widely agree that PrEP medications are effective and advisable for people at risk from sharing needles—many of whom are also at risk from sexual contact.
A statistic widely circulated by the CDC and other state and federal health agencies is that oral PrEP pills are shown to reduce risk of HIV transmission associated with IDU by at least 74 percent. However, despite the established link between sharing needles and HIV transmission, few studies have been conducted on the efficacy of PrEP medications in this context and most of the existing data represent patients who weren’t necessarily adhering to the treatment regimen as prescribed—which suggests that these medications have even greater potential, if at-risk drug users have access to treatment options that fit them. For many people, a clinic appointment twice a year would be more sustainable than a medication that has to be taken every day to be fully effective.
Though transmission has been steadily declining, approximately 31,800 people in the US were diagnosed with HIV in 2022, the most recent year for which the CDC has comprehensive data.
“[A]dherence to available PrEP regimens is suboptimal,” the agency wrote in its September 18 clinical recommendation, published in the Morbidity and Mortality Weekly Report. Lenacapavir “provides the potential to improve PrEP adherence and thus enhance HIV prevention in the United States. Additional research is needed to understand [its] effectiveness in persons who inject drugs.”
Image via United States Department of Health and Human Services