The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn.
The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
While the CDC’s position was hailed by HIV advocacy groups, many pointed to the remaining roadblocks that prevent wider access, especially for those without health insurance.
In August, CVS Health confirmed that it won’t currently be adding the drug to its commercial plans or Affordable Care Act (ACA) formularies, citing a “careful review of clinical, financial and regulatory considerations,” a spokesperson told Fierce Pharma at the time.
CVS’s ACA formularies specifically are guided by recommendations from the U.S. Department of Health and Human Services’ Preventive Services Task Force (USPSTF), which has not yet added Yeztugo to its PrEP guidelines. The USPSTF was created by Congress in the 1980s but acts as a separate body made up of volunteer primary care experts.
Still, with the CDC thumbs-up and a recent endorsement from the World Health Organization, plus the International Antiviral Society-USA Panel updating its PrEP guidelines to include Yeztugo, dozens of HIV advocacy organizations are calling on CVS Health to reconsider its decision and “cover Yeztugo without delay.”
In a Sept. 18 letter (PDF) to CVS Health’s CEO David Joyner, 64 groups—including the HIV + Hepatitis Policy Institute, AIDS United and others—pushed back on CVS’s USPSTF-based decision. According to the letter, the USPSTF’s recommendations are typically updated on a five-year cycle and, importantly, doesn’t make drug-specific endorsements; the task force recommends the prescription of PrEP in general, not any particular products.
The organizations further stressed the urgency of eliminating barriers to PrEP uptake, emphasizing that “everyone” benefits from wider PrEP access, including private insurers. Long-acting options like Gilead’s can help avoid the high long-term cost of lifetime HIV treatment, the letter notes.
“The entire world is excited about this PrEP drug that for the first time resulted in zero infections in clinical trials, and was hailed by Science magazine as the 2024 Breakthrough of the Year,” the HIV + Hepatitis Policy Institute’s executive director Carl Schmid said in a separate statement. “Now we must make sure that everyone who wants it is able to access it.”
Gilead, for its part, committed to helping to ensure that people in the U.S. without insurance coverage can still benefit from the drug, it said in a Sept. 18 statement. The company offers Yeztugo “free of charge” to eligible people through its advancing access medication assistance program.
