The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences\u2019 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.<\/p>\n
The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead\u2019s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA\u2019s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.<\/p>\n
Based on the studies, the CDC \u201cstrongly recommends\u201d Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug \u201chas the potential to improve PrEP adherence and thus enhance HIV prevention.\u201d
\nWhile the CDC\u2019s position was hailed by HIV advocacy groups, many pointed to the remaining roadblocks that prevent wider access, especially for those without health insurance.<\/p>\n
In August, CVS Health confirmed that it won\u2019t currently be adding the drug to its commercial plans or Affordable Care Act (ACA) formularies, citing a \u201ccareful review of clinical, financial and regulatory considerations,\u201d a spokesperson told Fierce Pharma at the time.
\nCVS\u2019s ACA formularies specifically are guided by recommendations from the U.S. Department of Health and Human Services\u2019 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.
\nStill, 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 \u201ccover Yeztugo without delay.\u201d<\/p>\n
In a Sept. 18 letter (PDF) to CVS Health\u2019s CEO David Joyner, 64 groups\u2014including the HIV + Hepatitis Policy Institute, AIDS United and others\u2014pushed back on CVS\u2019s USPSTF-based decision. According to the letter, the USPSTF\u2019s recommendations are typically updated on a five-year cycle and, importantly, doesn\u2019t make drug-specific endorsements; the task force recommends the prescription of PrEP in general, not any particular products.<\/p>\n
The organizations further stressed the urgency of eliminating barriers to PrEP uptake, emphasizing that \u201ceveryone\u201d benefits from wider PrEP access, including private insurers. Long-acting options like Gilead\u2019s can help avoid the high long-term cost of lifetime HIV treatment, the letter notes.<\/p>\n
\u201cThe 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,\u201d the HIV + Hepatitis Policy Institute\u2019s executive director Carl Schmid said in a separate statement. \u201cNow we must make sure that everyone who wants it is able to access it.\u201d<\/p>\n
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 \u201cfree of charge\u201d to eligible people through its advancing access medication assistance program.<\/p>\n","protected":false},"excerpt":{"rendered":"
The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences\u2019 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 […]<\/p>\n","protected":false},"author":2,"featured_media":1885,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[37],"tags":[525,524,99],"class_list":{"0":"post-1884","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-industry-news","8":"tag-but-advocacy-groups-say-access-barriers-remain","9":"tag-cdc-strongly-backs-gileads-hiv-prep-yeztugo","10":"tag-gilead-sciences-gild-o"},"yoast_head":"\n