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Commission hears presentation on once‑every‑six‑months PrEP option Yesdugo (lenacapavir) and implementation questions
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Summary
Jordan Nawas presented FDA-approved lenacapavir (Yesdugo) as a twice‑yearly subcutaneous PrEP option, reviewed trial results and implementation challenges; commissioners asked about Medicaid coverage, pharmacy administration and access for underserved groups.
Baton Rouge — Jordan Nawas, a clinical associate professor at Xavier University of Louisiana, briefed the Louisiana Commission on HIV and Hepatitis C on Sept. 9 about lenacapavir (brand name Yesdugo), an FDA‑approved long‑acting HIV pre‑exposure prophylaxis (PrEP) option that is administered as a subcutaneous injection every six months.
Why it matters: Lenacapavir provides a long‑acting, twice‑yearly PrEP option that may improve adherence and expand choices for people who have difficulty with daily oral pills. Nawas said clinical trials showed high efficacy across diverse populations, including cisgender women, men who have sex with men, transgender and gender‑diverse participants.
What the presenter described: Nawas said initial dosing consists of two subcutaneous injections administered at separate sites on day 1 plus an oral loading dose (two 300‑mg tablets totaling 600 mg) on day 1 and again on day 2; thereafter a single subcutaneous injection is given every six months. He described the Purpose 1 trial (primarily cisgender women in sub‑Saharan Africa) in which he said there were zero infections in the lenacapavir arm versus 39 in the comparator arm, and the Purpose 2 trial (including men who have sex with men, transgender and gender‑diverse people) in which he said there were 2 infections in the lenacapavir arm versus 9 in the comparator arm.
Safety and monitoring: Nawas said the drug was generally well tolerated, with injection‑site reactions the most common adverse event; serious drug‑related adverse events were not observed in trials. He emphasized the need for HIV testing, including HIV RNA (nucleic acid) testing when acute infection is suspected, before initiation and prior to each subsequent injection to reduce the risk of resistance.
Access and coverage questions: Commissioner Lauren Ritchie asked whether Louisiana Medicaid covers lenacapavir for PrEP. Chair Veil Kendall stated during the meeting, “Currently, Louisiana Medicaid is covering lindocaprevir for PrEP. That is happening.” (transcript wording used by speakers). Commissioner Burgess added that state law requires Medicaid to provide HIV‑related medications without prior authorization hurdles and urged reporting of any denials to the state Medicaid office.
Implementation challenges discussed: Nawas and commissioners discussed clinic logistics for six‑monthly injections in rural areas, pharmacy involvement and the possibility of pharmacy or patient self‑administration in the future. Nawas said pharmacists prescribing and administering PrEP is a potential future route and noted logistical barriers remain while the drug is new to practice. Nawas also noted manufacturer patient‑assistance programs for uninsured patients and recommended PrEP navigators and state programs to assist access for uninsured or underinsured patients.
Discussion, not decision: Commissioners asked questions about coverage, clinical logistics, adverse‑event counseling and participation of diverse populations in the trials. The commission took no formal action; the presentation and questions were for information.
Ending: Nawas urged providers to integrate the option into comprehensive prevention programs while maintaining regular HIV and STI testing and harm‑reduction services. Commissioners asked for the presentation slides and for continued updates on access and uptake in Louisiana.
