Gilead Sciences Inc GILD stock is trading lower during the premarket trading session on Wednesday.
According to a Tuesday report in the Wall Street Journal, the Health and Human Services Department (HHS) is considering substantial reductions in federal funding for domestic HIV prevention.
According to people familiar with the matter, the WSJ reports that the plans could be announced within a day. However, they are not final and could still be changed or canceled.
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The Centers for Disease Control and Prevention (CDC) has a department focused on preventing HIV and other infectious diseases. It provides funding for state and local programs, including HIV tracking, syringe services, and community outreach, the WSJ writes.
Meanwhile, the Trump administration is planning significant staff cuts at the CDC as part of a broader reorganization, according to WSJ sources. The agency's structure makes it vulnerable to such changes since no single law defines its mission or programs.
Mitchell Warren, executive director of HIV prevention group AVAC, says the CDC's pre-exposure prophylaxis (PrEP) program could be reduced or cut. Launched last fall as a pilot program, it provides free medication to help prevent HIV.
PrEP is used by people who are HIV-negative and at high risk of being exposed to HIV infection.
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In 2021, the FDA approved ViiV Healthcare's Apretude, the first injectable form of PrEP administered every two months. ViiV Healthcare is owned by Pfizer Inc. PFE, GSK plc GSK, and Shinogi Ltd.
In 2023, the agency allocated approximately $1.3 billion to combat HIV, viral hepatitis, sexually transmitted infections, and tuberculosis. Roughly 75% of those funds support state and local health departments, nonprofits, and other organizations engaged in disease prevention and outbreak response.
"No final decision on streamlining CDC's HIV Prevention Division has been made," the WSJ report added, citing the department's spokesman.
Gilead filed for regulatory approval of lenacapavir for PrEP (twice a year) last year and expects a potential commercial launch in 2025.
Gilead also revealed that it is developing a once-yearly injectable formulation for lenacapavir. In its investor presentation, the company expects the pivotal Phase 3 pharmacokinetics study's first patient to be in 2025, and potential regulatory filings will begin in late 2027.
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