U.S. National Institutes of Health has launched two clinical trials to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs.
The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months.
Gilead Sciences Inc. GILD sponsored and funded the studies implemented through the HIV Prevention Trails Network (HPTN).
The HPTN is supported by grants from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) and co-funding from NIDA and other NIH institutes.
FDA has already approved Lenacapavir for HIV treatment, in combination with other antiretroviral therapy, of heavily treatment-experienced individuals.
Lenacapavir is the first long-acting injectable to be offered with administration just once every six months.
Cisgender women—people who self-identify as female and were assigned female sex at birth—and people who inject drugs accounted for 18% and 7% of new HIV diagnoses in the United States in 2021, respectively.
The first trial will enroll cisgender women, with a focus on making enrollment accessible to women who self-identify as Black and/or Latina.
The second trial will enroll a diverse group of people who inject drugs.
In both studies, participants will be randomly assigned to receive either injectable lenacapavir or an FDA-approved PrEP formulation consisting of oral tenofovir disoproxil fumarate and emtricitabine.
Price Action: GILD shares are up 1.06% at $64.11 at the last check on Tuesday.
HIV/AIDS ribbon via Shutterstock
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