Gilead posts Phase 1 data to support twice yearly potential of HIV therapy
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Gilead Sciences (NASDAQ:GILD) announced Phase 1 data for its HIV antiviral lenacapavir on Wednesday to support its twice-yearly use along with investigational HIV antibodies Teropavimab and Zinlirvimab.
Also known as Sunlenca, lenacapavir, in combination with other antiretroviral(s), is currently authorized in the U.S. for HIV infection.
In the 20-patient study, 90% of participants receiving the experimental therapy maintained virologic suppression at Week 26. One subject withdrew from the study at Week 12 with viral suppression, and another had a virologic rebound at Week 16.
There were no serious adverse events ((AEs)), and no AEs caused patients to discontinue the trial.
âIn this study we found that lenacapavir and bNAbs in a combination approach may have a significant role to play in the future treatment of HIV,â said Dr. Joseph Eron, the lead study investigator.
 âNovel long-acting HIV treatment options will drive the next chapter in care and may help meet the therapy needs and preferences of people living with HIV,â added Eron, who also serves as the Chief of the Infectious Diseases division at the University of North Carolina School of Medicine.
Gilead (GILD) plans to advance the therapeutic regimen to a Phase 2 trial later this year.
In December, the FDA authorized lenacapavir as a new twice-yearly therapeutic option for adults with multi-drug resistant (MDR) HIV-1 infection along with other antiretrovirals.