Gilead Sciences presented new results from its Phase 2/3 CAPELLA study focused on its investigational, long-acting HIV-1 capsid inhibitor, lenacapavir.
The trial, which involved heavily treatment-experienced people with multi-drug resistant HIV-1 infection, showed that lenacapavir had substantial virologic suppression for 26 weeks.
In November, the company had announced that 88% of lenacapavir recipients in the trial had at least a 0.5 log10 reduction in HIV-1 viral load after 14 days of functional monotherapy.
“The CAPELLA trial enrolled people who were failing their regimens with a detectable viral load and had very few remaining options due to multi-drug resistance, which presents a formidable barrier to treatment,” said Dr. Diana Brainard, senior vice president, virology therapeutic area at Gilead Sciences in a statement. “These interim results from the CAPELLA trial demonstrate lenacapavir’s potential to be a foundational, long-acting agent of future HIV treatment regimens.”
Roche’s Fuzeon (enfuvirtide) was the first subcutaneous drug to win FDA approval for treating HIV-infected patients. It must be administered multiple times daily, in contrast to lenacapavir.
Injectable drugs remain one of the quickest growing segments among HIV therapies.
Filed Under: clinical trials, Drug Discovery, Infectious Disease