Gilead’s HIV-1 Drug Achieves High Rates of Virologic Suppression

Gilead recently announced one-year results from an ongoing Phase 2/3 CAPELLA trial evaluating its HIV-1 capsid inhibitor, lenacapavir, in individuals with multi-drug resistant HIV.

The trial demonstrated that lenacapavir, administered simultaneously every six months with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in individuals with HIV who did not respond to their current therapy.

Eighty-three percent of people with high unmet medical needs who received lenacapavir combined with a background regimen received an undetectable viral load at Weeks 52. And patients achieved a mean increase in CD4 count of 83 cells/ microliter.

Notably, researchers found no serious adverse events with drug use.

“I am really encouraged by the results presented today showing that the positive outcomes achieved with lenacapavir can be sustained at one year of treatment, which is a remarkable achievement for this group of people living with HIV who have limited treatment options and are at a greater risk of progressing to AIDS, Onyema Ogbuagu, MD, FACP, director of HIV clinical trials program at Yale School of Medicine, said in the announcement.

“The potential of a long-acting antiretroviral treatment option that may achieve and maintain an undetectable viral load would be a true advancement that could potentially transform how providers care for certain patients with the virus,” Ogbuagu continued.

Lenacapavir is a first-in-class, investigational long-acting HIV-1 capsid inhibitor currently in development to treat and prevent HIV-1 infection. Lenacapavir has no known cross-resistance to other drug classes. LenacapavirIf FDA-approved, lenacapavir would be the only HIV-1 treatment option administered twice a year with FDA approval.

Previous data from last year showed that lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/ milliliters from baseline compared with patients who receivedreceive placebo during the 14-day functional monotherapy period.

And patients who received lenacapavir achieved a significantly greater mean decrease in viral load than those who received placebo during the functional monotherapy period.

Gilead stated that the recent trial results support the ongoing evaluation and further development of lenacapavir combined with other long-acting partner agents to treat HIV-1 infection and support the company’s long-acting oral and injectable development program.