Policy & Regulation
Gilead's Lenacapavir Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living with HIV
19 November 2020 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) is released topline results from the Phase 2/3 CAPELLA trial evaluating the company's investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug resistant HIV-1 infection, the company said.

The study found that 88% of participants receiving lenacapavir (n=21/24) experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% of those receiving placebo (n=2/12).

Lenacapavir is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection.

If approved, lenacapavir would be the first HIV capsid inhibitor available for the treatment of HIV-1 infection.

In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multidrug resistance in combination with other antiretroviral drugs.

In CAPELLA, 36 adults with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2: 1 to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy).

Of the 24 people randomized to the lenacapavir group, the median baseline viral load was 4.2 log10 copies/mL and 67% had a CD4 count of less than 200 cells/uL.

A statistically significant greater proportion of participants receiving lenacapavir met the primary endpoint of a viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo at the end of the 14-day functional monotherapy period (88% vs. 17%, p