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Gilead Sciences' Lenacapavir Meets Primary Endpoint In Phase 2/3 HIV Study

Gilead Sciences Inc.'s. (GILD) investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, met primary endpoint in Phase 2/3 Study in heavily treatment-experienced people with multidrug resistant HIV-1 infection.

The Phase 2/3 CAPELLA study found that 88% of participants receiving lenacapavir 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.

According to the company, Lenacapavir was generally safe and well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations for any reason through the 14-day period, including no discontinuations due to adverse events.

The most common adverse events observed in the portion of the study include injection site swelling (21%) and injection site nodules (17%), the majority of which were Grade 1 or 2 in severity.

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, the company said in a statement.

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.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not known. There is no cure for HIV or AIDS.

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