Gilead’s lenacapavir meets primary goal in heavily treated and multidrug resistant HIV-1
pharmafile | November 19, 2020 | News story | Research and Development | Gilead, HIV, pharma
Gilead has pulled back the curtain on promising new data for its long-acting HIV-1 capsid inhibitor lenacapavir for heavily treated and multidrug resistant HIV-1 infection, an area of great unmet need.
The Phase 2/3 data was generated from 36 recruited patients with multi-class HIV drug resistance and detectable viral load who were not seeing their disease controlled with their current regimen.
Fourteen days following initial dose, 88% of lenacapavir patients saw a reduction in their viral load of at least 0.5 log10 copies/mL compared to 17% of placebo patients achieving the same, meaning Gilead’s drug met the primary endpoint of the study.
Furthermore, lenacapavir patients saw a “significantly greater” average change in their viral load compared to placebo patients. No serious adverse events were reported.
“There is an urgent and critical need for innovative treatment options for people living with HIV who have limited treatment options and are not able to maintain virologic suppression on their current therapy, whether from challenges adhering to a complex regimen or HIV mutations that cause drug resistance,” commented Dr Edwin DeJesus, Medical Director at the Orlando Immunology Center. “The initial CAPELLA trial results demonstrate that lenacapavir led to a rapid decline in viral load in heavily treatment-experienced people with multidrug resistance living with HIV. This clinical response could potentially have an important impact on individual patients and public health.”
Should the therapy go on to secure regulatory approval, it would be the first HIV capsid inhibitor to be made available to patients in this indication.
Matt Fellows
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