GSK’s ViiV Healthcare says ATLAS Phase III study met primary endpoint

ViiV Healthcare (GSK) presented comprehensive 48-week data from the ATLAS pivotal phase III studies of the novel, investigational, long-acting regimen of cabotegravir and rilpivirine. These two studies met their primary endpoints, showing that the combination of ViiV Healthcare’s cabotegravir and Janssen’s (JNJ) rilpivirine, injected every four weeks, was non-inferior in maintaining viral suppression in adults infected with human immunodeficiency virus type-1 when compared to a standard of care, daily, oral three-drug regimen. These data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections in Seattle, Washington. The phase III ATLAS study met its primary endpoint, with cabotegravir and rilpivirine demonstrating non-inferiority to an oral three-drug regimen of two nucleoside reverse transcriptase inhibitors plus a third agent, as measured by the proportion of participants with plasma HIV-1 RNA greater than or equal to50 copies per millilitre using the FDA Snapshot algorithm at Week 48. The study found virologic suppression rates at Week 48 were similar between treatment arms.
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