ViiV Healthcare, which is majority owned by GSK (GSK), said Tuesday that a phase 3b study has met its primary endpoint, showing that at six months, Cabenuva saw "superior rates of viral suppression" compared with oral antiretroviral therapy in adults and adolescents with HIV-1, who had detectable virus when they started the trial.

The trial has enrolled 326 participants in eight countries at 85 study sites, the company said.

The results follow a previous trial that showed that Cabenuva was superior to daily oral therapy in keeping viral suppression for people with HIV who had reached viral suppression on oral antiretroviral therapy but had a history of adherence challenges, ViiV said.

The latest trial addressed a "remaining evidence gap by evaluating direct initiation of the regimen in people who still had detectable virus at study entry," the company said.

ViiV said the latest results will now be shared with health regulators.

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