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J&J's single-tablet HIV regimen meets main goal of phase 3 Emerald study


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J&J's single-tablet HIV regimen meets main goal of phase 3 Emerald study

Johnson & Johnson said its single-tablet regimen containing four HIV drugs met the main goal of a phase 3 study in infected adults whose viral levels were already controlled by medication.

The tablet — which includes darunavir 800 milligrams, cobicistat 150 milligrams, emtricitabine 200 milligrams and tenofovir alafenamide 10 milligrams worked as well as continuing treatment with a boosted protease inhibitor plus emtricitabine and tenofovir disoproxil fumarate in keeping HIV at bay, according to the Emerald trial by J&J's Janssen Pharmaceutica NV unit.

The study's main goal, as stipulated by the U.S. Food and Drug Administration, was the proportion of patients with virologic rebound, meaning that the viral level in the body has exceeded a certain threshold, through 48 weeks.

At the end of that period, cumulative virologic rebound was 2.5% for patients who switched to the single-tablet regimen, compared with 2.1% in those who continued their milligrams treatment.

Through 48 weeks, researchers did not observe any mutations that would have made the virus more resistant to treatment with the study drugs.

Virologic suppression was 94.9% for those taking the J&J tablet and 93.7% for the other patients at the end of 48 weeks. The single tablet failed to keep the virus below a certain level in 0.8% of patients, compared with 0.5% virologic failure for the other group. There were no discontinuations for virologic failure.

The single-tablet regimen also appeared to be as safe as the other combination.