Gilead Sciences Inc. said early Monday that its HIV combination treatment had similar safety and efficacy results in two late-stage clinical trials to the standard of care. The data, along with two other late-stage clinical trials, are the basis of Gilead's U.S. and European regulatory submissions, the company said. The combination of the drugs bictegravir and emtricitabine/tenofovir alafenamide is intended for patients who are new to treatment. One of the phase 3 studies, which enrolled 629 patients, found that 92.4% of patients on the BIC/FTC/TAF combination treatment achieved the primary endpoint at week 48, compared with 93% of patients achieving the primary endpoint on the other regimen. In the other study, which enrolled 645 patients, 89.4% of those on the BIC/FTC/TAF regimen and 92.9% of those on another regimen achieved the primary endpoint at week 48. In both studies, discontinuations due to adverse events were low, according to Gilead. Two studies looking at the combination in virologically suppressed adult patients are ongoing and are also part of the company's U.S. and European regulatory submissions, Gilead said. Gilead shares surged 0.7% in pre-market trade before declining 0.2% pre-market. Shares have surged 11.3% over the last three months, compared with a 4.1% rise in the S&P 500 .
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