Similarly, results from Study 103 show that 83 percent of Stribild patients (n=294/353) and 82 percent of patients receiving the atazanavir-based regimen (n=292/355) achieved HIV RNA < 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -4.5 to +6.7 percent for Stribild vs. the atazanavir-based regimen; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -12 percent).In both Studies 102 and 103, rates of discontinuation due to adverse events were similar across all treatment groups (5 percent for Stribild in each study, 7 percent for Atripla and 6 percent for the atazanavir-based regimen). The most common adverse events occurring in at least 10 percent of Stribild patients in Study 102 were diarrhea, nausea, upper respiratory infection, headache, abnormal dreams, fatigue, depression and insomnia; in Study 103, they were diarrhea, nausea, upper respiratory infection, headache, nasopharyngitis, depression, back pain and fatigue. In Study 102, there were consistently higher reports at each study visit through 96 weeks of abnormal dreams and dizziness in the Atripla arm, with 14 percent and 4 percent of patients experiencing abnormal dreams and dizziness, respectively, on the Atripla arm vs. 8 percent and 1 percent, respectively on the Stribild arm at 96 weeks. Similarly, in Study 103, reports of diarrhea were consistently higher through 96 weeks of treatment on the atazanavir-based arm compared to Stribild, with 4 percent of Stribild patients vs. 9 percent of patients on an atazanavir-based regimen experiencing this problem at 96 weeks.
Gilead’s Once-Daily Single Tablet Regimen StribildTM Maintains High Viral Suppression Through Two Years Of Therapy Among Treatment-Naïve HIV Patients
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