The most common adverse events occurring in greater than or equal to 10 percent of patients in either treatment arm included jaundice (21 percent in the cobicistat arm vs. 16 percent in the ritonavir arm), ocular icterus (18 percent in both arms), nausea (18 percent vs. 16 percent), diarrhea (15 percent vs. 20 percent), headache (11 percent vs. 16 percent), nasopharyngitis (11 percent vs. 15 percent), hyperbilirubinemia (11 percent vs. 10 percent) and upper respiratory infection (10 percent vs. 8 percent).The median increases in serum creatinine were 0.13 mg/dL for the cobicistat arm and 0.09 mg/dL for the ritonavir arm at 48 weeks (p<0.001). Discontinuation rates due to renal adverse events were low and comparable in both arms (1.7 percent in the cobicistat arm vs. 1.4 percent in the ritonavir arm).
Gilead’s Boosting Agent Cobicistat For HIV Therapy As Effective As Ritonavir In Pivotal Phase 3 Study
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