Three percent and 4 percent of elvitegravir and raltegravir patients, respectively, discontinued treatment due to adverse events. The frequency of serious adverse events was similar in both arms. The most common serious adverse events occurring in three or more patients in either group were pneumonia, cellulitis, suicidal ideation, dyspnea, bronchitis, chest pain and hepatitis.Laboratory abnormalities (Grade 3-4) occurring in greater than or equal to 5 percent of patients in either treatment arm were total bilirubin, AST, ALT, GGT, amylase, creatine kinase, total cholesterol and hematuria. The frequency of laboratory abnormalities was also similar in both treatment arms with the exception of Grade 3-4 liver abnormalities, which were higher among patients taking raltegravir (7 percent GGT; 5 percent ALT; 6 percent AST) as compared to elvitegravir (3 percent GGT; 2 percent ALT; 2 percent AST) with p-values less than or equal to 0.05 for all liver tests.
Gilead’s HIV Integrase Inhibitor Elvitegravir Dosed Once Daily As Effective As Twice-Daily Raltegravir Over Two Years Of Therapy In Pivotal Phase 3 Study
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