1%) patients, both in group 1. No patient required a blood transfusion or erythropoietin. Increases in total bilirubin level greater than 2 times the upper limit of normal (ULN) check details were reported in 15.4% of patients in group 1 and in 1.1% of patients in group 2 (P < .001), with 8.8% of patients in group 1 and 0% in group 2 reporting greater than 3 times the ULN. Mean levels of total bilirubin peaked at week 1 (predominantly indirect bilirubin) and were reduced at week 2 in both groups, although levels remained increased throughout the treatment period only in group 1 ( Supplementary Figure 3). The mean total bilirubin level at week 1 was 1.6 mg/dL in group

1 and 0.9 mg/dL in group 2; by week 2, the mean levels were reduced to 1.2 and 0.7 mg/dL, respectively. learn more Five (5.5%) patients in group 1 and 2 (2.1%) patients in group 2 reported hyperbilirubinemia; 3 (3.3%) patients in group 1 reported jaundice. One hyperbilirubinemia and 1 jaundice event were moderate in severity and the remaining events were judged as mild; none led to study drug discontinuation. Ribavirin dose modification occurred in 5 patients, 3 owing to anemia, 1 owing to hyperbilirubinemia, and 1 was dose adjusted owing to a decrease in weight; all achieved SVR12. The percentage of patients with postbaseline alanine aminotransferase

(ALT) levels greater than 3 times the ULN was similarly low for both treatment groups. No patient experienced a postbaseline ALT level greater than 5 times the ULN. One patient in group 2 had an aspartate aminotransferase (AST) level greater than 5 times the ULN at a single study visit, all subsequent values were normal. Twelve weeks of treatment with these regimens normalized liver enzyme levels in almost all patients with high baseline liver enzyme levels: 96.9% (63 of 65) and 100% (66 of 66) of group 1 and group 2 patients, respectively normalized high baseline ATL levels after being treated; AST levels were normalized in 98.4% (60 of 61) and 91.8% (56 of 61) of group 1 and group 2 patients, respectively. Median

changes from baseline in aminotransferase values at the final treatment visit were Urease similar when comparing treatment groups (ALT, -35.0 vs -36.0 U/L; AST, -22.0 vs -21.0 U/L for group 1 and group 2, respectively). PEARL-II examined an all-oral, interferon-free regimen with or without RBV exclusively in pegIFN/RBV treatment-experienced, noncirrhotic patients with HCV genotype 1b infection. The intent-to-treat SVR12 rates of 96.6%–100% in patients receiving the 12-week regimen of ABT-450/ritonavir/ombitasvir and dasabuvir with or without RBV, respectively, were superior to the historical rate of telaprevir plus pegIFN/RBV. The SVR12 rates of this multitargeted regimen with RBV confirm results of the phase 2b AVIATOR study17 in prior null responders, the most difficult to cure of pegIFN/RBV nonresponders, and further expands efficacy conclusions to patients who were partial responders and relapsers to pegIFN/RBV treatment.