Hemoglobin levels over time.

<p>Mean hemoglobin by treatment group over time is shown. The mean reduction at the end of treatment for the pooled ribavirin-containing arms was approximately 2.5 g/dL. TID16W/TID28W/TID40W, faldaprevir 120 mg once daily, deleobuvir 600 mg three times daily, and ribavirin for 16, 28, and 40 weeks, respectively; BID28W, faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and ribavirin for 28 weeks; TID28W-NR, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily without ribavirin for 28 weeks.</p

CONSORT flowchart for the OPTEX trial.

<p>CONSORT flowchart for the OPTEX trial.</p

Baseline demographics and disease characteristics.

<p>^aFibrosis stage was determined by either METAVIR score or fibroscan result; if a METAVIR score was not available, then a fibroscan result was used (fibroscan <9.5 = ≤F2 and fibroscan ≥9.5 = ≥F3). TID16W/TID28W/TID40W, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily plus ribavirin for 16, 28, and 40 weeks, respectively; BID28W, faldaprevir 120 mg once daily and deleobuvir 600 mg twice daily plus ribavirin for 28 weeks; TID28W-NR, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily, without ribavirin, for 28 weeks.</p><p>Baseline demographics and disease characteristics.</p

SF-36 Physical and Mental Health.

<p>SF-36 Physical and Mental Health.</p

Multivariate logistic regression model.

<p>Multivariate logistic regression model.</p

Subgroupanalysis.

<p>Subgroupanalysis.</p

Inosine triphosphatase (<i>ITPA</i>) gene single-nucleotide polymorphisms by treatment arm.

<p>TID16W/TID28W/TID40W, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily plus ribavirin for 16, 28, and 40 weeks, respectively; BID28W, faldaprevir 120 mg once daily and deleobuvir 600 mg twice daily plus ribavirin for 28 weeks; TID28W-NR, faldaprevir 120 mg once daily and deleobuvir 600 mg three times daily, without ribavirin, for 28 weeks.</p><p>Inosine triphosphatase (<i>ITPA</i>) gene single-nucleotide polymorphisms by treatment arm.</p

Factors associated with anemia in univariate and multivariate analyses, all treated patients.

<p>Ribavirin-containing arms are pooled and all patients have the rs1127354 CC genotype. Covariates included age (<60 years vs ≥60 years), gender, weight (<75 kg vs ≥75 kg), fibrosis stage (F0–F2 vs F3–F4), presence of cirrhosis (yes/no), body mass index (<25 kg/m² vs ≥25 kg/m²), rs6051702 genotype (ITPA-deficient (CC/CA) vs–non-deficient (AA)), baseline hemoglobin (<15 g/dL vs ≥15 g/dL), faldaprevir, deleobuvir, and ribavirin trough levels through week 12, and baseline ribavirin dose. ITPA, inosine triphosphatase.</p><p>Factors associated with anemia in univariate and multivariate analyses, all treated patients.</p

Historical control group.

<p>* Patients who were HCV-RNA positive (>29 IU/mL) at week 4 but HCV-RNA negative at week 12</p><p>** Patients who were HCV-RNA positive (>50 IU/mL) at week 4 but HCV-RNA negative at week 12</p><p>Historical control group.</p

Severe adverse events.

<p>Severe adverse events.</p