A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Hoffmann-La Roche129 enrolled

Overview

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/=18 and \<70 years of age at initiation of treatment * Body weight between 50 kg and 125 kg at baseline * Chronic hepatitis C, genotype 1 * Chronic liver disease consistent with HCV infection * Compensated liver disease (Child-Pugh Grade A) Exclusion Criteria: * Pregnant or lactating women, and male partners of pregnant women * Chronic hepatitis C, genotype 2, 3, 4, 5 or 6 * Previous treatment with interferon or ribavirin * Positive for hepatitis A, hepatitis B or HIV infection * History or evidence of a medical condition associated with liver disease other than chronic hepatitis C * Decompensated liver disease and/or liver disease Child-Pugh classification \>6 * Hepatocellular carcinoma * History or evidence of esophageal bleeding * Hemoglobinopathy, or any other cause for possible hemolysis * Hb \<11 g/dL in women, \<12 g/L in males

Locations (15)

Unnamed facility

Vitória, Espírito Santo, Brazil

Unnamed facility

Salvador, Estado de Bahia, Brazil

Unnamed facility

Juiz de Fora, Minas Gerais, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Unnamed facility

Joinville, Santa Catarina, Brazil

Unnamed facility

Sao Jose Do Rio Preto, Santa Catarina, Brazil

Unnamed facility

Botucatu, São Paulo, Brazil

Unnamed facility

Campinas, São Paulo, Brazil

Unnamed facility

Campinas, São Paulo, Brazil

...and 5 more locations

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression

Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.

Time frame: At Week 72

Percentage of Participants With Incidence of Anemia

Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb \< 11 gram per decilitre (g/dL) for women and Hb \< 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.

Time frame: Up to Week 72

Secondary Outcomes

Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression

Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a \>= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.

Time frame: Weeks 4, 12, 24, 48, 60 and 72

Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment

Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.

Time frame: Up to Week 72

Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12

Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: \< 1.0 log IU/ml; \>= 1.0 and \< 2.0 log IU/ml; \>= 2.0 and \< 3.0 log IU/ml; \>= 3.0 and \<4.0 log IU/ml; \>= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10\^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.

Time frame: From Baseline (Week 0) to Week 12