REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

Hoffmann-La Roche948 enrolled

Overview

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

948

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients \>=18 years of age; * CHC infection; * liver biopsy (in \<24 calendar months of first dose), with results consistent with CHC infection; * use of 2 forms of contraception during study and 6 months after the study in both men and women; * Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for \>=12 weeks. Exclusion Criteria: * women who are pregnant or breastfeeding; * male partners of women who are pregnant; * conditions associated with decompensated liver disease; * other forms of liver disease, including liver cancer; * human immunodeficiency virus infection.

Locations (104)

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Scottsdale, Arizona, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Pasadena, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Number of Participants With Sustained Virological Response Rate

Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.

Time frame: Up to 72 weeks (Group A) and 48 weeks (Group D)

Secondary Outcomes

Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)

SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.

Time frame: At Week 48 and Week 72

Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)

Time frame: At Week 48 and Week 72

Percentage of Participants With Undetectable HCV-RNA

The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 IU/mL measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end) are reported. End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (\<50 IU/mL) at study day of last dose of study medication (+/- 28 days).

Time frame: At Week 12, 24, 48 and EOT

Percentage of Participants With >=2log Drop in HCV-RNA

Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.

Time frame: At Week 12 and 24

Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)

The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (\<50 IU/ML) and not quantifiable (\<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.

Time frame: At Week 12 and 24

Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response

Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.

Time frame: Week 96 (Group A and C) and Week 72 (Group B and D)

Percentage of Participants With Relapse After End of Treatment

The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.

Time frame: Week 96 (Group A and C) and Week 72 (Group B and D)