A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623428

MV21371

2007-004993-15

Details and patient eligibility

About

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Full description

During a pre-study run-in phase patients with chronic hepatitis C genotype 2/3, who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care and did not achieve a rapid viral response (RVR) (defined as Hepatitis C virus (HCV) RNA <15 IU/mL at Week 4 of treatment measured with the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test) were eligible for the study and entered the screening phase between treatment Week 4 and 8 as soon as the result of the Week 4 HCV RNA test was available.

Eligible patients entered the study and continued with the dose regimens of PEG-IFN alfa-2a and ribavirin they were taking prior to enrolment into the trial up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24, were randomized at treatment Week 24 to one of the two study groups. Upon randomization, participants either stopped treatment (equaling 24 weeks of treatment) or continued treatment for another 24 weeks (equaling 48 weeks of treatment). A treatment free follow-up period of 24 weeks (for participants in the 48-week treatment group) or 48 weeks (participants in the 24-week treatment group) completed the study.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• serological evidence of chronic hepatitis C (CHC);
• CHC genotype 2 or 3;
• receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
• compensated liver disease.

Exclusion criteria

• pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
• coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
• history or other evidence of decompensated liver disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

PEG-IFN alfa-2a + Ribavirin for 24 weeks

Experimental group

Description:

After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a

PEG-IFN alfa-2a + Ribavirin for 48 weeks

Active Comparator group

Description:

After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a