A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

Chugai Pharmaceutical300 enrolled

Overview

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy. Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo. All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Chronic Hepatitis C

Interventions

peginterferon alfa-2aDRUG

rivavirinDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL)) * elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening * liver biopsy findings consistent with a diagnosis of chronic hepatitis C. Exclusion Criteria: * Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) * leukopenia (fewer than 3,000 white blood cells per cubic millimeter) * thrombocytopenia (fewer than 90,000 platelets per cubic millimeter) * anemia (less than 12 g hemoglobin per deciliter ) * hepatitis B co-infection * decompensated liver disease * organ transplant * creatinine clearance less than 50 milliliters per minute * poorly controlled psychiatric disease * poorly controlled diabetes * malignant neoplastic disease * severe cardiac or chronic pulmonary disease * immunologically mediated disease * retinopathy.

Outcomes

Primary Outcomes

Sustained virological response, defined as undetectable HCV-RNA (<50IU per milliliter) after 24 weeks of untreated follow-up (week 72).

Secondary Outcomes

Biochemical response (normalization of serum alanine aminotransferase activity),

Virological response (HCV-RNA <50IU per milliliter) at the end of therapy.

Data from ClinicalTrials.gov

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