Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Nanogen Pharmaceutical Biotechnology Joint Stock Company100 enrolled

Overview

This study presents a clinical study on the efficacy and safety of Pegnano combined with Barivir (Ribavirin) in treating treatment-naïve patients with Chronic Hepatitis C at Kien Giang General Hospital. The study aims to provide affordable treatment options while evaluating the virological response and side effects associated with the therapy

This study evaluates the efficacy and safety of Pegnano (Peginterferon alfa-2a) combined with Barivir (Ribavirin) in treatment-naïve patients with chronic hepatitis C (HCV). Conducted at Kien Giang General Hospital from March 2011 to March 2013, this uncontrolled clinical trial enrolled 100 outpatients aged 18-65 with HCV RNA \>80 IU/mL and compensated liver disease. Patients received Pegnano (180 mcg, subcutaneous, weekly) and Barivir (15 mg/kg daily, oral) for 24 weeks (genotypes 2, 3) or 48 weeks (genotypes 1, 4, 5, 6), with possible extension to 72 weeks for genotype 1 with late virological response. The primary goal is to assess virological responses (rapid, early, end-of-treatment, and sustained at 24 weeks) by genotype and IL28B rs12979860 polymorphism, alongside safety through adverse event monitoring. Efficacy is measured via HCV RNA levels using real-time PCR, while safety is evaluated through clinical and paraclinical assessments every 4 weeks. The study aims to provide evidence for affordable HCV treatment options in Vietnam using locally produced drugs

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Hepatitis C

Interventions

Peginterferon Alfa-2ADRUG

180 mcg, subcutaneous injection, once weekly

Ribavirin Oral ProductDRUG

15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with chronic hepatitis C. * Age 18-65 years. * No previous treatment with interferon or peginterferon. * HCV RNA serum baseline \>80 IU/mL. * Compensated liver disease (total bilirubin \<25.6 µmol/L, INR \<1.5, serum albumin \>3.4 g/dL, no ascites or hepatic encephalopathy). * Normal hematological and biochemical parameters (hemoglobin \>12 g/dL for males, \>11 g/dL for females; neutrophils \>1500 cells/µL; platelets \>75,000 cells/µL; serum creatinine \<1.5 mg/dL or \<132 µmol/L). Exclusion Criteria: * Depression. * Autoimmune hepatitis or other autoimmune diseases. * Unstable hyperthyroidism or hypothyroidism. * Severe medical conditions (e.g., hypertension, congestive heart failure, angina, uncontrolled diabetes, COPD). * Decompensated cirrhosis. * Co-infection with HIV or hepatitis B. * Pregnant women or those unwilling to use effective contraception.

Outcomes

Primary Outcomes

Sustained Virological Response (SVR)

Percentage of patients with undetectable HCV RNA 24 weeks after treatment completion, measured by real-time reverse transcriptase PCR. In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy. In this study, SVR and SVR24 are interchangeable.

Time frame: 24 weeks post-treatment

Secondary Outcomes

Rapid Virological Response (RVR)

Percentage of patients with undetectable HCV RNA at week 4, measured by real-time reverse transcriptase PCR. In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy.

Time frame: Week 4

Complete Early Virological Response (cEVR)

Percentage of patients with undetectable HCV RNA at week 12 (in non-RVR patients), measured by real-time reverse transcriptas PCR. In this study, the term "undetectable HCV RNA" refers to the absence of detectable Hepatitis C viral RNA in the patient's serum as measured by Real-Time reverse transcriptase PCR. This method exhibits high sensitivity and specificity, enabling the accurate quantification of HCV RNA. An 'undetectable' result indicates that the viral load was below the lower limit of detection of the assay used (negative). Virological responses were assessed at multiple time points, including week 4 (RVR), week 12 (cEVR), at the end of treatment (EOT), and 12 or 24 weeks post-treatment (SVR12, SVR24). Achieving 'undetectable HCV RNA' at these points was used to determine the effectiveness of the therapy.

Data from ClinicalTrials.gov

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