A Pilot Study To Evaluate the Efficacy of Response Guided Therapy of Peginterferon Alfa Plus Ribavirin in the Treatment of Patients With HCV/HBV Co-Infection

Phase 4

Completed

• Conditions: HBV/HCV Co-infection

• Registration Number: NCT02339337
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects were randomized into 2 groups at treatment initiation. Subjects who were randomized into the genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day) for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for 6 months. For subjects who were randomized into the response guided therapy (RGT) group, the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1, a pre-treatment low viral load (LVL, \< 400000 IU/mL) and RVR (defined asHCV RNA \<50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2014-06
• Status Verified: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-12
• Last Update Submitted: 2015-01-12
• Study First Posted: 2015-01-15
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA.
• negative HBeAg
• serum alanine aminotransferase (ALT) levels between 1-10-fold of the upper limit of normal (ULN)
• treatment naive or had previously failed interferon monotherapy.

Exclusion Criteria

• decompensated liver disease (Child-Pugh score ≥ 7)
• Pregnant or breast-feeding women
• serum creatinine ≥ 2 mg/dL
• evidence of alcoholism or drug abuse
• any other known disease that was not suitable for Peg-IFN therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of HCV sustained virological response	6 months after completion of therapy