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
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
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.
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.