The HEP-NET B/C co-infection trial: A prospective multicenter study to investigate the efficacy of pegylated interferon-α2b and ribavirin in patients with HBV/HCV co-infection☆

Background/Aims

The efficacy of pegylated interferon alpha and ribavirin in HBV/HCV co-infected patients is unknown.

Methods

Nineteen patients with chronic HBV/HCV co-infection (HBsAg and HCV-RNA positive; 10 HCV-genotype 1; 9 HCV-genotype 2 or 3) were included in this prospective multicenter pilot study. Baseline HBV-DNA was negative in 13 individuals. All patients received weight-adjusted PEG-IFN-α2b and ribavirin for 48 weeks.

Results

In the intent-to-treat analysis, a biochemical and an HCV-RNA response were observed in 12 and 14 patients, respectively (63% and 74%). At the end of the treatment as well as at the end of the follow-up the HCV-RNA response was 93% (14/15) in patients adherent to therapy (86% in genotype 1 and 100% in genotypes 2 and 3 infection). Two of the five initially HBV-DNA positive patients with follow-up available were HBV-DNA negative at follow-up week 24. In contrast, HBV-DNA became detectable after the clearance of HCV in four initially HBV-DNA negative patients.

Conclusions

Combination therapy with PEG-IFN-a2b and ribavirin is highly effective in inducing a virological response concerning HCV in patients with HBV/HCV co-infection. However, HBV replication may increase after the clearance of HCV and thus close monitoring for both the viruses is recommended even in patients with initially undetectable HBV-DNA.

Abbreviations: ALT, alanine aminotransferase, HBV, hepatitis B virus, HCV, hepatitis C virus, SAE, serious adverse event, HBV-GT, hepatitis B genotype, HCV-GT, hepatitis C genotype, e/anti-e, HBe antigen/anti-HBe antibody, FU, follow-up

Keywords: HBV/HCV co-infection, Peginterferon-a2b, Ribavirin, Hepatitis C clearance