The effect of Pegylated interferon (Peg-interferon) α-2b or its combination with lamivudine on liver histology of patients with chronic Hepatitis B is unknown.
Dr Monika van Zonneveld and colleagues from the Netherlands conducted a double-blinded, randomized, multi-center study.
The investigators assessed histological changes in 110 Hepatitis B e-antigen-positive chronic Hepatitis B patients.
The patients were treated for 52 weeks with Pegylated interferon α-2b in combination with either lamivudine or as monotherapy with placebo.
Liver biopsies were taken before and at the end of treatment.
All biopsies were blinded and scored according to the Ishak system.
The team found that the combination of Pegylated interferon α-2b with lamivudine improved necroinflammatory scores in 48% of patients.
The necroinflammatory score improved in 53% of patients of the Pegylated interferon α-2b monotherapy group.
|Peg-interferon α-2b monotherapy improved necroinflammation in 78% of responders|
The investigators observed that fibrosis score improved in 33% of patients of the combination therapy group vs 22% of patients of the monotherapy group.
The team reported 42 responders, defined as serum Hepatitis B e-antigen negative at the end of therapy.
Responders showed a larger decline in necroinflammatory score than non-responders.
Among patients receiving Pegylated interferon α-2b monotherapy, necroinflammation improved in 78% of responders vs 43% of non-responders.
The team noted that with monotherapy, necroinflammation improved in 76% of patients with normal alanine transferase levels.
Necroinflammation improved only in 40% of patients with abnormal alanine transferase levels, and receiving monotherapy.
The investigators noted that fibrosis scores in the Pegylated interferon α-2b monotherapy group improved more often in responders than in non-responders.
In the combination therapy group, the team found no significant association between virological and biochemical endpoints and histological improvement.
Dr van Zonneveld's team concluded, “Treatment with Pegylated interferon α-2b therapy improves liver necroinflammation in Hepatitis B e-antigen-positive chronic Hepatitis B patients, particularly in responders to therapy.”
“Pegylated interferon α-2b also improves fibrosis in responders.”
“Addition of lamivudine to Pegylated interferon α-2b did not further improve the histological outcome.”