Overview

Pegylated Interferon and Entecavir Combination in Chronic Hepatitis B (CHB)

Status:
Unknown status

Trial end date:
2013-03-01

Target enrollment:
0

Participant gender:
All

Summary

According to published literature, treatment with pegylated interferon (Peg-IFN) is associated with end of treatment response in treatment naive patients with chronic hepatitis B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN results in improvement of liver histology and down regulation of progression to cirrhosis of liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is that only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral drug, entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes improvement of liver histology in only 30%, possibly because of its lack of immune modulatory ability like Peg-IFN. Also, ETV treatment is associated with several complications like emergence of HBV mutant. The aim of this study is to assess whether the combination of these two 'unique' anti-viral drugs offer the best possible outcome to treatment-naïve CHB patients, in terms of treatment response (virological and biochemical), treatment cost and duration and adverse events.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Treatments:

Entecavir
Interferons

Criteria

Inclusion Criteria:

- HBsAg positive >6 months, HBeAg positive or negative, serum ALT normal or raised and
HBV DNA >1000 copies/ml in HBeAg negative or HBV DNA >10000 copies/ml in HBeAg
positive.

Exclusion Criteria:

- Coinfection with HCV or HIV, cirrhosis of liver