Pegylated Interferon and Entecavir Combination in Chronic Hepatitis B (CHB)
Status:
Unknown status
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh