A Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
Lead SponsorAsian Institute Of Medical Sciences
Indication/ConditionCirrhosis Due to Hepatitis B
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
Entacavir-0.5 mg ,OD,for
Tenofovir ,300 mg,OD,for 48 weeks
Inclusion Criteria: Age (18 years- 70 years) Hbv surface antigen positive > 6 months HbeAg (positive or negative both) Hbv DNA 10^3 ALT ULN No evidence of HCC Platelets count > 30 thousands CTP score > 7 Hepatic encephalopathy (grade 1 - 2 only) No prior Drug resistance Exclusion Criteria: Age < 18 years HCC patients Prior drug resistance Current HE > 2 Solid organ transplantation Inadequate hematological function Co infection with hepatitis C and HIV Autoimmune disorders Pregnancy and Breast feeding Other hepatic diseases Patients on immunosuppressant or chemotherapy agents