HCV genotype 3 related chronic hepatitis & compensated cirrhosis
Conditions
Interventions
The study will be carried out at the Hepatology Department of BSMMU, Dhaka.
Consenting participants meeting inclusion/exclusion criteria will be randomized into 2 arms using simple randomization
Arm
Sponsors
Department of Hepatology Bangabandhu Sheikh Mujib Medical University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than 18 years 2. Hepatitis C Virus (HCV) genotype 3 3. Chronic hepatitis/ Compensated Cirrhosis 4. Detectable HCV RNA in blood 5. Platelet count >90,000 /cmm
Exclusion criteria
Exclusion criteria: 1. Decompensated cirrhosis 2. Co-infected with Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) 3. Hepatocellular carcinoma 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response at 12 weeks (SVR 12, defined as undetectability of HCV viral load in blood for 12 consecutive weeks) [At baseline, 28 days after commencement of treatment (RVR), at the end of treatment (ETR) and 12 weeks from the completion of treatment (SVR12)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse effects i. Any hypersensitivity reaction (determined through patient reports and/or hospital admissions ii. Bone marrow suppression (leucopenia, anaemia, thrombocytopenia or pancytopenia as determined by full blood count) iii.Sepsis or major infection (determined clinically) [Arm A will be assessed at 1, 2, 4, 8, 12 and 24 weeks, arm B will be assessed at 1, 2, 4, 8, 12, 24 and 36 weeks ] HCV RNA (viral load) [Arm A will be assessed at 0, 4, 12 and 24 weeks and Arm B will be assessed at 0, 4, 24 and 36 weeks] Complications such as anemia, bleeding manifestations or features of decompensation such as edema, jaundice, ascites and encephalopathy [ ] | — |
Contacts
Public ContactMainuddin Ahmed
Resident, Department of Hepatology
Outcome results
None listed