Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

Zagazig University250 enrolled

Overview

This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Hepatitis C

Interventions

Daclatasvir 60 MG Oral Tablet [Daklinza]DRUG

Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with HCV genotype 4 * Age ≥ 18 years * HCV RNA≥ 104 IU/mL * Screening ECG without clinically significant abnormalities. Exclusion Criteria: * Total serum bilirubin \> 3 mg/dl. * Serum albumin \< 2.8 g/dl. * INR ≥ 1.7 * Platelet count \< 50000/mm3. * Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI). * Extra hepatic malignancy except after two years of disease free interval * Pregnancy or inability to use contraception. * Inadequately controlled diabetes mellitus (HbA1c \> 9%).

Outcomes