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

Zagazig University

Status: Unknown

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]; Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]; Drug: Ribavirin Oral Product

Study type: Observational

Funder types: Other

Identifiers

NCT02772744

2667-20-3-2016

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%).

Trial design

250 participants in 3 patient groups

Group 1: Easy to treat group

Description:

* Treatment naïve * Total serum bilirubin ≤ 1.2 mg/dl * Serum albumin ≥ 3.5 g/dl * International normalized ratio ≤ 1.2 * Platelet count ≥ 150000 mm3 This group will be receiving Sofosbuvir + daclatasvir for 12 weeks.

Treatment:

Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]

Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]

Group 2: Difficult to treat group

Description:

* Peg interferon treatment experienced. * Total serum bilirubin ≥ 1.2 mg/dl * Serum albumin ≤ 3.5 g/dl * International normalized ratio ≥ 1.2 * Platelet count ≤ 150000 mm3 This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks.

Treatment:

Drug: Ribavirin Oral Product

Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]

Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]

Group 3: Sofosbuvir resistant cases

Description:

This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.

Treatment:

Drug: Ribavirin Oral Product

Drug: Daclatasvir 60 MG Oral Tablet [Daklinza]

Drug: Sofosbuvir 400 MG Oral Tablet [Sovaldi]