Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT02772744
- Lead Sponsor
- Zagazig University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
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%).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1: Easy to treat group Daclatasvir 60 MG Oral Tablet [Daklinza] * 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. Group 3: Sofosbuvir resistant cases Sofosbuvir 400 MG Oral Tablet [Sovaldi] This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks. Group 3: Sofosbuvir resistant cases Ribavirin Oral Product This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks. Group 2: Difficult to treat group Daclatasvir 60 MG Oral Tablet [Daklinza] * 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. Group 1: Easy to treat group Sofosbuvir 400 MG Oral Tablet [Sovaldi] * 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. Group 2: Difficult to treat group Sofosbuvir 400 MG Oral Tablet [Sovaldi] * 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. Group 2: Difficult to treat group Ribavirin Oral Product * 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. Group 3: Sofosbuvir resistant cases Daclatasvir 60 MG Oral Tablet [Daklinza] This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks.
- Primary Outcome Measures
Name Time Method Efficacy measured by Sustained Virologic Response Rate 12 weeks posttreatment Incidence of grade 3/4 adverse events [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Neutropenia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Neutropenia: Grade 3, 500-749/mm3; Grade 4, \<500/mm3
Incidence of Lymphopenia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Lymphopenia: Grade 3, 350-499/mm3; Grade 4, \<350/mm3
Incidence of anaemia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, \<7.0 g/dL
Incidence of Thrombocytopenia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, \<25 000/mm3
Incidence of (Increased total Bilirubin) [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, \>5×ULN
Incidence of elevated Alanine Aminotransferase [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, \>10×ULN
Incidence of Fatigue [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Headache [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Pruritus [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Insomnia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Rash [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Nausea [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen) Incidence of Myalgia [Safety] Within the treatment period (12 or 24 weeks according to the treatment regimen)
- Secondary Outcome Measures
Name Time Method Health Related Quality of Life (HRQoL) 24 weeks HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey)