Hepatitis C
Conditions
Keywords
Hepatitis C virus genotype 4, Antiviral, Virologic Response
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.
Interventions
DRUGDaclatasvir 60 MG Oral Tablet [Daklinza]
Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
DRUGSofosbuvir 400 MG Oral Tablet [Sovaldi]
Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
Ribavirin (twice-daily) dosed according to body weight (\<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
Sponsors
Cairo University
Zagazig University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Myalgia [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) | — |
| 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) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQoL) | 24 weeks | HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey) |
Contacts
Primary ContactAhmed Negida
Backup ContactHussien Ahmed, MD
Outcome results
None listed