Chronic Hepatitis C
Conditions
Keywords
HCV, Relapse, treatment failure
Brief summary
This study aims to assess the role of ribavirin as an adjuvant to sofosbuvir/velpatasvir/voxilaprevir combination in retreatment of chronic hepatitis C with previous treatment failure.
Interventions
DRUGSofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥ 18 years) patients with chronic hepatitis C and detectable HCV RNA by Polymerase Chain Reaction (PCR) after completion of previous direct-acting antiviral regimen, and eligible for antiviral treatment.
Exclusion criteria
* Patients with decompensated cirrhosis (Child-Pugh score B and C). * Patients with platelet count less than 50000/ mm³. * Patients with HCC or extrahepatic malignancy. * Pregnancy or inability to use an effective contraceptive method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of sustained virological response (SVR) | 12 weeks post treatment | Percentage of patients with Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) SVR12 is defined as HCV RNA \< the lower limit of quantitation 12 weeks following the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | During 12 weeks of treatment | Tolerability assessment by reporting any adverse events in addition to laboratory abnormalities via continuous monitoring of CBC, transaminases, serum bilirubin, and serum creatinine at baseline and every 4 weeks during treatment. |
Countries
Egypt
Outcome results
None listed