Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Beni-Suef University
- Enrollment
- 946
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
Study Overview
Brief Summary
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Detailed Description
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.
SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-cirrhotic treatment-naïve participants
- •FIB-4 < 3.25
- •albumin > 3.5
- •total bilirubin < 1.2 mg/dl
- •international normalized ratio (INR) < 1.2
- •platelet count > 150,000 mm
- •experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
- •Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis
Exclusion Criteria
- •liver disease of non-HCV etiology
- •hepatitis B or human immune-deficiency virus (HIV) infection
- •poorly controlled diabetic (HbA1C > 9) participants
- •hepatocellular carcinoma
- •a history of extra-hepatic malignancy within 5 years prior to the study
- •pregnant or breast feeding
- •renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
- •evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
- •blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
- •major severe illnesses such as congestive heart failure and respiratory failure.
Arms & Interventions
SOF/DCV
Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks.
This arm included non-cirrhotic treatment-naïve patients
Intervention: (SOF and DCV) (Drug)
SOF/DCV/RBV + Cirrhosis
This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
Intervention: (SOF, DCV, and RBV) (Drug)
SOF/DCV/RBV + Non-Cirrhosis
This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
Intervention: (SOF, DCV, and RBV) (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
Time Frame: 12 weeks after last dose
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
Time Frame: up for 12 weeks after planned End of Treatment (EOT).
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Secondary Outcomes
- Percentage of Participants With Viral relapse(12 weeks after last dose)
- Percentage of Participants With On-treatment Virologic Failure(up tp 24 weeks)
Investigators
Mohammed Abdel-Gabbar, Ph.D
Associate Prof
Beni-Suef University