Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

Beni-Suef University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Hepatitis C Virus Infection

Treatments: Drug: (SOF and DCV); Drug: (SOF, DCV, and RBV)

Study type: Interventional

Funder types: Other

Identifiers

NCT04387526

SOF-DCV-RBV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 946 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 mm3.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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946 participants in 3 patient groups

SOF/DCV

Active Comparator group

Description:

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

Treatment:

Drug: (SOF and DCV)

SOF/DCV/RBV + Cirrhosis

Active Comparator group

Description:

This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.

Treatment:

Drug: (SOF, DCV, and RBV)

SOF/DCV/RBV + Non-Cirrhosis

Active Comparator group

Description:

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.

Treatment:

Drug: (SOF, DCV, and RBV)