Clinical trial NCT04387526: Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4
Official title: Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis C Virus Infection
Keywords: Sofosbuvir
Daclatasvir
Ribavirin
HCV GT 4
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 946
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
timeFrame: 12 weeks after last dose
measure: Number of Participants With Adverse Events in Each Treatment Arm
timeFrame: up for 12 weeks after planned End of Treatment (EOT).
Secondary outcomes:
measure: Percentage of Participants With Viral relapse
timeFrame: 12 weeks after last dose
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: up tp 24 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12.