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

Chronic Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387526
• Other study ID #: SOF-DCV-RBV
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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-a-/RBV, SOF/peg-IFN-a +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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• (SOF and DCV)

• (SOF, DCV, and RBV)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs.	12 weeks after last dose
Primary	Number of Participants With Adverse Events in Each Treatment Arm	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	up for 12 weeks after planned End of Treatment (EOT).
Secondary	Percentage of Participants With Viral relapse	Viral relapse was HCV RNA level = 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT.	12 weeks after last dose
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml	up tp 24 weeks

External Links

•   This link describes the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4.