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

May 13, 2020 updated by: Mohammed Abdel-Gabbar, Ph.D, Beni-Suef University

Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

946

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: (SOF and DCV)
Other Names:
  • Sovaldi is a trade name of sofosbuvir
  • Daklinza is a trade name of daclatasvir
Active Comparator: 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.
Drug: (SOF, DCV, and RBV)
Other Names:
  • Sovaldi is a trade name of sofosbuvir
  • Daklinza is a trade name of daclatasvir
Active Comparator: 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.
Drug: (SOF, DCV, and RBV)
Other Names:
  • Sovaldi is a trade name of sofosbuvir
  • Daklinza is a trade name of daclatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after last dose
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
up for 12 weeks after planned End of Treatment (EOT).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With On-treatment Virologic Failure
Time Frame: up tp 24 weeks
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
Percentage of Participants With Viral relapse
Time Frame: 12 weeks after last dose
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOF-DCV-RBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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