Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

May 9, 2020 updated by: Mohammed Abdel-Gabbar, Ph.D, Beni-Suef University

Sofosbuvir in Combination With Ribavirin or Simeprevir: Real-life Study of Patients With Hepatitis C Genotype 4

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2

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:

  • Participants with plasma HCV RNA level >10,000 IU/L for the two groups.
  • Treatment-experienced patients in group 1 were those who had previously failed treatment with classical peg-IFN/RBV therapy.
  • Treatment-experienced patients in group 2 were those who had previously failed treatment with SOF/RBV

Exclusion Criteria:

  • coinfected with hepatitis B virus or human immunodeficiency virus infection,
  • any cause of liver disease other than HCV GT4 infection;
  • liver decompensation,
  • hepatocellular carcinoma,
  • major severe illness, such as renal failure, congestive heart failure, thyroid dysfunction, respiratory failure, autoimmune disease and poorly controlled diabetes (HbA1C >9)
  • Participants with blood picture abnormalities, such as anemia (hemoglobin concentration of 10 g/or less) and thrombocytopenia (platelet count <50,000 cells/mm3)

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 + RBV (Naive)
For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).
Drug: Sofosbuvir + Simeprevir + Ribavirin
Other Names:
  • Olysio is a trade name of simeprevir
  • Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + RBV (Experienced)
For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg).
Drug: Sofosbuvir + Simeprevir + Ribavirin
Other Names:
  • Olysio is a trade name of simeprevir
  • Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + SMV (Naive)
For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.
Drug: Sofosbuvir + Simeprevir + Ribavirin
Other Names:
  • Olysio is a trade name of simeprevir
  • Sovaldi is a trade name of sofosbuvir
Active Comparator: SOF + SMV (Expereined)
For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule.
Drug: Sofosbuvir + Simeprevir + Ribavirin
Other Names:
  • Olysio is a trade name of simeprevir
  • Sovaldi is a trade name of sofosbuvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HCV 12
Time Frame: 12 weeks after last dose
HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT).
12 weeks after last dose
Number of Participants With Adverse Events
Time Frame: up for 12 weeks after planned EOT.

An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study.

A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity
up for 12 weeks after planned EOT.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic relapse
Time Frame: 12 weeks after the last dose
Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT
12 weeks after the last dose
Percentage of Participants With Virologic null response
Time Frame: 24 or 36 weeks stating from the first dose
Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period
24 or 36 weeks stating from the first 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, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 9, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 9, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOF-SMV-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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