Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Chronic Hepatitis C Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

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Sofosbuvir + Simeprevir + Ribavirin

Intervention Type DRUG

Other Intervention Names

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Olysio is a trade name of simeprevir Sovaldi is a trade name of sofosbuvir

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No