Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

Study Overview
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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).

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).

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

Conditions
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Chronic Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: Sofosbuvir + Simeprevir + Ribavirin


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOF + RBV (Naive)<br>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<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|
| Active Comparator: SOF + RBV (Experienced)<br>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<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|
| Active Comparator: SOF + SMV (Naive)<br>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<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|
| Active Comparator: SOF + SMV (Expereined)<br>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<br> <br> * Other names: Sovaldi is a trade name of sofosbuvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HCV 12 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Egyptian patients, HCV GT4, Naive, Ribavirin, Simeprevir, Sofosbuvir, Experinced