Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Study Overview
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Brief Summary
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This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

Detailed Description
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Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks. Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.

Official Title
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Effectiveness of Sofosbuvir/Pegylated-interferon Plus Ribavirin in Treatment of Hepatitis C Virus Genotype 4 Patients

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: SOF/RBV/PegINFα-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml. Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy. - Exclusion Criteria:Participants with one or more of HCV coinfected with hepatitis B virus (HBV) human immunodeficiency virus (HIV) had any liver disease other than chronic HCV GT4 infection. had a history of liver decompensation serum a-fetoprotein (AFP) > 100 ng/ml evidence of hepatocellular carcinoma major severe illness such as respiratory, renal, heart failure or autoimmune disease non-compliance with treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Treatment-naive<br>Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) | Drug: SOF/RBV/PegINFα-2<br>* SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C<br>|
| Active Comparator: Treatment-experienced<br>Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) | Drug: SOF/RBV/PegINFα-2<br>* SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C<br>|

What is the study measuring?
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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 | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 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 | An adverse event (AE) is defined as any untoward medical occurrence in a participant or i 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 | Screening until 30 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT. | 12 weeks after last dose | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV genotype 4, sofosbuvir, Peg-interferon α-2, ribavirin, Egyptian patients, Experinced, Naive