Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

Phase 1

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: SOF/RBV/PegINFα-2

• Registration Number: NCT04382339
• Lead Sponsor: Beni-Suef University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-naive	SOF/RBV/PegINFα-2	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)
Treatment-experienced	SOF/RBV/PegINFα-2	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)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12	12 weeks after last dose	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm	Screening until 30 days after last dose	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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral relapse	12 weeks after last dose	Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA \> 15 IU/ml levels 12 weeks after planned EOT.
Percentage of Participants With On-treatment Virologic Failure	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