ٍٍSofosbuvir/Simeprevir/Daclatasvir/Ribavirin and HCV Genotype 4-infected Egyptian Experienced Participants

Phase 1

Completed

• Conditions: Chronic Hepatitis C Virus Infection
• Interventions: Drug: SOF/SMV/DCV/RBV

• Registration Number: NCT04387539
• Lead Sponsor: Beni-Suef University

Brief Summary

Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)

Detailed Description

Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.

In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-10
• Study First Submitted QC: 2020-05-10
• Last Update Submitted: 2020-05-10
• Study First Posted: 2020-05-14
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Experienced Egyptian participants with HCV GT4 infection who had failed prior DAA treatments [SOF/DCV or SOF/SMV or SOF/pegylated interferon/RBV or SOF/RBV]
• Fibrosis-4 score in non-cirrhotic participants is <1.45-3.25: (None or moderate fibrosis)
• Fibrosis-4 score in cirrhotic participants is >3.25: (Advanced fibrosis or cirrhosis)

Exclusion Criteria

• HCV coinfected with hepatitis B virus (HBV) or 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
Non-Cirrhotic	SOF/SMV/DCV/RBV	SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks
Cirrhotic	SOF/SMV/DCV/RBV	SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm	12 weeks after last dose	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm	Screening up to 12 weeks after last dose	An adverse event (AE) is defined as any untoward medical occurrence in a participant 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	Up to 12 weeks after last dose	Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( \> 15 IU/ml) levels 12 weeks after planned EOT.

Trial Locations

Locations (1)

Health Administration at Beni-Seuf; 🇪🇬 Bani Sweif, Egypt