Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Phase 1

Completed

• Conditions: Chronic Hepatitis C Virus Infection
• Interventions: Drug: SOF plus (OBV/PTV/r) plus RBV

• Registration Number: NCT04391985
• Lead Sponsor: Beni-Suef University

Brief Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Detailed Description

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-13
• Last Update Submitted: 2020-05-13
• Study First Posted: 2020-05-18
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
• The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 > 3.25 (advanced fibrosis or cirrhosis), albumin < 3.5, total bilirubin > 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion Criteria

• liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
• poorly controlled diabetes (HbA1C > 8)
• participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
• renal failure
• evidence of hepatic decompensation
• blood picture abnormalities such as anemia (hemoglobin concentration of < 10 g/dL)
• thrombocytopenia (platelets count < 50,000 cells/mm3).
• major severe illness such as congestive heart failure and respiratory failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-cirrhotic Participants	SOF plus (OBV/PTV/r) plus RBV	The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.
Cirrhotic Participants	SOF plus (OBV/PTV/r) plus RBV	The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated 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/ml 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)

Beni-Suef University; 🇪🇬 Beni-Suef, Egypt