Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

Phase 2

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: PR4 + LDV/SOF + SMV 8 wk; Drug: PR4 + LDV/SOF + SMV 6 wk; Drug: PR4 + LDV/SOF + ASV 4 wk; Drug: PR4 + LDV/SOF + ASV 8 wk; Drug: PR4 + LDV/SOF + SMV 4 wk; Drug: PR4 + LDV/SOF + ASV 6 wk; Drug: PR4 + LDV/SOF + ASV 12 wk; Drug: PR4 + LDV/SOF + SMV 12 wk

• Registration Number: NCT02583685
• Lead Sponsor: Humanity and Health Research Centre

Brief Summary

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-15
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Individuals with chronic HCV GT1b infection;
• HCV RNA ≥ 10000 IU/mL at screening;
• Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
• Cirrhosis determination; a liver biopsy may be required;
• Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion Criteria

• Pregnant or nursing female or male with pregnant female partner;
• HIV or HBV co-infection;
• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
• Active or recent history (≤ 1 year) of drug or alcohol abuse;
• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PR4 + LDV/SOF + SMV 8 wk	PR4 + LDV/SOF + SMV 8 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \> 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks.
PR4 + LDV/SOF + SMV 6 wk	PR4 + LDV/SOF + SMV 6 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks.
PR4 + LDV/SOF + ASV 4 wk	PR4 + LDV/SOF + ASV 4 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks.
PR4 + LDV/SOF + ASV 8 wk	PR4 + LDV/SOF + ASV 8 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \> 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks.
PR4 + LDV/SOF + SMV 4 wk	PR4 + LDV/SOF + SMV 4 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks.
PR4 + LDV/SOF + ASV 6 wk	PR4 + LDV/SOF + ASV 6 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks.
PR4 + LDV/SOF + ASV 12 wk	PR4 + LDV/SOF + ASV 12 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks.
PR4 + LDV/SOF + SMV 12 wk	PR4 + LDV/SOF + SMV 12 wk	Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA \<2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy	Post treatment Week 12	SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)	Baseline up to Week 24

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment	Baseline up to Week 24
Treatment adherence	Baseline to Week 12	To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
Change in health related quality of life evaluated with questionnaires	Up to Posttreatment Week 24	To evaluate the change in health-related quality of life during and after treatment with questionnaires
Change in mental health evaluated with questionnaires	Up to Posttreatment Week 24	To evaluate the change in mental health during and after treatment with questionnaires
Liver disease progression	Up to 10 years	Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.

Trial Locations

Locations (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital; 🇨🇳 Beijing, Beijing, China

Humanity and Health GI and Liver Centre; 🇨🇳 Hong Kong, Hong Kong, China