Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

Debiopharm International SA340 enrolled

Overview

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

Hepatitis C Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion criteria: * Chronic hepatitis C viral infection * Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit) * HCV genotype 2 or 3 * No previous treatment for hepatitis C infection Exclusion criteria: * Evidence of cirrhosis at the time of screening * Evidence of hepatocellular carcinoma at the time of screening * Any other cause of relevant liver disease other than HCV * Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) * Other protocol-defined inclusion/exclusion criteria may apply

Locations (73)

Scripps Clinic

La Jolla, California, United States

Sharp Rees-Stealy Medical Group, Inc.

San Diego, California, United States

Research and Education Inc.

San Diego, California, United States

Island View Gastroenterology Associates

Ventura, California, United States

Hawai Medical Center East LLC

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)

RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.

Time frame: after 4 weeks of treatment

Secondary Outcomes

Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)

RVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.

Time frame: after 4 weeks of treatment

Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)

Time frame: after 4 weeks of treatment

Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)

Time frame: after 4 weeks of treatment

Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)

cEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.

Time frame: after 12 weeks of treatment

Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)

Time frame: after 12 weeks of treatment

Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)

Time frame: after 12 weeks of treatment

Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)

ETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.

Time frame: at end of treatment, within 24 weeks

Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)

Time frame: at end of treatment, within 24 weeks

Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)

Time frame: at end of treatment, within 24 weeks

Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)

SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.

Time frame: 12 weeks after the end of treatment

Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)

Time frame: 12 weeks after the end of treatment

Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)

Time frame: 12 weeks after the end of treatment

Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)

Time frame: 24 weeks after the end of treatment

Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)

Time frame: 24 weeks after the end of treatment

Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)

Time frame: 24 weeks after the end of treatment

Percentage of Participants With On-treatment Viral Breakthrough

Viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOD) during treatment

Time frame: within 24 weeks of treatment

Percentage of Participants With Viral Relapse

Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.

Time frame: within 24 weeks after the end of treatment