This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,081
ALV 200 mg soft gel capsules administered orally
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)
SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.
Time frame: 12 weeks after the end of treatment
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
Time frame: 24 weeks after the end of treatment
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)
RVR4 was defined as serum HCV RNA \< LOQ after 4 weeks of treatment.
Time frame: after 4 weeks of treatment
Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment
EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \< LOQ after 12 weeks of treatment.
Time frame: after 12 weeks of treatment
Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment
pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.
Time frame: after 12 weeks of treatment
Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment
cEVR was defined as serum HCV RNA \< LOQ after 12 weeks of treatment.
Time frame: after 12 weeks of treatment
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ALV placebo soft gel capsules administered orally
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Ventura, California, United States
Novartis Investigative Site
Bradenton, Florida, United States
Novartis Investigative Site
Maitland, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Springfield, Illinois, United States
...and 136 more locations
Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment
eRVR was defined as achieving RVR4 and maintaining HCV RNA \< LOQ until Week 12.
Time frame: from 4 to 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks
ETR was defined as serum HCV RNA \< LOQ at treatment end (completed or prematurely discontinued).
Time frame: at treatment end within 48 weeks
Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks
ALT abnormalities were summarized as participants who had either: * ALT \> 2 x upper limit of normal (ULN) during the study and \> 2 x ULN at baseline * ALT \> 3 x ULN during the study and \> 2 x ULN at baseline
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks
Grading was according to the Modified Division of Microbiology \& Infectious Diseases (DMID) Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Time frame: within 48 weeks
Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks
Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.
Time frame: within 48 weeks