The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
459
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 With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively.
Time frame: 12 weeks after treatment
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively.
Time frame: 24 weeks after treatment
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Time frame: after 4 weeks of treatment
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
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ALV placebo soft gel capsules administered orally
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
Orlando, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Topeka, Kansas, United States
...and 65 more locations
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively.
Time frame: within 48 weeks
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Time frame: Up to 48 weeks
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment 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 (\< LOQ) during treatment
Time frame: within 48 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment.
Time frame: within 24 weeks after treatment