This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,175
180 µg sc weekly for 48 weeks
1200 mg po daily for 48 weeks
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
1400-1600 mg po daily for 48 weeks
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Huntsville, Alabama, United States
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Fresno, California, United States
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Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Time frame: Week 72
SVR-24 (Actual Treatment Period)
SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
Time frame: 24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)
SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 60).
Time frame: 12 weeks after end of treatment
SVR-12 (Actual Treatment Period)
SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.
Time frame: 12 weeks after end of treatment
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La Jolla, California, United States
Unnamed facility
Lancaster, California, United States
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Los Angeles, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Sacramento, California, United States
...and 174 more locations