This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Unnamed facility
Milwaukee, Wisconsin, United States
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Edmonton, Alberta, Canada
Unnamed facility
Edmonton, Alberta, Canada
Unnamed facility
Abbotsford British Columbia, British Columbia, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Vernon, British Columbia, Canada
Unnamed facility
Victoria, British Columbia, Canada
Unnamed facility
Halifax, Nova Scotia, Canada
...and 13 more locations
Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
Time frame: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
Percentage of Participants With SVR (Groups C, D, E, and F)
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.
Time frame: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)
Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were \<15 IU/mL at the end of treatment. Early virological response (EVR) was defined as \>=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (\<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were \<15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a \>=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still \>=15 IU/mL at that time point.
Time frame: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)
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