The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
1.5 ug/kg/week SC for 12 or 24 weeks
Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
Time frame: Evaluated at the end of 6 months
Virologic Response at the End of Treatment Follow-up (ETR)
ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks treatment (depending on treatment arm) was \<15 IU/mL.
Time frame: At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was \<15 IU/mL.
Time frame: At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
Time frame: Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
Number of Participants With Rapid Virologic Response (RVR)
Participants were considered to have RVR if serum HCV RNA level at 2 or 4 weeks of treatment was below the cut off value of the referring local laboratory of each participating site.
Time frame: Evaluated at 2 and 4 weeks of treatment
Number of Peripheral Blood Mononuclear Cells (PBMCs)
Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
Time frame: Treatment Weeks 2, 4, 8, and 12
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