The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
257
800 mg three times daily orally
1.5 mcg/kg weekly subcutaneously
800-1400 mg twice-daily divided orally based on body weight
Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \< Lower Limit of Quantification \[LLoQ\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Time frame: Follow-up Week (FW) 12 (up to 40 weeks)
Percentage of Participants With Undetectable HCV RNA Across Treatment
The percentage of participants with undetectable HCV RNA (HCV RNA \<LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Time frame: TW4, TW8, and TW12
Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment
The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA \<LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Time frame: TW4, TW8, and TW12
Percentage of Participants With Relapse
The percentage of viral relapse (defined as confirmed HCV RNA \>15 IU/mL after End-of-Treatment \[EOT\]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
Time frame: From EOT to FW12 (up to 12 weeks)
Percentage of Participants With Neutropenia
The percentage of participants with neutropenia (neutrophil count \<0.75 x10\^9/L) is summarized for each arm.
Time frame: Up to 60 weeks
Percentage of Participants With Anemia
The percentage of participants with anemia (hemoglobin \[Hgb\] \<10 g/dL) was determined in each arm.
Time frame: Up to 60 weeks
Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.
Time frame: From TW1 through TW48
Percentage of Participants With Treatment-Related Serious AEs (SAEs)
A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.
Time frame: Up to 60 weeks
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