The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Phase 3 Completed 238 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Timeline

Start: 2011-11-23
Primary completion: 2013-10-21
Completion: 2013-10-21

Outcome

Met primary endpoint

registry RGT BOC + PR vs PBO + PR (Control); p <0.0001; Adjusted Difference in Percentages 29.2 (95% CI 16.4 to 41.5) NCT01425203 ↗

paper SVR was 74.8% in the boceprevir plus PR arm compared with 46.2% in the control arm, with a stratification-adjusted treatment difference of 29.2% (95%CI: 16.4-41.5; P < 0.0001). PMID 26962399 ↗

Publications

Results Isakov V, Nikitin I, Chulanov V, Ogurtsov P, Lukyanova E, Long J, Wahl J, Helmond FA; P08160 Trial Investigators. Boceprevir plus peginterferon/ribavirin for treatment of chronic hepatitis C in Russia. World J Hepatol. 2016 Feb 28;8(6):331-9. doi: 10.4254/wjh.v8.i6.331.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boceprevir	Small molecule	800 mg	Oral
Background	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	Subcutaneous
Background	Ribavirin	Small molecule	800 mg	Oral
Background	Ribavirin	Small molecule	1400 mg	Oral