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Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED) (SPRINT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705432
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 14, 2011
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Biological: Peginterferon alfa-2b (PEG)
Drug: Ribavirin (RBV)
Drug: Placebo
Drug: Boceprevir
Enrollment 1472
Recruitment Details 1472 participants were enrolled in this study.
Pre-assignment Details 373 participants were screened but not randomized. 1099 participants were randomized. Only 1097 received at least one dose of PegIntron (PEG) + Ribavirin (RBV) (lead-in treatment).
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Period Title: Treatment Period
Started 311 316 311 52 52 55
STARTED BOCEPREVIR/PLACEBO 297 303 299 47 47 55
Completed 148 205 190 11 24 25
Not Completed 163 111 121 41 28 30
Reason Not Completed
Adverse Event             45             37             51             12             8             9
Treatment failure             92             42             33             25             13             14
Non medical reason             26             32             37             4             7             7
Period Title: Follow-up Period (Upto Week 72)
Started 278 295 291 42 44 53
Completed 207 252 266 28 38 46
Not Completed 71 43 25 14 6 7
Reason Not Completed
Adverse Event             2             1             1             0             0             0
Non medical reason             69             42             24             14             6             7
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks Total
Hide Arm/Group Description Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. Total of all reporting groups
Overall Number of Baseline Participants 311 316 311 52 52 55 1097
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 311 participants 316 participants 311 participants 52 participants 52 participants 55 participants 1097 participants
<40 years 51 45 49 6 3 4 158
>= 40 and <65 years 246 261 255 45 47 51 905
>=65 years 14 10 7 1 2 0 34
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 311 participants 316 participants 311 participants 52 participants 52 participants 55 participants 1097 participants
Female
140
  45.0%
116
  36.7%
123
  39.5%
17
  32.7%
23
  44.2%
22
  40.0%
441
  40.2%
Male
171
  55.0%
200
  63.3%
188
  60.5%
35
  67.3%
29
  55.8%
33
  60.0%
656
  59.8%
1.Primary Outcome
Title Sustained Virologic Response (SVR) Rate
Hide Description

Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.

HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.

If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.

Time Frame At Follow-up Week (FW) 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description:
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 311 316 311 52 52 55
Measure Type: Number
Unit of Measure: Percentage of participants
40.2 66.8 68.5 23.1 42.3 52.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I - 1. Placebo + PEG + RBV, Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square test
Comments Adjustments were made for for baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 26.6
Confidence Interval (2-Sided) 95%
19.1 to 34.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort I - 1. Placebo + PEG + RBV, Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square test
Comments Adjustments were made for baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 28.3
Confidence Interval (2-Sided) 95%
20.8 to 35.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort II - 1. Placebo + PEG + RBV, Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0440
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square test
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 19.2
Confidence Interval (2-Sided) 95%
1.6 to 36.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort II - 1. Placebo + PEG + RBV, Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 29.7
Confidence Interval (2-Sided) 95%
12.2 to 47.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)
Hide Description

Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR.

Time Frame At FW 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description:
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 297 303 299 47 47 55
Measure Type: Number
Unit of Measure: Percentage of participants
42.1 69.6 71.2 25.5 46.8 52.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort I - 1. Placebo + PEG + RBV, Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR rates
Estimated Value 27.5
Confidence Interval (2-Sided) 95%
19.2 to 35.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort I - 1. Placebo + PEG + RBV, Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR rates
Estimated Value 29.1
Confidence Interval (2-Sided) 95%
21.5 to 36.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cohort II - 1. Placebo + PEG + RBV, Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0366
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square test
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 21.3
Confidence Interval (2-Sided) 95%
2.3 to 40.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cohort II - 1. Placebo + PEG + RBV, Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0107
Comments [Not Specified]
Method Cochran-Mantel Haenszel Chi-square
Comments Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).
Method of Estimation Estimation Parameter The difference in SVR
Estimated Value 27.2
Confidence Interval (2-Sided) 95%
9.0 to 45.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
Hide Description

Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.

HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.

Time Frame At FW 12 and at 72 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description:
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 311 316 311 52 52 55
Measure Type: Number
Unit of Measure: Participants
At follow-up week 12 127 209 209 11 21 29
72 weeks after randomization 120 194 205 11 20 27
4.Secondary Outcome
Title Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Hide Description

Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

Time Frame At Treatment Week 2, 4, 8, 12, 16, or 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description:
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 311 316 311 52 52 55
Measure Type: Number
Unit of Measure: Participants
Treatment week 2 8 11 8 0 1 0
Treatment week 4 28 18 20 2 1 0
Treatment week 8 56 190 182 4 18 22
Treatment week 12 108 237 231 10 25 33
Treatment week 16 138 231 237 15 26 36
Treatment week 20 157 231 231 15 27 32
5.Secondary Outcome
Title Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Hide Description

Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

Time Frame At Treatment Week 4, 8, 12, 16, 20
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.
Arm/Group Title Cohort I - 1. Placebo + PEG + RBV Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks Cohort II - 1. Placebo + PEG + RBV Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Hide Arm/Group Description:
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
Overall Number of Participants Analyzed 311 316 311 52 52 55
Measure Type: Number
Unit of Measure: Participants
Treatment week 4 (n=28, 18, 20, 2, 1, 0) 27 16 18 2 1 0
Treatment week 8 (n=56, 190, 182, 4, 18, 22) 48 170 166 3 14 18
Treatment week 12 (n=108, 237, 231, 10, 25, 33) 90 205 204 7 19 26
Treatment week 16 (n=138, 231, 237, 15, 26, 36) 106 205 210 12 20 26
Treatment week 20 (n=157, 231, 231, 15, 27, 32) 118 201 208 12 21 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG + RBV BOCEPREVIR + PEG + RBV - 24 WEEKS BOCEPRIVIR + PEG + RBV - 44 WEEKS
Hide Arm/Group Description Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.

  • At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
  • At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
All-Cause Mortality
PEG + RBV BOCEPREVIR + PEG + RBV - 24 WEEKS BOCEPRIVIR + PEG + RBV - 44 WEEKS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
PEG + RBV BOCEPREVIR + PEG + RBV - 24 WEEKS BOCEPRIVIR + PEG + RBV - 44 WEEKS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/363 (8.54%)      42/368 (11.41%)      45/366 (12.30%)    
Blood and lymphatic system disorders       
ANAEMIA  1  1/363 (0.28%)  1 3/368 (0.82%)  5 4/366 (1.09%)  7
APLASIA PURE RED CELL  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
LEUKOCYTOSIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
LEUKOPENIA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 2/366 (0.55%)  2
NEUTROPENIA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 2/366 (0.55%)  3
PANCYTOPENIA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
THROMBOCYTOPENIA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 3/366 (0.82%)  3
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
ATRIAL FIBRILLATION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
ATRIAL FLUTTER  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
CARDIAC ARREST  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
CARDIO-RESPIRATORY ARREST  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
CORONARY ARTERY DISEASE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
CORONARY ARTERY OCCLUSION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
HYPERTROPHIC CARDIOMYOPATHY  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
MYOCARDIAL INFARCTION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
TACHYCARDIA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Ear and labyrinth disorders       
DEAFNESS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Endocrine disorders       
HYPOTHYROIDISM  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Eye disorders       
CONJUNCTIVITIS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
OPTIC NEUROPATHY  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
PAPILLOEDEMA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN  1  1/363 (0.28%)  1 1/368 (0.27%)  1 1/366 (0.27%)  1
ABDOMINAL PAIN LOWER  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
COLITIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
COLONIC POLYP  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
GASTRITIS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
GASTROINTESTINAL HAEMORRHAGE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
HAEMATEMESIS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
HAEMORRHOIDAL HAEMORRHAGE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
HAEMORRHOIDS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
MALLORY-WEISS SYNDROME  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
NAUSEA  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
PANCREATITIS  1  2/363 (0.55%)  2 0/368 (0.00%)  0 0/366 (0.00%)  0
PANCREATITIS ACUTE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
UMBILICAL HERNIA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
VOMITING  1  1/363 (0.28%)  1 0/368 (0.00%)  0 2/366 (0.55%)  2
General disorders       
CHEST DISCOMFORT  1  0/363 (0.00%)  0 0/368 (0.00%)  0 2/366 (0.55%)  2
CHEST PAIN  1  0/363 (0.00%)  0 1/368 (0.27%)  1 4/366 (1.09%)  4
DEATH  1  2/363 (0.55%)  2 0/368 (0.00%)  0 0/366 (0.00%)  0
FATIGUE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
MALAISE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
PYREXIA  1  2/363 (0.55%)  2 1/368 (0.27%)  1 3/366 (0.82%)  3
Hepatobiliary disorders       
CHOLECYSTITIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
CHOLECYSTITIS ACUTE  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
CHOLELITHIASIS  1  2/363 (0.55%)  2 0/368 (0.00%)  0 0/366 (0.00%)  0
CHOLELITHIASIS OBSTRUCTIVE  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Immune system disorders       
SARCOIDOSIS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  2
Infections and infestations       
ABSCESS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
ABSCESS LIMB  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
APPENDICITIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
ATYPICAL MYCOBACTERIAL INFECTION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
BACTERAEMIA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
BRONCHITIS  1  0/363 (0.00%)  0 2/368 (0.54%)  2 0/366 (0.00%)  0
CELLULITIS  1  1/363 (0.28%)  1 1/368 (0.27%)  1 2/366 (0.55%)  2
DIVERTICULITIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
ENTEROCOLITIS INFECTIOUS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
EPIGLOTTITIS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
GASTROENTERITIS  1  0/363 (0.00%)  0 2/368 (0.54%)  2 2/366 (0.55%)  2
INFECTED BITES  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
INJECTION SITE INFECTION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
PERIRECTAL ABSCESS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
PNEUMONIA  1  1/363 (0.28%)  1 3/368 (0.82%)  4 1/366 (0.27%)  1
PNEUMONIA PNEUMOCOCCAL  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
SCROTAL ABSCESS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
SINUSITIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
STAPHYLOCOCCAL INFECTION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
TRACHEOBRONCHITIS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
UPPER RESPIRATORY TRACT INFECTION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Injury, poisoning and procedural complications       
ACCIDENTAL OVERDOSE  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
ALCOHOL POISONING  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
OVERDOSE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  2
POST PROCEDURAL COMPLICATION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
ROAD TRAFFIC ACCIDENT  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
SPINAL FRACTURE  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
TRANSFUSION REACTION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
VASCULAR PSEUDOANEURYSM  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
WOUND DEHISCENCE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Investigations       
WHITE BLOOD CELL COUNT DECREASED  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Metabolism and nutrition disorders       
DEHYDRATION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
HYPOKALAEMIA  1  0/363 (0.00%)  0 2/368 (0.54%)  2 0/366 (0.00%)  0
HYPONATRAEMIA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
FLANK PAIN  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
GROIN PAIN  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
INTERVERTEBRAL DISC PROTRUSION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
MUSCULOSKELETAL CHEST PAIN  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BLADDER CANCER  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
BREAST CANCER  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
COLON CANCER  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
HEPATIC NEOPLASM MALIGNANT  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
LUNG ADENOCARCINOMA  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
PANCREATIC CARCINOMA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
PROSTATE CANCER  1  1/363 (0.28%)  1 1/368 (0.27%)  1 0/366 (0.00%)  0
Nervous system disorders       
CAROTID ARTERY STENOSIS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
CEREBRAL ISCHAEMIA  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
DIZZINESS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  2
HYPOAESTHESIA  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
LOSS OF CONSCIOUSNESS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
MOTOR NEURONE DISEASE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
MUSCLE SPASTICITY  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
SYNCOPE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 4/366 (1.09%)  4
Psychiatric disorders       
AFFECTIVE DISORDER  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
ALCOHOL ABUSE  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
ANXIETY  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
BIPOLAR I DISORDER  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
COMPLETED SUICIDE  1  1/363 (0.28%)  1 1/368 (0.27%)  1 0/366 (0.00%)  0
DEPRESSION  1  1/363 (0.28%)  1 1/368 (0.27%)  1 1/366 (0.27%)  1
DRUG ABUSE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
DRUG DEPENDENCE  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
INTENTIONAL SELF-INJURY  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
PERSONALITY DISORDER  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
PSYCHIATRIC DECOMPENSATION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
SUICIDAL IDEATION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 4/366 (1.09%)  4
SUICIDE ATTEMPT  1  1/363 (0.28%)  1 0/368 (0.00%)  0 1/366 (0.27%)  1
Renal and urinary disorders       
GLOMERULONEPHRITIS MINIMAL LESION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
RENAL TUBULAR NECROSIS  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Reproductive system and breast disorders       
SCROTAL PAIN  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Respiratory, thoracic and mediastinal disorders       
COUGH  1  0/363 (0.00%)  0 0/368 (0.00%)  0 2/366 (0.55%)  2
DYSPNOEA  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
HAEMOPTYSIS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
PLEURAL FIBROSIS  1  0/363 (0.00%)  0 1/368 (0.27%)  1 0/366 (0.00%)  0
PNEUMOTHORAX  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
PULMONARY EMBOLISM  1  0/363 (0.00%)  0 2/368 (0.54%)  2 0/366 (0.00%)  0
Skin and subcutaneous tissue disorders       
PRURITUS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
RASH ERYTHEMATOUS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
Social circumstances       
ALCOHOL USE  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
PHYSICAL ASSAULT  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Surgical and medical procedures       
CHOLECYSTECTOMY  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
LARYNGEAL OPERATION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
SKIN NEOPLASM EXCISION  1  1/363 (0.28%)  1 0/368 (0.00%)  0 0/366 (0.00%)  0
Vascular disorders       
ACCELERATED HYPERTENSION  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
ARTERIAL THROMBOSIS LIMB  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
HYPERTENSIVE CRISIS  1  0/363 (0.00%)  0 0/368 (0.00%)  0 1/366 (0.27%)  1
HYPOTENSION  1  0/363 (0.00%)  0 1/368 (0.27%)  1 1/366 (0.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG + RBV BOCEPREVIR + PEG + RBV - 24 WEEKS BOCEPRIVIR + PEG + RBV - 44 WEEKS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   353/363 (97.25%)      365/368 (99.18%)      363/366 (99.18%)    
Blood and lymphatic system disorders       
ANAEMIA  1  107/363 (29.48%)  188 182/368 (49.46%)  292 179/366 (48.91%)  352
LEUKOPENIA  1  33/363 (9.09%)  81 31/368 (8.42%)  83 45/366 (12.30%)  126
NEUTROPENIA  1  77/363 (21.21%)  208 91/368 (24.73%)  216 93/366 (25.41%)  257
THROMBOCYTOPENIA  1  7/363 (1.93%)  16 16/368 (4.35%)  50 19/366 (5.19%)  38
Eye disorders       
DRY EYE  1  16/363 (4.41%)  16 13/368 (3.53%)  13 22/366 (6.01%)  24
VISION BLURRED  1  14/363 (3.86%)  15 23/368 (6.25%)  25 22/366 (6.01%)  25
Gastrointestinal disorders       
ABDOMINAL PAIN  1  20/363 (5.51%)  30 25/368 (6.79%)  28 23/366 (6.28%)  28
ABDOMINAL PAIN UPPER  1  32/363 (8.82%)  40 30/368 (8.15%)  41 44/366 (12.02%)  54
CONSTIPATION  1  32/363 (8.82%)  34 22/368 (5.98%)  24 32/366 (8.74%)  34
DIARRHOEA  1  79/363 (21.76%)  103 80/368 (21.74%)  104 100/366 (27.32%)  125
DRY MOUTH  1  40/363 (11.02%)  45 39/368 (10.60%)  42 43/366 (11.75%)  51
DYSPEPSIA  1  32/363 (8.82%)  39 29/368 (7.88%)  35 33/366 (9.02%)  40
GASTROOESOPHAGEAL REFLUX DISEASE  1  8/363 (2.20%)  9 19/368 (5.16%)  22 20/366 (5.46%)  22
NAUSEA  1  153/363 (42.15%)  199 175/368 (47.55%)  231 159/366 (43.44%)  212
VOMITING  1  57/363 (15.70%)  70 75/368 (20.38%)  99 70/366 (19.13%)  90
General disorders       
ASTHENIA  1  70/363 (19.28%)  129 55/368 (14.95%)  86 70/366 (19.13%)  132
CHILLS  1  102/363 (28.10%)  114 134/368 (36.41%)  156 121/366 (33.06%)  139
FATIGUE  1  217/363 (59.78%)  279 196/368 (53.26%)  250 209/366 (57.10%)  290
INFLUENZA LIKE ILLNESS  1  93/363 (25.62%)  160 91/368 (24.73%)  113 83/366 (22.68%)  102
INJECTION SITE ERYTHEMA  1  47/363 (12.95%)  55 46/368 (12.50%)  48 37/366 (10.11%)  38
INJECTION SITE REACTION  1  44/363 (12.12%)  46 45/368 (12.23%)  46 39/366 (10.66%)  39
IRRITABILITY  1  86/363 (23.69%)  106 81/368 (22.01%)  104 83/366 (22.68%)  111
PAIN  1  34/363 (9.37%)  36 41/368 (11.14%)  43 37/366 (10.11%)  41
PYREXIA  1  120/363 (33.06%)  196 123/368 (33.42%)  180 117/366 (31.97%)  218
Infections and infestations       
SINUSITIS  1  15/363 (4.13%)  18 16/368 (4.35%)  20 19/366 (5.19%)  22
Investigations       
WEIGHT DECREASED  1  46/363 (12.67%)  54 43/368 (11.68%)  50 52/366 (14.21%)  64
Metabolism and nutrition disorders       
DECREASED APPETITE  1  90/363 (24.79%)  101 97/368 (26.36%)  107 89/366 (24.32%)  98
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  66/363 (18.18%)  84 69/368 (18.75%)  87 72/366 (19.67%)  103
BACK PAIN  1  40/363 (11.02%)  45 30/368 (8.15%)  33 40/366 (10.93%)  45
MUSCLE SPASMS  1  23/363 (6.34%)  25 15/368 (4.08%)  20 18/366 (4.92%)  20
MYALGIA  1  94/363 (25.90%)  125 78/368 (21.20%)  98 92/366 (25.14%)  120
PAIN IN EXTREMITY  1  19/363 (5.23%)  21 11/368 (2.99%)  12 21/366 (5.74%)  24
Nervous system disorders       
DISTURBANCE IN ATTENTION  1  27/363 (7.44%)  30 22/368 (5.98%)  23 18/366 (4.92%)  18
DIZZINESS  1  59/363 (16.25%)  74 80/368 (21.74%)  97 66/366 (18.03%)  70
DYSGEUSIA  1  64/363 (17.63%)  68 137/368 (37.23%)  143 156/366 (42.62%)  164
HEADACHE  1  153/363 (42.15%)  264 168/368 (45.65%)  233 167/366 (45.63%)  311
MEMORY IMPAIRMENT  1  21/363 (5.79%)  21 9/368 (2.45%)  9 24/366 (6.56%)  28
PARAESTHESIA  1  13/363 (3.58%)  32 10/368 (2.72%)  11 19/366 (5.19%)  23
Psychiatric disorders       
ANXIETY  1  42/363 (11.57%)  49 50/368 (13.59%)  57 48/366 (13.11%)  65
DEPRESSION  1  78/363 (21.49%)  86 82/368 (22.28%)  103 69/366 (18.85%)  85
INSOMNIA  1  118/363 (32.51%)  137 117/368 (31.79%)  145 122/366 (33.33%)  141
MOOD SWINGS  1  6/363 (1.65%)  7 13/368 (3.53%)  17 19/366 (5.19%)  21
Respiratory, thoracic and mediastinal disorders       
COUGH  1  76/363 (20.94%)  87 56/368 (15.22%)  69 74/366 (20.22%)  100
DYSPNOEA  1  59/363 (16.25%)  66 68/368 (18.48%)  87 84/366 (22.95%)  94
DYSPNOEA EXERTIONAL  1  30/363 (8.26%)  33 42/368 (11.41%)  44 31/366 (8.47%)  39
EPISTAXIS  1  13/363 (3.58%)  15 19/368 (5.16%)  23 21/366 (5.74%)  21
OROPHARYNGEAL PAIN  1  22/363 (6.06%)  24 14/368 (3.80%)  18 33/366 (9.02%)  34
Skin and subcutaneous tissue disorders       
ALOPECIA  1  99/363 (27.27%)  105 75/368 (20.38%)  82 104/366 (28.42%)  109
DRY SKIN  1  66/363 (18.18%)  77 67/368 (18.21%)  72 86/366 (23.50%)  98
PRURITUS  1  98/363 (27.00%)  130 87/368 (23.64%)  101 94/366 (25.68%)  138
RASH  1  83/363 (22.87%)  124 93/368 (25.27%)  111 88/366 (24.04%)  119
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

In this multicenter trial, initially, the investigator may only publish study results together with the other sites, unless specific written permission is obtained in advance from the sponsor.

The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a 45 day period from the time submitted to the sponsor for review.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705432    
Obsolete Identifiers: NCT00795431
Other Study ID Numbers: P05216
EUDRACT # 2007-005508-42
First Submitted: June 24, 2008
First Posted: June 26, 2008
Results First Submitted: May 13, 2011
Results First Posted: June 14, 2011
Last Update Posted: April 7, 2017