Trial Outcomes & Findings for Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED) (NCT NCT00708500)
NCT ID: NCT00708500
Last Updated: 2017-04-07
Results Overview
SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
404 participants
Primary outcome timeframe
At Follow-up Week 24
Results posted on
2017-04-07
Participant Flow
154 participants who discontinued during the treatment phase (including those from lead in and/or boceprevir/placebo) entered the follow up phase
Participant milestones
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
STARTED
|
80
|
162
|
162
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Treated With PEG2b + RBV
|
80
|
162
|
161
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
COMPLETED
|
78
|
156
|
160
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
NOT COMPLETED
|
2
|
6
|
2
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
STARTED
|
78
|
156
|
160
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
COMPLETED
|
23
|
104
|
105
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
NOT COMPLETED
|
55
|
52
|
55
|
|
FOLLOWUP
STARTED
|
77
|
151
|
158
|
|
FOLLOWUP
COMPLETED
|
37
|
136
|
143
|
|
FOLLOWUP
NOT COMPLETED
|
40
|
15
|
15
|
Reasons for withdrawal
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Adverse Event
|
1
|
3
|
1
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Subject withdrawal unrelated to Tx
|
1
|
0
|
0
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Subject withdrawal related to Tx
|
0
|
1
|
0
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Subject withdrew consent
|
0
|
2
|
0
|
|
Treatment (Tx): 4 WEEK LEAD-IN PERIOD
Randomized but not treated
|
0
|
0
|
1
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Adverse Event
|
1
|
10
|
19
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Treatment Failure
|
49
|
36
|
29
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Lost to Follow-up
|
0
|
1
|
0
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Subject withdrawal unrelated to Tx
|
3
|
1
|
4
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Subject withdrawal related to Tx
|
2
|
0
|
1
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Subject withdrew consent
|
0
|
2
|
1
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Non-compliance with protocol
|
0
|
1
|
1
|
|
Tx: RECEIVING BOCEPREVIR/PLACEBO
Administrative
|
0
|
1
|
0
|
|
FOLLOWUP
Adverse Event
|
0
|
1
|
0
|
|
FOLLOWUP
Lost to Follow-up
|
1
|
6
|
4
|
|
FOLLOWUP
Subject withdrawal unrelated to Tx
|
3
|
4
|
5
|
|
FOLLOWUP
Subject withdrew consent
|
31
|
4
|
5
|
|
FOLLOWUP
Non-compliance with protocol
|
5
|
0
|
1
|
Baseline Characteristics
Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 Participants
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 Participants
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 Participants
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
52.9 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
52.7 years
STANDARD_DEVIATION 7.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
135 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
268 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: At Follow-up Week 24Population: FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
SVR is defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with chronic hepatitis C (CHC) genotype 1 who failed prior treatment.
Outcome measures
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 Participants
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 Participants
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 Participants
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population.
|
21.3 Percentage of Participants
|
58.6 Percentage of Participants
|
66.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Follow-up Week 24Population: mITT = all randomized subjects who received at least one dose of boceprevir (experimental arms) or boceprevir placebo (control arm).
SVR is defined as undetectable plasma HCV-RNA at Follow-up Week 24. This outcome measure evaluates SVR after treatment with boceprevir and PEG2b plus RBV versus PEG2b plus RBV alone in participants with CHC genotype 1 who failed prior treatment. This key secondary efficacy endpoint was added as per the second protocol amendment on 02 DEC 2009.
Outcome measures
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=78 Participants
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=156 Participants
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=160 Participants
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Sustained Virologic Response (SVR) Rate in the Modified Intent to Treat (mITT) Population.
|
21.8 Percentage of Participants
|
60.9 Percentage of Participants
|
66.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 2, 4, 8, or 12Population: FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
Having undetectable HCV-RNA at Week 2, 4, 8, or 12 was considered Early Virologic Response.
Outcome measures
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 Participants
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 Participants
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 Participants
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Number of Participants With Early Virologic Response.
Week 2
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Early Virologic Response.
Week 4
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Early Virologic Response.
Week 8
|
7 participants
|
74 participants
|
84 participants
|
|
Number of Participants With Early Virologic Response.
Week 12
|
23 participants
|
111 participants
|
121 participants
|
SECONDARY outcome
Timeframe: At Follow-up Week 12 and at 72 weeks after randomizationPopulation: FAS = all randomized subjects who received at least one dose of any study medication (Peg, RBV, or boceprevir/placebo).
Outcome measures
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 Participants
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 Participants
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 Participants
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
Follow-Up Week 12
|
16 participants
|
97 participants
|
105 participants
|
|
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
72 Weeks Post Randomization
|
17 participants
|
93 participants
|
105 participants
|
Adverse Events
Placebo+PEG2b+RBV, x 44 Weeks
Serious events: 4 serious events
Other events: 77 other events
Deaths: 0 deaths
Boceprevir+PEG2b+RBV, Response Guided Therapy
Serious events: 16 serious events
Other events: 159 other events
Deaths: 0 deaths
Boceprevir+PEG2b+RBV, x 44 Weeks
Serious events: 23 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 participants at risk
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 participants at risk
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 participants at risk
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/80
|
0.00%
0/162
|
3.1%
5/161 • Number of events 5
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Cardiac disorders
MYOPERICARDITIS
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/80
|
1.2%
2/162 • Number of events 2
|
0.00%
0/161
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS NECROTISING
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
General disorders
ASTHENIA
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
General disorders
CHEST PAIN
|
1.2%
1/80 • Number of events 1
|
1.2%
2/162 • Number of events 3
|
0.62%
1/161 • Number of events 1
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
General disorders
PYREXIA
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 2
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
1.2%
1/80 • Number of events 2
|
0.00%
0/162
|
0.00%
0/161
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/80
|
0.00%
0/162
|
1.9%
3/161 • Number of events 3
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
1.2%
1/80 • Number of events 1
|
0.00%
0/162
|
0.00%
0/161
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/80
|
1.2%
2/162 • Number of events 2
|
0.00%
0/161
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Nervous system disorders
PARKINSONISM
|
1.2%
1/80 • Number of events 1
|
0.00%
0/162
|
0.00%
0/161
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/80
|
1.9%
3/162 • Number of events 3
|
0.62%
1/161 • Number of events 1
|
|
Psychiatric disorders
HOMICIDAL IDEATION
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.62%
1/161 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/80
|
1.9%
3/162 • Number of events 3
|
1.2%
2/161 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/80
|
1.2%
2/162 • Number of events 2
|
0.00%
0/161
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Surgical and medical procedures
ABDOMINAL HERNIA REPAIR
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/80
|
0.00%
0/162
|
0.62%
1/161 • Number of events 1
|
|
Vascular disorders
PHLEBITIS
|
0.00%
0/80
|
0.62%
1/162 • Number of events 1
|
0.00%
0/161
|
Other adverse events
| Measure |
Placebo+PEG2b+RBV, x 44 Weeks
n=80 participants at risk
Participants in Arm 1 (control) received pegylated interferon alfa 2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by boceprevir placebo + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir+PEG2b+RBV, Response Guided Therapy
n=162 participants at risk
Participants in Arm 2 (experimental) were assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8.
PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 32 weeks, then:
* 36-week regimen: Participants who have undetectable HCV-RNA at Treatment Week 8 discontinue treatment and enter 36 weeks of post treatment follow-up.
* 48-week regimen: Participants who have detectable HCV-RNA at Treatment Week 8 are assigned an additional 12 weeks of therapy, followed by 24 weeks of post treatment follow-up. Placebo replaces boceprevir for the remaining 12 weeks of therapy, and this switch will occur in a blinded fashion.
|
Boceprevir+PEG2b+RBV, x 44 Weeks
n=161 participants at risk
Participants in Arm 3 (experimental) received PEG2b + RBV (WBD) for 4 weeks followed by boceprevir + PEG2b + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Nervous system disorders
DIZZINESS
|
10.0%
8/80 • Number of events 8
|
16.0%
26/162 • Number of events 29
|
16.1%
26/161 • Number of events 36
|
|
Nervous system disorders
DYSGEUSIA
|
11.2%
9/80 • Number of events 9
|
43.2%
70/162 • Number of events 79
|
44.7%
72/161 • Number of events 86
|
|
Nervous system disorders
HEADACHE
|
48.8%
39/80 • Number of events 50
|
42.6%
69/162 • Number of events 95
|
39.8%
64/161 • Number of events 82
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.0%
4/80 • Number of events 5
|
6.2%
10/162 • Number of events 10
|
3.1%
5/161 • Number of events 5
|
|
Psychiatric disorders
ANXIETY
|
7.5%
6/80 • Number of events 7
|
11.7%
19/162 • Number of events 25
|
12.4%
20/161 • Number of events 23
|
|
Psychiatric disorders
DEPRESSION
|
15.0%
12/80 • Number of events 12
|
11.1%
18/162 • Number of events 21
|
17.4%
28/161 • Number of events 39
|
|
Psychiatric disorders
INSOMNIA
|
23.8%
19/80 • Number of events 33
|
30.9%
50/162 • Number of events 65
|
29.2%
47/161 • Number of events 62
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.5%
14/80 • Number of events 20
|
18.5%
30/162 • Number of events 36
|
24.8%
40/161 • Number of events 59
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
17.5%
14/80 • Number of events 14
|
17.9%
29/162 • Number of events 42
|
24.8%
40/161 • Number of events 46
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.0%
4/80 • Number of events 4
|
13.6%
22/162 • Number of events 23
|
8.7%
14/161 • Number of events 14
|
|
Blood and lymphatic system disorders
ANAEMIA
|
20.0%
16/80 • Number of events 20
|
43.2%
70/162 • Number of events 117
|
46.6%
75/161 • Number of events 125
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
1.2%
1/80 • Number of events 3
|
2.5%
4/162 • Number of events 12
|
6.8%
11/161 • Number of events 18
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
10.0%
8/80 • Number of events 12
|
14.2%
23/162 • Number of events 60
|
14.3%
23/161 • Number of events 43
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/80
|
1.2%
2/162 • Number of events 4
|
6.2%
10/161 • Number of events 12
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
10.0%
8/80 • Number of events 8
|
2.5%
4/162 • Number of events 4
|
6.8%
11/161 • Number of events 12
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.5%
2/80 • Number of events 2
|
8.6%
14/162 • Number of events 23
|
7.5%
12/161 • Number of events 16
|
|
Gastrointestinal disorders
CONSTIPATION
|
7.5%
6/80 • Number of events 6
|
9.3%
15/162 • Number of events 17
|
11.8%
19/161 • Number of events 22
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.2%
13/80 • Number of events 21
|
23.5%
38/162 • Number of events 59
|
24.8%
40/161 • Number of events 59
|
|
Gastrointestinal disorders
DRY MOUTH
|
8.8%
7/80 • Number of events 8
|
13.0%
21/162 • Number of events 25
|
16.1%
26/161 • Number of events 32
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.2%
5/80 • Number of events 5
|
6.8%
11/162 • Number of events 16
|
6.2%
10/161 • Number of events 13
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/80
|
5.6%
9/162 • Number of events 9
|
5.6%
9/161 • Number of events 9
|
|
Gastrointestinal disorders
NAUSEA
|
37.5%
30/80 • Number of events 37
|
44.4%
72/162 • Number of events 89
|
42.2%
68/161 • Number of events 99
|
|
Gastrointestinal disorders
STOMATITIS
|
2.5%
2/80 • Number of events 2
|
6.2%
10/162 • Number of events 11
|
3.1%
5/161 • Number of events 6
|
|
Gastrointestinal disorders
VOMITING
|
7.5%
6/80 • Number of events 6
|
14.2%
23/162 • Number of events 27
|
14.9%
24/161 • Number of events 33
|
|
General disorders
ASTHENIA
|
16.2%
13/80 • Number of events 20
|
18.5%
30/162 • Number of events 43
|
23.6%
38/161 • Number of events 59
|
|
General disorders
CHILLS
|
30.0%
24/80 • Number of events 36
|
34.6%
56/162 • Number of events 94
|
31.1%
50/161 • Number of events 63
|
|
General disorders
FATIGUE
|
50.0%
40/80 • Number of events 59
|
53.7%
87/162 • Number of events 137
|
57.1%
92/161 • Number of events 115
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
25.0%
20/80 • Number of events 20
|
25.3%
41/162 • Number of events 51
|
23.6%
38/161 • Number of events 44
|
|
General disorders
INJECTION SITE ERYTHEMA
|
8.8%
7/80 • Number of events 17
|
13.6%
22/162 • Number of events 24
|
9.9%
16/161 • Number of events 33
|
|
General disorders
INJECTION SITE REACTION
|
8.8%
7/80 • Number of events 10
|
5.6%
9/162 • Number of events 12
|
9.9%
16/161 • Number of events 17
|
|
General disorders
IRRITABILITY
|
12.5%
10/80 • Number of events 13
|
19.1%
31/162 • Number of events 38
|
22.4%
36/161 • Number of events 41
|
|
General disorders
PAIN
|
3.8%
3/80 • Number of events 5
|
6.8%
11/162 • Number of events 12
|
9.3%
15/161 • Number of events 15
|
|
General disorders
PYREXIA
|
25.0%
20/80 • Number of events 32
|
27.8%
45/162 • Number of events 58
|
29.8%
48/161 • Number of events 67
|
|
Infections and infestations
BRONCHITIS
|
7.5%
6/80 • Number of events 6
|
1.9%
3/162 • Number of events 5
|
3.7%
6/161 • Number of events 7
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.5%
6/80 • Number of events 9
|
3.1%
5/162 • Number of events 6
|
2.5%
4/161 • Number of events 4
|
|
Infections and infestations
SINUSITIS
|
8.8%
7/80 • Number of events 7
|
4.3%
7/162 • Number of events 10
|
2.5%
4/161 • Number of events 5
|
|
Investigations
WEIGHT DECREASED
|
8.8%
7/80 • Number of events 8
|
13.0%
21/162 • Number of events 27
|
9.3%
15/161 • Number of events 19
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.2%
13/80 • Number of events 15
|
22.8%
37/162 • Number of events 38
|
28.6%
46/161 • Number of events 56
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
16.2%
13/80 • Number of events 15
|
21.0%
34/162 • Number of events 36
|
24.2%
39/161 • Number of events 53
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.2%
5/80 • Number of events 7
|
8.0%
13/162 • Number of events 16
|
8.7%
14/161 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
23.8%
19/80 • Number of events 28
|
28.4%
46/162 • Number of events 82
|
21.7%
35/161 • Number of events 42
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.0%
4/80 • Number of events 4
|
1.9%
3/162 • Number of events 4
|
6.2%
10/161 • Number of events 13
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
7.5%
6/80 • Number of events 7
|
6.8%
11/162 • Number of events 11
|
7.5%
12/161 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
5.0%
4/80 • Number of events 4
|
6.2%
10/162 • Number of events 11
|
4.3%
7/161 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.2%
5/80 • Number of events 5
|
4.3%
7/162 • Number of events 8
|
5.6%
9/161 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
2.5%
2/80 • Number of events 2
|
2.5%
4/162 • Number of events 4
|
6.8%
11/161 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
16.2%
13/80 • Number of events 14
|
25.9%
42/162 • Number of events 44
|
18.0%
29/161 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.8%
7/80 • Number of events 11
|
21.6%
35/162 • Number of events 40
|
23.0%
37/161 • Number of events 45
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
17.5%
14/80 • Number of events 17
|
19.1%
31/162 • Number of events 41
|
19.3%
31/161 • Number of events 47
|
|
Skin and subcutaneous tissue disorders
RASH
|
6.2%
5/80 • Number of events 6
|
16.7%
27/162 • Number of events 32
|
14.9%
24/161 • Number of events 40
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER