Trial Outcomes & Findings for A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response (NCT NCT00758043)
NCT ID: NCT00758043
Last Updated: 2021-03-26
Results Overview
SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification \[LLOQ\] of 25 IU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
540 participants
Primary outcome timeframe
24 weeks after the last planned dose of study treatment
Results posted on
2021-03-26
Participant Flow
Participant milestones
| Measure |
T12PR24 (eRVR+)
Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
162
|
160
|
118
|
100
|
|
Overall Study
COMPLETED
|
161
|
119
|
79
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
41
|
39
|
100
|
Reasons for withdrawal
| Measure |
T12PR24 (eRVR+)
Telaprevir + peginterferon-alfa-2a (Peg-IFN-alfa-2a) + ribavirin (RBV) for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
20
|
12
|
62
|
|
Overall Study
Lack of Efficacy
|
0
|
6
|
18
|
12
|
|
Overall Study
Refused Further Treatment
|
0
|
11
|
5
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
4
|
|
Overall Study
Required Prohibited Medication
|
0
|
0
|
1
|
3
|
|
Overall Study
Non-Compliant With study Drug
|
0
|
0
|
0
|
1
|
|
Overall Study
Other Reasons
|
0
|
1
|
0
|
5
|
Baseline Characteristics
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
Baseline characteristics by cohort
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
Total
n=540 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
158 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
532 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
49.3 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
325 Participants
n=21 Participants
|
|
Region of Enrollment
North America
|
154 participants
n=5 Participants
|
151 participants
n=7 Participants
|
106 participants
n=5 Participants
|
98 participants
n=4 Participants
|
509 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
2 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after the last planned dose of study treatmentPopulation: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification \[LLOQ\] of 25 IU/mL).
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
SVR24 (Statistical Analysis 1)
|
149 participants
|
140 participants
|
76 participants
|
23 participants
|
|
Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
SVR24 (Statistical Analysis 2)
|
149 participants
|
144 participants
|
78 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 72 weeks after the last planned dose of study treatmentPopulation: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
|
141 participants
|
140 participants
|
76 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
|
162 participants
|
159 participants
|
0 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 12 weeks after last dose of study treatmentPopulation: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment
|
151 participants
|
144 participants
|
79 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Week 24 or Week 48Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)
|
159 participants
|
154 participants
|
97 participants
|
59 participants
|
SECONDARY outcome
Timeframe: From EOT to Week 48 or Week 72Population: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Randomized Subjects Who Relapse
|
9 participants
|
1 participants
|
5 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From EOT to Week 48 or Week 72Population: The population analyzed included all subjects in the Full Analysis (FA) Set. All subjects in the FA Set received at least 1 dose of study drug.
Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Proportion of Enrolled Subjects Who Relapse
|
9 participants
|
4 participants
|
11 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 72Population: The population analyzed included all subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
T12PR24 (eRVR+)
n=162 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 Participants
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 Participants
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Subjects With AEs
|
161 participants
|
160 participants
|
117 participants
|
99 participants
|
|
Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Subjects With SAEs
|
4 participants
|
16 participants
|
7 participants
|
22 participants
|
Adverse Events
T12PR24 (eRVR+)
Serious events: 4 serious events
Other events: 161 other events
Deaths: 0 deaths
T12PR48 (eRVR+)
Serious events: 16 serious events
Other events: 160 other events
Deaths: 0 deaths
T12PR48 (eRVR-)
Serious events: 7 serious events
Other events: 117 other events
Deaths: 0 deaths
Other
Serious events: 22 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T12PR24 (eRVR+)
n=162 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 participants at risk
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.62%
1/162
|
2.5%
4/160
|
0.00%
0/118
|
7.0%
7/100
|
|
Blood and lymphatic system disorders
ANAEMIA HAEMOLYTIC AUTOIMMUNE
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.62%
1/162
|
0.00%
0/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/162
|
1.2%
2/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Infections and infestations
APPENDICITIS
|
0.62%
1/162
|
0.00%
0/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Infections and infestations
BURSITIS INFECTIVE
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/162
|
1.2%
2/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
CRYPTOGENIC ORGANISING PNEUMONIA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Hepatobiliary disorders
LIVER DISORDER
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST NEOPLASM
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THROAT CANCER
|
0.62%
1/162
|
0.00%
0/160
|
0.00%
0/118
|
0.00%
0/100
|
|
Psychiatric disorders
MANIA
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Congenital, familial and genetic disorders
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/162
|
0.00%
0/160
|
0.00%
0/118
|
1.0%
1/100
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
POLYMYOSITIS
|
0.00%
0/162
|
0.00%
0/160
|
0.85%
1/118
|
0.00%
0/100
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/162
|
0.62%
1/160
|
0.00%
0/118
|
0.00%
0/100
|
Other adverse events
| Measure |
T12PR24 (eRVR+)
n=162 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 12 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR+)
n=160 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
|
T12PR48 (eRVR-)
n=118 participants at risk
Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by 36 weeks of Peg-IFN-alfa-2a and RBV; subjects did not achieve an extended rapid viral response (eRVR-) and were assigned to this group
|
Other
n=100 participants at risk
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20 were not randomized or assigned to a treatment regimen.
|
|---|---|---|---|---|
|
General disorders
FATIGUE
|
67.9%
110/162
|
69.4%
111/160
|
68.6%
81/118
|
67.0%
67/100
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
29.0%
47/162
|
25.0%
40/160
|
28.0%
33/118
|
21.0%
21/100
|
|
Gastrointestinal disorders
CHILLS
|
18.5%
30/162
|
24.4%
39/160
|
16.1%
19/118
|
26.0%
26/100
|
|
General disorders
PYREXIA
|
12.3%
20/162
|
20.0%
32/160
|
18.6%
22/118
|
22.0%
22/100
|
|
General disorders
IRRITABILITY
|
18.5%
30/162
|
16.2%
26/160
|
20.3%
24/118
|
12.0%
12/100
|
|
General disorders
INJECTION SITE ERYTHEMA
|
14.2%
23/162
|
14.4%
23/160
|
15.3%
18/118
|
17.0%
17/100
|
|
General disorders
PAIN
|
8.6%
14/162
|
11.2%
18/160
|
5.1%
6/118
|
9.0%
9/100
|
|
General disorders
OEDEMA PERIPHERAL
|
4.3%
7/162
|
6.9%
11/160
|
3.4%
4/118
|
1.0%
1/100
|
|
General disorders
INJECTION SITE RASH
|
3.7%
6/162
|
4.4%
7/160
|
6.8%
8/118
|
1.0%
1/100
|
|
General disorders
INJECTION SITE REACTION
|
5.6%
9/162
|
4.4%
7/160
|
3.4%
4/118
|
2.0%
2/100
|
|
General disorders
MALAISE
|
0.62%
1/162
|
5.6%
9/160
|
0.85%
1/118
|
2.0%
2/100
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
58.6%
95/162
|
51.9%
83/160
|
46.6%
55/118
|
40.0%
40/100
|
|
Skin and subcutaneous tissue disorders
RASH
|
37.0%
60/162
|
38.8%
62/160
|
39.8%
47/118
|
33.0%
33/100
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
17.3%
28/162
|
30.6%
49/160
|
28.0%
33/118
|
6.0%
6/100
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
27/162
|
15.6%
25/160
|
20.3%
24/118
|
7.0%
7/100
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULA
|
16.7%
27/162
|
10.6%
17/160
|
9.3%
11/118
|
6.0%
6/100
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
11.7%
19/162
|
11.9%
19/160
|
8.5%
10/118
|
9.0%
9/100
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
6.2%
10/162
|
5.6%
9/160
|
7.6%
9/118
|
8.0%
8/100
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
5.6%
9/162
|
7.5%
12/160
|
4.2%
5/118
|
4.0%
4/100
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
4.9%
8/162
|
3.8%
6/160
|
4.2%
5/118
|
7.0%
7/100
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
4.9%
8/162
|
5.0%
8/160
|
3.4%
4/118
|
2.0%
2/100
|
|
Gastrointestinal disorders
NAUSEA
|
43.8%
71/162
|
47.5%
76/160
|
51.7%
61/118
|
45.0%
45/100
|
|
Gastrointestinal disorders
DIARRHOEA
|
29.6%
48/162
|
33.8%
54/160
|
32.2%
38/118
|
24.0%
24/100
|
|
Gastrointestinal disorders
VOMITING
|
15.4%
25/162
|
16.2%
26/160
|
21.2%
25/118
|
20.0%
20/100
|
|
Gastrointestinal disorders
ANORECTAL DISCOMFORT
|
21.6%
35/162
|
15.6%
25/160
|
15.3%
18/118
|
8.0%
8/100
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
17.9%
29/162
|
14.4%
23/160
|
12.7%
15/118
|
11.0%
11/100
|
|
Gastrointestinal disorders
DYSPEPSIA
|
11.1%
18/162
|
13.1%
21/160
|
11.0%
13/118
|
8.0%
8/100
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.6%
9/162
|
9.4%
15/160
|
9.3%
11/118
|
7.0%
7/100
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.2%
10/162
|
8.1%
13/160
|
10.2%
12/118
|
5.0%
5/100
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.6%
9/162
|
7.5%
12/160
|
6.8%
8/118
|
3.0%
3/100
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.2%
10/162
|
7.5%
12/160
|
3.4%
4/118
|
2.0%
2/100
|
|
Gastrointestinal disorders
ANAL PRURITUS
|
2.5%
4/162
|
7.5%
12/160
|
5.1%
6/118
|
4.0%
4/100
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
3.1%
5/162
|
4.4%
7/160
|
5.9%
7/118
|
4.0%
4/100
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
4.3%
7/162
|
3.8%
6/160
|
1.7%
2/118
|
6.0%
6/100
|
|
Gastrointestinal disorders
TOOTHACHE
|
1.2%
2/162
|
3.1%
5/160
|
5.9%
7/118
|
0.00%
0/100
|
|
Nervous system disorders
HEADACHE
|
37.7%
61/162
|
35.6%
57/160
|
43.2%
51/118
|
35.0%
35/100
|
|
Nervous system disorders
DIZZINESS
|
17.9%
29/162
|
18.8%
30/160
|
9.3%
11/118
|
13.0%
13/100
|
|
Nervous system disorders
DYSGEUSIA
|
11.1%
18/162
|
15.0%
24/160
|
11.9%
14/118
|
6.0%
6/100
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
3.1%
5/162
|
6.9%
11/160
|
7.6%
9/118
|
4.0%
4/100
|
|
Nervous system disorders
HYPOAESTHESIA
|
3.1%
5/162
|
5.0%
8/160
|
4.2%
5/118
|
4.0%
4/100
|
|
Nervous system disorders
PARAESTHESIA
|
1.9%
3/162
|
5.0%
8/160
|
5.1%
6/118
|
1.0%
1/100
|
|
Psychiatric disorders
INSOMNIA
|
30.9%
50/162
|
38.8%
62/160
|
37.3%
44/118
|
26.0%
26/100
|
|
Psychiatric disorders
DEPRESSION
|
13.6%
22/162
|
21.9%
35/160
|
23.7%
28/118
|
22.0%
22/100
|
|
Psychiatric disorders
ANXIETY
|
9.9%
16/162
|
11.2%
18/160
|
11.0%
13/118
|
17.0%
17/100
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.62%
1/162
|
1.2%
2/160
|
5.1%
6/118
|
0.00%
0/100
|
|
Blood and lymphatic system disorders
ANAEMIA
|
42.0%
68/162
|
41.2%
66/160
|
32.2%
38/118
|
40.0%
40/100
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
14.2%
23/162
|
22.5%
36/160
|
26.3%
31/118
|
13.0%
13/100
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.5%
4/162
|
3.8%
6/160
|
5.1%
6/118
|
5.0%
5/100
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
2.5%
4/162
|
3.8%
6/160
|
5.1%
6/118
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
21.0%
34/162
|
25.6%
41/160
|
31.4%
37/118
|
15.0%
15/100
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.5%
30/162
|
25.0%
40/160
|
16.1%
19/118
|
18.0%
18/100
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
8.0%
13/162
|
7.5%
12/160
|
14.4%
17/118
|
7.0%
7/100
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
6.2%
10/162
|
5.6%
9/160
|
8.5%
10/118
|
9.0%
9/100
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
4.3%
7/162
|
5.6%
9/160
|
4.2%
5/118
|
5.0%
5/100
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
1.9%
3/162
|
6.2%
10/160
|
1.7%
2/118
|
3.0%
3/100
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
18.5%
30/162
|
16.9%
27/160
|
20.3%
24/118
|
17.0%
17/100
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
13.0%
21/162
|
17.5%
28/160
|
16.9%
20/118
|
9.0%
9/100
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.4%
12/162
|
12.5%
20/160
|
7.6%
9/118
|
5.0%
5/100
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
2.5%
4/162
|
6.9%
11/160
|
5.1%
6/118
|
6.0%
6/100
|
|
Infections and infestations
SINUSITIS
|
3.7%
6/162
|
7.5%
12/160
|
2.5%
3/118
|
5.0%
5/100
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.1%
5/162
|
5.0%
8/160
|
5.9%
7/118
|
2.0%
2/100
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.7%
6/162
|
2.5%
4/160
|
5.9%
7/118
|
1.0%
1/100
|
|
Infections and infestations
BRONCHITIS
|
1.9%
3/162
|
3.8%
6/160
|
2.5%
3/118
|
5.0%
5/100
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
5/162
|
5.0%
8/160
|
2.5%
3/118
|
1.0%
1/100
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.9%
16/162
|
15.0%
24/160
|
4.2%
5/118
|
8.0%
8/100
|
|
Metabolism and nutrition disorders
ANOREXIA
|
5.6%
9/162
|
7.5%
12/160
|
10.2%
12/118
|
10.0%
10/100
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
3.7%
6/162
|
4.4%
7/160
|
5.9%
7/118
|
3.0%
3/100
|
|
Eye disorders
VISION BLURRED
|
9.9%
16/162
|
8.8%
14/160
|
10.2%
12/118
|
12.0%
12/100
|
|
Eye disorders
DRY EYE
|
6.2%
10/162
|
6.9%
11/160
|
4.2%
5/118
|
1.0%
1/100
|
|
Investigations
WEIGHT DECREASED
|
4.3%
7/162
|
9.4%
15/160
|
7.6%
9/118
|
5.0%
5/100
|
Additional Information
Robert Kauffman, MD, PhD
Vertex Pharmaceuticals Incorporated
Phone: 617-444-6158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60