Trial Outcomes & Findings for A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance. (NCT NCT00545233)
NCT ID: NCT00545233
Last Updated: 2012-05-07
Results Overview
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
155 participants
Primary outcome timeframe
Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
Results posted on
2012-05-07
Participant Flow
Patients randomized to the pioglitazone arm participated in a 16-week pioglitazone run-in (Week -16 to Week 0) prior to beginning anti-HCV therapy: PEG-INF alpha-2a \[Pegasys\] plus ribavarin \[Copegus\]. Patients randomized to the without pioglitazone arm started anti-HCV therapy immediately.
Participant milestones
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
76
|
|
Overall Study
Safety Set
|
77
|
75
|
|
Overall Study
Intent-to-Treat (ITT)
|
77
|
73
|
|
Overall Study
COMPLETED
|
33
|
41
|
|
Overall Study
NOT COMPLETED
|
46
|
35
|
Reasons for withdrawal
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Violation of Selection Criteria at Entry
|
5
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Refused Treatment
|
9
|
7
|
|
Overall Study
Failure to Return
|
4
|
6
|
|
Overall Study
Insufficient response
|
14
|
15
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
Baseline characteristics by cohort
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=40 years
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
>40 years
|
71 participants
n=5 Participants
|
65 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatmentPopulation: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
|
-3.5 IU/mL
Standard Error 0.22
|
-3.7 IU/mL
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapyPopulation: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
Week 24 (N=60, 72)
|
-4.0 IU/mL
Standard Error 0.23
|
-3.9 IU/mL
Standard Error 0.21
|
|
Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
Week 48 (N=62, 73)
|
-3.5 IU/mL
Standard Error 0.27
|
-3.6 IU/mL
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 24, 48, 60, 72Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.
Virologic response was defined as undetectable HCV RNA \< 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Participants Achieving Virologic Response
Weeks 4
|
6.5 Percentage of Participants
|
16.4 Percentage of Participants
|
|
Percentage of Participants Achieving Virologic Response
Week 12
|
33.8 Percentage of Participants
|
49.3 Percentage of Participants
|
|
Percentage of Participants Achieving Virologic Response
Week 24
|
46.8 Percentage of Participants
|
63.0 Percentage of Participants
|
|
Percentage of Participants Achieving Virologic Response
Week 48
|
39.0 Percentage of Participants
|
56.2 Percentage of Participants
|
|
Percentage of Participants Achieving Virologic Response
Week 60
|
26.0 Percentage of Participants
|
39.7 Percentage of Participants
|
|
Percentage of Participants Achieving Virologic Response
Week 72
|
26.0 Percentage of Participants
|
38.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72Population: Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Week 12
|
58.4 Percentage of Participants
|
76.7 Percentage of Participants
|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Weeks 4
|
41.6 Percentage of Participants
|
52.1 Percentage of Participants
|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Week 24
|
51.9 Percentage of Participants
|
72.6 Percentage of Participants
|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Week 48
|
39.0 Percentage of Participants
|
54.8 Percentage of Participants
|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Week 60
|
26.0 Percentage of Participants
|
41.1 Percentage of Participants
|
|
Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Week 72
|
26.0 Percentage of Participants
|
37.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 72Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
|
15.6 Percentage of Participants
|
19.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 48 WeeksPopulation: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
|
15.6 Percentage of Participants
|
13.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 48 WeeksPopulation: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period
|
45.5 Percentage of Participants
|
30.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Randomization (Week-16),Weeks -12, -8, -4 and 0Population: Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Week 0 (n=64)
|
-0.03 IU/mL
Standard Error 0.046
|
—
|
|
Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Week -12 (n=74)
|
-0.01 IU/mL
Standard Error 0.037
|
—
|
|
Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Week -8 (n=68)
|
0.00 IU/mL
Standard Error 0.049
|
—
|
|
Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Week -4 (n=66)
|
0.07 IU/mL
Standard Error 0.048
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 24 (n=47, 61)
|
-0.5 mmol/L
Standard Error 0.30
|
-0.3 mmol/L
Standard Error 0.15
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 44 (n=37, 43)
|
-0.4 mmol/L
Standard Error 0.33
|
-0.2 mmol/L
Standard Error 0.25
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 4 (n=58, 70)
|
-0.4 mmol/L
Standard Error 0.24
|
-0.2 mmol/L
Standard Error 0.17
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 8 (n=57, 68)
|
-0.7 mmol/L
Standard Error 0.25
|
-0.1 mmol/L
Standard Error 0.33
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 12 (n=55, 66)
|
-0.8 mmol/L
Standard Error 0.25
|
-0.6 mmol/L
Standard Error 0.28
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 16 (n=53, 61)
|
-0.8 mmol/L
Standard Error 0.26
|
-0.5 mmol/L
Standard Error 0.36
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 20 (n=46, 57)
|
-0.6 mmol/L
Standard Error 0.19
|
-0.3 mmol/L
Standard Error 0.19
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 28 (n=51, 62)
|
-0.4 mmol/L
Standard Error 0.16
|
-0.3 mmol/L
Standard Error 0.16
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 32 (n=39, 47)
|
-0.5 mmol/L
Standard Error 0.19
|
-0.5 mmol/L
Standard Error 0.23
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 36 (n=38, 46)
|
-0.6 mmol/L
Standard Error 0.20
|
-0.4 mmol/L
Standard Error 0.23
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 40 (n=44, 50)
|
-0.4 mmol/L
Standard Error 0.20
|
-0.7 mmol/L
Standard Error 0.20
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 48 (n=34, 46)
|
-0.5 mmol/L
Standard Error 0.22
|
-0.1 mmol/L
Standard Error 0.24
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 60 (n=33, 41)
|
-0.6 mmol/L
Standard Error 0.23
|
-0.1 mmol/L
Standard Error 0.34
|
|
Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Week 72 (n=30, 38)
|
-0.6 mmol/L
Standard Error 0.22
|
-0.1 mmol/L
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 8 (N=4, 27)
|
-40.6 pmol/L
Standard Error 33.1
|
7.3 pmol/L
Standard Error 37.1
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 12 (N=52, 65)
|
-34.4 pmol/L
Standard Error 17.2
|
-36.0 pmol/L
Standard Error 23.8
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 16 (N=5, 5)
|
-59.0 pmol/L
Standard Error 49.9
|
-162.2 pmol/L
Standard Error 198.8
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 20 (N=2, 3)
|
132.6 pmol/L
Standard Error 127.8
|
180.1 pmol/L
Standard Error 644.4
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 24 (N=42, 60)
|
-38.4 pmol/L
Standard Error 16.7
|
-29.1 pmol/L
Standard Error 10.1
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 28 (N=12, 13)
|
11.8 pmol/L
Standard Error 44.6
|
-21.2 pmol/L
Standard Error 30.1
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 32 (N=2, 3)
|
-47.2 pmol/L
Standard Error 36.8
|
41.7 pmol/L
Standard Error 119.5
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 36 (N=0, 2)
|
NA pmol/L
Standard Error NA
No participants with data in this arm at Week 36.
|
41.0 pmol/L
Standard Error 33.3
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 40 (N=8, 2)
|
2.0 pmol/L
Standard Error 71.0
|
62.2 pmol/L
Standard Error 76.0
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 44 (N=4, 0)
|
370.5 pmol/L
Standard Error 405.6
|
NA pmol/L
Standard Error NA
No participants with data for this arm at Week 44.
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 48 (N=32, 46)
|
-38.0 pmol/L
Standard Error 20.7
|
-14.3 pmol/L
Standard Error 17.2
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 60 (N=1, 3)
|
-13.2 pmol/L
Standard Error NA
Only 1 participant with data. Unable to calculate standard error.
|
91.0 pmol/L
Standard Error 66.8
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 72 (N=30, 40)
|
-61.4 pmol/L
Standard Error 17.2
|
-4.8 pmol/L
Standard Error 26.3
|
|
Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Week 4 (N=56, 43)
|
6.4 pmol/L
Standard Error 20.9
|
-28.4 pmol/L
Standard Error 30.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 4 (n=3, 5)
|
-0.4 Percent
Standard Error 0.35
|
-0.1 Percent
Standard Error 0.22
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 8 (n=4, 28)
|
-0.9 Percent
Standard Error 0.13
|
-1.0 Percent
Standard Error 0.18
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 12 (n=50, 65)
|
-1.1 Percent
Standard Error 0.10
|
-1.5 Percent
Standard Error 0.12
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 16 (n=5, 4)
|
-0.8 Percent
Standard Error 0.12
|
-1.7 Percent
Standard Error 0.64
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 20 (n=1, 4)
|
-0.6 Percent
Standard Error NA
Only 1 participant unable to calculate standard error.
|
-1.3 Percent
Standard Error 0.30
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 24 (n=41, 51)
|
-1.0 Percent
Standard Error 0.10
|
-1.5 Percent
Standard Error 0.12
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 28 (n=11, 12)
|
-0.7 Percent
Standard Error 0.20
|
-1.1 Percent
Standard Error 0.17
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 32 (n=2, 2)
|
-1.0 Percent
Standard Error 0.40
|
-1.7 Percent
Standard Error 0.80
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA Percent
Standard Error NA
No participants with data in this arm for Week 36.
|
-0.5 Percent
Standard Error 0.05
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 40 (n=8, 1)
|
-0.3 Percent
Standard Error 0.28
|
-1.8 Percent
Standard Error NA
Only 1 participant with data. Unable to calculate standard error.
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 44 (n=7, 0)
|
-0.7 Percent
Standard Error 0.22
|
NA Percent
Standard Error NA
No participants with data in this arm at Week 44.
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 48 (N=31, 46)
|
-0.8 Percent
Standard Error 0.13
|
-1.1 Percent
Standard Error 0.15
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 60 (N=1, 2)
|
-0.2 Percent
Standard Error NA
Only 1 participant with data. Unable to calculate standard error.
|
-0.1 Percent
Standard Error 0.30
|
|
Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Week 72 (N=29, 38)
|
-0.1 Percent
Standard Error 0.10
|
-0.1 Percent
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Insulin resistance (IR) is calculated using the following formula: HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. Baseline for "with pioglitazone" arm occurred prior to the start of 16 week run-in period and for "without pioglitazone" arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated. A normal patient can have a HOMA score up to 3. A patient with a score of \>3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 4 (n=54, 42)
|
0.6 HOMA Score
Standard Error 1.31
|
-0.8 HOMA Score
Standard Error 1.52
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 8 (n=3, 25)
|
-2.3 HOMA Score
Standard Error 1.74
|
0.6 HOMA Score
Standard Error 1.80
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 12 (n=51, 63)
|
-2.0 HOMA Score
Standard Error 0.74
|
-2.1 HOMA Score
Standard Error 1.07
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 16 (n=5, 5)
|
-3.2 HOMA Score
Standard Error 2.28
|
-9.1 HOMA Score
Standard Error 7.96
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 20 (n=2, 3)
|
4.0 HOMA Score
Standard Error 4.60
|
10.5 HOMA Score
Standard Error 32.38
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 24 (n=42, 60)
|
-1.8 HOMA Score
Standard Error 0.74
|
-1.3 HOMA Score
Standard Error 0.45
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 28 (n=10, 13)
|
0.8 HOMA Score
Standard Error 1.95
|
-1.0 HOMA Score
Standard Error 1.36
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 32 (n=2, 2)
|
-1.8 HOMA Score
Standard Error 1.27
|
4.2 HOMA Score
Standard Error 6.81
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA HOMA Score
Standard Error NA
No participants with data in this arm at Week 36.
|
2.0 HOMA Score
Standard Error 0.41
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 40 (n=6, 2)
|
0.2 HOMA Score
Standard Error 4.00
|
1.0 HOMA Score
Standard Error 3.91
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 44 (n=4, 0)
|
30.4 HOMA Score
Standard Error 31.74
|
NA HOMA Score
Standard Error NA
No participants with data in this arm at Week 44.
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 48 (n=30, 44)
|
-1.6 HOMA Score
Standard Error 0.98
|
-0.3 HOMA Score
Standard Error 0.91
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 60 (n=1, 2)
|
0.6 HOMA Score
Standard Error NA
Only 1 participant with data. Unable to calculate standard error.
|
5.0 HOMA Score
Standard Error 3.83
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Week 72 (n=27, 35)
|
-2.7 HOMA Score
Standard Error 1.01
|
-0.1 HOMA Score
Standard Error 1.39
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 36 (n=38, 46)
|
0.1 mmol/L
Standard Error 0.11
|
0.5 mmol/L
Standard Error 0.15
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 4 (n=61, 72)
|
0.5 mmol/L
Standard Error 0.21
|
0.4 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 40 (n=45, 49)
|
0.2 mmol/L
Standard Error 0.12
|
0.4 mmol/L
Standard Error 0.13
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 44 (n=37, 43)
|
0.3 mmol/L
Standard Error 0.23
|
0.3 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 48 (n=34, 46)
|
0.2 mmol/L
Standard Error 0.13
|
0.5 mmol/L
Standard Error 0.18
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 60 (n=33, 41)
|
-0.2 mmol/L
Standard Error 0.11
|
0.3 mmol/L
Standard Error 0.16
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 72 (n=30, 39)
|
-0.1 mmol/L
Standard Error 0.16
|
0.2 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 8 (n=58, 69)
|
0.2 mmol/L
Standard Error 0.09
|
0.5 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 12 (n=56, 68)
|
0.2 mmol/L
Standard Error 0.11
|
0.7 mmol/L
Standard Error 0.23
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 16 (n=53, 62)
|
0.2 mmol/L
Standard Error 0.08
|
0.6 mmol/L
Standard Error 0.20
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 20 (n=46, 59)
|
0.2 mmol/L
Standard Error 0.11
|
0.6 mmol/L
Standard Error 0.16
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 24 (n=47, 61)
|
0.5 mmol/L
Standard Error 0.26
|
0.3 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 28 (n=52, 62)
|
0.2 mmol/L
Standard Error 0.10
|
0.4 mmol/L
Standard Error 0.14
|
|
Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Week 32 (n=38, 47)
|
0.3 mmol/L
Standard Error 0.13
|
0.5 mmol/L
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 8 (n=58, 69)
|
-0.2 mmol/L
Standard Error 0.07
|
-0.6 mmol/L
Standard Error 0.08
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 12 (n=56, 68)
|
-0.2 mmol/L
Standard Error 0.07
|
-0.6 mmol/L
Standard Error 0.09
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 16 (n=53, 62)
|
-0.3 mmol/L
Standard Error 0.07
|
-0.7 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 20 (n=46, 59)
|
-0.3 mmol/L
Standard Error 0.08
|
-0.6 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 24 (n=47, 61)
|
-0.2 mmol/L
Standard Error 0.09
|
-0.7 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 28 (n=52, 62)
|
-0.3 mmol/L
Standard Error 0.08
|
-0.7 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 32 (n=38, 47)
|
-0.4 mmol/L
Standard Error 0.10
|
-0.8 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 36 (n=38, 46)
|
-0.3 mmol/L
Standard Error 0.10
|
-0.7 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 40 (n=45, 49)
|
-0.3 mmol/L
Standard Error 0.08
|
-0.8 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 44 (n=37, 43)
|
-0.2 mmol/L
Standard Error 0.11
|
-0.8 mmol/L
Standard Error 0.13
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 48 (n=34, 46)
|
-0.3 mmol/L
Standard Error 0.11
|
-0.7 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 60 (n=33, 41)
|
0.0 mmol/L
Standard Error 0.15
|
0.1 mmol/L
Standard Error 0.14
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 72 (n=30, 39)
|
0.3 mmol/L
Standard Error 0.15
|
0.2 mmol/L
Standard Error 0.14
|
|
Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Week 4 (n=61, 72)
|
-0.2 mmol/L
Standard Error 0.08
|
-0.5 mmol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 20 (n=46, 56)
|
-0.2 mmol/L
Standard Error 0.07
|
-0.6 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 44 (n=36, 43)
|
-0.2 mmol/L
Standard Error 0.08
|
-0.7 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 48 (n=34, 44)
|
-0.3 mmol/L
Standard Error 0.09
|
-0.7 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 60 (n=33, 39)
|
0.1 mmol/L
Standard Error 0.12
|
0.1 mmol/L
Standard Error 0.13
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 72 (n=30, 38)
|
0.2 mmol/L
Standard Error 0.10
|
0.0 mmol/L
Standard Error 0.13
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 24 (n=45, 60)
|
-0.2 mmol/L
Standard Error 0.08
|
-0.6 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 28 (n=52, 60)
|
-0.2 mmol/L
Standard Error 0.08
|
-0.6 mmol/L
Standard Error 0.09
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 32 (N=38, 44)
|
-0.40 mmol/L
Standard Error 0.09
|
-0.7 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 36 (n=37, 44)
|
-0.2 mmol/L
Standard Error 0.08
|
-0.7 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 40 (n=44, 49)
|
-0.3 mmol/L
Standard Error 0.08
|
-0.7 mmol/L
Standard Error 0.11
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 4 (n=58, 70)
|
-0.3 mmol/L
Standard Error 0.07
|
-0.5 mmol/L
Standard Error 0.07
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 8 (n=57, 66)
|
-0.2 mmol/L
Standard Error 0.06
|
-0.6 mmol/L
Standard Error 0.08
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 12 (n=55, 62)
|
-0.2 mmol/L
Standard Error 0.07
|
-0.5 mmol/L
Standard Error 0.10
|
|
Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Week 16 (n=53, 58)
|
-0.2 mmol/L
Standard Error 0.07
|
-0.6 mmol/L
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control. Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 4 (n=61, 72)
|
-0.1 mmol/L
Standard Error 0.04
|
-0.1 mmol/L
Standard Error 0.03
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 20 (n=46, 59)
|
-0.1 mmol/L
Standard Error 0.04
|
-0.2 mmol/L
Standard Error 0.04
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 24 (n=47, 61)
|
-0.2 mmol/L
Standard Error 0.03
|
-0.2 mmol/L
Standard Error 0.04
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 28 (n=52, 62)
|
-0.1 mmol/L
Standard Error 0.03
|
-0.2 mmol/L
Standard Error 0.04
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 32 (n=38, 47)
|
-0.2 mmol/L
Standard Error 0.04
|
-0.3 mmol/L
Standard Error 0.04
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 36 (n=38, 46)
|
-0.1 mmol/L
Standard Error 0.04
|
-0.3 mmol/L
Standard Error 0.05
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 40 (n=45, 49)
|
-0.1 mmol/L
Standard Error 0.03
|
-0.3 mmol/L
Standard Error 0.05
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 44 (n=37, 43)
|
-0.1 mmol/L
Standard Error 0.04
|
-0.2 mmol/L
Standard Error 0.05
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 8 (n=58, 69)
|
-0.1 mmol/L
Standard Error 0.03
|
-0.2 mmol/L
Standard Error 0.03
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 12 (n=56, 68)
|
-0.1 mmol/L
Standard Error 0.03
|
-0.2 mmol/L
Standard Error 0.03
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 16 (n=53, 62)
|
-0.2 mmol/L
Standard Error 0.03
|
-0.2 mmol/L
Standard Error 0.03
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 72 (n=30, 39)
|
0.2 mmol/L
Standard Error 0.07
|
0.1 mmol/L
Standard Error 0.04
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 48 (n=34, 46)
|
-0.1 mmol/L
Standard Error 0.05
|
-0.2 mmol/L
Standard Error 0.05
|
|
Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Week 60 (n=33, 41)
|
0.1 mmol/L
Standard Error 0.06
|
-0.1 mmol/L
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 4 (n=56, 41)
|
-1.9 pg/mL
Standard Error 0.88
|
-0.9 pg/mL
Standard Error 1.26
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 8 (n=5, 25)
|
-3.7 pg/mL
Standard Error 3.93
|
1.1 pg/mL
Standard Error 0.36
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 12 (n=51, 45)
|
-2.0 pg/mL
Standard Error 0.89
|
2.8 pg/mL
Standard Error 3.84
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 16 (n=5, 4)
|
-1.2 pg/mL
Standard Error 1.74
|
0.6 pg/mL
Standard Error 1.85
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 20 (n=2, 3)
|
0.7 pg/mL
Standard Error 0.38
|
-3.5 pg/mL
Standard Error 3.64
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 24 (n=42, 57)
|
-1.1 pg/mL
Standard Error 1.50
|
-1.8 pg/mL
Standard Error 1.31
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 28 (n=12, 12)
|
-0.7 pg/mL
Standard Error 1.73
|
-0.1 pg/mL
Standard Error 0.68
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 32 (n=2, 2)
|
-0.8 pg/mL
Standard Error 0.90
|
-1.0 pg/mL
Standard Error 0.07
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 40 (n=7, 1)
|
-3.3 pg/mL
Standard Error 1.58
|
3.6 pg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA pg/mL
Standard Error NA
No participants with data in this arm for Week 36
|
2.7 pg/mL
Standard Error 2.66
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 44 (n=4, 0)
|
-2.1 pg/mL
Standard Error 0.35
|
NA pg/mL
Standard Error NA
No participants with data in this arm for Week 44
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 48 (n=32, 44)
|
-2.5 pg/mL
Standard Error 0.91
|
-1.4 pg/mL
Standard Error 1.33
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 60 (n=1, 2)
|
-2.4 pg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
-1.4 pg/mL
Standard Error 0.20
|
|
Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Week 72 (n=29, 37)
|
-3.7 pg/mL
Standard Error 1.54
|
-2.0 pg/mL
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 12 (n=51, 45)
|
-17666 pg/mL
Standard Error 1655
|
-11447 pg/mL
Standard Error 2141
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 4 (n=56, 41)
|
-14891 pg/mL
Standard Error 1406
|
-7256 pg/mL
Standard Error 1711
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 8 (n=5, 25)
|
-16224 pg/mL
Standard Error 8318
|
-13955 pg/mL
Standard Error 2190
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 16 (n=5, 4)
|
-6164 pg/mL
Standard Error 8199
|
-14570 pg/mL
Standard Error 4272
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 20 (n=2, 3)
|
-10653 pg/mL
Standard Error 1886
|
-11290 pg/mL
Standard Error 10160
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 24 (n=42, 57)
|
-15976 pg/mL
Standard Error 1727
|
-13875 pg/mL
Standard Error 1619
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 28 (n=12, 12)
|
-4071 pg/mL
Standard Error 2864
|
-9242 pg/mL
Standard Error 3185
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 32 (n=2, 2)
|
-19750 pg/mL
Standard Error 12614
|
-18973 pg/mL
Standard Error 5737
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA pg/mL
Standard Error NA
No participants with data in this arm for Week 36
|
8724 pg/mL
Standard Error 12181
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 40 (n=7, 1)
|
-3119 pg/mL
Standard Error 4460
|
1785 pg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 44 (n=4, 0)
|
-6415 pg/mL
Standard Error 5890
|
NA pg/mL
Standard Error NA
No participants with data in this arm for Week 44
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 48 (n=32, 44)
|
-16510 pg/mL
Standard Error 2573
|
-10149 pg/mL
Standard Error 2285
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 60 (n=1, 2)
|
-14539 pg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
-3612 pg/mL
Standard Error 5410
|
|
Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Week 72 (n=29, 37)
|
-6403 pg/mL
Standard Error 2504
|
-1347 pg/mL
Standard Error 2327
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 4 (n=56, 39)
|
13.0 μg/mL
Standard Error 1.15
|
1.6 μg/mL
Standard Error 0.80
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 8 (n=5, 23)
|
12.2 μg/mL
Standard Error 5.11
|
-1.1 μg/mL
Standard Error 0.60
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 12 (n=49, 45)
|
10.7 μg/mL
Standard Error 1.17
|
0.3 μg/mL
Standard Error 0.59
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 16 (n=5, 4)
|
9.0 μg/mL
Standard Error 2.30
|
-1.0 μg/mL
Standard Error 0.41
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 20 (n=2, 3)
|
3.0 μg/mL
Standard Error 2.00
|
4.0 μg/mL
Standard Error 0.58
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 24 (n=41, 55)
|
12.5 μg/mL
Standard Error 1.27
|
0.2 μg/mL
Standard Error 0.57
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 28 (n=11, 11)
|
4.4 μg/mL
Standard Error 2.18
|
-1.0 μg/mL
Standard Error 1.39
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 32 (n=2, 2)
|
13.0 μg/mL
Standard Error 4.00
|
1.5 μg/mL
Standard Error 0.50
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA μg/mL
Standard Error NA
No participants with data in this arm for Week 36
|
0.0 μg/mL
Standard Error 1.00
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 40 (n=7, 1)
|
2.9 μg/mL
Standard Error 1.61
|
-4.0 μg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 44 (n=3, 0)
|
3.7 μg/mL
Standard Error 1.67
|
NA μg/mL
Standard Error NA
No participants with data in this arm for Week 44
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 48 (n=31, 44)
|
10.8 μg/mL
Standard Error 1.70
|
0.3 μg/mL
Standard Error 0.62
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 60 (n=1, 2)
|
-1.0 μg/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
3.0 μg/mL
Standard Error 1.00
|
|
Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Week 72 (n=29, 36)
|
8.2 μg/mL
Standard Error 2.07
|
-0.1 μg/mL
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 4 (n=56, 39)
|
-1.8 ng/mL
Standard Error 1.38
|
-2.4 ng/mL
Standard Error 0.73
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 8 (n=5, 22)
|
-1.9 ng/mL
Standard Error 1.43
|
-3.0 ng/mL
Standard Error 0.89
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 12 (n=48, 44)
|
-3.1 ng/mL
Standard Error 1.38
|
-3.8 ng/mL
Standard Error 1.01
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 16 (n=5, 4)
|
-6.4 ng/mL
Standard Error 6.67
|
-7.9 ng/mL
Standard Error 7.37
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 20 (n=2, 3)
|
-2.9 ng/mL
Standard Error 0.70
|
-4.0 ng/mL
Standard Error 1.85
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 24 (n=42, 54)
|
-5.8 ng/mL
Standard Error 1.55
|
-5.0 ng/mL
Standard Error 0.84
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 28 (n=11, 11)
|
-3.7 ng/mL
Standard Error 2.05
|
-4.1 ng/mL
Standard Error 1.93
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 32 (n=2, 2)
|
-4.5 ng/mL
Standard Error 1.10
|
-4.9 ng/mL
Standard Error 0.90
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 36 (n=0, 2)
|
NA ng/mL
Standard Error NA
No participants with data in this arm for Week 36
|
-1.5 ng/mL
Standard Error 1.20
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 40 (n=7, 1)
|
-4.8 ng/mL
Standard Error 2.32
|
11.5 ng/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 44 (n=3, 0)
|
6.0 ng/mL
Standard Error 8.70
|
NA ng/mL
Standard Error NA
No participants with data in this arm for Week 44
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 48 (n=31, 43)
|
-4.6 ng/mL
Standard Error 1.31
|
-5.5 ng/mL
Standard Error 1.25
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 60 (n=1, 2)
|
3.4 ng/mL
Standard Error NA
Only 1 participant unable to calculate standard error
|
-0.6 ng/mL
Standard Error 1.50
|
|
Change From Baseline in Leptin Levels at Each Time Point Assessed
Week 72 (n=29, 36)
|
1.3 ng/mL
Standard Error 2.12
|
1.4 ng/mL
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels). Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=73 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 8 (n=2, 2)
|
-0.1 mmol/L
Standard Error 0.08
|
0.0 mmol/L
Standard Error 0.31
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 60 (n=1, 0)
|
0.1 mmol/L
Standard Error NA
Only 1 participant unable to calculate standard error
|
NA mmol/L
Standard Error NA
No participants with data in this arm for Week 60
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 4 (n=55, 35)
|
0.0 mmol/L
Standard Error 0.09
|
0.1 mmol/L
Standard Error 0.05
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 12 (n=52, 32)
|
-0.0 mmol/L
Standard Error 0.07
|
0.2 mmol/L
Standard Error 0.12
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 16 (n=5, 3)
|
-0.0 mmol/L
Standard Error 0.16
|
-0.1 mmol/L
Standard Error 0.26
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 20 (n=2, 3)
|
-0.5 mmol/L
Standard Error 0.34
|
0.1 mmol/L
Standard Error 0.38
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 24 (n=40, 31)
|
-0.1 mmol/L
Standard Error 0.09
|
0.2 mmol/L
Standard Error 0.05
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 28 (n=11, 5)
|
0.0 mmol/L
Standard Error 0.09
|
0.1 mmol/L
Standard Error 0.13
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 32 (n=2, 1)
|
0.3 mmol/L
Standard Error 0.12
|
-0.4 mmol/L
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 36 (n=0, 1)
|
NA mmol/L
Standard Error NA
No participants with data in this arm for Week 36
|
0.2 mmol/L
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 40 (n=8, 1)
|
0.2 mmol/L
Standard Error 0.31
|
-0.3 mmol/L
Standard Error NA
Only 1 participant unable to calculate standard error
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 44 (n=4, 0)
|
-0.0 mmol/L
Standard Error 0.05
|
NA mmol/L
Standard Error NA
No participants with data in this arm for Week 44
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 48 (n=32, 24)
|
-0.2 mmol/L
Standard Error 0.09
|
0.0 mmol/L
Standard Error 0.05
|
|
Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Week 72 (n=30, 19)
|
-0.2 mmol/L
Standard Error 0.11
|
0.1 mmol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72Population: Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.
The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.
Outcome measures
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 Participants
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=75 Participants
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 16 (n=50, 62)
|
6.0 Percentage of Participants
|
4.8 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 32 (n=37, 46)
|
5.4 Percentage of Participants
|
4.3 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 4 (n=61, 71)
|
6.6 Percentage of Participants
|
12.7 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 8 (n=57, 69)
|
5.3 Percentage of Participants
|
7.2 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 12 (n=55, 67)
|
10.9 Percentage of Participants
|
11.9 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 20 (n=46, 59)
|
8.7 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 24 (n=45, 60)
|
2.2 Percentage of Participants
|
10.0 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 28 (n=46, 59)
|
8.7 Percentage of Participants
|
3.4 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 36 (n=37, 46)
|
5.4 Percentage of Participants
|
6.5 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 40 (n=42, 44)
|
4.8 Percentage of Participants
|
2.3 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 44 (n=36, 40)
|
0 Percentage of Participants
|
2.5 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 48 (n=32, 45)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 60 (n=1, 3)
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Week 72 (n=30, 39)
|
3.3 Percentage of Participants
|
7.7 Percentage of Participants
|
Adverse Events
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
Serious events: 10 serious events
Other events: 68 other events
Deaths: 0 deaths
PEG-INF Alpha-2a + Ribavirin
Serious events: 9 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 participants at risk
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=75 participants at risk
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Eye disorders
Retinopathy
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
2.7%
2/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Appendicitis
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Device related sepsis
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Suicidal ideation
|
2.6%
2/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Panic attack
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
Other adverse events
| Measure |
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
n=77 participants at risk
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
|
PEG-INF Alpha-2a + Ribavirin
n=75 participants at risk
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)\[Pegasys\] subcutaneous (sc) once a week plus ribavirin \[Copegus\] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.5%
15/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
17.3%
13/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
8/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
18.7%
14/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.9%
3/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
14.7%
11/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Fatigue
|
39.0%
30/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
46.7%
35/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Influenza like illness
|
16.9%
13/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
16.0%
12/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Pyrexia
|
15.6%
12/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
9.3%
7/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Injection site erythema
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
22.7%
17/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Irritability
|
10.4%
8/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
9.3%
7/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Pain
|
15.6%
12/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
4.0%
3/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Chills
|
7.8%
6/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Injection site reaction
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
8.0%
6/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
2.7%
2/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
33.8%
26/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
28.0%
21/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.7%
9/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
13.3%
10/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
6/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
12.0%
9/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
7.8%
6/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
8.0%
6/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
3/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
8.0%
6/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
5.3%
4/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
11/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
25.3%
19/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.3%
1/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
5.3%
4/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.1%
27/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
32.0%
24/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.5%
15/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
16.0%
12/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
2/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
5.3%
4/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
2.7%
2/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
27.3%
21/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
30.7%
23/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
11.7%
9/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
30.7%
23/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Anxiety
|
2.6%
2/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
12.0%
9/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Psychiatric disorders
Suicidal ideation
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Nervous system disorders
Headache
|
18.2%
14/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
26.7%
20/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
15.6%
12/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
16.0%
12/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
4.0%
3/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
9/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
16.0%
12/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
13.3%
10/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
2/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
9.3%
7/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.1%
7/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
2.7%
2/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
8/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
6/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
2.7%
2/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
7.8%
6/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
1.3%
1/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
5/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
11/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
16.0%
12/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
5.3%
4/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Investigations
Weight decreased
|
3.9%
3/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
10.7%
8/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Investigations
Weight increased
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Investigations
White blood cell count decreased
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
0.00%
0/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.0%
10/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
10.7%
8/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Eye disorders
Vision blurred
|
5.2%
4/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
2.6%
2/77 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
6.7%
5/75 • 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER