Trial Outcomes & Findings for A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response (NCT NCT00623428)
NCT ID: NCT00623428
Last Updated: 2013-07-22
Results Overview
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
235 participants
Primary outcome timeframe
24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Results posted on
2013-07-22
Participant Flow
Patients with Chronic Hepatitis C, Genotype 2 or 3 who had started therapy with PEG-IFN alfa-2a plus ribavirin according to local standard of care during a pre-study run-in phase and did not achieve a rapid viral response defined as HCV RNA \<15 IU/mL at Week 4 of treatment were eligible and entered the screening phase between treatment Weeks 4-8.
235 patients enrolled and continued with the dose regimens they were taking prior to enrolment up to Week 24 of treatment. Patients who achieved at least a 2-log10 drop of HCV RNA at Week 12 (compared to HCV RNA prior to treatment initiation) or had HCV RNA \<15 IU/mL and who were still taking study medication at Week 24, were randomized at Week 24.
Participant milestones
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Treatment Period
STARTED
|
95
|
93
|
|
Treatment Period
COMPLETED
|
95
|
66
|
|
Treatment Period
NOT COMPLETED
|
0
|
27
|
|
Follow-up Period
STARTED
|
95
|
93
|
|
Follow-up Period
COMPLETED
|
66
|
78
|
|
Follow-up Period
NOT COMPLETED
|
29
|
15
|
Reasons for withdrawal
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
After 24 weeks of treatment with pegylated-interferon (peginterferon) alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Treatment Period
Adverse event/intercurrent illness
|
0
|
9
|
|
Treatment Period
Death
|
0
|
1
|
|
Treatment Period
Did not cooperate / refused treatment
|
0
|
13
|
|
Treatment Period
Insufficient therapeutic response
|
0
|
2
|
|
Treatment Period
Other
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
0
|
1
|
|
Follow-up Period
Relapse post-treatment
|
11
|
3
|
|
Follow-up Period
Failure to return
|
10
|
2
|
|
Follow-up Period
Patient withdrew consent
|
5
|
4
|
|
Follow-up Period
HCV-RNA detectable at end of treatment
|
2
|
1
|
|
Follow-up Period
Did not cooperate
|
0
|
3
|
|
Follow-up Period
Reason not specified
|
1
|
1
|
|
Follow-up Period
Death
|
0
|
1
|
Baseline Characteristics
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.8 years
STANDARD_DEVIATION 9.83 • n=99 Participants
|
48.6 years
STANDARD_DEVIATION 10.12 • n=107 Participants
|
48.7 years
STANDARD_DEVIATION 9.95 • n=206 Participants
|
|
Age, Customized
≤ 50 years
|
47 participants
n=99 Participants
|
53 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Age, Customized
> 50 years
|
48 participants
n=99 Participants
|
40 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian or white
|
82 participants
n=99 Participants
|
81 participants
n=107 Participants
|
163 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or oriental
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Hepatitis C virus (HCV) genotype
HCV Genotype 2
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Hepatitis C virus (HCV) genotype
HCV Genotype 3
|
76 participants
n=99 Participants
|
74 participants
n=107 Participants
|
150 participants
n=206 Participants
|
|
Pre-treatment HCV ribonucleic acid (RNA)
|
6.11 log10 IU/mL
STANDARD_DEVIATION 0.624 • n=99 Participants
|
6.17 log10 IU/mL
STANDARD_DEVIATION 0.773 • n=107 Participants
|
6.14 log10 IU/mL
STANDARD_DEVIATION 0.700 • n=206 Participants
|
|
Region
Non-U.S.
|
85 participants
n=99 Participants
|
82 participants
n=107 Participants
|
167 participants
n=206 Participants
|
|
Region
U.S.
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.Population: All randomized patients.
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment
|
52 percentage of participants
|
57 percentage of participants
|
PRIMARY outcome
Timeframe: 24 weeks after actual end of treatment (range from Week 48 to Week 72).Population: All randomized patients.
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment
|
52 percentage of participants
|
61 percentage of participants
|
SECONDARY outcome
Timeframe: Week 72Population: All randomized patients.
Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA \<15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period. Participants without Week 72 measurements were considered non-responders in the analysis.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation
|
44 percentage of participants
|
57 percentage of participants
|
SECONDARY outcome
Timeframe: End of Treatment (Week 24 and Week 48 for each treatment group respectively).Population: All randomized patients. A backward imputation approach was used when the HCV RNA measurement at end of treatment was missing and HCV RNA was \<15 IU/mL at the first measurement after the end of treatment time window (the patient was regarded as having virological response at end of treatment).
Virological response at the end of treatment was defined as the percentage of participants with HCV RNA \<15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With Virological Response at End of Treatment
|
93 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).Population: Randomized patients with virological response at the end of treatment and at least one post-treatment HCV RNA measurement.
Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment. Virological response at end of treatment is defined as a single last HCV RNA measurement \<15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication. Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement \<15 IU/ml at least 20 weeks after treatment end.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=83 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=80 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With Virological Relapse
|
41 percentage of participants
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after actual end of treatment (range from Week 36 to Week 60)Population: All randomized patients.
Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment
|
52 percentage of participants
|
61 percentage of participants
|
SECONDARY outcome
Timeframe: From Week 1 through Week 72.An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 Participants
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 Participants
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AE
|
81 participants
|
88 participants
|
|
Number of Participants With Adverse Events (AEs)
Severe AE
|
13 participants
|
24 participants
|
|
Number of Participants With Adverse Events (AEs)
AE related to PEG-IFN alfa-2a
|
78 participants
|
86 participants
|
|
Number of Participants With Adverse Events (AEs)
AE related to ribavirin
|
72 participants
|
83 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious AE
|
4 participants
|
11 participants
|
|
Number of Participants With Adverse Events (AEs)
SAE related to PEG-IFN alfa-2a
|
0 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
SAE related to ribavirin
|
0 participants
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
Deaths
|
0 participants
|
1 participants
|
Adverse Events
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
Serious events: 11 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 participants at risk
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 participants at risk
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Psychiatric disorders
Alcohol abuse
|
1.1%
1/95 • 72 weeks.
|
0.00%
0/93 • 72 weeks.
|
|
Psychiatric disorders
Depression
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.1%
1/95 • 72 weeks.
|
0.00%
0/93 • 72 weeks.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Infections and infestations
Sepsis
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.1%
1/95 • 72 weeks.
|
0.00%
0/93 • 72 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
1.1%
1/95 • 72 weeks.
|
0.00%
0/93 • 72 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.1%
1/95 • 72 weeks.
|
0.00%
0/93 • 72 weeks.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/95 • 72 weeks.
|
1.1%
1/93 • 72 weeks.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2a + Ribavirin for 24 Weeks
n=95 participants at risk
After 24 weeks of treatment with peginterferon alfa-2a (PEG-IFN alfa-2a) 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.
|
PEG-IFN Alfa-2a + Ribavirin for 48 Weeks
n=93 participants at risk
After 24 weeks of treatment with PEG-IFN alfa-2a 180 μg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA \<15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.
|
|---|---|---|
|
General disorders
Fatigue
|
34.7%
33/95 • 72 weeks.
|
50.5%
47/93 • 72 weeks.
|
|
General disorders
Asthenia
|
18.9%
18/95 • 72 weeks.
|
15.1%
14/93 • 72 weeks.
|
|
General disorders
Pyrexia
|
11.6%
11/95 • 72 weeks.
|
11.8%
11/93 • 72 weeks.
|
|
General disorders
Influenza like illness
|
14.7%
14/95 • 72 weeks.
|
7.5%
7/93 • 72 weeks.
|
|
General disorders
Irritability
|
12.6%
12/95 • 72 weeks.
|
4.3%
4/93 • 72 weeks.
|
|
General disorders
Chills
|
1.1%
1/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.9%
17/95 • 72 weeks.
|
21.5%
20/93 • 72 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
15/95 • 72 weeks.
|
18.3%
17/93 • 72 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.7%
13/95 • 72 weeks.
|
15.1%
14/93 • 72 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
8/95 • 72 weeks.
|
9.7%
9/93 • 72 weeks.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
13/95 • 72 weeks.
|
25.8%
24/93 • 72 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
7/95 • 72 weeks.
|
15.1%
14/93 • 72 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
7/95 • 72 weeks.
|
8.6%
8/93 • 72 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
2/95 • 72 weeks.
|
10.8%
10/93 • 72 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
3/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
3/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
2/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Psychiatric disorders
Insomnia
|
22.1%
21/95 • 72 weeks.
|
22.6%
21/93 • 72 weeks.
|
|
Psychiatric disorders
Depression
|
13.7%
13/95 • 72 weeks.
|
11.8%
11/93 • 72 weeks.
|
|
Psychiatric disorders
Sleep disorder
|
6.3%
6/95 • 72 weeks.
|
6.5%
6/93 • 72 weeks.
|
|
Psychiatric disorders
Anxiety
|
5.3%
5/95 • 72 weeks.
|
4.3%
4/93 • 72 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
8/95 • 72 weeks.
|
19.4%
18/93 • 72 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
10/95 • 72 weeks.
|
14.0%
13/93 • 72 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
7/95 • 72 weeks.
|
6.5%
6/93 • 72 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
9/95 • 72 weeks.
|
3.2%
3/93 • 72 weeks.
|
|
Nervous system disorders
Headache
|
17.9%
17/95 • 72 weeks.
|
32.3%
30/93 • 72 weeks.
|
|
Nervous system disorders
Dizziness
|
6.3%
6/95 • 72 weeks.
|
9.7%
9/93 • 72 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
7/95 • 72 weeks.
|
12.9%
12/93 • 72 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
9/95 • 72 weeks.
|
9.7%
9/93 • 72 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.4%
8/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
5/95 • 72 weeks.
|
5.4%
5/93 • 72 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.4%
8/95 • 72 weeks.
|
9.7%
9/93 • 72 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
7/95 • 72 weeks.
|
7.5%
7/93 • 72 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.4%
8/95 • 72 weeks.
|
16.1%
15/93 • 72 weeks.
|
|
Investigations
Weight decreased
|
7.4%
7/95 • 72 weeks.
|
9.7%
9/93 • 72 weeks.
|
|
Vascular disorders
Hypertension
|
2.1%
2/95 • 72 weeks.
|
8.6%
8/93 • 72 weeks.
|
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