Trial Outcomes & Findings for Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584) (NCT NCT00736242)
NCT ID: NCT00736242
Last Updated: 2015-02-19
Results Overview
SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).
Recruitment status
COMPLETED
Target enrollment
232 participants
Primary outcome timeframe
From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
Results posted on
2015-02-19
Participant Flow
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to violation of inclusion criteria, violation of exclusion criteria and no application of peginterferon alfa-2b (PEG-IFN alfa-2b).
Participant milestones
| Measure |
PEG-IFN Alfa-2b + RBV
Participants received a combination of PEG-IFN alfa-2b plus ribavirin (RBV) according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Overall Study
STARTED
|
232
|
|
Overall Study
Participants in Safety Analysis Set
|
229
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2b + RBV
n=229 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Age, Customized
≤40 years
|
108 participants
n=5 Participants
|
|
Age, Customized
≥40 years
|
119 participants
n=5 Participants
|
|
Age, Customized
Missing Data
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for ≥6 months before the first application of PEG-IFN alfa-2b, Human Immunodeficiency Virus \[HIV\] co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.
SVR was defined as undetectable serum Hepatitis C Virus ribonucleic acid (HCV-RNA) at End of Treatment (EOT) and at the End of Follow-up (EOF).
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=181 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Number of Participants With Sustained Virologic Response (SVR)
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73 participants
|
SECONDARY outcome
Timeframe: At Treatment Week 4Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 4
RVR was defined as undetectable serum HCV-RNA at week 4.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=194 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Number of Participants With Rapid Virologic Response (RVR)
|
28 participants
|
SECONDARY outcome
Timeframe: From Treatment Week 1 to Treatment Week 12Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with a documented visit at Treatment Week 12.
EVR was defined as undetectable serum HCV-RNA at week 12 and/or a ≥2 log decline in HCV-RNA levels at week 12 from baseline.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=180 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Number of Participants With Early Virologic Response (EVR)
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101 participants
|
SECONDARY outcome
Timeframe: From EOT to EOF (up to 72 weeks)Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, with HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with documented visits at EOT or at follow-up 24 weeks after EOT.
Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA. SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=181 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Participant Study Status at End of Follow-up (EOF)
Not Evaluable/Not Documented
|
16 participants
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Participant Study Status at End of Follow-up (EOF)
SVR
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73 participants
|
|
Participant Study Status at End of Follow-up (EOF)
Relapse
|
16 participants
|
|
Participant Study Status at End of Follow-up (EOF)
Non-response
|
60 participants
|
|
Participant Study Status at End of Follow-up (EOF)
Lost to Follow-up/Premature Discontinuation
|
16 participants
|
SECONDARY outcome
Timeframe: From the Baseline Visit up to EOF (up to 72 weeks)Population: Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.
HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR). HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=203 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
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|---|---|
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Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HCV-RNA (+) [n=203]
|
193 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HCV-RNA (-) [n=203]
|
0 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HCV-RNA Missing [n=203]
|
10 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HCV-RNA (+) [n=197]
|
187 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HCV-RNA (-) [n=197]
|
3 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HCV-RNA Missing [n=197]
|
7 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 2 HCV-RNA (+) [n=200]
|
27 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 2 HCV-RNA (-) [n=200]
|
3 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 2 HCV-RNA Missing [n=200]
|
170 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HCV-RNA (+) [n=194]
|
104 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HCV-RNA (-) [n=194]
|
28 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HCV-RNA Missing [n=194]
|
62 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 6 HCV-RNA (+) [n=168]
|
14 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 6 HCV-RNA (-) [n=168]
|
11 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 6 HCV-RNA Missing [n=168]
|
143 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 8 HCV-RNA (+) [n=185]
|
37 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 8 HCV-RNA (-) [n=185]
|
26 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 8 HCV-RNA Missing [n=185]
|
122 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HCV-RNA (+) [n=180]
|
50 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HCV-RNA (-) [n=180]
|
70 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HCV-RNA Missing [n=180]
|
60 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 18 HCV-RNA (+) [n=153]
|
22 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 18 HCV-RNA (-) [n=153]
|
44 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 18 HCV-RNA Missing [n=153]
|
87 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HCV-RNA (+) [n=142]
|
14 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HCV-RNA (-) [n=142]
|
75 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HCV-RNA Missing [n=142]
|
53 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 30 HCV-RNA (+) [n=93]
|
8 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 30 HCV-RNA- [n=93]
|
37 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 30 HCV-RNA Missing [n=93]
|
48 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 36 HCV-RNA (+) [n=85]
|
6 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 36 HCV-RNA (-) [n=85]
|
45 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 36 HCV-RNA Missing [n=85]
|
34 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 42 HCV-RNA (+) [n=78]
|
5 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 42 HCV-RNA (-) [n=78]
|
28 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 42 HCV-RNA Missing [n=78]
|
45 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HCV-RNA (+) [n=73]
|
8 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HCV-RNA (-) [n=73]
|
52 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HCV-RNA Missing [n=73]
|
13 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HCV-RNA (+) [n=158]
|
61 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HCV-RNA (-) [n=158]
|
71 participants
|
|
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HCV-RNA Missing [n=158]
|
26 participants
|
SECONDARY outcome
Timeframe: From the Baseline Visit up to EOF (up to 72 weeks)Population: Efficacy Analysis Set: all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b.
HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment. HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=203 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
|
|---|---|
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Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HIV-RNA (+) [n=203]
|
106 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HIV-RNA (-) [n=203]
|
86 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (anamnesis) HIV-RNA Missing [n=203]
|
11 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HIV-RNA (+) [n=197]
|
97 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HIV-RNA (-) [n=197]
|
90 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Baseline (lab) HIV-RNA Missing [n=197]
|
10 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HIV-RNA (+) [n=194]
|
16 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HIV-RNA (-) [n=194]
|
35 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 4 HIV-RNA Missing [n=194]
|
143 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HIV-RNA (+) [n=180]
|
27 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HIV-RNA (-) [n=180]
|
71 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 12 HIV-RNA Missing [n=180]
|
82 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HIV-RNA (+) [n=142]
|
25 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HIV-RNA (-) [n=142]
|
55 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 24 HIV-RNA Missing [n=142]
|
62 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HCV-RNA+ [n=73]
|
19 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HIV-RNA (-) [n=73]
|
38 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Week 48 HIV-RNA Missing [n=73]
|
16 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HIV-RNA (+) [n=158]
|
58 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HIV-RNA (-) [n=158]
|
72 participants
|
|
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
EOF HIV-RNA Missing [n=158]
|
28 participants
|
SECONDARY outcome
Timeframe: From the Baseline Visit up to EOF (up to 72 weeks)Population: Analysis was performed on all participants in the Efficacy Analysis Set (all participants with HCV-RNA detectable for at least 6 months before the first application of PEG-IFN alfa-2b, HIV co-infection, and who had received any amount of PEG-IFN alfa-2b) with data available.
The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=193 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
|
|---|---|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Baseline [n=193]
|
495.0 cells/μL
Interval 44.0 to 1861.0
|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Week 4 [n=61]
|
410.0 cells/μL
Interval 164.0 to 985.0
|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Week 12 [n=94]
|
363.0 cells/μL
Interval 110.0 to 1155.0
|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Week 24 [n=86]
|
310.0 cells/μL
Interval 93.0 to 838.0
|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Week 48 [n=58]
|
330.0 cells/μL
Interval 118.0 to 790.0
|
|
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
EOF [n=138]
|
484.5 cells/μL
Interval 82.0 to 1303.0
|
SECONDARY outcome
Timeframe: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).Population: Safety Analysis Set: All participants who received any amount of PEG-IFN alfa-2b. If the application of any PEG-IFN alfa-2b was not certain, the participant was considered part of this set. Participants who were not treated with PEG-IFN alfa-2b were also included in this set providing they did not violate any inclusion or exclusion criterion.
An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a congenital anomaly or birth defect.
Outcome measures
| Measure |
PEG-IFN Alfa-2b + RBV
n=229 Participants
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
|
|---|---|
|
Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
|
16 participants
|
Adverse Events
PEG-IFN Alfa-2b + RBV
Serious events: 16 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2b + RBV
n=229 participants at risk
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Cardiac disorders
Myocardial Infarction
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
4/229 • Number of events 4
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
3/229 • Number of events 3
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
General disorders
Fatigue
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
General disorders
Pyrexia
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Investigations
Haemoglobin Decreased
|
0.87%
2/229 • Number of events 2
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Investigations
Weight Decreased
|
0.87%
2/229 • Number of events 2
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Nervous system disorders
Disturbance in Attention
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Nervous system disorders
Dizziness
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Nervous system disorders
Paraesthesia
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Psychiatric disorders
Depression
|
0.87%
2/229 • Number of events 2
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Surgical and medical procedures
Hospitalisation
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Nervous system disorders
Headache
|
0.44%
1/229 • Number of events 1
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2b + RBV
n=229 participants at risk
Participants received a combination of PEG-IFN alfa-2b plus RBV according to routine clinical practice and locally-approved product recommendations for a minimum of 12 weeks. No investigational medicinal product was provided by the sponsor.
|
|---|---|
|
General disorders
Fatigue
|
5.7%
13/229 • Number of events 16
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Nervous system disorders
Headache
|
6.1%
14/229 • Number of events 20
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Psychiatric disorders
Depression
|
5.2%
12/229 • Number of events 12
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
|
Psychiatric disorders
Sleep Disorder
|
6.1%
14/229 • Number of events 16
Of 232 participants enrolled, only 229 patients were included in the Safety Analysis Set and had documented baseline data. Three participants were excluded due to 1) violation of inclusion criteria, 2) violation of exclusion criteria and 3) no application of PEG-IFN alfa-2b.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER