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Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)

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ClinicalTrials.gov Identifier: NCT00736242
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : April 8, 2013
Last Update Posted : February 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Chronic Hepatitis C
Hepatitis C
HIV Infections
Interventions Biological: PEG-IFN alfa-2b
Drug: RBV
Enrollment 232

Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 232
Participants in Safety Analysis Set 229
Completed 107
Not Completed 125
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 229 participants
≤40 years 108
≥40 years 119
Missing Data 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants
Female
41
  17.9%
Male
188
  82.1%
1.Primary Outcome
Title Number of Participants With Sustained Virologic Response (SVR)
Hide Description 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).
Time Frame From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participants
73
2.Secondary Outcome
Title Number of Participants With Rapid Virologic Response (RVR)
Hide Description RVR was defined as undetectable serum HCV-RNA at week 4.
Time Frame At Treatment Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: participants
28
3.Secondary Outcome
Title Number of Participants With Early Virologic Response (EVR)
Hide Description

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.

Time Frame From Treatment Week 1 to Treatment Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 180
Measure Type: Number
Unit of Measure: participants
101
4.Secondary Outcome
Title Participant Study Status at End of Follow-up (EOF)
Hide Description

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.

Time Frame From EOT to EOF (up to 72 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: participants
Not Evaluable/Not Documented 16
SVR 73
Relapse 16
Non-response 60
Lost to Follow-up/Premature Discontinuation 16
5.Secondary Outcome
Title Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Hide Description

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.

Time Frame From the Baseline Visit up to EOF (up to 72 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Measure Type: Number
Unit of Measure: participants
Baseline (anamnesis) HCV-RNA (+) [n=203] 193
Baseline (anamnesis) HCV-RNA (-) [n=203] 0
Baseline (anamnesis) HCV-RNA Missing [n=203] 10
Baseline (lab) HCV-RNA (+) [n=197] 187
Baseline (lab) HCV-RNA (-) [n=197] 3
Baseline (lab) HCV-RNA Missing [n=197] 7
Week 2 HCV-RNA (+) [n=200] 27
Week 2 HCV-RNA (-) [n=200] 3
Week 2 HCV-RNA Missing [n=200] 170
Week 4 HCV-RNA (+) [n=194] 104
Week 4 HCV-RNA (-) [n=194] 28
Week 4 HCV-RNA Missing [n=194] 62
Week 6 HCV-RNA (+) [n=168] 14
Week 6 HCV-RNA (-) [n=168] 11
Week 6 HCV-RNA Missing [n=168] 143
Week 8 HCV-RNA (+) [n=185] 37
Week 8 HCV-RNA (-) [n=185] 26
Week 8 HCV-RNA Missing [n=185] 122
Week 12 HCV-RNA (+) [n=180] 50
Week 12 HCV-RNA (-) [n=180] 70
Week 12 HCV-RNA Missing [n=180] 60
Week 18 HCV-RNA (+) [n=153] 22
Week 18 HCV-RNA (-) [n=153] 44
Week 18 HCV-RNA Missing [n=153] 87
Week 24 HCV-RNA (+) [n=142] 14
Week 24 HCV-RNA (-) [n=142] 75
Week 24 HCV-RNA Missing [n=142] 53
Week 30 HCV-RNA (+) [n=93] 8
Week 30 HCV-RNA- [n=93] 37
Week 30 HCV-RNA Missing [n=93] 48
Week 36 HCV-RNA (+) [n=85] 6
Week 36 HCV-RNA (-) [n=85] 45
Week 36 HCV-RNA Missing [n=85] 34
Week 42 HCV-RNA (+) [n=78] 5
Week 42 HCV-RNA (-) [n=78] 28
Week 42 HCV-RNA Missing [n=78] 45
Week 48 HCV-RNA (+) [n=73] 8
Week 48 HCV-RNA (-) [n=73] 52
Week 48 HCV-RNA Missing [n=73] 13
EOF HCV-RNA (+) [n=158] 61
EOF HCV-RNA (-) [n=158] 71
EOF HCV-RNA Missing [n=158] 26
6.Secondary Outcome
Title Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Hide Description

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

Time Frame From the Baseline Visit up to EOF (up to 72 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 203
Measure Type: Number
Unit of Measure: participants
Baseline (anamnesis) HIV-RNA (+) [n=203] 106
Baseline (anamnesis) HIV-RNA (-) [n=203] 86
Baseline (anamnesis) HIV-RNA Missing [n=203] 11
Baseline (lab) HIV-RNA (+) [n=197] 97
Baseline (lab) HIV-RNA (-) [n=197] 90
Baseline (lab) HIV-RNA Missing [n=197] 10
Week 4 HIV-RNA (+) [n=194] 16
Week 4 HIV-RNA (-) [n=194] 35
Week 4 HIV-RNA Missing [n=194] 143
Week 12 HIV-RNA (+) [n=180] 27
Week 12 HIV-RNA (-) [n=180] 71
Week 12 HIV-RNA Missing [n=180] 82
Week 24 HIV-RNA (+) [n=142] 25
Week 24 HIV-RNA (-) [n=142] 55
Week 24 HIV-RNA Missing [n=142] 62
Week 48 HCV-RNA+ [n=73] 19
Week 48 HIV-RNA (-) [n=73] 38
Week 48 HIV-RNA Missing [n=73] 16
EOF HIV-RNA (+) [n=158] 58
EOF HIV-RNA (-) [n=158] 72
EOF HIV-RNA Missing [n=158] 28
7.Secondary Outcome
Title Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Hide Description 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.
Time Frame From the Baseline Visit up to EOF (up to 72 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 193
Median (Full Range)
Unit of Measure: cells/μL
Baseline [n=193]
495.0
(44.0 to 1861.0)
Week 4 [n=61]
410.0
(164.0 to 985.0)
Week 12 [n=94]
363.0
(110.0 to 1155.0)
Week 24 [n=86]
310.0
(93.0 to 838.0)
Week 48 [n=58]
330.0
(118.0 to 790.0)
EOF [n=138]
484.5
(82.0 to 1303.0)
8.Secondary Outcome
Title Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
Hide Description

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.

Time Frame From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 229
Measure Type: Number
Unit of Measure: participants
16
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title PEG-IFN Alfa-2b + RBV
Hide Arm/Group Description 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.
All-Cause Mortality
PEG-IFN Alfa-2b + RBV
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN Alfa-2b + RBV
Affected / at Risk (%) # Events
Total   16/229 (6.99%)    
Blood and lymphatic system disorders   
Anaemia  1/229 (0.44%)  1
Cardiac disorders   
Myocardial Infarction  1/229 (0.44%)  1
Gastrointestinal disorders   
Diarrhoea  1/229 (0.44%)  1
Nausea  4/229 (1.75%)  4
Vomiting  3/229 (1.31%)  3
General disorders   
Fatigue  1/229 (0.44%)  1
Pyrexia  1/229 (0.44%)  1
Injury, poisoning and procedural complications   
Toxicity to Various Agents  1/229 (0.44%)  1
Investigations   
Haemoglobin Decreased  2/229 (0.87%)  2
Weight Decreased  2/229 (0.87%)  2
Musculoskeletal and connective tissue disorders   
Pain in Extremity  1/229 (0.44%)  1
Nervous system disorders   
Disturbance in Attention  1/229 (0.44%)  1
Dizziness  1/229 (0.44%)  1
Paraesthesia  1/229 (0.44%)  1
Headache  1/229 (0.44%)  1
Psychiatric disorders   
Depression  2/229 (0.87%)  2
Psychotic Disorder  1/229 (0.44%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1/229 (0.44%)  1
Dyspnoea  1/229 (0.44%)  1
Surgical and medical procedures   
Hospitalisation  1/229 (0.44%)  1
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN Alfa-2b + RBV
Affected / at Risk (%) # Events
Total   39/229 (17.03%)    
General disorders   
Fatigue  13/229 (5.68%)  16
Nervous system disorders   
Headache  14/229 (6.11%)  20
Psychiatric disorders   
Depression  12/229 (5.24%)  12
Sleep Disorder  14/229 (6.11%)  16
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00736242     History of Changes
Other Study ID Numbers: P04584
First Submitted: July 30, 2008
First Posted: August 15, 2008
Results First Submitted: December 21, 2012
Results First Posted: April 8, 2013
Last Update Posted: February 19, 2015