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

February 2, 2015 updated by: Merck Sharp & Dohme LLC

Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)

The objective of the study was to assess the safety and efficacy of peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin (RBV) administered to participants coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). Participants were treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study assessed the rates of eradication of the HCV and the rates of serious adverse events reported with PEG-IFN alfa-2b (1.5 ug/kg/week) and RBV (800-1200 mg/day) in common medical practice in Germany.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this observational, non-interventional study, the time of enrollment and start of treatment was the sole decision of the physician. No investigational medicinal product was provided by the sponsor.

Study Type

Observational

Enrollment (Actual)

232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.

Description

Inclusion Criteria:

  • ≥ 18 years of age eligible for treatment according to the Summary of Product Characteristics (SmPC)
  • Presence of chronic Hepatitis C (with elevated liver enzymes and without decompensation)
  • Presence of HCV-RNA and known genotype of the infecting hepatitis C virus
  • HIV infection confirmed by positive Enzyme Linked Immunosorbent Assay (ELISA) and Western blot and Cluster of differentiation (CD) 4 cell count >200/mL
  • Treatment-naïve
  • Platelets ≥ 75,000/mm^3
  • Neutrophil counts ≥ 1,500/mm^3
  • Thyroid Stimulating Hormone (TSH) must be within normal limits
  • Hemoglobin ≥ 10 g/dL (females); ≥ 11 g/dL (males)
  • Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
  • Sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.

Exclusion Criteria:

  • Contraindications according to the European approval and to the SmPC
  • Pretreatment of chronic hepatitis C
  • Liver decompensation
  • Hypersensitivity to the active substance or to any interferons or to any of the excipients
  • Pregnant woman
  • Women who are breast feeding
  • Existence of or history of psychiatric condition, particular depression, suicidal ideation or suicide attempt
  • A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
  • Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance < 50 ml/min.
  • Autoimmune hepatitis or history of autoimmune disease
  • Severe hepatic dysfunction or decompensated cirrhosis of the liver
  • Pre-existing thyroid disease unless it can be controlled with conventional therapy
  • Epilepsy and/or compromised central nervous system function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PEG-IFN alfa-2b + RBV
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.
Biological: PEG-IFN alfa-2b
Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling
Other Names:
  • SCH 054031
  • PegIntron
Drug: RBV
Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling
Other Names:
  • Rebetol
  • SCH 018908

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Sustained Virologic Response (SVR)
Time Frame: From End of Treatment to 24 weeks post-treatment (up to 72 weeks)
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).
From End of Treatment to 24 weeks post-treatment (up to 72 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Rapid Virologic Response (RVR)
Time Frame: At Treatment Week 4
RVR was defined as undetectable serum HCV-RNA at week 4.
At Treatment Week 4
Number of Participants With Early Virologic Response (EVR)
Time Frame: From Treatment Week 1 to 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.
From Treatment Week 1 to Treatment Week 12
Participant Study Status at End of Follow-up (EOF)
Time Frame: From EOT to EOF (up to 72 weeks)

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.
From EOT to EOF (up to 72 weeks)
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Time Frame: From the Baseline Visit up to EOF (up to 72 weeks)

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.
From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Time Frame: From the Baseline Visit up to EOF (up to 72 weeks)

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
From the Baseline Visit up to EOF (up to 72 weeks)
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Time Frame: From the Baseline Visit up to EOF (up to 72 weeks)
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.
From the Baseline Visit up to EOF (up to 72 weeks)
Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
Time Frame: From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).

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.
From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on PEG-IFN alfa-2b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe