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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Hepatitis C Hepatitis C HIV Infections Biological: PEG-IFN alfa-2b Drug: RBV

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 Design

Study Type : Observational
Actual Enrollment : 232 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
Study Start Date : December 2005
Primary Completion Date : December 2011
Study Completion Date : December 2011

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00736242     History of Changes
Other Study ID Numbers: P04584
First Posted: August 15, 2008    Key Record Dates
Results First Posted: April 8, 2013
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action