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

NCT ID: NCT00736242

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Chronic Hepatitis C; Hepatitis C; HIV Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

PEG-IFN alfa-2b

Intervention Type: BIOLOGICAL

Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling

RBV

Intervention Type: DRUG

Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling

Interventions

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

Intervention Type: BIOLOGICAL

RBV

Ribavirin administered at a dose of 800-1200 mg/day (on a weight-basis) according to the EMEA-approved labeling

Intervention Type: DRUG

Other Intervention Names

SCH 054031; PegIntron; Rebetol; SCH 018908

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04584

Identifier Type: -

Identifier Source: org_study_id