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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alpha; Peginterferon alfa-2b; Ribavirin

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