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.
Number of Participants With Rapid Virologic Response (RVR)Number of Participants With Early Virologic Response (EVR)
Participant Study Status at End of Follow-up (EOF)
Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment
Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment
Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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