N/A
Completed N=232
Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
Source: ClinicalTrials.gov NCT00736242 ↗Enrolled (actual)
232
Serious AEs
7.0%
Results posted
Apr 2013
Primary outcomePrimary: Number of Participants With Sustained Virologic Response (SVR) — 73 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Virologic Response (SVR) |
73 | — |
| SECONDARY Number of Participants With Rapid Virologic Response (RVR) |
28 | — |
| SECONDARY Number of Participants With Early Virologic Response (EVR) |
101 | — |
| SECONDARY Participant Study Status at End of Follow-up (EOF) |
16; 73; 16; 60; 16 | — |
| SECONDARY Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment |
193; 0; 10; 187; 3; 7 | — |
| SECONDARY Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment |
106; 86; 11; 97; 90; 10 | — |
| SECONDARY Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment |
495.0; 410.0; 363.0; 310.0; 330.0; 484.5 | — |
| SECONDARY Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment |
16 | — |
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
Data sourced from ClinicalTrials.gov (NCT00736242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.