Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 主要终点
- Number of Participants With Sustained Virologic Response (SVR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PEG-IFN alfa-2b (Biological)
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.
干预措施: RBV (Drug)
结局指标
主要结局
Number of Participants With Sustained Virologic Response (SVR)
时间窗: 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).
次要结局
- Participant Study Status at End of Follow-up (EOF)(From EOT to EOF (up to 72 weeks))
- Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment(From the Baseline Visit up to EOF (up to 72 weeks))
- Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment(From the Baseline Visit up to EOF (up to 72 weeks))
- Number of Participants With Rapid Virologic Response (RVR)(At Treatment Week 4)
- Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment(From the Baseline Visit up to EOF (up to 72 weeks))
- Number of Participants With Early Virologic Response (EVR)(From Treatment Week 1 to Treatment Week 12)
- Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment(From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).)