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

HIV Infections Clinical Trial

Official title:

Treatment of Chronic Hepatitis C in HIV-infected Patients With PegIntron Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736242
• Other study ID #: P04584
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: February 2, 2015
• Start date: December 2005
• Est. completion date: December 2011

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections

Intervention

Biological:
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sustained Virologic Response (SVR)	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).	From End of Treatment to 24 weeks post-treatment (up to 72 weeks)	No
Secondary	Number of Participants With Rapid Virologic Response (RVR)	RVR was defined as undetectable serum HCV-RNA at week 4.	At Treatment Week 4	No
Secondary	Number of Participants With Early Virologic Response (EVR)	EVR was defined as undetectable serum HCV-RNA at week 12 and/or a; =2 log decline in HCV-RNA levels at week 12 from baseline.	From Treatment Week 1 to Treatment Week 12	No
Secondary	Participant Study Status at End of Follow-up (EOF)	Participant study status was assessed at the End of Follow-up (defined as 24 weeks after the end of treatment) based on serum levels of HCV-RNA.; SVR was defined as defined as undetectable serum HCV-RNA at EOT and EOF, Relapse was defined as undetectable HCV-RNA at EOT with detectable HCV-RNA at EOF, and Non-response was defined as a detectable serum HCV-RNA at EOT.	From EOT to EOF (up to 72 weeks)	No
Secondary	Number of Participants With Hepatitis C Virus (HCV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment	HCV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment by Polymerase Chain Reaction (PCR).; HCV-RNA (+) = HCV-RNA positive, HCV-RNA (-) = HCV-RNA negative, HCV-RNA Missing = HCV-RNA data not documented, not applicable, not known, not examined, or missing.	From the Baseline Visit up to EOF (up to 72 weeks)	No
Secondary	Number of Participants With Human Immunodeficiency Virus (HIV)-RNA Negativity During PEG-IFN Alfa-2b/RBV Treatment	HIV-RNA negativity/positivity was documented at baseline in the medical history (anamnesis), and assessed within the laboratory (lab) at baseline and during treatment.; HIV-RNA (+) = HIV-RNA positive, HIV-RNA (-) = HIV-RNA negative, HIV-RNA Missing = HIV-RNA data not documented, not applicable, not known, not examined, or missing	From the Baseline Visit up to EOF (up to 72 weeks)	No
Secondary	Median Cluster of Differentiation 4 (CD4) Cell Count During PEG-IFN Alfa-2b/RBV Treatment	The CD4 helper T cell count was used to assess participant HIV status and was determined in the laboratory at baseline and during the study course.	From the Baseline Visit up to EOF (up to 72 weeks)	No
Secondary	Number of Participants With A Serious Adverse Event (SAE) During PEG-IFN Alfa-2b/RBV Treatment	An SAE was any adverse drug/biologic/device experience occurring at any dose that resulted in death, was life-threatening (i.e. placed the participant, in the view of the initial reporter, at immediate risk of death from the AE as it occurred), was a persistent or significant disability/incapacity, required in-patient hospitalization, or prolonged hospitalization, or led to a; congenital anomaly or birth defect.	From First Participant Visit (12/30/2005) up to 30 days after Last Participant Visit (12/31/2011).	Yes