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

NCT00736242 | Completed Results

• 1 other identifier: P04584
• Study Type: observational
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Hepatitis C; Hepatitis C; HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Number of Participants With Rapid Virologic Response (RVR)

  At Treatment Week 4

• Number of Participants With Early Virologic Response (EVR)

  From Treatment Week 1 to Treatment Week 12

• 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)

Study Arms (1)

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.

Biological: PEG-IFN alfa-2b; Drug: RBV

Interventions

PEG-IFN alfa-2b BIOLOGICAL

Peginterferon alfa-2b administered subcutaneously at a dose 1.5 ug/kg/week, according to the European Medicines Agency (EMEA)-approved labeling

Also known as: SCH 054031, PegIntron

PEG-IFN alfa-2b + RBV

RBV DRUG

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

Also known as: Rebetol, SCH 018908

PEG-IFN alfa-2b + RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects coinfected with HIV and HCV seen in common medical practice by general practitioners and clinical doctors at 30 sites all over Germany.

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; HIV Infections

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2008
• First Posted: August 15, 2008
• Study Start: December 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 19, 2015
• Results First Posted: April 8, 2013

Record last verified: 2015-02