Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Post-marketing Surveillance of HIV-infected Patients With Chronic Hepatitis C Treated With PegIntron Pen and Rebetol (Study P04584)
