Chronic hepatitis C, in combination with peginterferon alfa-2a (Pegasys), in patients with compensated liver disease previously untreated with alpha interferon, including patients co-infected with HIV.
Adult Dose for COPEGUS:
Take with food in 2 divided doses. ≥18yrs: Genotype 1, 4: (<75kg): 1g/day for 48 weeks; (≥75kg): 1.2g/day for 48 weeks. Genotype 2, 3: 800mg/day for 24 weeks. HIV patients: 800mg/day for 48 weeks. Reduce dose or discontinue if severe reactions or hematologic abnormalities occur. Cardiac disease: discontinue if cardiovascular status deteriorates; reduce dose or discontinue if hemoglobin levels decrease; see literature. Renal impairment (CrCl<50mL/min): not recommended.
Children's Dose for COPEGUS:
≤18yrs: not recommended.
Autoimmune hepatitis. Significant or unstable cardiac disease, hemoglobinopathies (eg, thalassemia, sickle-cell anemia): not recommended. Renal dysfunction (CrCl <50mL/min). Hepatic decompensation before or during therapy. Male partners of pregnant women. Pregnancy (Cat. X).
Women of childbearing potential: obtain negative pregnancy test immediately before starting therapy. Women of childbearing potential and men: use 2 forms of effective contraception during and for 6 months following treatment. Do baseline CBC (and at weeks 2 and 4 or more often if needed), white counts with differential, platelet counts, blood chemistry, thyroid, and monthly pregnancy tests (during and for 6 months after treatment). Suspend or discontinue if cardiovascular status deteriorates. Psychiatric disorders. Autoimmune disorders. Organ transplant. Pancreatitis. Decompensated hepatitis C. Nonresponders to interferon. Co-infection with hepatitis B virus. Maintain adequate hydration. Nursing mothers: not recommended.
Avoid alcohol. May antagonize stavudine, zidovudine. Caution with NRTIs; monitor for toxicities. Concomitant didanosine: not recommended.
Anemia and other hematological disorders, flu-like symptoms, cardiac events, pulmonary events, psychiatric effects, dizziness, GI upset, weight loss, alopecia, rash, pruritus, diabetes, pancreatitis.
Register pregnant women exposed to Copegus by calling (800) 593-2214 (see Contraindications).