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1 Indications And Usage Pegasys Is An Inducer Of The Innate Immune Response Indicated For The Treatment Of Chronic Hepatitis C (Chc) ( 1.1 ) Adult Patients: In Combination Therapy With Other Hepatitis C Virus Drugs For Adults With Compensated Liver Disease. Pegasys Monotherapy Is Indicated Only If Patient Has Contraindication Or Significant Intolerance To Other Hcv Drugs. Pediatric Patients: In Combination With Ribavirin For Pediatric Patients 5 Years Of Age And Older With Compensated Liver Disease Chronic Hepatitis B (Chb) ( 1.2 ) Adult Patients: Treatment Of Adults With Hbeag-Positive And Hbeag-Negative Chronic Hepatitis B (Chb) Infection Who Have Compensated Liver Disease And Evidence Of Viral Replication And Liver Inflammation Pediatric Patients: Treatment Of Non-Cirrhotic Pediatric Patients 3 Years Of Age And Older With Hbeag-Positive Chb And Evidence Of Viral Replication And Elevations In Serum Alanine Aminotransferase (Alt) 1.1 Chronic Hepatitis C (Chc) Adult Patients: Pegasys, As Part Of A Combination Regimen With Other Hepatitis C Virus (Hcv) Antiviral Drugs, Is Indicated For The Treatment Of Adults With Chc And Compensated Liver Disease. For Information About The Safe And Effective Use Of Other Hcv Antiviral Drugs To Be Used In Combination With Pegasys, Refer To Their Prescribing Information. Pegasys Monotherapy Is Only Indicated For The Treatment Of Patients With Chc And Compensated Liver Disease If There Are Contraindications Or Significant Intolerance To Other Hcv Antiviral Drugs. Pediatric Patients: Pegasys In Combination With Ribavirin Is Indicated For The Treatment Of Pediatric Patients 5 Years Of Age And Older With Chc And Compensated Liver Disease. Limitations Of Use : Pegasys Alone Or In Combination With Ribavirin Without Additional Hcv Antiviral Drugs Is Not Recommended For Treatment Of Patients With Chc Who Previously Failed Therapy With An Interferon-Alfa. Pegasys Is Not Recommended For Treatment Of Patients With Chc Who Have Had Solid Organ Transplantation [See Use In Specific Populations (8.8) ] . 1.2 Chronic Hepatitis B (Chb) Adult Patients: Pegasys Is Indicated For The Treatment Of Adults With Hbeag-Positive And Hbeag-Negative Chb Infection Who Have Compensated Liver Disease And Evidence Of Viral Replication And Liver Inflammation. Pediatric Patients: Pegasys Is Indicated For The Treatment Of Hbeag-Positive Chb In Non-Cirrhotic Pediatric Patients 3 Years Of Age And Older With Evidence Of Viral Replication And Elevations In Serum Alanine Aminotransferase (Alt).
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