|
1 Indications And Usage Ribavirin Capsules Are A Nucleoside Analogue Indicated In Combination With Interferon Alfa-2b (Pegylated And Nonpegylated) For The Treatment Of Chronic Hepatitis C (Chc) In Patients 3 Years Of Age Or Older With Compensated Liver Disease. ( 1.1 ) Patients With The Following Characteristics Are Less Likely To Benefit From Re-Treatment After Failing A Course Of Therapy: Previous Nonresponse, Previous Pegylated Interferon Treatment, Significant Bridging Fibrosis Or Cirrhosis, And Genotype 1 Infection. 1.1 Chronic Hepatitis C (Chc) Ribavirin Capsules In Combination With Interferon Alfa-2b (Pegylated And Nonpegylated) Are Indicated For The Treatment Of Chronic Hepatitis C (Chc) In Patients 3 Years Of Age And Older With Compensated Liver Disease [See Warnings And Precautions (5.9 , 5.10) , And Use In Specific Populations (8.4) ]. The Following Points Should Be Considered When Initiating Ribavirin Capsules Combination Therapy With Pegintron ® Or Intron A ® : Combination Therapy With Ribavirin Capsules/pegintron Is Preferred Over Ribavirin Capsules/intron A As This Combination Provides Substantially Better Response Rates [See Clinical Studies (14) ]. Patients With The Following Characteristics Are Less Likely To Benefit From Re-Treatment After Failing A Course Of Therapy: Previous Nonresponse, Previous Pegylated Interferon Treatment, Significant Bridging Fibrosis Or Cirrhosis, And Genotype 1 Infection [See Clinical Studies (14) ]. No Safety And Efficacy Data Are Available For Treatment Duration Lasting Longer Than One Year.
|