Ribavirin indications and usage
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Indications And Usage
Chronic Hepatitis C (CHC)
REBETOL® (ribavirin) in combination with interferon alfa-2b (pegylated and nonpegylated) is 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 REBETOL combination therapy with PegIntron® or INTRON A®:
- These indications are based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose.
- Combination therapy with REBETOL/PegIntron is preferred over REBETOL/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 of longer than one year.[1]
References
- ↑ "REBETOL (RIBAVIRIN) CAPSULE REBETOL (RIBAVIRIN) LIQUID [MERCK SHARP & DOHME CORP.]". Retrieved 6 January 2014.
Adapted from the FDA Package Insert.