DOSAGE AND ADMINISTRATION
CHC Monoinfection
The recommended dose of ribavirin tablet is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.
The daily dose of ribavirin tablet is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 5).
In the pivotal clinical trials, patients were instructed to take ribavirin tablets with food; therefore, patients are advised to take ribavirin tablets with food.
Table 5 Peginterferon alfa-2a and Ribavirin Tablets Dosing Recommendations
Genotype
|
Peginterferon alfa-2a Dose
|
Ribavirin Tablets Dose
|
Duration
|
Genotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.
|
Genotype 1, 4 |
180 mcg |
<75 kg = 1000 mg ≥75 kg = 1200 mg |
48 weeks 48 weeks |
Genotype 2, 3 |
180 mcg |
800 mg |
24 weeks |
CHC with HIV Coinfection
The recommended dose for hepatitis C in HCV/HIV coinfected patients is peginterferon alfa-2a 180 mcg sc once weekly and ribavirin tablets 800 mg po daily for a total of 48 weeks, regardless of genotype.
Dose Modifications
If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued.
Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see
WARNINGS).
Table 6 Ribavirin Tablets Dosage Modification Guidelines
Laboratory Values
|
Reduce Only Ribavirin Tablets Dose to 600 mg/day
if:
|
Discontinue Ribavirin Tablets if:
|
Hemoglobin in patients with no cardiac disease |
<10 g/dL |
<8.5 g/dL |
Hemoglobin in patients with history of stable cardiac disease |
≥2 g/dL decrease in hemoglobin during any 4 week period treatment |
<12 g/dL despite 4 weeks at reduced dose |
Once ribavirin tablet has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that ribavirin tablets be increased to its original assigned dose (1000 mg to 1200 mg).
Renal Impairment
Ribavirin tablets should not be used in patients with creatinine clearance <50 mL/min (see
WARNINGS
and
CLINICAL PHARMACOLOGY: Special Populations).
|