Usual Adult Dose for Chronic Hepatitis C

1125 mg orally twice a day (10 to 14 hours apart) with food (not low fat)

Duration of therapy: 12 weeks in combination with peginterferon alfa and ribavirin

Comments:

• HCV-RNA levels should be monitored at weeks 4 and 12 to determine combination therapy duration and assess for treatment futility.

Approved indication: In combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in patients with compensated liver disease (including cirrhosis) who are therapy-naive or who have previously used interferon-based therapy, including prior null responders, partial responders, and relapsers

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.
End-stage renal disease: Data not available

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A, score 5 to 6): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C, score 7 or greater) or decompensated liver disease: Not recommended.

Dose Adjustments

To prevent treatment failure, telaprevir dosage must not be reduced or interrupted. The prescribing information for peginterferon alfa and/or ribavirin should be consulted for appropriate dose adjustments. If peginterferon alfa or ribavirin is stopped for any reason, telaprevir must also be discontinued.

Recommended therapy duration in therapy-naive and prior relapse patients:
HCV-RNA undetectable at weeks 4 and 12:
Triple therapy (telaprevir, peginterferon alfa, and ribavirin): First 12 weeks
Dual therapy (peginterferon alfa and ribavirin): Additional 12 weeks
Total therapy duration: 24 weeks

HCV-RNA detectable (1000 international units/mL or less) at weeks 4 and/or 12:
Triple therapy: First 12 weeks
Dual therapy: Additional 36 weeks
Total therapy duration: 48 weeks

Recommended therapy duration in prior partial and null responder patients:
Triple therapy: First 12 weeks
Dual therapy: Additional 36 weeks
Total therapy duration: 48 weeks

Therapy discontinuation is recommended in all patients if HCV-RNA levels are greater than 1000 international units/mL at 4 or 12 weeks of therapy (telaprevir therapy complete at 12 weeks), or if HCV-RNA levels remain detectable at 24 weeks of therapy.

Precautions

US BOXED WARNING:

• SERIOUS SKIN REACTIONS: Fatal and nonfatal serious skin reactions (including Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms [DRESS], and toxic epidermal necrolysis) reported with telaprevir combination therapy. Fatal cases reported in patients with progressive rash and systemic symptoms who continued telaprevir combination therapy after serious skin reaction was identified. For serious skin reactions (including rash with systemic symptoms or progressive severe rash), this drug, peginterferon alfa, and ribavirin must be stopped at once. Discontinuation of other agents associated with serious skin reactions should be considered. Patients should be referred for urgent medical care without delay.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Must use in combination with peginterferon alfa and ribavirin.
• Always take each dose within 30 minutes after eating food containing about 20 g of fat.
• Swallow tablets whole; do not chew, crush, break, cut, or dissolve tablets before swallowing.
• Adequate fluid intake during therapy is important.
• The manufacturer's product information should be consulted regarding missed doses.

General:

• The prescribing information for peginterferon alfa and ribavirin should be consulted for additional information.

Monitoring:

• Endocrine: Chemistry evaluations, including TSH (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
• General: HCV-RNA levels (at weeks 4 and 12 and as clinically indicated); monthly pregnancy tests (immediately prior to, during, and for 6 months after stopping ribavirin therapy)
• Hematologic: Hematology evaluations, including hemoglobin, white cell differential, and platelet count (prior to and at weeks 2, 4, 8, and 12 and as clinically appropriate; earlier and more frequent monitoring of hemoglobin for some patients)
• Hepatic: Chemistry evaluations, including hepatic enzymes and bilirubin (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
• Metabolic: Chemistry evaluations, including electrolytes and uric acid (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)
• Renal: Chemistry evaluations, including serum creatinine (prior to and at weeks 2, 4, 8, and 12 or as clinically indicated)

Patient advice:

• Hydration and fluid intake during telaprevir combination therapy are important; learn to recognize signs and symptoms of dehydration (e.g., thirst, dry mouth, decreased urine output, more concentrated urine); contact healthcare provider if oral fluid intake is poor or if severe vomiting and/or diarrhea occur.

Frequently asked questions

• What are the new drugs for the treatment of hepatitis C?