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Ombitasvir / Paritaprevir / Ritonavir Dosage

Applies to the following strength(s): 12.5 mg-75 mg-50 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Chronic Hepatitis C

2 tablets orally once a day (in the morning)

Recommended Regimen and Duration of Therapy:
-Genotype 4, without cirrhosis or with compensated cirrhosis (Child-Pugh A): Ombitasvir/paritaprevir/ritonavir plus ribavirin for 12 weeks
---Therapy-naive patients without cirrhosis who cannot take or tolerate ribavirin: May consider ombitasvir/paritaprevir/ritonavir for 12 weeks

Comments:
-The manufacturer product information should be consulted for ribavirin dosing recommendations; the manufacturer product information for ribavirin should be consulted regarding dose adjustments.

Use: In combination with ribavirin, for the treatment of patients with genotype 4 chronic HCV infection without cirrhosis or with compensated cirrhosis

Renal Dose Adjustments

Mild, moderate, or severe renal dysfunction: No adjustment recommended.

Comments:
-If required, the manufacturer product information for ribavirin should be consulted regarding use in patients with renal dysfunction.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
Moderate to severe liver dysfunction (Child-Pugh B and C): Contraindicated

Precautions

US BOXED WARNING:
-RISK OF HBV REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: All patients should be tested for evidence of current/prior HBV infection before starting this drug. HBV reactivation has been reported during or after completion of HCV direct-acting antiviral therapy in HCV/HBV-coinfected patients who were not receiving HBV antiviral therapy; some cases resulted in fulminant hepatitis, hepatic failure, and death. HCV/HBV-coinfected patients should be monitored for hepatitis flare or HBV reactivation during HCV therapy and posttherapy follow-up; appropriate patient management for HBV infection should be started as clinically indicated.

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:
-Before starting this drug, test all patients for evidence of current/prior HBV infection; measure hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
-Before starting this drug, assess hepatic laboratory and clinical evidence of hepatic decompensation.
-Administer with a meal, without regard to fat or calorie content.

Storage requirements:
-Store at or below 30C (86F).

General:
-Each fixed-dose combination tablet contains ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg.
-Before starting ribavirin, patients should be assessed for underlying cardiac disease and the manufacturer product information for ribavirin should be consulted for additional information.

Monitoring:
-Hepatic: For clinical signs/symptoms of hepatic decompensation in patients with compensated cirrhosis; hepatic laboratory tests, including direct bilirubin levels, in patients with compensated cirrhosis (at baseline, during first 4 weeks of therapy, and as clinically indicated); hepatic laboratory tests (during first 4 weeks of therapy, then as clinically indicated thereafter); ALT (if increases above baseline levels)

Patient advice:
-Read the US FDA-approved patient information (Medication Guide) for this drug and review the Medication Guide for ribavirin, if applicable.
-Watch for signs of liver inflammation/failure (e.g., early signs: fatigue, weakness, lack of appetite, nausea and vomiting; later signs: jaundice, onset of confusion, abdominal swelling, discolored feces); consult healthcare provider immediately if these symptoms develop.
-Avoid missing doses and complete the entire course of therapy.

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