Ombitasvir / Paritaprevir / Ritonavir Dosage

Applies to the following strengths: 12.5 mg-75 mg-50 mg

Usual Adult Dose for:

Chronic Hepatitis C

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

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:

Each fixed-dose combination tablet contains ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg.
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.

CONTRAINDICATIONS:

If used with ribavirin: Contraindications to ribavirin
Moderate to severe liver dysfunction (Child-Pugh B and C)
Coadministration with drugs highly dependent on CYP450 3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events, including alfuzosin, ranolazine, dronedarone, colchicine (in patients with renal and/or liver dysfunction), lurasidone, pimozide, ergotamine, dihydroergotamine, methylergonovine, ethinyl estradiol-containing products (e.g., combined oral contraceptives), cisapride, atorvastatin, lovastatin, simvastatin, everolimus, sirolimus, tacrolimus, lomitapide, efavirenz, oral midazolam, triazolam, sildenafil (for treatment of pulmonary arterial hypertension)
Coadministration with drugs that are moderate or strong inducers of CYP450 3A and may lead to reduced efficacy of this drug, including carbamazepine, phenytoin, phenobarbital, apalutamide, rifampin, St. John's wort
Known hypersensitivity to ritonavir (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome)

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:

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.
Take extreme care to avoid pregnancy during use of this drug with ribavirin and within 6 months of stopping ribavirin in female patients and female partners of male patients; inform healthcare provider immediately in the event of pregnancy.
Avoid missing doses and complete the entire course of therapy; do not remove tablets from daily dose pack until you are ready to take them.