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Dasabuvir / Ombitasvir / Paritaprevir / Ritonavir Dosage

Applies to the following strength(s): 200 mg-8.33 mg-50 mg-33.33 mg

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

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

Dasabuvir: 250 mg orally twice a day (morning and evening)

Ombitasvir/paritaprevir/ritonavir fixed-dose combination tablet: 2 tablets orally once a day (in the morning)

Recommended Regimen and Duration of Therapy:
-Genotype 1a, without cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 12 weeks
-Genotype 1a, with cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 24 weeks (12 weeks may be considered for some patients based on prior treatment history)
-Genotype 1b, without cirrhosis: Dasabuvir and ombitasvir/paritaprevir/ritonavir for 12 weeks
-Genotype 1b, with cirrhosis: Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 12 weeks

Liver transplant recipients with normal liver function and mild fibrosis (Metavir fibrosis score 2 or lower): Dasabuvir, ombitasvir/paritaprevir/ritonavir, and ribavirin for 24 weeks, regardless of HCV genotype 1 subtype

Comments:
-Before starting this product, patients should be assessed for laboratory and clinical evidence of hepatic decompensation.
-Recommended for therapy-naive or interferon-experienced patients, including those with HCV/HIV-1 coinfection
-The dosing recommendations for genotype 1a should be followed for patients with unknown genotype 1 subtype or with mixed genotype 1 infection.
-The manufacturer product information should be consulted for ribavirin dosing recommendations (if applicable), regarding dosing of concomitant HIV-1 antiviral drugs in HCV/HIV-1 coinfected patients, and regarding use with calcineurin inhibitors in liver transplant recipients.

Use: With or without ribavirin, for the treatment of patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis

Renal Dose Adjustments

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

Comments:
-If applicable, 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

Dose Adjustments

No adjustment recommended for this product.

If applicable, the manufacturer product information for ribavirin should be consulted regarding dose adjustments.

Precautions

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:
-Administer with a meal, without regard to fat or calorie content.
-Consult the manufacturer product information regarding missed doses.

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

General:
-This product is ombitasvir/paritaprevir/ritonavir fixed-dose combination tablets copackaged with dasabuvir tablets.
-Each fixed-dose combination tablet contains ombitasvir 12.5 mg, paritaprevir 75 mg, and ritonavir 50 mg.
-If used with ribavirin: The manufacturer product information for ribavirin should be consulted for additional information.

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

Patient advice:
-Read the US FDA-approved patient information (Medication Guide) for this product 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.

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