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Harvoni Dosage

Generic name: LEDIPASVIR 90mg, SOFOSBUVIR 400mg
Dosage form: tablet, film coated

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

Testing Prior to the Initiation of Therapy

Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with HARVONI [see Warnings and Precautions (5.1)].

Recommended Dosage

The recommended dosage of HARVONI is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)].

Relapse rates are affected by baseline host and viral factors and differ between treatment durations for certain subgroups [see Clinical Studies (14)].

Table 1 shows the recommended HARVONI treatment regimen and duration based on patient population.

For patients with HCV/HIV-1 coinfection, follow the dosage recommendations in Table 1 [see Clinical Studies (14)]. Refer to Drug Interactions (7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

Table 1 Recommended Treatment Regimen and Duration for HARVONI in Patients with Genotype 1, 4, 5 or 6 HCV
Patient Population Treatment Regimen and Duration
HARVONI for 8 weeks can be considered in treatment-naïve genotype 1 patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL [see Clinical Studies (14.2)].
Treatment-experienced patients include those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor.
HARVONI+ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin [see Clinical Studies (14.2)]. See footnote ¶ for ribavirin dosage recommendations.
In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food. If the starting dosage of ribavirin is not well tolerated, the dosage should be reduced as clinically indicated based on hemoglobin levels.
The daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food.
Genotype 1 Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks*
Treatment-experienced without cirrhosis HARVONI 12 weeks
Treatment-experienced with compensated cirrhosis (Child-Pugh A) HARVONI 24 weeks
Treatment-naïve and treatment-experienced with decompensated cirrhosis (Child-Pugh B or C) HARVONI + ribavirin§ 12 weeks
Genotype 1 or 4 Treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) HARVONI + ribavirin 12 weeks
Genotype 4, 5 or 6 Treatment-naïve and treatment-experienced, without cirrhosis or with compensated cirrhosis (Child-Pugh A) HARVONI 12 weeks

For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information [see Clinical Studies (14.5)].

Severe Renal Impairment and End Stage Renal Disease

No dosage recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate [eGFR] less than 30 mL/min/1.73 m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].