Generic name: LEDIPASVIR 90mg, SOFOSBUVIR 400mg
Dosage form: tablet, film coated
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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)].
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.
|||Patient Population||Treatment Regimen and Duration|
|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)].
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- Drug class: antiviral combinations