Generic name: LEDIPASVIR 90mg, SOFOSBUVIR 400mg
Dosage form: tablet, film coated
The information at Drugs.com 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)].
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)].
More about Harvoni (ledipasvir / sofosbuvir)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 299 Reviews – Add your own review/rating
- Drug class: antiviral combinations