HARVONI 400 MG / 90 MG 28 TAB هارفوني 400 مجم / 90 مجم 28 قرص

** Harvoni™ (ledipasvir, sofosbuvir) 90 mg / 400 mg 28 Tablets. GILEAD ACCESS PROGRAM. POM. Rx only.

** Harvoni™ Tablets:
Each bottle contains 28 film-coated tablets.
Each tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir

** Therapeutic indications:
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults.

** Posology:
.. The recommended dose of Harvoni is one tablet once daily with or without food.
.. Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups:

@@ Patients with genotype 1, 4, 5 or 6 CHC:

# Patients without cirrhosis:
Harvoni for 12 weeks.
– Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients.
– Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options.

# Patients with compensated cirrhosis:
Harvoni + ribavirin for 12 weeks
or
Harvoni (without ribavirin) for 24 weeks.
– Harvoni (without ribavirin) for 12 weeks may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options.

# Patients who are post-liver transplant without cirrhosis or with compensated cirrhosis:
Harvoni + ribavirin for 12 weeks.
– Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.

# Patients with decompensated cirrhosis, irrespective of transplant status:
Harvoni + ribavirin for 12 weeks.
– Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin.

@@ Patients with genotype 3 CHC:
Patients with compensated cirrhosis and/or prior treatment failure:
Harvoni + ribavirin for 24 weeks.

** Pharmacotherapeutic group:
Direct-acting antiviral, ATC code: not yet assigned

** Mechanism of action:
– Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function. In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
– Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.

** ALERT: Find out about medicines that should NOT be taekn with Harvoni™

** Dispense only in original container.

** Store below 30 degrees C (86 degrees F).
Keep out of the reach of children.