• Chronic hepatitis C virus infection:
    • Treatment-naïve: 1 tab OD *12/52
      • May consider 8 week treatment duration in non-HIV infected patients without cirrhosis and with pre-treatment HCV RNA levels <6 million units/mL
      • Give with ribavirin in patients with decompensated cirrhosis or liver transplant
    • Treatment-experienced: 1 tab OD *12/52
      • May give with ribavirin
      • May give *24/52 in patients with decompensated cirrhosis

Tablet: 90mg/400mg

Take with or without food

Ledipasvir: HCV NS5A Inhibitor. It inhibits non-structural protein 5A (NS5A), limiting viral replication

Sofosbuvir: HCV Polymerase Inhibitor. It is a nucleotide prodrug which undergoes metabolism to the active uridine analog triphosphate. It inhibits non-structural protein 5B RNA-dependent RNA polymerase (NS5B RdRp), terminating viral replication

  • Asthenia
  • Headache
  • Fatigue
  • Cough
  • Myalgia
  • Nausea
  • Dyspnea
  • Irritability
  • Diarrhea
  • Insomnia
  • Dizziness
  • Elevated bilirubin
  • Hyperlipasemia
  • Depression
  • Hypersensitivity to components
  • Breastfeeding (patients with cracked nipples or bleeding nipples)

WARNING:

  • Hepatitis B reactivation in HCV/HBV co-infected patients on or those who completed HCV direct-acting antiviral treatment who were not on anti-HBV treatment, including cases resulting in fulminant hepatitis, hepatic failure and death
  • Test all patients for current or prior HBV infection before starting treatment
  • Screen all patients for HBV infection before initial treatment
  • Monitor for hepatitis flare or signs and symptoms of HBV reactivation during treatment and after discontinuation
  • Initiate anti-HBV treatment if needed
  • Carbamazepine
  • Fosphenytoin
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Tipranavir

                          Drug Status

Availability Prescription only
Pregnancy Category B; consider delaying pregnancy until treatment completed
Breastfeeding Avoid breastfeeding if nipples cracked or bleeding otherwise may use
Schedule Not controlled
BRAND NAME STRENGTH FORMULATION PACK SIZE MANUFACTURER DISTRIBUTOR
Harvoni 90mg/400mg Tablet 28’s Gilead Sciences Phillips Therapeutics
Ledvir 90mg/400mg Tablet 28’s Mylan Labs C/O Surgilinks Ltd Surgilinks Ltd