Harvoni

sofosbuvir/ledipasvir (SOF/LDV)

FDA approved for use in HIV/HCV co-infection
Genotype
  • 1
  • 4
  • 5
  • 6

Standard Dose

One tablet once daily with or without food. Tablet contains 400 mg of sofosbuvir and 90 mg of ledipasvir. Duration of therapy is 12 or 24 weeks, depending upon treatment experience and level of cirrhosis. In some cases, an 8-week treatment duration is possible. Ribavirin may be added in people with decompensated cirrhosis or liver transplant recipients with cirrhosis (compensated or decompensated). See treatment duration tables at positivelyaware.com/harvoni. The number of weeks on treatment depends on such things as cirrhosis status and previous therapy. Harvoni is FDA approved for use in children age 3 and older or weighing at least 37.4 pounds (17 kg), with oral pellets for children that age who weigh less (see below for more details).

Harvoni is now FDA approved for people with renal (kidney) disease, with no need to make any dosage adjustments.

Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose.

Black Box Warning

Before starting treatment with any direct-acting antiviral (DAA), including Harvoni, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could get worse or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation for more information and consult your medical provider.

Manufacturer

brand: Gilead Sciences; authorized generic: Asegua Therapeutics LLC

AWP

brand: $37,800/ month;
authorized generic: $14,400 / month

Potential Side Effects and Toxicity

Potential Drug Interactions

More Information