Harvoni

ledipasvir/sofosbuvir, LDV/SOF

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

Standard Dose

One tablet once daily without regard to food. Tablet contains 90 mg of ledipasvir and 400 mg of sofosbuvir. 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. See treatment table for this page online. Ribavirin may be added in patients with decompensated cirrhosis or liver transplant patients without cirrhosis. See treatment duration table for this page online. 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 12 and older or weighing at least 77 pounds (35 kg).

Sofosbuvir-based regimens are not recommended in people with creatinine clearance (CrCl) less than 30 mL/min.

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

Gilead Sciences

AWP

$37,800 / month

Potential Side Effects and Toxicity

Potential Drug Interactions

More Information