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. Treatment is usually 12 weeks, but ribavirin may be added or treatment may be extended to 24 weeks for certain patients. In some cases, an 8-week treatment duration is possible. See the first page of the package insert.

Each tablet used for adults contains 400 mg of sofosbuvir and 90 mg of ledipasvir. Dosing in children age 3 and older is based on body weight (see below), and smaller tablets as well as packets of pellets are available to use in pediatrics. The brand name is dispensed in a bottle; the authorized generic is dispensed in a blister pack. The authorized generic was created to help lower cost and has identical ingredients as the brand name.

Take missed dose as soon as possible unless it is less than 12 hours until 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 worsen or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. People with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation on page 37 for more information and consult your medical provider.

Harvoni dosing

Body weight

Dosing of Epclusa

Harvoni daily dose

At least 77 lbs. (35 kg)

One 400/90 mg tablet daily

or: Two 200/45 mg tablets daily 

or: Two 200/45 mg packets of pellets daily

400/90 mg daily

37.4–77 lbs.

(17 kg to less than 35 kg)

One 200/45 mg tablet daily or: One 200/45 mg packet of pellets daily

200/45 mg daily

Less than 37.4 lbs.

(17 kg)
One 150/33.75 mg packet of pellets daily 150/33.75 mg daily

Manufacturer

brand: Gilead Sciences; authorized generic: Asegua Therapeutics LLC

AWP

brand (all available doses:
$37,800/ month;
authorized generic 400/90mg
Tablets only: $14,400 / month

Potential Side Effects and Toxicity

Potential Drug Interactions

More Information