Standard DoseOne 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.
Manufacturerbrand: Gilead Sciences; authorized generic: Asegua Therapeutics LLC
AWPbrand: $37,800/ month;
authorized generic: $14,400 / month
Potential Side Effects and Toxicity
Harvoni is generally well tolerated, and very few people need to discontinue treatment due to side effects. The most commonly reported side effects are fatigue, headache, nausea, diarrhea, and insomnia, and are all considered to be mild in severity. Additional side effects observed in patients with decompensated cirrhosis or after liver transplant were thought to be due to their medical condition rather than the medication. Harvoni has not been studied in pregnant or nursing women, so its impact on fetal development or nursing babies is unknown.
Pregnant women or women who are trying to become pregnant should avoid use if the addition of ribavirin is required (see ribavirin page).
Potential Drug Interactions
Before starting Harvoni, be sure to tell your medical provider or pharmacist about all of the medications, supplements, and herbal products you take, whether they are prescribed, over-the-counter, or illicit. It is also important to inform them of any changes as they happen during treatment. Harvoni should not be taken within 4 hours of antacids. If taking H2-receptor antagonists, take Harvoni at the same time or separate by 12 hours at a dose that does not exceed doses comparable to famotidine 40 mg twice per day. Use of proton pump inhibitors (PPI) is not recommended, but if medically necessary, Harvoni should be taken at the same time as a PPI comparable to omeprazole 20 mg or lower under fasted conditions (on an empty stomach). Use caution and monitor renal function when taking Harvoni with tenofovir disoproxil fumarate (TDF). Avoid use if patient is taking TDF with an HIV protease inhibitor, ritonavir, or cobicistat due to possible increase in TDF concentrations resulting in adverse reactions. Do not take Harvoni with St. John’s wort, and in general, herbal products should be avoided due to lack of information regarding potential for interaction. It should not be taken with the rifamycin antimicrobials, such as rifabutin, rifampin, or rifapentine, nor should it be taken with the anticonvulsants carbamazepine, phenytoin, phenobarbital, or oxcarbazepine, as they reduce the concentrations of sofosbuvir and may reduce its effectiveness. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should decide if your statin should be continued or changed during treatment with Harvoni. No sofosbuvir-based HCV regimens are to be used with amiodarone due to possible symptomatic bradycardia (slow heart rate). Signs of bradycardia include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains, and confusion or memory problems. Consult a medical provider should any of these symptoms occur.
Harvoni was an exciting development for treating HCV in 2014 as it was the first one-pill, once-daily regimen with minimal side effects and high cure rates with treatment durations ranging from 8 to 24 weeks. Although there are now many treatment options available, Harvoni is still commonly used. Harvoni is FDA approved for use in children age 3 and older. The dosage amount depends on the weight of the child. The list is too long for inclusion here, but check out the HCV guidelines (hcvguidelines.org/unique-populations/children) for a list of approved treatments and dosage strength for children with HCV genotypes 1, 4, 5, and 6 with either no cirrhosis or compensated cirrhosis.