Harvoni
Ledipasvir/sofosbuvir (LDV/SOF)
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Standard Dose
One tablet once daily with or without food for adults and adolescents weighing 77 pounds or more (≥35 kg). Lower-dose tablets and pellets are available for pediatric patients aged 3 years and older and weighing less than 77 pounds. Treatment is usually 12 weeks, but recommendations vary depending on genotype, treatment history, cirrhosis status, and baseline HCV RNA or viral load. For some people, treatment may require the addition of ribavirin and/or a longer duration of therapy (24 weeks). In some cases, an 8-week treatment duration is possible. SEE treatment duration recommendations at hcvguidelines.org.Take missed dose as soon as possible unless it is less than 12 hours before your next dose. Do not double up on your next dose.
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. Pediatric formulations are currently only available as brand name.
Manufacturer
Brand: Gilead SciencesAuthorized generic: Asegua Therapeutics LLC
AWP
Harvoni (all available doses): $40,500/ monthAuthorized generic (400/90 mg tablets): $15,429 / 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 people 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 individuals, so its impact on fetal development or nursing babies is unknown. Pregnant persons or anyone 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 recreational. It is also important to inform them of any changes to your medications 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). Harvoni should not be taken with the HIV medication tipranavir/ritonavir. If taking tenofovir disoproxil fumarate (TDF) with an HIV protease inhibitor, ritonavir, or cobicistat, closely monitor for toxicities, due to possible increase in TDF concentrations resulting in adverse reactions, such as decreased renal function. 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 both components of Harvoni and may reduce its effectiveness. Do not take Harvoni with St. John’s wort; in general, herbal products should be avoided due to lack of information regarding potential for interaction. 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. Sofosbuvir-based HCV regimens should be avoided if taking 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.
More Information
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 prescribed.
Harvoni can be used in several special populations. It can safely be used in people with kidney disease, including those on dialysis, with no need for dosage adjustment. It is FDA approved for use in children ages 3 and older. It is also recommended to be used in people after they receive a liver or kidney transplant.
For more information, GO TO hcvguidelines.org.
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. 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.