Standard DoseOne tablet once daily with or without food. Each tablet contains 100 mg of grazoprevir and 50 mg of elbasvir. The number of weeks on treatment depends on genotype, previous therapy, and presence of NS5A polymorphisms (mutations that may make the Zepatier less effective). Ribavirin may also be added in patients with certain baseline NS5A polymorphisms. See treatment duration tables at positivelyaware.com/drug-guides/zepatier.
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.
AWP$8,736 / month
Potential Side Effects and Toxicity
Zepatier is very well tolerated with minimal side effects. In clinical trials, very few people—around 1%—discontinued treatment due to side effects. The most commonly reported side effects are fatigue and headaches. These side effects are considered mild and are comparable in patients with and without cirrhosis. Nausea, insomnia, and diarrhea have also been reported. Zepatier has not been studied in pregnant women or nursing mothers, so its impact on fetal development or nursing babies is unknown. Pregnant persons or individuals who are trying to become pregnant should avoid use if the addition of ribavirin is required (see ribavirin page).
Potential Drug Interactions
Before starting Zepatier, 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 important to report any changes to your medications as they happen during treatment. Zepatier should not be taken with HIV medications that require a booster (meaning they require another medication such as ritonavir or cobicistat to increase the drug levels in the body), such as atazanavir, darunavir, or elvitegravir. Zepatier should also not be taken with the HIV medications efavirenz or etravirine. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should determine if your statin may be continued or changed during treatment with Zepatier. There are no interactions with methadone or other common medications used for opioid, alcohol, or nicotine dependency. Unlike several of the other HCV medications, Zepatier does not interact with acid reducing agents. 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. It cannot be taken with St. John’s wort; in general, herbal products should be avoided due to lack of information regarding potential for interaction.
Zepatier was an excellent medication upon its release, but it is not used much any longer as the other newer DAAs are preferred due to potential need for an additional lab test, possible need for ribavirin addition, and limited genotypes (only 1 and 4) covered. If you have HCV genotype 1a, you will need to get an HCV drug resistance blood test before starting Zepatier. If your hepatitis C virus is resistant, you will have to add ribavirin and take the combination for an additional four weeks (16 weeks total). This improves its effectiveness and allows the medication to overcome resistance, dramatically improving your chances for cure.
It is an excellent regimen for patients with kidney disease, including those on hemodialysis, with 99% achieving a cure. NS3/4A protease inhibitors, such as grazoprevir, are contraindicated in people with moderate or severe liver impairment (Child-Pugh B/C), which is also called decompensated cirrhosis. Using Zepatier in decompensated cirrhosis may cause significantly higher amounts of grazoprevir in the blood and may increase ALT (a liver enzyme).
For more information, go to hcvguidelines.org.
Black Box Warning
Before starting treatment with any direct-acting antiviral (DAA), including Epclusa, 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. (link to Black Box Warning)