Zepatier

50 mg elbasvir/100 mg grazoprevir (EBR/GZR)

FDA approved for use in HIV/HCV co-infection

Genotype

Standard Dose

One tablet once daily with or without food for adults and children age 12 and older and weighing 66 pounds or more (≥30 kg). The typical duration of therapy is 12 weeks, but recommendations vary depending on genotype, treatment history, cirrhosis status, presence of HIV co-infection and presence of NS5A polymorphisms (genetic mutations that may make Zepatier less effective). 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.

Manufacturer

Merck

AWP

Zepatier (50/100 mg tablets): $8,736 / month

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 recreational. It is impor-tant to report any changes to your medications as they happen during treatment. Zepatier should not be taken with HIV medications that require a booster (ritonavir or cobicistat), such as atazanavir and darunavir, to increase drug levels. Zepatier should 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 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.

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 or without cirrhosis. Nausea, insomnia and diarrhea have also been reported. Zepatier has not been studied in people who are pregnant or nursing, so its impact on fetal development or nursing babies is unknown.

See “Black Box Warning” on hepatitis B testing and treatment.

More Information

Zepatier was an excellent medication when it was released, but it is no longer used as much as the other newer treatments are preferred due to potential need for an additional lab test 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 should be prescribed an alternate regimen. It is an excellent regimen for people with kidney disease, including those on hemodialysis, with 99% achieving a cure. NS3/4A protease inhibitors, such as grazoprevir, are contraindicated (cannot be taken) 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.