STEPS

New Drug Reviews

Elbasvir/Grazoprevir (Zepatier) for Hepatitis C Virus Infection

 

Am Fam Physician. 2017 Mar 15;95(6):393-394.

Elbasvir/grazoprevir (Zepatier) is a fixed-dose combination of a hepatitis C virus (HCV) NS5A inhibitor and HCV NS3/4A protease inhibitor. It is labeled for the treatment of chronic HCV genotype 1 or 4 infection in treatment-naive or treatment-experienced adults with or without compensated cirrhosis. It is also labeled for use in patients coinfected with human immunodeficiency virus 1 (HIV-1).

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DrugDosageDose formCost*

Elbasvir/grazoprevir (Zepatier)

One tablet per day for 12 or 16 weeks, with or without ribavirin†

50-mg/100-mg tablets

$60,000 for a 12-week course and $80,000 for a 16-week course


*—Estimated retail price of treatment based on information obtained at http://www.goodrx.com (accessed December 23, 2016).

†—The duration of treatment and the need for adding ribavirin depend on previous treatment and the presence of polymorphisms; product labeling should be consulted for current recommendations.

DrugDosageDose formCost*

Elbasvir/grazoprevir (Zepatier)

One tablet per day for 12 or 16 weeks, with or without ribavirin†

50-mg/100-mg tablets

$60,000 for a 12-week course and $80,000 for a 16-week course


*—Estimated retail price of treatment based on information obtained at http://www.goodrx.com (accessed December 23, 2016).

†—The duration of treatment and the need for adding ribavirin depend on previous treatment and the presence of polymorphisms; product labeling should be consulted for current recommendations.

SAFETY

Clinically significant reactions are rare with elbasvir/grazoprevir treatment. In studies of approximately 1,700 patients, 1% of patients had an alanine aminotransferase level greater than five times the upper limit of normal.1 Increases in alanine aminotransferase levels were usually asymptomatic and occurred at or after two months of treatment. Most cases resolved during or at completion of therapy. Elbasvir/grazoprevir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score of B or C). No dosage adjustments are necessary for patients with any level of renal impairment, including those on hemodialysis.

Elbasvir/grazoprevir is metabolized in the liver via the cytochrome P450 3A enzyme system and can be affected by the many medications that induce or inhibit this system. Carbamazepine (Tegretol), efavirenz (Sustiva), phenytoin (Dilantin), rifampin, and St. John's wort will dramatically decrease plasma concentrations of both elbasvir and grazoprevir. Cyclosporine (Sandimmune)

Address correspondence to Jessica Early, MD, at jearly@challiance.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

REFERENCES

1. DailyMed. Label: Zepatier—elbasvir and grazoprevir tablet, film coated [prescribing information]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164dc02a-9180-426a-b8b5-04ab39d2bbd4. Accessed July 21, 2016.

2. Zeuzum S, Ghalib R, Reddy KR, et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med. 2015;163(1):1–13.

3. Roth D, Nelson DR, Bruchfeld A, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study [published correction appears in Lancet. 2015;386(10006):1824]. Lancet. 2015;386(10003):1537–1545.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.

 

 

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