STEPS

New Drug Reviews

Glecaprevir/Pibrentasvir (Mavyret) for the Treatment of Chronic Hepatitis C

 

Am Fam Physician. 2018 Nov 15;98(10):601-602.

Glecaprevir/pibrentasvir (Mavyret) is a combination of a hepatitis C virus (HCV) NS3/4A protease inhibitor and an HCV NS5A inhibitor. It is labeled for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis based on the Child-Pugh class A criteria. Glecaprevir/pibrentasvir is also labeled for the treatment of adult patients with HCV genotype 1 infection who have previously been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.1

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DrugDosageDose formCost*

Glecaprevir/pibrentasvir (Mavyret)

Three tablets taken once daily with food for eight to 16 weeks

100-mg/40-mg tablet

$26,000 for an eight-week course and $54,000 for a 16-week course


*—Estimated retail price of one course of treatment based on information obtained at http://www.goodrx.com (accessed September 28, 2018).

DrugDosageDose formCost*

Glecaprevir/pibrentasvir (Mavyret)

Three tablets taken once daily with food for eight to 16 weeks

100-mg/40-mg tablet

$26,000 for an eight-week course and $54,000 for a 16-week course


*—Estimated retail price of one course of treatment based on information obtained at http://www.goodrx.com (accessed September 28, 2018).

Safety

Glecaprevir/pibrentasvir has been shown to be relatively safe. As with other antiviral agents in this class, the greatest safety concern is that it may reactivate hepatitis B virus (HBV) in coinfected patients. This occurs in up to 24% of patients with chronic HBV infection and in 1% to 4% of those with resolved HBV infection, and can lead to fulminant hepatitis, hepatic failure, and death.1,2 Although no participants in premarketing studies experienced reactivation, patients should be monitored for HBV reactivation during and after treatment. Glecaprevir/pibrentasvir is not recommended for patients with moderate to severe hepatic impairment (Child-Pugh class B and C). Glecaprevir/pibrentasvir has the potential to interact with several drugs, such as rifampin, atazanavir (Reyataz), carbamazepine (Tegretol), efavirenz (Sustiva), and St. John's wort.3 Glecaprevir/pibrentasvir can increase the effect of dabigatran (Pradaxa); prescribers should refer to the pharmaceutical label of dabigatran for dosing instructions. In patients

Address correspondence to Anupriya Grover, DO, at agrover@challiance.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

1. Daily Med. Drug label information. Mavyret—glecaprevir and pibrentasvir tablet, film coated. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7bf99777-0401-9095-8645-16c6e907fcc0. Accessed April 2, 2018.

2. Mücke MM, Backus LI, Mücke VT, et al. Hepatitis B virus reactivation during direct-acting antiviral therapy for hepatitis C: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2018;3(3):172–180.

3. Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Cross Discipline Team Leader, Division Director, and ODE Director Summary Review. NDA 209394 glecaprevir/pibrentasvir. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209394Orig1s000SumR.pdf. Accessed June 5, 2018.

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, Assistant Medical Editor.

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

 

 

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