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Aliment Pharmacol Ther. 2018 Jun;47(11):1511-1522. doi: 10.1111/apt.14635. Epub 2018 Apr 17.

Real-world use of elbasvir-grazoprevir in patients with chronic hepatitis C: retrospective analyses from the TRIO network.

Author information

1
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
2
Saint Louis University School of Medicine, St. Louis, MO, USA.
3
Beth Israel Deaconess Medical Center, Boston, MA, USA.
4
Trio Health Analytics, La Jolla, CA, USA.
5
Merck & Co., Inc., Kenilworth, NJ, USA.
6
Queens Medical Center, University of Hawaii, Honolulu, HI, USA.
7
Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.

Abstract

BACKGROUND:

Elbasvir-grazoprevir is indicated for chronic hepatitis C virus (HCV) genotypes 1 and 4.

AIM:

To evaluate the utilization and outcomes of chronic HCV patients treated with elbasvir-grazoprevir in the United States.

METHODS:

We conducted a retrospective cohort study of adults treated with elbasvir-grazoprevir with or without ribavirin for chronic HCV genotypes 1 or 4 infection. Data were collected from healthcare providers and specialty pharmacies through Innervation Platform, a proprietary, cloud-based disease management program from Trio Health. The primary endpoint was per protocol sustained virological response 12 weeks post-treatment (SVR12).

RESULTS:

Among 470 patients treated in 2016, 95% had HCV genotype 1 infection, 80% (373/468) were HCV treatment naïve and 70% (327/468) had non-cirrhotic disease. Almost 3 quarters (73%) of patients received care in community practices. The majority (89%) of patients received elbasvir-grazoprevir for 12 weeks. Per protocol SVR12 rates were 99% (396/402) for HCV genotype 1 and 95% (21/22) for HCV genotype 4. Among patients with Stage 4 or 5 chronic kidney diseases, 99% (113/114) achieved SVR12. In univariate analyses, variables significantly associated with per protocol SVR12 for the entire sample were therapy duration (P = 0.001), treatment experience (P = 0.016), and cirrhosis status (P = 0.001). However, among HCV genotype 1 patients, no variables were significant. Intent-to-treat SVR12 rates were 89% (396/447) for HCV genotype 1 and 91% (21/23) for HCV genotype 4.

CONCLUSION:

Elbasvir-grazoprevir is highly effective, and in this 2016 cohort, its use was predominantly in patients with HCV genotype 1 and as a 12-week therapy without ribavirin.

PMID:
29665097
DOI:
10.1111/apt.14635

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