Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Saint Louis University School of Medicine, St. Louis, MO, USA.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
Trio Health Analytics, La Jolla, CA, USA.
Merck & Co., Inc., Kenilworth, NJ, USA.
Queens Medical Center, University of Hawaii, Honolulu, HI, USA.
Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.
Elbasvir-grazoprevir is indicated for chronic hepatitis C virus (HCV) genotypes 1 and 4.
To evaluate the utilization and outcomes of chronic HCV patients treated with elbasvir-grazoprevir in the United States.
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).
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.
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.