Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection

Abstract Introduction Real-world treatment of hepatitis C virus (HCV) infection is complicated by many factors that are controlled for in the rigorous clinical trial setting. The aim of the present study was to assess the efficacy of elbasvir/grazoprevir in a Veterans Affairs population with chronic...

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Main Authors: Amy Puenpatom, Yumei Cao, Xian Yu, Fasiha Kanwal, Hashem B. El-Serag, Jennifer R. Kramer
Format: Article
Language:English
Published: Adis, Springer Healthcare 2020-04-01
Series:Infectious Diseases and Therapy
Subjects:
Online Access:https://doi.org/10.1007/s40121-020-00293-7
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spelling doaj-cd3b816f0ad94caf9c8bdafba367de852021-04-18T11:04:53ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822020-04-019235536510.1007/s40121-020-00293-7Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b InfectionAmy Puenpatom0Yumei Cao1Xian Yu2Fasiha Kanwal3Hashem B. El-Serag4Jennifer R. Kramer5Merck & Co., Inc.Center for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical CenterCenter for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical CenterCenter for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical CenterCenter for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical CenterCenter for Innovations in Quality, Effectiveness and Safety (IQuESt), Michael E. DeBakey VA Medical CenterAbstract Introduction Real-world treatment of hepatitis C virus (HCV) infection is complicated by many factors that are controlled for in the rigorous clinical trial setting. The aim of the present study was to assess the efficacy of elbasvir/grazoprevir in a Veterans Affairs population with chronic HCV genotype 1b infection. Methods This was a retrospective analysis of a cohort of patients aged ≥ 18 years with chronic HCV genotype 1b infection and ≥ 1 prescription of elbasvir/grazoprevir between February 1, 2016, and August 31, 2017. The primary analysis was conducted in the per-protocol population, which included all patients who had at least 11 weeks of treatment and had an available assessment for sustained virologic response (SVR) based on virologic data post–follow-up week 4. Results The per-protocol population included 3371 patients. Overall, 97.3% of patients were male, 60.3% were black, and 85.5% were HCV treatment–experienced. Comorbidities in this population included hypertension (74.4%), history of alcohol use (55.7%), and depression (54.8%). In total, 97.5% of patients (3288/3371) achieved SVR. Among patient sub-groups, SVR was achieved by 96.0% (290/302) of those with chronic kidney disease stage 4/5, 97.8% (1527/1561) of those with a history of drug use, and 96.6% (831/860) of those with cirrhosis. No statistically significant differences were observed in the proportions of patients achieving SVR, regardless of age, race, HCV treatment history, viral load level, treatment regimen/duration, history of drug or alcohol use, HIV co-infection, or chronic kidney disease. Conclusion Elbasvir/grazoprevir was highly effective in individuals with HCV genotype 1b infection in a large national Veterans Affairs clinical setting.https://doi.org/10.1007/s40121-020-00293-7Hepatitis CLiver fibrosisReal-worldVeteransViral hepatitis
collection DOAJ
language English
format Article
sources DOAJ
author Amy Puenpatom
Yumei Cao
Xian Yu
Fasiha Kanwal
Hashem B. El-Serag
Jennifer R. Kramer
spellingShingle Amy Puenpatom
Yumei Cao
Xian Yu
Fasiha Kanwal
Hashem B. El-Serag
Jennifer R. Kramer
Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
Infectious Diseases and Therapy
Hepatitis C
Liver fibrosis
Real-world
Veterans
Viral hepatitis
author_facet Amy Puenpatom
Yumei Cao
Xian Yu
Fasiha Kanwal
Hashem B. El-Serag
Jennifer R. Kramer
author_sort Amy Puenpatom
title Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
title_short Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
title_full Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
title_fullStr Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
title_full_unstemmed Effectiveness of Elbasvir/Grazoprevir in US Veterans with Chronic Hepatitis C Virus Genotype 1b Infection
title_sort effectiveness of elbasvir/grazoprevir in us veterans with chronic hepatitis c virus genotype 1b infection
publisher Adis, Springer Healthcare
series Infectious Diseases and Therapy
issn 2193-8229
2193-6382
publishDate 2020-04-01
description Abstract Introduction Real-world treatment of hepatitis C virus (HCV) infection is complicated by many factors that are controlled for in the rigorous clinical trial setting. The aim of the present study was to assess the efficacy of elbasvir/grazoprevir in a Veterans Affairs population with chronic HCV genotype 1b infection. Methods This was a retrospective analysis of a cohort of patients aged ≥ 18 years with chronic HCV genotype 1b infection and ≥ 1 prescription of elbasvir/grazoprevir between February 1, 2016, and August 31, 2017. The primary analysis was conducted in the per-protocol population, which included all patients who had at least 11 weeks of treatment and had an available assessment for sustained virologic response (SVR) based on virologic data post–follow-up week 4. Results The per-protocol population included 3371 patients. Overall, 97.3% of patients were male, 60.3% were black, and 85.5% were HCV treatment–experienced. Comorbidities in this population included hypertension (74.4%), history of alcohol use (55.7%), and depression (54.8%). In total, 97.5% of patients (3288/3371) achieved SVR. Among patient sub-groups, SVR was achieved by 96.0% (290/302) of those with chronic kidney disease stage 4/5, 97.8% (1527/1561) of those with a history of drug use, and 96.6% (831/860) of those with cirrhosis. No statistically significant differences were observed in the proportions of patients achieving SVR, regardless of age, race, HCV treatment history, viral load level, treatment regimen/duration, history of drug or alcohol use, HIV co-infection, or chronic kidney disease. Conclusion Elbasvir/grazoprevir was highly effective in individuals with HCV genotype 1b infection in a large national Veterans Affairs clinical setting.
topic Hepatitis C
Liver fibrosis
Real-world
Veterans
Viral hepatitis
url https://doi.org/10.1007/s40121-020-00293-7
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