Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 14 (8), e0218759
eCollection

Initial Uptake, Time to Treatment, and Real-World Effectiveness of All-Oral Direct-Acting Antivirals for Hepatitis C Virus Infection in the United States: A Retrospective Cohort Analysis

Affiliations

Initial Uptake, Time to Treatment, and Real-World Effectiveness of All-Oral Direct-Acting Antivirals for Hepatitis C Virus Infection in the United States: A Retrospective Cohort Analysis

Paul Y Kwo et al. PLoS One.

Abstract

Background: Data on initiation and utilization of direct-acting antiviral therapies for hepatitis C virus infection in the United States are limited. This study evaluated treatment initiation, time to treatment, and real-world effectiveness of direct-acting antiviral therapy in individuals with hepatitis C virus infection treated during the first 2 years of availability of all-oral direct-acting antiviral therapies.

Methods: A retrospective cohort analysis was undertaken using electronic medical records and chart review abstraction of hepatitis C virus-infected individuals aged >18 years diagnosed with chronic hepatitis C virus infection between January 1, 2014, and December 31, 2015 from the Indiana University Health database.

Results: Eight hundred thirty people initiated direct-acting antiviral therapy during the 2-year observation window. The estimated incidence of treatment initiation was 8.8%±0.34% at the end of year 1 and 15.0%±0.5% at the end of year 2. Median time to initiating therapy was 300 days. Using a Cox regression analysis, positive predictors of treatment initiation included age (hazard ratio, 1.008), prior hepatitis C virus treatment (1.74), cirrhosis (2.64), and history of liver transplant (1.5). History of drug abuse (0.43), high baseline alanine aminotransferase levels (0.79), hepatitis B virus infection (0.41), and self-pay (0.39) were negatively associated with treatment initiation. In the evaluable population (n = 423), 83.9% (95% confidence interval, 80.1-87.3%) of people achieved sustained virologic response.

Conclusion: In the early years of the direct-acting antiviral era, <10% of people diagnosed with chronic hepatitis C virus infection received direct-acting antiviral treatment; median time to treatment initiation was 300 days. Future analyses should evaluate time to treatment initiation among those with less advanced fibrosis.

Conflict of interest statement

P.Y.K. has received grants from the Regenstrief Institute relevant to the work under consideration, and has also received grants and personal fees from AbbVie, BMS, Merck, and Janssen; grants from Gilead and Target Registries; and personal fees from Quest. A.P. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and holds stock in Merck and Co., Inc., Kenilworth, NJ, USA. This does not alter our adherence to PLOS ONE policies on sharing data and materials (as detailed online in the guide for authors http://journals.plos.org/plosone/s/competinginterests). Z.Z., S.L.H, A.A.K., and D.M. declare no conflicts of interest.

Figures

Fig 1
Fig 1. Kaplan–Meier curve: Time to treatment initiation.

Similar articles

See all similar articles

References

    1. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterology and Hepatology. 2017;2(3):161–76. Epub 2017/04/14. 10.1016/S2468-1253(16)30181-9 . - DOI - PubMed
    1. Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138(2):513–21, 21 10.1053/j.gastro.2009.09.067 - DOI - PubMed
    1. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361(6):580–93. 10.1056/NEJMoa0808010 - DOI - PubMed
    1. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy RK, Bzowej NH, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405–16. 10.1056/NEJMoa1012912 - DOI - PubMed
    1. Poordad F, McCone J, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195–206. 10.1056/NEJMoa1010494 - DOI - PMC - PubMed

Publication types

Grant support

The funder provided support in the form of salaries [AP], grants and personal fees [PYK], and medical writing assistance. The specific roles of these authors are articulated in the “author contributions” section. The study sponsor (Merck & Co., Inc.) was involved in the design of the study, collection of data, and the decision to publish. Medical writing assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All authors, including employees of the study sponsor, were involved in the preparation of the manuscript.
Feedback