Retrospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 14, 2016; 22(38): 8558-8567
Published online Oct 14, 2016. doi: 10.3748/wjg.v22.i38.8558
Retrospective analysis of hepatitis C infected patients treated through an integrated care model
James M Levin, Shabnam Dabirshahsahebi, Mindy Bauer, Eric Huckins
James M Levin, Shabnam Dabirshahsahebi, Mindy Bauer, Eric Huckins, Department of Infectious Disease, Dean Clinic, Madison, WI 53715, United States
Author contributions: Levin JM and Huckins E contributed to the study idea, study design, manuscript writing, and final revision of the article; Dabirshahsahebi S and Bauer M contributed to the literature search, manuscript writing, and final revision of the article.
Institutional review board statement: This study was submitted and reviewed by Dr. Harold F. Bennett, MD, PHD from the DEAN IRB and determined to be exempt from further IRB review since the research involves the study of existing data and identifiers to subjects will be coded.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: James M Levin, MD, Department of Infectious Disease, Dean Clinic, 1313 Fish Hatchery Rd., Madison, WI 53715, United States. jmlevin@wisc.edu
Telephone: +1-608-2528000 Fax: +1-608-2837325
Received: June 4, 2016
Peer-review started: June 4, 2016
First decision: July 12, 2016
Revised: July 27, 2016
Accepted: August 23, 2016
Article in press: August 23, 2016
Published online: October 14, 2016
Processing time: 137 Days and 13.9 Hours
Abstract
AIM

To determine if our health system’s integrated model reflects sustained virologic response (SVR) outcomes similar to those in clinical trial data, maximizes adherence, and averts drug interactions.

METHODS

Subjects with chronic hepatitis C had their medical records reviewed from November 1st, 2014 through March 1st, 2016. Patients eligible for treatment were entered into an integrated care model therapy algorithm. The primary outcome was SVR12 based on intention to treat (ITT) analysis. Inclusion criteria consisted of both treatment naïve and experienced patients over the age of 18 who were at least twelve weeks post-therapy completion with any genotype (GT) or METAVIR score. Secondary outcomes included adherence, adverse events, and number of drug interaction interventions.

RESULTS

At the time of analysis, 133 patients had reached twelve weeks post therapy with ITT. In the ITT analysis 70 patients were GT 1a, 26 GT 1b, 23 could not be differentiated between GT 1a or 1b, 8 GT 2, 4 GT 3, and 2 patients with multiple genotypes. The ITT treatment regimens consisted of 97 sofosbuvir (SOF)/ledipasvir (LDV), 8 SOF/LDV and ribavirin (RBV), 7 SOF and Simeprevir (SMV), 6 3D and RBV, 1 3D, 11 SOF and RBV, and 1 SOF, peg interferon alpha, and RBV. The overall SVR12 rate was 93% in the ITT analysis with a total of 6 patients relapsing. In patients with cirrhosis, 89% obtained SVR12. All 33 patients who were previous treatment failures achieved SVR12. Drug-drug interactions were identified in 56.4% of our patient population, 69 of which required interventions made by the pharmacist. The most common side effects were fatigue (41.4%), headache (28.6%), nausea (18.1%), and diarrhea (8.3%). No serious adverse effects were reported.

CONCLUSION

Dean Health System’s integrated care model successfully managed patients being treated for hepatitis C virus (HCV). The integrated care model demonstrates high SVR rates amongst patients with different levels of fibrosis, genotypes, and HCV treatment history.

Keywords: Hepatitis C; Medication adherance; Direct acting antiviral; Sustained viral response; Integrated care model

Core tip: There are new effective options for treating hepatitis C virus. To maximize their effectiveness our health system developed an innovative integrated care model to manage these patients. Through our original therapy algorithm we were able to closely monitor patients from time of insurance approval to the time of obtaining a sustained virologic response (SVR). This real world retrospective study analyses our patient’s SVR rate, adherence, and interventions made by the patient care team. Additionally it will provide a model for other systems to improve their care coordination and response with direct acting antiviral treatment.