Accessible Unlicensed Requires Authentication Published by De Gruyter June 15, 2016

The Impact of Delayed Hepatitis C Viral Load Suppression on Patient Risk: Historical Evidence from the Veterans Administration

Tara Matsuda, Jeffrey S. McCombs, Ivy Tonnu-Mihara, Justin McGinnis and D. Steven Fox

Abstract

Background:

The high cost of new hepatitis C (HCV) treatments has resulted in “watchful waiting” strategies being developed to safely delay treatment, which will in turn delay viral load suppression (VLS).

Objective:

To document if delayed VLS adversely impacted patient risk for adverse events and death.

Methods:

187,860 patients were selected from the Veterans Administration’s (VA) clinical registry (CCR), a longitudinal compilation of electronic medical records (EMR) data for 1999–2010. Inclusion criteria required at least 6 months of CCR/EMR data prior to their HCV diagnosis and sufficient data post-diagnosis to calculate one or more FIB-4 scores. Primary outcome measures were time-to-death and time-to-a composite of liver-related clinical events. Cox proportional hazards models were estimated separately using three critical FIB-4 levels to define early and late viral response.

Results:

Achieving an undetectable viral load before the patient’s FIB-4 level exceed pre-specified critical values (1.00, 1.45 and 3.25) effectively reduced the risk of an adverse clinical events by 33–35% and death by 21–26%. However, achieving VLS after FIB-4 exceeds 3.25 significantly reduced the benefit of viral response.

Conclusions:

Delaying VLS until FIB-4 >3.25 reduces the benefits of VLS in reducing patient risk.


Corresponding author: Jeffrey S. McCombs, PhD, Department of Pharmaceutical and Health Economics, School of Pharmacy, Leonard Schaeffer Center for Health Policy and Economics, University of Southern California, 635 Downey Way, 2nd Floor, Los Angeles, CA 90089, USA, Phone: +213 821 7941, Fax: +213 740 3460

  1. Conflict of interest: Financial support for the development of the database used in this research was provided by Bristol-Myers Squibb [BMS]. The University of Southern California maintained all rights to publication. The University sub-contracted with the Veterans Affairs Department for access to the data. Conflict of Interest Disclosures: Drs. McCombs and Fox received salary and travel support under the terms of the research grant between Abbvie Pharmaceuticals and USC designed to continue previous research. Tara Matsuda and Justin McGinnis were supported as a USC graduate research assistant under the terms of the grant. Dr. Ivy Tonnu-Mihara is employed by the VA. Employees of BMS and Abbvie were not involved with the analyses included in this research or in the drafting of this manuscript. BMS employees were involved as co-authors of earlier publications and manuscripts using the same database. The research did not involve specific drugs or drugs marketed by BMS.

  2. Research funding: This research used a database developed under a previous study funded by BMS.

  3. Author statement: Drs. McCombs and Fox received salary and travel support under the terms of the research grant between Abbvie Pharmaceuticals and USC designed to continue previous research. Tara Matsuda and Justin McGinnis were supported as a USC graduate research assistant under the terms of the grant. Dr. Ivy Tonnu-Mihara is employed by the VA.

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Published Online: 2016-6-15
Published in Print: 2016-12-1

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