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RRP 12-245 – HSR&D Study

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RRP 12-245
Veterans' Adherence to Direct-Acting Antiviral Treatment for Hepatitis C
Jack A Clark PhD
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, MA
Funding Period: November 2012 - August 2014

BACKGROUND/RATIONALE:
An estimated 2.7% of VHA patients have active, chronic HCV, 3 to 4 times the prevalence in the general public. HCV is a leading cause of cirrhosis, liver cancer, liver failure, liver transplantation, disability, and ultimately death. HCV is treatable, with new direct-acting antiviral treatments (DAAT) achieving 90% cure rates in clinical trials. However, effectiveness requires patient adherence to treatment regimens, and little is known about this in VHA patients with HCV. .

OBJECTIVE(S):
The goal of this study was to characterize patients' self-management of DAAT in order to design an appropriate intervention to support adherence to DAAT. The development of effective interventions to promote adherence requires detailed knowledge of how patients actually engage in medication self-management in material and social circumstances of their lives. We need accurate knowledge of adherence levels, how patients achieve adherence, how their actions fall short of full adherence, and their reasons for engaging in these actions. Hence, we conducted a developmental formative evaluation of DAAT self-medication practices and adherence to prescribed regimens to guide the development of clinical interventions to support adherence. Through a detailed, qualitative study of patients who are actively engaged in DAAT, we sought to accomplish two specific aims:
1. Identify barriers and facilitators to patients' adherence to DAAT regimens.
2. Evaluate relationships between barriers and facilitators and adherence.

METHODS:
We planned to recruit a sample of 32 patients who are undergoing DAAT. We would conduct in-depth, qualitative interviews to elicit detailed, extended accounts of self-management of the DAAT regimen. We would also assess adherence using objective (MEMS caps) and self-report measures. We would recruit patients and collect data relating to two intervals (observation windows) in the course of treatment: (1) the first four weeks of DAAT with all three drugs and (2) a four week window after the first 8 or 16 weeks of DAAT, depending on the specific drug. The first window is a critical period for achieving early viral response, with failure to do so signaling treatment futility. The second window would capture possible diminished adherence-a typical pattern-albeit without a longitudinal design. Analyses of the qualitative data focused on describing actions as first described by patients, and identifying barriers to and facilitators of self-management relating to information, motivation, behavioral skills, side effects, and attributes of the material and social context of patients' activities that they identify as relevant.

FINDINGS/RESULTS:
We successfully recruited and interviewed 5 patients: 3 prescribed a first generation DAA (boceprevir) in combination with pegylated interferon and ribavirin, and 2 prescribed a second generation DAA (sofosbuvir). Patient recruitment was severely challenged by a hiatus in HCV treatment early in the study as VA physicians awaited the introduction of the second generation drugs that would eliminate the need for pegylated interferon. After the hiatus, recruitment was limited by clinical procedures for the selective allocation of second generation drugs according to significant need. Our major findings are:
(1) Reported adherence, in detailed accounts of behavior, was very high. Lapses, reported by 2 subjects, were infrequent and described as minor, as their accounts emphasized fastidious adherence: "I had to have myself a little bit of a schedule and I just used my head as a schedule, and the pill boxes, you know what I mean, and I'd stick, of course you're going to miss here and there, I did, I'll be honest with you, but not, not two days in a row, never. I'd always, I wouldn't make up for it, I'd just forget that day and start the next because you can't double up like that on anything."
(2) Veterans expressed strong motivations to adhere to regimens and complete treatment, reflecting both medical and moral (e.g., prove oneself to be a responsible patient) rationales. That is, they strived to cure their infections, stave off the outcomes of cirrhosis while they still had time, and counter the stigma of HCV with demonstrations of their personal worth.
(3) Veterans are conscious of the high costs of DAAT medications, which spurs adherence. "No, I've taken this thing seriously [I: Okay] right from the beginning and the thought into my head? Yeah, but I'm not going to do it because you know, like I said it's serious [stuff], you know. So I'm just sucking it up and doing it. [I: Well I'm interested in how people suck it up, so how often do you get the thought? [P: Huh?] How often do you get the thought? P: Not often [I: Yeah] maybe once or twice, you know, yeah, but just, what's the sense? [I: Yeah] I mean on top of the fact that I'm mindful of the expense of this whole treatment process, um, I'm also mindful of the fact that I'm defeating the purpose if I skip the medication, you know, and the benefit of skipping it, is, there is none because it's still in my system and I am going to take the next dose, so what did I accomplish by missing that dose? Nothing, I didn't accomplish anything except give myself a guilty conscience for not doing what I'm supposed to be doing, you know. So I can't say I haven't thought about it, but it's a fleeting thought

IMPACT:
Notwithstanding its limited success, this study provides some valuable data about Veterans' strong, complex motivations to adhere to DAAT. The findings are informing the design of studies that will yet improve the capability of VA providers to address and understand the behavioral competencies and challenges that characterize self-management of hepatitis C treatment; and improve ability of VA providers to provide well-informed cognitive, emotional, and practical support to ensure adherence to difficult regimens.

PUBLICATIONS:

Journal Articles

  1. Clark JA, Gifford AL. Resolute efforts to cure hepatitis C: Understanding patients' reasons for completing antiviral treatment. Health (London, England : 1997). 2015 Sep 1; 19(5):473-89.


DRA: Infectious Diseases
DRE: Treatment - Observational
Keywords: QUERI Implementation
MeSH Terms: none

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