TY - JOUR
T1 - Determinants of Treatment Eligibility in Veterans With Hepatitis C Viral Infection
AU - Taylor, Janice
AU - Carr-Lopez, Sian
AU - Robinson, Amy
AU - Malmstrom, Robert
AU - Duncan, Karsten
AU - Maniar, Archana
AU - Re, A. C.Del
AU - Carmichael, Jannet M.
PY - 2017/1/1
Y1 - 2017/1/1
N2 - Purposes The objective of this study was to determine the percentage of veterans with active hepatitis C virus (HCV) infection who were deemed to be candidates for treatment and to identify factors associated with treatment ineligibility. Methods This was a multisite, retrospective cohort analysis of veterans with HCV infection within the Veteran Integrated Service Network 21. Patients evaluated between August and November 2015 who were viremic and not receiving HCV treatment were included in the analysis. Reasons for treatment exclusion were determined by an experienced clinician and recorded into a regional population management dashboard. Descriptive statistics were used to describe the population. The t test for normally distributed data, the Mann-Whitney rank sum test for data that failed normality testing, or the χ2 test were used to examine differences between the treatment eligible and ineligible cohorts. Generalized linear mixed-effects models were conducted to estimate patient outcomes relevant to various disease states and characteristics while controlling for interfacility variability. Findings The cohort included 1,003 veterans within 5 medical centers; 988 (98.5%) were male, and 625 (62%) had a fibrosis 4 score >3.25, indicating the presence of ALD. According to clinician classification, 478 (48%) were considered HCV treatment candidates, whereas 525 (52%) were determined to be treatment ineligible. The most common reasons documented by clinicians for treatment ineligibility included unstable or uncontrolled comorbidities (n = 118 [22.4%]), excessive alcohol use (n = 116 [22.1%]), and treatment refusal by the patient (n = 69 [13%]). On the basis of statistical modeling and reporting odds ratios (ORs) and 95% CIs, diagnoses of active alcohol use disorder (OR = 0.68; 95% CI, 0.47–0.98; P = 0.038), hepatocellular carcinoma (OR = 0.24; 95% CI, 0.13–0.47; P < 0.001), and palliative care status (OR = 0.21; 95% CI, 0.05–0.99; P = 0.049) were statistically associated with treatment ineligibility, whereas posttraumatic stress disorder (OR = 1.48; 95% CI, 1.01–2.18; P = 0.046) was associated with treatment eligibility. There were no statistically significant differences found for other psychiatric diagnoses or an encounter for homelessness. Implications Results of this study indicate that a high percentage of patients may not be considered treatment eligible at initial clinical review. Within this veteran population, the presence of uncontrolled comorbidities and excessive alcohol use were the most commonly reported reasons for treatment ineligibility. On the basis of this analysis, processes could be established to address modifiable barriers to treatment, thus expanding the number of individuals receiving potentially curative therapy for HCV infection.
AB - Purposes The objective of this study was to determine the percentage of veterans with active hepatitis C virus (HCV) infection who were deemed to be candidates for treatment and to identify factors associated with treatment ineligibility. Methods This was a multisite, retrospective cohort analysis of veterans with HCV infection within the Veteran Integrated Service Network 21. Patients evaluated between August and November 2015 who were viremic and not receiving HCV treatment were included in the analysis. Reasons for treatment exclusion were determined by an experienced clinician and recorded into a regional population management dashboard. Descriptive statistics were used to describe the population. The t test for normally distributed data, the Mann-Whitney rank sum test for data that failed normality testing, or the χ2 test were used to examine differences between the treatment eligible and ineligible cohorts. Generalized linear mixed-effects models were conducted to estimate patient outcomes relevant to various disease states and characteristics while controlling for interfacility variability. Findings The cohort included 1,003 veterans within 5 medical centers; 988 (98.5%) were male, and 625 (62%) had a fibrosis 4 score >3.25, indicating the presence of ALD. According to clinician classification, 478 (48%) were considered HCV treatment candidates, whereas 525 (52%) were determined to be treatment ineligible. The most common reasons documented by clinicians for treatment ineligibility included unstable or uncontrolled comorbidities (n = 118 [22.4%]), excessive alcohol use (n = 116 [22.1%]), and treatment refusal by the patient (n = 69 [13%]). On the basis of statistical modeling and reporting odds ratios (ORs) and 95% CIs, diagnoses of active alcohol use disorder (OR = 0.68; 95% CI, 0.47–0.98; P = 0.038), hepatocellular carcinoma (OR = 0.24; 95% CI, 0.13–0.47; P < 0.001), and palliative care status (OR = 0.21; 95% CI, 0.05–0.99; P = 0.049) were statistically associated with treatment ineligibility, whereas posttraumatic stress disorder (OR = 1.48; 95% CI, 1.01–2.18; P = 0.046) was associated with treatment eligibility. There were no statistically significant differences found for other psychiatric diagnoses or an encounter for homelessness. Implications Results of this study indicate that a high percentage of patients may not be considered treatment eligible at initial clinical review. Within this veteran population, the presence of uncontrolled comorbidities and excessive alcohol use were the most commonly reported reasons for treatment ineligibility. On the basis of this analysis, processes could be established to address modifiable barriers to treatment, thus expanding the number of individuals receiving potentially curative therapy for HCV infection.
KW - direct-acting antivirals
KW - hepatitis C
KW - population management
KW - pretreatment assessment
KW - treatment candidate
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U2 - 10.1016/j.clinthera.2016.11.019
DO - 10.1016/j.clinthera.2016.11.019
M3 - Article
C2 - 27989619
AN - SCOPUS:85007559679
VL - 39
SP - 130
EP - 137
JO - Clinical Therapeutics
JF - Clinical Therapeutics
SN - 0149-2918
IS - 1
ER -