Racial Differences in the Evaluation and Treatment of Hepatitis C

Racial Differences in the Evaluation and Treatment of Hepatitis C Among Veterans: A Retrospective Cohort Study

Posted on: Friday, 2 May 2008, 06:00 CDT

By Rousseau, Christine M Ioannou, George N; Todd-Stenberg, Jeffrey A; Sloan, Kevin L; Larson, Meaghan F; Forsberg, Christopher W; Dominitz, Jason A

Objectives. We examined the association between race and hepatitis C virus (HCV) evaluation and treatment of veterans in the Northwest Network of the Department of Veterans Affairs (VA). Methods. In our retrospective cohort study, we used medical records to determine antiviral treatment of 4263 HCV-infected patients from 8 VA medical centers. Secondary outcomes included specialty referrals, laboratory evaluation, viral genotype testing, and liver biopsy. Multiple logistic regression was used to adjust for clinical (measured through laboratory results and International Classification of Diseases, Ninth Revision, codes) and sociodemographic factors.

Results. Blacks were less than half as likely as Whites to receive antiviral treatment (odds ratio OR

Conclusions. Race is associated with receipt of medical care for various medical conditions. Further investigation is warranted to help understand whether patient preference or provider bias may explain why HCV-infected Blacks were less likely to receive medical care than Whites. (Am J Public Health. 2008;98: 846-852. doi:10.2105/ AJPH.2007.113225)

Hepatitis C virus (HCV) is the leading chronic blood-borne pathogen in the United States, infecting approximately 2.7 million Americans.1 In response to several reports indicating that HCV was more common among veterans than among the general US population,2-6 the Department of Veterans Affairs (VA) conducted a nationwide survey of HCV infection among veterans who used VA facilities; it found that prevalence was at least twice as high among veterans.7 This increased prevalence, which was found to be associated with traditional risk factors of infection (e.g., transfusion, intravenous drug use) likely to be more common among users of VA facilities, left the VA facing significant challenges in providing medical care for this population.

Antiviral therapy has improved over the past decade, especially with the introduction of interferon and ribavirin combination therapy. 8-13 However, because these antiviral treatments have several contraindications, only 13% to 30% of infected individuals are eligible for therapy.14-16 Furthermore, because of possible side effects, long antiviral treatment duration, limited efficacy, and high antiviral treatment cost, many choose not to be treated.15

Black Americans are twice as likely to be infected with HCV as White Americans1 and have several characteristics associated with lower treatment response rates (e.g., greater transcriptional response to interferon, high frequency of genotype 1 infection, high Histological Activity Index17 scores, increased weight, increased iron stores).1,18-20 Blacks have also been shown to be less likely to respond to interferon monotherapy.21-23 Although there is some evidence to suggest that combination therapy at least partially eliminates this difference,19 more recent studies have reported that Whites are more likely than are Blacks to have sustained response to peginterferon alfa-2b and ribavirin.24-26 Nevertheless, antiviral treatment remains recommended for HCV-infected individuals regardless of race.27

In the VA, Blacks have been found to be less likely than Whites to undergo diagnostic imaging and treatment for a variety of conditions, including cerebrovascular disease, peripheral vascular disease, esophageal cancer, and psychosis.28-33 Provider racial bias, clinical factors, sociodemographic factors (race, economic status, marital status, homelessness, etc.), or patient preference for medical treatment could explain these observed differences. However, race was not associated with delay in seeking care or with attitudes, beliefs, and experiences related to cardiac care at VA facilities.34,35 Because the VA system has a relatively homogeneous patient population with regard to sociodemographic status and is an equal access health care system, sociodemographic factors are less likely to be involved in racial differences associated with treatment than in private sector health care.

Because treatment decisionmaking for HCV infection is complex, involving several clinical and sociodemographic factors, treatment practices are relatively subjective, allowing potential biases to become more evident. Furthermore, the substantial risk of side effects, combined with the incomplete viral response to therapy, results in some patients electing to defer therapy. We sought to determine whether there were racial differences in the evaluation and treatment for HCV in the VA system.

METHODS

Database

Patients were identified through the VA Consumer Health Information and Performance Sets database, which included clinical and administrative medical records from each of the 8 VA medical centers of the Northwest Network: Anchorage, Alaska; Boise, Idaho; Portland, White City, and Roseburg, Oregon; and Puget Sound (Seattle and Tacoma), Spokane, and Walla Walla, Washington. Liver biopsy results were available only for patients treated at the VA Puget Sound facility (where 75% of all Black veterans' liver biopsies were performed) through manual review of medical records. For logistical reasons, liver biopsies from the remaining facilities were not available.

Study Population

Because only those patients with documented viremia are eligible for antiviral treatment, we identified all veterans (n

HCV polymerase chain reaction (PCR) test result from January 1, 2000, to December 31, 2002 (enrollment period). In general, patients were first tested with an HCV antibody test, which, if positive, was routinely confirmed with a PCR test. Among the patients with a positive antibody test result for HCV during the study period, 92% of Blacks and 89% of Whites had confirmatory PCR testing. The date of the first PCR positive result during the enrollment period was defined as the date of study entry. Additional clinical data from January 1, 1994, to December 31, 2003, were extracted to determine comorbidities and outcomes.

Patients with 1 or more of the following absolute contraindications36 to antiviral therapy at any time up to the end of the study were excluded (n

In general, clerical staff recorded race at the time of registration; however, this was not always completed. To validate the race information in the VA databases, we used data from a study of 34789 veterans who self-reported race as part of a previously published study40 (David Au, MD, VA Puget Sound Health Care System, written communication, June 14, 2007). On the basis of self- reported race in this earlier study, we determined that the racial distribution among those classified as "unknown race" (26.1%) was the same as the distribution among those with known race in the VA database, indicating that race information was unlikely to be missing in a biased manner.

Outcome Variables

The primary outcome measure was any prescription during the enrollment period or subsequent year for anti-HCV medications (i.e., interferon alpha, pegylated interferon alpha, or ribavirin). Secondary outcome measures, reflecting intermediate steps in the treatment decision, were measured during the enrollment period plus 1 year following; they included (1) referral to a specialty clinic (defined as the scheduling of an appointment to see a specialist in gastroenterology or infectious disease, whether or not patient attended), (2) liver biopsy (identified through inpatient and outpatient ICD-9 procedure codes, current procedural terminology codes, and surgical specimen descriptions), (3) complete laboratory evaluation (defined as test results for all of the following: white blood cell count, hemoglobin concentration, platelet count, serum creatinine, serum bilirubin, serum alanine aminotransferase, prothrombin time-international normalized ratio, and serum albumin), and (4) viral genotype testing. Clinical and Sociodemographic Variables

ICD-9 diagnostic and procedure codes, Current Procedural Terminology codes, and laboratory data were used to identify clinical and sociodemographic variables that may have influenced the decision to treat HCV with antiviral therapy.36 Compensated cirrhosis was identified through codes for alcoholic, nonalcoholic, or biliary cirrhosis. Abnormal laboratory test results within 1 year prior to and 3 months following study entry were defined with the criteria shown in Table 1. Serum alanine aminotransferase levels were evaluated within 5 years prior to study entry and were classified as ever elevated (

U/L) or normal. HIV infection was defined by a diagnosis of HIV or a positive HIV laboratory test result. Individuals with compensated cirrhosis, abnormal laboratory test results, persistently normal serum alanine aminotransferase, or HIV infection as defined here were considered to have contraindications to treatment.

Viral genotype was grouped by expected antiviral treatment outcome: genotype 1 or 4 (more resistant to antiviral treatment) and genotype 2 or 3 (more susceptible to antiviral treatment). Liver fibrosis was categorized as follows: 0 (no fibrosis), 1 (portal fibrosis), 2 (periportal fibrosis with few septae), 3 (bridging fibrosis), and 4 (cirrhosis). For assessment of comorbidity, the Charlson index41,42 was adapted to the database. Psychological disorders were categorized as previously described43 and combined into 3 variables: (1) psychosis or bipolar disorder, (2) posttraumatic stress or anxiety disorder, and (3) depression. We examined both current psychiatric diagnoses (i.e., a diagnosis within 1 year of study entry) and those given prior to study entry. Because both of these analyses yielded similar results, only data from the latter are presented here. The presence of alcohol or drug abuse was defined by ICD-9 codes or a positive blood or urine test.

Age at entry was categorized as shown in Table 1. The medical facility was defined as the most frequently visited site during the 5 years prior to the patient's study entry. Homelessness and poverty were defined by ICD-9 codes. Priority status for VA health care indicated the level of compensation given to a veteran as determined by the number of the veteran's health conditions related to military service (i.e., military service-related connection) and income (i.e., means test); it was grouped into 5 categories: service- connected disability, below means test, compensable, above means test, and unknown. The number of appointments at any of the 8 facilities within 1 year prior to study entry was determined as a measure of VA health care utilization. Patient referral to either a gastroenterology or infectious disease specialty clinic and patient adherence was grouped into 1 variable with 3 categories: never referred to an appointment, referred but never attended an appointment, and referred to and attended at least 1 appointment.

Data Analysis

We extracted data from computerized medical records using specific key terms and exported the data into Stata 8.0 statistical software (StataCorp LP, College Station, Tex). Race/ethnicity and clinical or sociodemographic characteristics were compared by the / 2 or Wilcoxon rank sum test. We used multiple and conditional logistic regression (grouped by facility) to determine the association between race and outcome variables, adjusted for demographic variables (i.e., age, gender, facility, homelessness, marital status, priority status, poverty, year of entry into the study, number of appointments 1 year prior to entry log transformed ) and clinical variables (i.e., psychiatric diagnoses, alcohol or drug abuse, comorbidity, HIV status, cirrhosis, and each laboratory test except those tests that included a complete laboratory evaluation as the outcome ).

We used conditional logistic regression to account for the possibility that there may have been facility-specific determinates for treatment. Because the results of conditional logistic regression were similar to those of standard logistic regression, only the latter values are presented. The influence of genotype on the association between race/ethnicity and antiviral treatment was also evaluated by multiple and conditional regression; this evaluation was limited to those for whom viral genotypes (genotype 1 or 4 vs genotype 2 or 3) were available. Patients with unknown race were excluded from all regression analyses. Because race information was missing for 28% of the patients, in an additional analysis, we imputed race using chained equations.44 We performed standard logistic regression with the same covariates on the imputed data sets (n

HIV infection, white blood cell counts, hemoglobin concentration, serum bilirubin concentration, serum alanine aminotransferase concentration, prothrombin time-international normalized ratio, and serum albumin concentration (Table 1).

However, significantly greater proportions of Blacks than of Whites were homeless (P

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