Racial Differences in Eligibility for Hepatitis C Treatment
By James Learned
Black hepatitis C patients were significantly more likely to be deemed
ineligible for treatment, primarily due to neutropenia and uncontrolled
medical conditions, according to a recent study. Less strict neutrophil
eligibility criteria and more effective care for chronic diseases would
increase access to HCV treatment for black people.
In the July 2011 issue of Hepatology Michael Melia and colleagues, on behalf
of the IDEAL (Individualized Dosing Efficacy versus Flat Dosing to Assess
Optimal Pegylated Interferon Therapy) study team, described an analysis of
hepatitis C virus (HCV) treatment among black patients.
In the U.S. blacks are disproportionately infected with HCV. Approximately
3% of blacks are living with HCV compared to 1.5% of non-Hispanic whites.
Yet hepatitis C treatment rates for blacks have been relatively low in both
research settings and clinical practice. For example, whites are 64% more
likely than blacks to receive HCV treatment in the U.S. Veterans Affairs
Health System.
Multiple biomedical factors contribute to this disparity. Compared with
whites, blacks are more likely to have difficult-to-treat HCV genotype 1,
and they respond less well to interferon-based therapy. Socioeconomic
factors such as limited access to medical care, inadequate health insurance,
and bias may also contribute to low treatment rates.
Melia and colleagues analyzed data from the IDEAL study to better understand
the impact of race on HCV treatment eligibility. IDEAL screened more than
4400 people age 18-70 years from 118 community and academic medical centers.
Eligibility requirements included HCV genotype 1, no previous hepatitis C
treatment, and compensated liver disease. The primary endpoint was sustained
virological response (SVR) 24 weeks after finishing therapy.
The number of self-identified blacks in the study (19%) was representative
of HCV prevalence in the general population. All treatment and related care
was provided at no cost to the participants, which removed barriers to
access. Although IDEAL consisted of 3 arms comparing 1.0 or 1.5 mcg/kg/week
of pegylated interferon alfa-2b (PegIntron) or pegylated interferon alfa-2a
(Pegasys), all combined with ribavirin, the goal of this analysis was to
determine the rate of treatment eligibility by race and to determine the
reasons for those deemed ineligible.
A total of 4469 people were screened for the study -- 21.5% black and 78.5%
non-black. Of those screened, 3083 (69%) were found to be eligible and were
randomized to 1 of the 3 treatment arms. The remaining 1386 people (31%)
were found to be ineligible during the screening process.
Results
Compared with non-black patients, black participants were on average older,
heavier, and more likely to have HCV genotype 1b. Ineligibility during
screening was more frequent among blacks (40% of 962 screened) compared with
non-black patients (28.5% of 3507 screened). Overall, black patients were
41% more likely to be found ineligible during the screening process than
non-black patients. Racial differences were also observed among the subgroup
of 1038 patients deemed ineligible for treatment. Overall, 29.5% of blacks
(284 of 962 screened) and 21.5% of non-blacks (754 of 3507 screened) were
ineligible. Black patients were 37% less likely to be eligible to receive
HCV treatment in this study. Non-blacks were more likely than blacks to be
excluded because of undetectable HCV RNA or infection with genotype 2 or 3.
After restricting the analysis to patients with genotype 1, black patients
were 65% less likely to be eligible for HCV treatment than non-black
patients were. Compared with non-blacks, black patients were more likely to
be ineligible due to abnormal hematology (blood-work) findings, abnormal
blood chemistry values, and/or uncontrolled diabetes mellitus.
Hematological parameters affecting blacks more than non-blacks included
neutropenia (low white blood cell count) and anemia (low red blood cell
count or hemoglobin level), both of which are possible side effects of
pegyalted interferon/ribavirin treatment. Abnormal blood values more likely
to exclude black patients were elevated blood glucose and elevated serum
creatinine levels. Thrombocytopenia (low platelet count), however, was more
common among non-blacks than among blacks. Non-black patients were more
likely than blacks to be excluded from the study because of recent drug or
alcohol abuse. With respect to cardiac disease or psychiatric conditions
(including moderate-to-severe depression), no difference in treatment
eligibility was found between black and non-black patients. The authors
wrote, ".the IDEAL study population represents a unique sample of patients
who sought treatment for HCV in the U.S. Further, the criteria for HCV
treatment eligibility in this post-approval study were similar to those
recommended for use in routine clinical practice."
In this context, they continued, "the findings that nearly 25% of patients
presenting to medical centers for treatment of hepatitis C were ineligible
for pegyalted interferon/ribavirin and that black Americans were 65% more
likely than non-black Americans to be ineligible for therapy have important
public health implications."
The authors suggested that clinical practice and future trials could
increase HCV treatment eligibility among blacks by utilizing a less
conservative absolute neutrophil count (ANC) threshold to minimize the
unnecessary exclusion of black patients. "For example, if an ANC threshold
>1200/mm3 had been utilized in the present study, 50% of the black patients
excluded because of neutropenia would have been eligible."
The authors concluded that improvements in healthcare may also enhance
eligibility for HCV treatment among black Americans, particularly
interventions to help control obesity, diabetes, renal insufficiency, and
attendant complications.
Investigator affiliations:Johns Hopkins University School of Medicine,
Baltimore, MD; Duke Clinical Research Institute and Division of
Gastroenterology, Duke University, Durham, NC; Mt. Vernon Endoscopy Center,
Duke University, Durham, NC; Liver Institute of Virginia, Bon Secours Health
System, Newport News, VA; Louisiana State University Health Sciences Center,
Shreveport, LA; Thomas Jefferson University, Philadelphia, PA;
Kelsey-Seybold Research Foundation, Houston, TX; University of Alabama at
Birmingham Liver Center, Birmingham, AL; Pennsylvania Hospital,
Philadelphia, PA; Henry Ford Hospital, Detroit, MI; Metro Health Medical
Center, Cleveland, OH; Digestive Disease Associates, Baton Rouge, LA; Liver
Institute at Methodist Dallas, Dallas, TX; and Schering-Plough Research
Institute, now Merck Research Laboratories, Kenilworth, NJ.
M Melia, A Muir, J McCone, et al on behalf of the IDEAL Study Team. Racial
Differences in Hepatitis C Treatment Eligibility. Hepatology54(1):70-78
(abstract). July 2011.