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Racial Differences in Eligibility for Hepatitis C Treatment

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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.

8/2/11

Reference

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.