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LifeGuide [Hep Talk]

African Americans face medical barriers to HCV treatment
by Larry Buhl

In the U.S. blacks are disproportionately infected with the hepatitis C virus (HCV), and are less likely to receive treatment for HCV than whites. Treatment barriers go beyond affordability and lack of access to care. A new study shows that, significantly, many black patients with hepatitis C are more likely to be medically ineligible for treatment due to controllable and uncontrollable medical factors.

A recent study published in the July 2011 issue of Hepatology broke down some of the reasons why black patients have “red flag” factors that doctors say make a patient a poor candidate for treatment.

Michael Melia and colleagues, on behalf of the IDEAL (Individualized Dosing Efficacy versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy) study team, found that nearly twenty-five percent of patients sent to medical centers for treatment of hepatitis C were ineligible for traditional pegylated interferon/ribavirin and that black Americans were sixty-five percent more likely than non-black Americans to be ineligible.

Based on their research, the team found some important factors that influence the racial disparity in treatment eligibility:

• Compared with whites, blacks are more likely to have a genotype that responds less well to interferon-based therapy.

• Blacks tend to have lower neutrophil levels. Neutrophils, also known as polymorphonuclear leukocytes or PMNs, are a type of white blood cell that helps the body fight off infections.

• Black HCV patients are more likely to have abnormal blood work or chronic health issues that make them ineligible for treatment.

• Recent drug or alcohol abuse was higher for the black participants.

IDEAL screened more than 4,400 people age eighteen to seventy years from 118 community and academic medical centers. Eligibility requirements included HCV genotype 1, no previous HCV treatment, and compensated liver disease. The primary endpoint was sustained virological response (SVR) twenty-four weeks after finishing therapy.

The number of self-identified blacks in the study (nineteen percent) was representative of HCV prevalence in the general population. A total of 4,469 people were screened for the study—21.5 percent black and 78.5 percent non-black. Of those screened, 3,083 (sixty-nine percent) were found to be eligible and were randomized to one of the three treatment arms. The remaining 1,386 people (thirty-one percent) were found to be ineligible during the screening process.
Specifically, the study found:

• 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 (forty percent of 962 screened) compared with non-black patients (28.5 percent of 3,507 screened).

• Overall, black patients were forty-one percent more likely to be found ineligible during the screening process than non-black patients.

• Overall, 29.5 percent of blacks (284 of 962 screened) and 21.5 percent of non-blacks (754 of 3,507 screened) were ineligible.

• Black patients were thirty-seven percent less likely to be eligible to receive HCV treatment in this study.

• After restricting the analysis to patients with genotype 1, black patients were sixty-five percent 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 for treatment due to uncontrolled diabetes mellitus, elevated blood glucose or elevated serum creatine levels.

The higher prevalence of genotype 1 HCV in black patients is an uncontrollable factor, and experts do not yet understand why blacks are more prone to this genotype. However, the study’s authors suggest steps that can be taken to ensure that more blacks with HCV are eligible for treatment. They recommend improvements in overall healthcare, particularly interventions to help control obesity, diabetes, and renal insufficiency. They also suggested that using a less conservative absolute neutrophil count threshold would minimize the unnecessary exclusion of black patients.

The IDEAL study team only covered traditional HCV treatments of pegylated interferon and ribavirin, not the newer protease inhibitors that have entered the market. While the new drugs show great promise, doctors who prescribe them are doing so in combination with the older drugs. That means patients deemed “bad risks” for interferon and ribavirin therapy wouldn’t be able to take advantage of the protease inhibitors either.

Larry Buhl is a freelance journalist and screenwriter living in Los Angeles.

November 2011