Racial differences in hepatitis C treatment eligibility

Abstract

Black Americans are disproportionally infected with hepatitis C virus (HCV) and are less likely than whites to respond to treatment with peginterferon (PEG-IFN) plus ribavirin (RBV). The impact of race on HCV treatment eligibility is unknown. We therefore performed a retrospective analysis of a phase 3B multicenter clinical trial conducted at 118 United States community and academic medical centers to evaluate the rates of and reasons for HCV treatment ineligibility according to self-reported race. In all, 4,469 patients were screened, of whom 1,038 (23.2%) were treatment ineligible. Although blacks represented 19% of treated patients, they were more likely not to be treated due to ineligibility and/or failure to complete required evaluations (40.2%) than were nonblack patients (28.5%; P < 0.001). After the exclusion of persons not treated due to undetectable HCV RNA or nongenotype 1 infection, blacks were 65% less likely than nonblacks to be eligible for treatment (28.1% > 17.0%; relative risk, 1.65; 95% confidence interval, 1.46-1.87; P < 0.001). Blacks were more likely to be ineligible due to neutropenia (14% versus 3%, P < 0.001), anemia (7% versus 4%, P = 0.02), elevated glucose (8% versus 3%, P < 0.001), and elevated creatinine (5% versus 1%, P < 0.001).

Conclusion: Largely due to a higher prevalence of neutropenia and uncontrolled medical conditions, blacks were significantly less likely to be eligible for HCV treatment. Increased access to treatment may be facilitated by less conservative neutrophil requirements and more effective care for chronic diseases, namely, diabetes and renal insufficiency.

Trial registration: ClinicalTrials.gov NCT00081770.

Fig. 1

Flow diagram of all 4,469 patients evaluated for hepatitis C treatment in the IDEAL study.

Fig. 2

Prevalence of contraindications to HCV treatment among black and nonblack patients determined to be ineligible. ^aPatients may have had more than one reason for ineligibility, ^bIdentified by the investigator at the time of screening; no further information describing the specific preexisting or uncontrolled medical condition(s) was available.

Fig. 3

Prevalence of specific hematologic and metabolic abnormalities among black and nonblack patients determined to be ineligible for HCV treatment. ^aPatients may have had more than one reason for ineligibility. ^bHb levels <12 g/dL for women and <13 g/dL for men. ^cGlucose levels >140 mg/dL. ^dGreater than normal serum creatinine level.