HCV Triple Therapy is Equally effective in African-Americans and Non-African-Americans

J. Racial and Ethnic Health Disparities (2014) 1:319–325 DOI 10.1007/s40615-014-0039-x HCV Triple Therapy is Equally effective in African-Americans and Non-African-Americans John Wysocki & Celeste Newby & Luis Balart & Nathan Shores Received: 2 April 2014 / Revised: 9 July 2014 / Accepted: 23 July 2014 / Published online: 15 August 2014 # W. Montague Cobb-NMA Health Institute 2014 Abstract Real-world experience with HCV medications differs from original the index studies. AfricanAmericans (AA) are commonly underrepresented in clinical trials. Therefore, we hypothesized that postmarketing experience with the first generation HCV protease inhibitors (PI) (telaprevir and boceprevir) differs from premarket reports in clinically meaningful ways regarding patient race. We conducted a single-center, retrospective, observational analysis to evaluate the efficacy of HCV triple therapy in a nontrial setting. Clinical response and quantitative laboratory values were compared between AA and non-AA patients throughout the duration of treatment. Patients were included if they started triple therapy treatment after July 2011 and are not a part of any other clinical/pharmaceutical trials. Thirty-five patients with HCV genotype 1 were included in this study—22 nonAA and 13 AAs. AAs had a higher BMI compared to non-AA (33.6 vs 28.8, p=0.046). “High” baseline HCV RNA values (above 800,000 copies) were more prevalent in AA (69.2 %) vs non-AA (63.6 %). AA had less favorable IL28B genotypes; only 7.7 % had type CC compared to 40.9 % of non-AA. SVR12 was achieved 82 % of the time with each PI but there was no significance in type of PI used (p=1.00). Patients with cirrhosis were less likely to achieve SVR12 (40 %) compared to those without cirrhosis (88 %, p = 0.013). Thirty-three percent of the patients who received blood transfusions did not achieve SVR12 while every patient who did not require Electronic supplementary material The online version of this article (doi:10.1007/s40615-014-0039-x) contains supplementary material, which is available to authorized users. J. Wysocki (*) : C. Newby : L. Balart : N. Shores Department of Gastroenterology and Hepatology, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112, USA e-mail: transfusion achieved SVR12 (p=0.001). All patients with IL28B genotype CC achieved SVR12 (p=0.007). SVR12 did not differ among AA (77 %) and non-AA (86.4 %) (p=0.528). Keywords Hepatitis C . Hepatitis treatment . Triple therapy . Real-world experience . HCV treatment Introduction The prevalence of hepatitis C is higher in African-Americans compared to other races in the USA. According to NHANES III data, African-Americans had a prevalence of 3.2 % in the reported population compared to 1.5 % in the general US population [1–3]. Historically, African-Americans have been underrepresented in HCV trials. Mehlia et al. [4] concluded that African-Americans were 65 % less likely to be eligible for treatment given comorbidities such as cytopenia, diabetes mellitus, and chronic kidney disease. Given the prevalence of disease, especially in AfricanAmerican men born between 1945 and 1965, HCV related complications such as cirrhosis, decompensation, and HCC are a growing health concern [5]. A study from the National Center for Health Statistics suggests that racial disparities exist in HCV infection, with Africa-Americans having a twofold higher rate of death than expected [6]. Such trends are expected to continue, with the number of HCV cases and decompensation events peaking between 2020 and 2022. Enrollment of African-Americans in therapeutic trials for HCV has been disproportionate. According to 2011, US Census data estimated that 13.6 % of the population was African-American. The most recent major trials analyzing triple therapy treatment in HCV were able to enroll 7–27 % of the study participants as African-Americans [7–14]. Although improvements have been made in recruitment 320 diversity, the reality is that these are sponsored trials, with inclusion and exclusion criteria. A large percentage of African-Americans have not been eligible. There are no studies that describe this population of patients who do not qualify or do not choose to participate in drug trials. Furthermore, no single center has published real-world experiences that clinicians may expect to see from their diverse set of patients undergoing triple therapy for HCV. The goal of this study was to offer the largest cohort of triple therapy patients, with a specific focus on comparing the treatment experiences of Africa-Americans to non-African-Americans. J. Racial and Ethnic Health Disparities (2014) 1:319–325 Statistical Analysis Descriptive statistics for patients were reported in Table 1. A chi-squared test was used to compare categorical variables between White Americans and African-Americans. Continuous variables were summarized as means with standard deviation. ANOVA was performed to compare treatment outcomes relative to SVR12, ethnicity, and protease inhibitor. Significance was chosen to be <0.05. All statistical analysis was performed using SPSS. Results Methods Study Design This approved study is a retrospective, observational design conducted in a single center (Tulane Medical Center, Hepatology Clinic, New Orleans, LA, USA). Eligible candidates were patients with chronic HCV, genotype 1 as identified by detectable levels of serum HCV RNA (Roche COBAS TaqMan HCV assay), and HCV Genotype analysis (LabCorp, Burlington NC). IL28B genotype polymorphism (RT-PCR) was determined by a serum sample (LabCorp, Burlington NC). Severity of fibrosis was determined by liver biopsy, (FibroSure LabCorp, Burlington NC), or radiographic evidence. Additionally, eligibility required that subjects initiate and complete HCV triple therapy after July 2011, could not be a part of any other clinical/pharmaceutical trials, receive at least one dose of HCV protease inhibitor, and be at least 17 years of age. Patients were excluded if they received triple therapy treatment as part of an industry-sponsored clinical trial. Also, patients could not have concurrent HIV infection, hepatocellular carcinoma. Individual treatment regimens were based on the clinical judgment of his/her treating hepatologist. Data including labs, medications, clinic notes, nursing visits, and hospitalization records were extracted by hand from individual patient charts. End Points The primary end points were the comparative SVR12 of African-Americans versus White patients. Secondary endpoints included medication dosing, side effects, transfusion requirements, BMI, gender, previous treatment outcome, genotype, IL28B polymorphism, and final outcome (SVR12). Chen et al. recently demonstrated that the positive predictive value of SVR12 for SVR24 was 98 % and negative predictive value was 99 % [15]. As SVR12 was a treatment endpoint for this study, final treatment outcomes could vary slightly. A total of 35 patients w (...truncated)