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

• Published in: Journal of racial and ethnic health disparities 2014-12, Vol.1 (4), p.319-325
• Main Authors: Wysocki, John, Newby, Celeste, Balart, Luis, Shores, Nathan
• Format: Article
• Language: English
• Subjects: African Americans; Blood platelets; Blood transfusion; Blood transfusions; Cirrhosis; Clinical outcomes; Clinical research; Clinical trials; Efficacy; Epidemiology; First generation; Genotype & phenotype; Genotypes; Hepatitis C; Liver cancer; Liver cirrhosis; Medicine; Medicine & Public Health; ORIGINAL PAPERS; Patients; Polymorphism; Population; Protease inhibitors; Proteinase inhibitors; Quality of Life Research; Race; Social Inequality; Social Structure; Statistical analysis; Therapy
• ISSN: 2197-3792; 2196-8837
• DOI: 10.1007/s40615-014-0039-x

Real-world experience with HCV medications differs from original the index studies. African-Americans (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 non-AA 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 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).