Abstract
Background: The phase 3 studies of telaprevir (T) in combination with peginterferon α-2a and ribavirin (PR) in treatmentnaive genotype 1 chronic hepatitis C virus-infected patients (ADVANCE/ILLUMINATE) were not designed a priori to assess the effect of race and ethnicity on treatment response. However, these factors are important given the lower sustained virologic response (SVR) rates observed in black and Hispanic/Latino patients treated with PR. Goals: This retrospective pooled analysis evaluated the effect of race or ethnicity on treatment-naive patient response to telaprevirbased therapy and assessed resistant variant profiles. Materials and Methods: This analysis comprised patients enrolled in ADVANCE (N=363) and ILLUMINATE (N=540) who received 12 weeks of telaprevir in combination with PR followed by 12 or 36 weeks of PR alone and patients in ADVANCE (N=361) who received 48 weeks of PR alone. Race and ethnicity were selfreported and not mutually exclusive. Results: Higher SVR rates were observed with telaprevir-based therapy compared with PR in blacks [n=99 (62%) vs. n=28 (29%), respectively] and in Hispanics/Latinos [n=89 (72%) vs. n=38 (39%)]. The SVR was lower in telaprevir-treated blacks [n=99 (62%)] compared with nonblacks [n=791 (78%)] and in Hispanic/Latinos compared with non-Hispanics/Latinos [n=89 (72%) vs. n=801 (76%)]. Low discontinuation rates due to adverse events, including rash and anemia, were observed across subgroups. Resistance profiles were similar among the subgroups. Conclusions: Treatment-naive black and Hispanic/Latino patients with genotype 1 chronic hepatitis C virus infection may benefit from telaprevir-based therapy, an important finding given the lower SVR rates observed in these patients when they are treated with PR alone.
Original language | English (US) |
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Pages (from-to) | 336-344 |
Number of pages | 9 |
Journal | Journal of Clinical Gastroenterology |
Volume | 49 |
Issue number | 4 |
DOIs | |
State | Published - Apr 22 2015 |
Keywords
- Combination drug therapy
- Ethnology
- Hepatitis C virus
- Liver diseases
- Protease inhibitors
ASJC Scopus subject areas
- Gastroenterology