Sustained virologic response rates with telaprevir-based therapy in treatment-naive patients evaluated by race or ethnicity

Steven L. Flamm*, Andrew J. Muir, Michael W. Fried, K. Rajender Reddy, David R. Nelson, Natalie H. Bzowej, James C. Sullivan, Leif Bengtsson, Ralph DeMasi, Christopher I. Wright, Tara L. Kieffer, Shelley George, Nathalie Adda, Geoffrey M. Dusheiko

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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 languageEnglish (US)
Pages (from-to)336-344
Number of pages9
JournalJournal of Clinical Gastroenterology
Volume49
Issue number4
DOIs
StatePublished - Apr 22 2015

Keywords

  • Combination drug therapy
  • Ethnology
  • Hepatitis C virus
  • Liver diseases
  • Protease inhibitors

ASJC Scopus subject areas

  • Gastroenterology

Fingerprint Dive into the research topics of 'Sustained virologic response rates with telaprevir-based therapy in treatment-naive patients evaluated by race or ethnicity'. Together they form a unique fingerprint.

Cite this