Sustained virologic response rates with telaprevir-based therapy in treatment-naive patients evaluated by race or ethnicity.
BACKGROUND
The phase 3 studies of telaprevir (T) in combination with peginterferon α-2a and ribavirin (PR) in treatment-naive 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.


OBJECTIVE
This retrospective pooled analysis evaluated the effect of race or ethnicity on treatment-naive patient response to telaprevir-based therapy and assessed resistant variant profiles.


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 self-reported 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.
*Department of Medicine and Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL †Duke Clinical Research Institute, Durham ‡University of North Carolina at Chapel Hill, Chapel Hill, NC §University of Pennsylvania School of Medicine, Philadelphia, PA ∥Department of Medicine, University of Florida, Gainesville, FL ¶California Pacific Medical Center, San Francisco, CA #Vertex Pharmaceuticals Incorporated, Cambridge, MA **Janssen Research & Development, Titusville, NJ ††Royal Free and University College, London, UK.
Steven L
SL
Flamm
Andrew J
AJ
Muir
Michael W
MW
Fried
K Rajender
KR
Reddy
David R
DR
Nelson
Natalie H
NH
Bzowej
James C
JC
Sullivan
Leif
L
Bengtsson
Ralph
R
DeMasi
Christopher I
CI
Wright
Tara L
TL
Kieffer
Shelley
S
George
Nathalie
N
Adda
Geoffrey M
GM
Dusheiko
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000208:ethnology*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D019562:Viral Load / Q000187:drug effects*; D055815:Young Adult
D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C100416:peginterferon alfa-2a