EASL: Telaprevir in combination with Peg-INF2a and RBV increased SVR rates in treatment-naive patients regardless of race or ethnicity

Some impressive Telaprevir TVR) treatment naive pooled analysis data to be presented at the upcoming EASL meeting in Berlin, looking at SVR rate differences between race and ethnicity in the ADVANCE and ILLUMINATE trials. Specifically, differences between the TVR arms and Peg-inf2a/Ribavirin (PR). Most impressive were the differences in SVR, relapse and viral failure in Black/African American subjects. In the TVR + PR for 12 weeks, then PR for another 12 or 36 weeks depending on viral response, total SVR was 61%, relapse was 13% and viral failure was 9%. Compare this to the 48 week PR control arm, which showed 25% SVR, 36% relapse and 46% viral failure. Total TVR-related SVR was still lower than non-Black/African Americans (61% vs 75%, respectively) but the improvement from the current standard of care (48 weeks of PR) is significant and encouraging. See the full poster abstract here: http://www1.easl.eu/easl2011/program/Posters/Abstract222.htm

TELAPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN INCREASED SUSTAINED VIROLOGIC RESPONSE RATES IN TREATMENT-NAïVE PATIENTS REGARDLESS OF RACE OR ETHNICITY

G.M. Dusheiko1*, M.W. Fried2, R. Reddy3, D.R. Nelson4, N. Bzowej5, N. Adda6, C.I. Wright6, L. Bengtsson6, S. George6, S.L. Flamm7

1Royal Free and University College, London, UK, 2University of North Carolina at Chapel Hill, Chapel Hill, NC, 3University of Pennsylvania School of Medicine, Philadelphia, PA, 4University of Florida, Gainesville, FL, 5California Pacific Medical Center, San Francisco, CA, 6Vertex Pharmaceuticals Incorporated, Cambridge, MA, 7Northwestern University, Chicago, IL, USA. *g.dusheiko@medsch.ucl.ac.uk

Background and aims: ADVANCE and ILLUMINATE were Phase 3 randomized studies that evaluated the safety and efficacy of telaprevir (T) in combination with peginterferon alfa-2a (P) and ribavirin (R) in treatment-naïve genotype 1 HCV patients. In this pooled analysis, we evaluated the effect of race or ethnicity on the response to treatment with telaprevir-based therapy.

Methods: Patients who received 12 weeks of response-guided telaprevir-based therapy for a total treatment duration of 24 or 48 weeks (ADVANCE N=903 and ILLUMINATE N=540) were compared to ADVANCE patients who received 48 weeks of PR alone (N=361). Race and ethnicity were self-reported and were not mutually exclusive. Ethnicity was not reported in 13 patients as the question was not allowed per local regulations.

Results: Efficacy outcomes are presented in the Table. The most common ( ≥ 25% in any subgroup) adverse events in patients who received telaprevir-based therapy were: fatigue, pruritus, nausea, headache, anemia, rash, influenza-like illness, insomnia, neutropenia, and diarrhea. Discontinuations of all drugs during telaprevir phase were: due to adverse events (7% in T12PR and 4% in PR), rash events (1% in T12PR and 0% in PR) and anemia events (1% in T12PR and < 1% in PR).

View table here: http://www1.easl.eu/easl2011/program/Posters/Abstract222.htm

Conclusions: Telaprevir-based therapy provided a substantial improvement in SVR rates in Black/African American and Hispanic/Latino patient populations known to achieve lower SVR rates when treated with PR alone. Low rates of discontinuations of all drugs due to adverse events, rash and anemia events were observed across all subgroups during the telaprevir phase.