Exhibit 99.1
A STUDY OF TELAPREVIR (TVR) WITH PEGINTERFERON ALFA-2A (P) AND RIBAVIRIN (R) IN SUBJECTS WITH WELL-DOCUMENTED PRIOR P/R NULL RESPONSE, NON-RESPONSE OR RELAPSE: PRELIMINARY RESULTS
Fred Poordad, Mitchell Shiffman, Kenneth Sherman, Jill Smith, Min Yao, Shelley George, Nathalie Adda, John McHutchison for the VX06-950-107 Study Team
Background: VX06-950-107 is an ongoing open-label study of TVR/P/R in genotype 1 HCV subjects who failed to achieve SVR in the control arms (P/R) of the TVR Phase 2 studies. Study 107 provides a unique opportunity to correlate within individual subjects the anti-viral response to TVR/P/R with that of their original response to P/R. In this preliminary analysis we evaluated the anti-viral response to TVR/P/R at week 4 in non-responders to P/R.
Methods: Null-responders (NR) (<1 log10 decrease at week 4 or < 2 log10 decrease at week 12), non-responders at W24 (HCV RNA detectable) and relapsers from the P/R arms of PROVE studies were eligible. Study dosing consisted of 12 weeks TVR 750 mg q8 hour + P/R at standard doses, followed by 12 weeks P/R. In this study, subjects with HCV RNA >25IU/mL (Taqman™ assay; LOQ 25 IU/mL) at Week 4 met a stopping rule and discontinued.
Results: To date 54 subjects were enrolled, 52 were dosed and 32 completed Week 4 assessment: 24 male/8 female with median age of 51.5 years, 28 Caucasians, 3 Blacks, 1 Hispanic. Median baseline HCV RNA was 6.9 Log10IU/ml. 1 subject discontinued TVR and R due to fatigue. Results by prior virologic response to P/R regimen are summarized below:
Prior P/R Virologic Responses
in Phase 2 Studies | | HCV RNA at Week 4 on TVR/P/R
(12+12 regimen) |
| N | | <25 IU/mL
n (%)
Did not meet
Stopping Rule | | ≥25 IU/mL
n (%)
Met Stopping
Rule |
Week 4 NR | | 17 | | 12 (71) | | 5(a) (29) |
Week 12 NR | | 3 | | 2 (67) | | 1(b) (33) |
Week 24 detectable | | 7 | | 7 (100) | | 0 |
Week 20 Breakthrough | | 1 | | 1 (100) | | 0 |
Relapsers | | 4 | | 4 (100) | | 0 |
(a) 1 with 33, 1 with 43, 3 with >100 IU/mL
(b) 1 with 28 IU/mL
Conclusions: With TVR/P/R, 70% (14/20) of null responder subjects, 100% (7/7) of Week 24 detectable and 100% (4/4) relapsers to P/R achieved < 25 IU/mL at week 4. Only one subject had a virologic breakthrough. These results are promising, however SVR rates are yet to be determined.
