EX-99.1 2 a08-8996_1ex99d1.htm EX-99.1

 

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.