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Telaprevir, HCV Protease Inhibitor: results from PROVE1 and PROVE2 Studies at DDW
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ABSTRACTS from program book
Prove2 Study: Treatment of Chronic Hepatitis C with Telaprevir (TVR)in Combination with Peginterferon-Alfa-2a with or Without Ribavirin, Interim Analysis Results
160. Prove2 study: Treatment of chronic hepatitis C with Telaprevir (TVR)in combination with Peginterferon-alfa-2a with or without Ribavirin, Interim Analysis Results
Prove1: Results from a Phase 2 Study of Telaprevir with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Subjects with Hepatitis C
Gregory T Everson2, Ira M Jacobson5, Stuart C Gordon3, John G McHutchison4, Robert Kaufman1, Lindsay McNair1, Andrew Muir4
1. Vertex Pharamceuticals Inc., Cambridge, MA, USA, 2. University of Colorado Health Sciences Center, Aurora, CO, USA, 3. Henry Ford Health System, Detroit, MI, USA, 4. Duke Clinical Research Institute, Durham, NC, USA, 5. Weill Medical College of Cornell, New York, NY, USA
Background: PROVE1 is a randomized, placebo-controlled Phase 2 study of 750 mg q8h telaprevir (TVR) with Peg-IFN-alfa-2a 180 microg/week (P) and ribavirin 1000-1200 mg/day (R), in naive subjects with genotype 1 hepatitis C. 250 subjects were randomized into 4 groups: 175 subjects received TVR/PR for 12wks followed by PR for 0 (D:12wk:TVR/PR, n=17), 12 (C:24wk:TVR/PR, n=79) or 36wks (B:48wk:TVR/PR, n=79); the control group (A:48wk:PR, n=75) received 48wks of PR.
Methods: ITT analysis was performed when all subjects completed treatment and 24-week post-treatment follow-up.
Results:
There was a significant increase in the proportion of subjects with undetectable HCV RNA (LOD 10 IU/mL) in all TVR/PR groups compared to the control group at wk4 (RVR: 79% vs 11%) and at wk12 (70% vs 39%).
During the first 12wks, 9% of subjects in the TVR/PR groups never reached undetectable HCV RNA levels compared to 57% of subjects in the PR group.
At the EOT, the proportion of subjects with undetectable HCV RNA was substantially higher in the 48wk: TVR/PR group (B) than in the 48wk: PR control group (65% vs 45%).
The SVR rate for subjects in the 24wk: TVR/PR group (C) was substantially higher than in subjects in the 12wk: TVR/PR group (D) (61% vs 35%).
The relapse rate in patients with RVR who completed 12, and 24 weeks of therapy was 3/9 (33%) and 1/42 (2.4%), respectively.
Adverse events (AEs) leading to discontinuations were more frequent in the TVR/PR groups (13% vs. 3%). Rashes, gastrointestinal events and anemia were more common, and rashes more severe in the TVR/PR groups.
Grade 3 AEs were reported in 27.4% of subjects in the TVR/PR groups, and 24% of subjects in the PR control group. 11.4% of the subjects in the TVR/PR groups reported serious AEs compared to 5.3% in the PR control group.
Conclusions: Compared with current treatment, TVR-based therapy resulted in a high rate of RVR and subsequent on-treatment response rate. These results suggest potential for higher SVR rates with shorter duration of therapy in subjects with genotype 1. The final analysis will be executed when all subjects have completed 24-week post-treatment follow-up.
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