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100% SVR in IL28B SNP rs12979860 C/C patients treated with 12 weeks of telaprevir, peginterferon and ribavirin in the PROVE2 trial
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Reported by Jules Levin EASL 2012
Apr 18-22 Barcelona Spain
Bronowicki J-P1, Hezode C2, Bengtsson L3*, Pol S4, Bourliere M5, Serfaty L6, De Ledinghen V7, Tran A8, Benhamou Y9, Grange JD10, Mathurin P11, Marcellin P12, Trepo C13, Zarski J-P14, Seepersaud S3*, Kelliher K3*, Botfield M3*, Pawlotsky J-M2.
Nancy1; 2. Creteil; 3. VERTEX Pharmaceuticals Incorporated, Cambridge, USA; 4. Paris Cochin; 5. Marseille; 6. Paris St Antoine; 7. Bordeaux; 8. Nice; 9. Paris Pitie; 10. Paris Tenon; 11. Lille; 12. Clichy; 13. Lyon; 14. Grenoble - France, USA
*BL, SS, KK, and BM are employees and stock owners of Vertex Pharmaceuticals
ABSTRACT
Background and aim: The IL28B genotype is the strongest predictor of the sustained virological response (SVR) to peginterferon-based therapy. Of patients genotyped for IL28B in the ADVANCE trial, 90 % of genotype 1 patients with the IL28B CC genotype who received telaprevir, peginterferon and ribavirin achieved an SVR, most of them were eligible to receive 24-week total therapy. The aim of the present study was to evaluate SVR rates in CC and non-CC patients included in the PROVE2 trial who received 12 weeks of triple combination therapy.
Methods: In the PROVE2 trial, non-cirrhotic European treatment-naïve patients infected with HCV genotype 1 were randomized to 4 arms: 1) T12PR12: telaprevir (T), peginterferon alpha-2a (P) and ribavirin (R) for 12 weeks; 2) T12PR24: TPR for 12 weeks followed by PR for 12 weeks; 3) T12P12 (without R for 12 weeks); and 4) PR48 (control): PR for 48 weeks. The IL28B genotype at polymorphic site rs12979860 was determined in de-identified left-over specimens from treatment-naïve genotype 1 HCV patients from the PROVE2 French sites.
Results: 156 of 171 patients provided informed consent for genetic testing; data were available in 141 of them. Their characteristics were: male: 64%; mean age: 44.5 years; mean BMI: 23.7 kg/m2, mean baseline viral load: 6.5 log10 IU/mL, genotype 1 subtype: 1a 34%, 1b 52%, unknown 14%; Metavir fibrosis: F0 10%, F1 53%, F2 27%, F3 10%. The IL28B genotype was CC in 43 patients, CT in 83 and TT in 15. SVR rates according to the IL28B genotype are shown in the table in the different treatment arms. With the dosing regimen in this study, 100% of the CC patients achieved SVR with 12 weeks of triple combination therapy.
Conclusion: These results suggest that 12 weeks of the triple combination of telaprevir, peginterferon and ribavirin may be sufficient to cure IL28B CC treatment-naïve Caucasian/White patients infected with HCV genotype 1 without cirrhosis.
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