High sustained virologic response rates in rapid virologic response patients in the large real-world PROPHESYS cohort confirm results from randomized clinical trials

Authors


  • Potential conflicts of interest: P.M., Consulting: Roche, Gilead, BMS, Vertex, Novartis, Pharmasset, Janssen, Tibotec, MSD, Abbott; Grant/Research Support: Roche, Gilead, BMS, Vertex, Novartis, Pharmasset, Janssen - Tibotec, MSD, Boehringer Ingelheim, Abbott Pfizer, Echosens; Speaking and Teaching: Roche, Gilead, BMS, Novartis, Pharmasset, Janssen, Tibotec, MSD; H.C., Advisory Committees or Review Panels: Janssen, Roche; Grant/Research Support: Bristol-Myers Squibb, Janssen, Roche; Speaking and Teaching: Janssen, Roche; P.F., Advisory Committees or Review Panels: Roche; Speaking and Teaching: Roche; Grant/Research Support: Roche; A.H., Advisory Committees or Review Panels: Gilead, Tibotec; D.J., Advisory Committees or Review Panels: Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, Roche/Genentech, Merck, Pharmasset, Tibotec/J&J, Vertex, Pfizer; D.O., Consulting: Roche; M.P., Advisory Committees or Review Panels: Roche, MSD; M.R.T., Consulting: Hoffmann-La Roche, Abbott Labs, Anadys, Pharmasset, Akros, Bristol-Myers Squibb, Novartis, Merck, Inhibitex, Santaris, Glaxo Smithcline; Grant/Research Support: Vertex, Hoffmann-La Roche,GSK, Novartis, Bristol-Myers Squibb, Vertex Pharm, Idera, Conatus, Genentech, Mochida, Pharmasset, Sanofi-Aventis, Merck, Pfizer, Human Genome Sciences, Gilead, Johnson & Johnson, Zymogenetics, Akros, Scynexis, Santaris, Boehringer, Inhibitex, Idenix, Siemens, Anadys; M.L.S., Consulting: Conatus, Human Genome Sciences, Pfizer, Roche/Genentech. Romark, Merck,Exalenz; Speaking and Teaching: Bayer, BMS, Gilead, Roche/Genentech, Schering-Plough/Merck, Vertex,, Salix; Grant/Research Support: Abbott, Achillion, Anadys, BMS, Boehringer Ingelheim, Conatus, Gilead, Globeimmune, Human Genome Sciences, Idenix, Novartis, Roche/Genentech, Schering-Plough/Merck, Vertex, Zymogenetics, Mochida; Advisory Committees or Review Panels: Abbott, Achillion, Anadys, Bayer, BMS, Boehringer-Ingelheim, Conatus, Gilead, Globeimmune, Human Genome Sciences, Novartis, Pfizer, Roche/Genentech, Schering-Pough/Merck, Vertex, Zymogenetics; M.S. is an employee of IST GmBH. IST GmBH, have a contract with Roche to provide statistical support; F.T. is an employee of F. Hoffmann-La Roche and a shareholder of F. Hoffmann-La Roche; M.R., Advisory Committees or Review Panels: Roche, BMS, Merck, Janssen; M.C., G.M.D., G.L., A.M. have nothing to disclose.

  • Funded by Roche. Support for third-party writing assistance for this article was provided by F. Hoffmann-La Roche Ltd.

Abstract

The ability to predict which patients are most likely to achieve a sustained virologic response (SVR) with peginterferon/ribavirin would be useful in optimizing treatment for hepatitis C virus (HCV). The objective of this large international noninterventional cohort study was to investigate the predictive value (PV) of a virologic response (VR) by weeks 2, 4, and 12 of treatment on SVR. Treatment-naive HCV monoinfected patients (N = 7,163) age ≥18 years were prescribed peginterferon/ribavirin at the discretion of the treating physician according to country-specific requirements in accordance with the local label. The main outcome measure was the PV of a VR (HCV RNA <50 IU/mL) by weeks 2, 4, and 12 of treatment for SVR24 (HCV RNA <50 IU/mL after 24 weeks of untreated follow-up) by HCV genotype. The overall SVR24 rate was 49.4% (3,541/7,163; 95% confidence interval [CI]: 48.3-50.6%). SVR24 rates in patients with an HCV RNA titer <50 IU/mL by weeks 2, 4, and 12, respectively, were 66.2% (95% CI: 60.4-71.7%), 68.4% (95% CI: 65.7-71.0%), and 60.3% (95% CI: 58.5-62.1%) among genotype 1 patients; 82.0% (95% CI: 76.8-86.5%), 76.3% (95% CI: 73.3-79.1%), and 74.2% (95% CI: 71.3-76.9%) among genotype 2 patients; 67.3% (95% CI: 61.1-73.1%), 67.3% (95% CI: 64.2-70.3%), and 63.8% (95% CI: 61.0-66.6%) among genotype 3 patients; and 59.4% (95% CI: 40.6-76.3%), 63.3% (95% CI: 54.3-71.6%), and 54.3% (95% CI: 47.5-60.9%) among genotype 4 patients. The absence of a VR by week 12 had the highest negative PV across all genotypes. Conclusion: A VR by week 2 or 4 had the highest positive PV for SVR24 and differed according to HCV genotype. (HEPATOLOGY 2012;56:2039–2050)

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