In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions
Article first published online: 20 NOV 2013
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Volume 34, Issue 7, pages e217–e228, August 2014
How to Cite
Liver Int. 2014: 34: e217–e228
- Issue published online: 17 JUL 2014
- Article first published online: 20 NOV 2013
- Accepted manuscript online: 6 OCT 2013 09:26PM EST
- Manuscript Accepted: 25 SEP 2013
- Manuscript Received: 20 MAY 2013
- F. Hoffman-La Roche Ltd
- abbreviated therapy;
- clinical practice;
- hepatitis C;
- peginterferon alfa/ribavirin;
- physician behaviour;
- PROPHESYS ;
- ribavirin dose;
- treatment decisions;
- viral kinetics
Background & Aims
PROPHESYS is a large, multinational, non-interventional prospective cohort study of chronic hepatitis C patients treated with peginterferon alfa/ribavirin. This subanalysis assesses rates of premature treatment discontinuation stratified by on-treatment virological response (VR).
This PROPHESYS subanalysis is restricted to treatment-naive, hepatitis C virus (HCV) genotype (G)1/2/3 mono-infected patients who received peginterferon alfa-2a (40KD)/ribavirin with intended treatment duration of 48 (G1) or 24 weeks (G2/3). Early virological responses were classified into four mutually exclusive categories [rapid VR (RVR), complete early VR (cEVR), partial EVR (pEVR), no RVR/EVR], using standard criteria.
The likelihood for shortening treatment owing to good efficacy was highest among patients with an RVR and HCV RNA ≤400 000 IU/ml (G1 10.0%; G2/3 5.8%) whereas for poor efficacy, it was highest in G1 non-RVR/EVR patients with HCV RNA >400 000 IU/ml (56.6%). Factors significantly associated with early treatment discontinuation as a result of good efficacy in G1 patients included RVR vs. no RVR/EVR and, at baseline, lower HCV RNA, lower FIB-4 score, HCV infection via injection drug use. For G2/3 patients, factors included lower baseline HCV RNA and G2 vs. G3 infection. Most patients started with the recommended peginterferon alfa-2a dose, but a high proportion received a higher-than-recommended ribavirin dose.
Despite international guidelines, few physicians used early viral kinetics to abbreviate treatment. Therefore, relatively few patients with an RVR and low baseline HCV RNA abbreviated treatment. In addition, there were deviations in ribavirin starting doses, suggesting that physicians tailor treatment according to local guidelines or previous experience.