Lead-in period and week 8 as predictive tools for response to boceprevir therapy: a retrospective study of Spanish real clinical practice

Autores de IIS La Fe

• 

  Marina Berenguer Haym

  Autor

• Iker Fernandez Navamuel

  Autor

• José López Aldeguer

  Autor

Participantes ajenos a IIS La Fe

• Crespo J
• Pérez F
• González O
• Bárcena R
• Buti M
• Calleja JL
• en representación del grupo de investigadores del estudio LEAD-IN

Grupos

• Hepatología, Cirugia Hepatobiliopancreática y Trasplantes

• Investigacion clínica en enfermedades crónicas e Infección por el VIH

Abstract

Introduction: Most discontinuations due to lack of virological response occur during the first few weeks of hepatitis c virus (HCV) triple therapy. Improved knowledge of baseline factors and their correlation with boceprevir decision points may predict treatment success. Methods: An observational, retrospective study was conducted to describe the lead-in period as a clinical decision tool in HCV genotype 1 patients treated with boceprevir. Data were collected from the medical records of 186 consecutive patients distributed across 20 Spanish general hospitals. Results: This study included 171 patients. A total of 80% had fibrosis F3/F4, 74% were previously treated, and 26% were treatment-naive. After the lead-in period, 54.5% of the patients had a reduction of >= 1 log(10); this reduction occurred in 52.5% of those with advanced fibrosis. Boceprevir therapy was started in 94% of the patients. Discontinuations at week 4 were limited to null responders with cirrhosis. The baseline factors associated with virological response at week 4 were IL28B, previous response, and fibrosis score. At week 8, HCV-RNA was undetectable in 48.8% of the patients. The correlation between responses at weeks 8 and 12 was 88%. Conclusion: In the Spanish clinical setting, lead-in was mainly used as a clinical decision point for non-responders with cirrhosis. The good correlation between stopping rules at weeks 8 and 12 could be used to anticipate discontinuation, thus saving adverse events and costs. (C) 2015 Elsevier Espana, S.L.U. and AEEH y AEG. All rights reserved.

Keywords

• HCV; lead-in; boceprevir; pegylated interferon; ribavirin; SVR