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01.12.2018 | Research | Ausgabe 1/2018 Open Access

Virology Journal 1/2018

A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection

Zeitschrift:
Virology Journal > Ausgabe 1/2018
Autoren:
Fabien Zoulim, Christophe Moreno, Samuel S. Lee, Peter Buggisch, Andrzej Horban, Eric Lawitz, Chris Corbett, Oliver Lenz, Bart Fevery, Thierry Verbinnen, Umesh Shukla, Wolfgang Jessner
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12985-018-0936-4) contains supplementary material, which is available to authorized users.

Abstract

Background

Simeprevir is approved with pegylated interferon and ribavirin (PR) for chronic hepatitis C virus (HCV) genotype (GT) 1 and GT4 infection in the USA and the European Union.

Methods

This 3-year follow-up study assessed the durability of sustained virologic response (SVR) (undetectable HCV RNA 12 or 24 weeks after treatment end), and evaluated the persistence of treatment-emergent NS3/4A protease inhibitor resistance in patients not achieving SVR following treatment with simeprevir plus PR in the parent study. The maintenance of SVR after the last post-therapy follow-up visit of the parent study (LPVPS) was assessed using HCV RNA measurements. The persistence of treatment-emergent NS3 amino acid substitutions in patients with no SVR at LPVPS was assessed using population sequencing. No study medications were administered.

Results

Overall, 249 patients were enrolled (200 with SVR at LPVPS; 49 with no SVR at LPVPS); 40 patients discontinued prematurely (18 with SVR; 22 with no SVR). All 200 enrolled patients who achieved SVR in the parent study maintained SVR until the last available visit in this study (median follow-up time: 35.8 months). The treatment-emergent NS3 amino acid substitutions detected at time of failure in the parent study in 43/49 enrolled patients were no longer detected in 37/43 (86.0%) at the end of this study (median follow-up time: 179.9 weeks [41.3 months]).

Conclusion

This 3-year follow-up study provides evidence for the long-term durability of SVR (100%) after successful treatment with simeprevir plus PR. Treatment-emergent NS3 amino acid substitutions became undetectable in the majority of patients.

Trial registration

NCT01349465; ClinicalTrials.​gov.
Zusatzmaterial
Additional file 1: Results (liver disease evolution) Description of data: Hepatic disease progression was assessed as a secondary objective in this study with optional data collection, and the limited data available are displayed in this additional file. (DOCX 17 kb)
12985_2018_936_MOESM1_ESM.docx
Literatur
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