Journal article
Patterns of viral load decline with telaprevir-based therapy in patients with genotype 1 chronic HCV infection
Journal of clinical virology, Vol.59(3), pp.148-155
03/2014
DOI: 10.1016/j.jcv.2013.12.011
PMID: 24462470
Abstract
Telaprevir-based therapy is associated with rapid decline in HCV RNA, enabling the application of early futility rules.
To familiarize physicians with this paradigm, a comprehensive analysis of the most frequent HCV viral load profiles observed during treatment with telaprevir/Peg-IFN/RBV in Phase III trials is provided.
HCV RNA profiles were analyzed from 320 HCV genotype 1 treatment-naïve patients enrolled in the ADVANCE study, and 225 prior Peg-IFN/RBV treatment-experienced patients enrolled in the REALIZE study. Patients received 12 weeks of telaprevir with either 24 or 48 weeks of Peg-IFN alfa-2a/RBV. Patients with missing SVR assessments during follow-up, detectable HCV RNA at end of treatment but who did not have viral breakthrough (vBT), or with early vBT who discontinued telaprevir before time of failure were excluded.
All analyzed patients experienced a rapid decline in HCV RNA (>2.0 log10) by Day 14, irrespective of baseline characteristics and/or prior response to Peg-IFN/RBV (relapse, partial response and null response). Subsequently, HCV RNA continued to decline to undetectable levels in most patients. These patients went on to have one of the following outcomes: sustained virologic response, late vBT (after Week 12, i.e. during the Peg-IFN/RBV phase), or relapse. In the small subset of patients with early vBT or meeting a futility rule before Week 12, HCV RNA usually never became undetectable and/or increased rapidly after reaching the nadir.
HCV RNA profiles with telaprevir/Peg-IFN/RBV are different from those with Peg-IFN/RBV alone. It is important that clinicians understand these HCV RNA profiles and monitor patient viral load in order to apply futility rules correctly.
Details
- Title: Subtitle
- Patterns of viral load decline with telaprevir-based therapy in patients with genotype 1 chronic HCV infection
- Creators
- Gaston Picchio - Janssen (United States)Sandra De Meyer - Janssen (Belgium)Inge Dierynck - Janssen (Belgium)Anne Ghys - Janssen (Belgium)Linda Gritz - Vertex Pharmaceuticals (United States)Tara L. Kieffer - Vertex Pharmaceuticals (United States)Douglas J. Bartels - Vertex Pharmaceuticals (United States)Jim Witek - Janssen (United States)Leif Bengtsson - Vertex Pharmaceuticals (United States)Donghan Luo - Janssen (United States)Robert S. Kauffman - Vertex Pharmaceuticals (United States)Nathalie Adda - Transgenomic (United States)Christoph Sarrazin - Goethe University Frankfurt
- Resource Type
- Journal article
- Publication Details
- Journal of clinical virology, Vol.59(3), pp.148-155
- DOI
- 10.1016/j.jcv.2013.12.011
- PMID
- 24462470
- NLM abbreviation
- J Clin Virol
- ISSN
- 1386-6532
- eISSN
- 1873-5967
- Publisher
- Elsevier B.V
- Grant note
- name: Janssen Infectious Diseases BVBA; name: Vertex Pharmaceuticals Incorporated; DOI: 10.13039/100008897, name: Janssen Pharmaceuticals
- Language
- English
- Date published
- 03/2014
- Academic Unit
- Anatomy and Cell Biology
- Record Identifier
- 9984284454302771
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