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Nationwide experience of treatment with protease inhibitors in chronic hepatitis C patients in Denmark: identification of viral resistance mutations. | LitMetric

AI Article Synopsis

  • The study aimed to assess treatment outcomes and viral resistance in patients with chronic HCV genotype 1 infection undergoing triple therapy (protease inhibitors, pegylated-interferon, and ribavirin) in a typical clinical setting.
  • Of the 80 patients, only 47% achieved a cure, while the rest faced treatment discontinuation or relapse, with many displaying resistance to protease inhibitors.
  • The findings indicate a much lower cure rate compared to clinical trials, with a notable connection between treatment failure and the presence of resistance variants, particularly V36M and R155K.

Article Abstract

Background And Aims: The first standard of care in treatment of chronic HCV genotype 1 infection involving directly acting antivirals was protease inhibitors telaprevir or boceprevir combined with pegylated-interferon and ribavirin (triple therapy). Phase III studies include highly selected patients. Thus, treatment response and development of viral resistance during triple therapy in a routine clinical setting needs to be determined. The aims of this study were to investigate treatment outcome and identify sequence variations after triple therapy in patients with chronic HCV genotype 1 infection in a routine clinical setting.

Methods: 80 patients, who initiated and completed triple therapy in Denmark between May 2011 and November 2012, were included. Demographic data and treatment response were obtained from the Danish Database for Hepatitis B and C. Direct sequencing and clonal analysis of the RT-PCR amplified NS3 protease were performed in patients without cure following triple therapy.

Results: 38 (47%) of the patients achieved cure, 15 (19%) discontinued treatment due to adverse events and remained infected, and 27 (34%) experienced relapse or treatment failure of whom 15 of 21 analyzed patients had well-described protease inhibitor resistance variants detected. Most frequently detected protease variants were V36M and/or R155K, and V36M, in patients with genotype 1a and 1b infection, respectively.

Conclusions: The cure rate after triple therapy in a routine clinical setting was 47%, which is substantially lower than in clinical trials. Resistance variants towards protease inhibitors were seen in 71% of patients failing therapy indicating that resistance could have an important role in treatment response.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4249835PMC
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113034PLOS

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