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Published on: October 11, 2013
Hepatitis C late relapse in patients with directly acting antiviral-related sustained virological response at week 12
Mariantonietta Pisaturo1, Carmine Minichini1, Mario Starace1
1Laboratory for the Identification of Prognostic Factors of Response to the Treatment Against Infectious Diseases, University of Campania, Naples, Italy.
Insights
Late relapse after Hepatitis C Virus (HCV) direct-acting antiviral (DAA) therapy is infrequent but can occur. This study identified late relapses and suggests a 72-week post-treatment follow-up for HCV patients.
Area of Science:
- Hepatology
- Virology
- Infectious Diseases
Background:
- Direct-acting antiviral (DAA) regimens have revolutionized Hepatitis C Virus (HCV) treatment.
- Sustained virological response (SVR) is the primary goal of HCV therapy.
- Understanding treatment failure patterns, including late relapse, is crucial for optimizing patient management.
Purpose of the Study:
- To identify patients experiencing late relapse after DAA therapy.
- To characterize the clinical, epidemiological, and virological features of patients with late relapse.
- To evaluate the implications for post-treatment follow-up duration.
Main Methods:
- Enrolled 129 HCV patients who did not respond to an IFN-free regimen.
- Performed Sanger sequencing of NS3, NS5A, and NS5B regions at treatment failure.
- Utilized phylogenetic analysis for available pre-treatment serum samples.
Main Results:
- A late relapse (after 12 weeks post-DAA) occurred in 5.4% (7/129) of patients.
- Phylogenetic analysis suggested reactivation of the initial HCV strain in two late relapse cases.
- Re-infection could not be excluded in five other late relapse cases due to lack of pre-treatment samples.
Conclusions:
- Late relapse after DAA therapy is an infrequent event.
- The findings support the need for extended post-treatment follow-up, potentially up to 72 weeks.
- Further investigation into the mechanisms and implications of late HCV relapse is warranted.
Aim:
The aim of the present study was to identify, among the patients with failure to DAA regimen, those with a late relapse (after the achievement of a sustained virological response at week 12) and to characterize the clinical, epidemiological and virological features of these patients.
Material And Methods:
A total of 129 HCV patients with non-response to an IFN-free regimen were enrolled. Sanger sequencing of NS3, NS5A and NS5B was performed at failure by home-made protocols.
Results:
Of the 129 patients enrolled, 8 (6.2%) experienced a breakthrough, 15 (11.7%) non-response, 99 (76.7%) a relapse by week 12 after the end of DAA therapy, and 7 (5.4%) a late relapse (after week 12; median 24 weeks, range 24-72). For two of the seven patients with a late relapse, a serum sample collected before the start of the DAA regimen was available; phylogenetic analysis showed no change in sequences of NS3, NS5A and NS5B regions, suggesting a reactivation of the initial HCV strain; for the remaining five patients, no serum collected before the DAA regimen was available, and thus, a re-infection cannot be excluded.
Conclusions:
Although a late relapse is infrequent, the study suggests a post-treatment follow-up of 72 weeks.
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