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Hepatol Commun. 2017 May 22;1(5):379-390. doi: 10.1002/hep4.1050. eCollection 2017 Jul.

Sequencing of hepatitis C virus for detection of resistance to direct-acting antiviral therapy: A systematic review.

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Kirby Institute University of New South Wales Sydney Australia.
School of Medical Sciences, Faculty of Medicine University of New South Wales Sydney Australia.
Monogram Biosciences, Laboratory Corporation of America Holdings South San Francisco CA.
British Columbia Centre for Excellence in HIV/AIDS, St Paul's Hospital Vancouver Canada.
Forum for Collaborative HIV Research University of California Berkeley Washington DC.
Department of Experimental Medicine and Surgery University of Rome Tor Vergata Rome Italy.
Storr Liver Centre, The Westmead Institute for Medical Research University of Sydney Sydney Australia.
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Antiviral Products Silver Spring MD.
Department of Medicine University of Florida College of Medicine Gainesville FL.
National Reference Center for Viral Hepatitis B, C, and D, Department of Virology and INSERM U955, Hopital Henri Mondor Université Paris-Est Creteil France.
Toronto Western Hospital Liver Centre, University Health Network University of Toronto Toronto Canada.
Department of Medical Microbiology Academic Medical Center Amsterdam the Netherlands.
Clinical Microbiology Service Complejo Hospitalario Universitario de Granada Granada Spain.
Section of Clinical Virology, Department of Medical Science Uppsala University Uppsala Sweden.


The significance of the clinical impact of direct-acting antiviral (DAA) resistance-associated substitutions (RASs) in hepatitis C virus (HCV) on treatment failure is unclear. No standardized methods or guidelines for detection of DAA RASs in HCV exist. To facilitate further evaluations of the impact of DAA RASs in HCV, we conducted a systematic review of RAS sequencing protocols, compiled a comprehensive public library of sequencing primers, and provided expert guidance on the most appropriate methods to screen and identify RASs. The development of standardized RAS sequencing protocols is complicated due to a high genetic variability and the need for genotype- and subtype-specific protocols for multiple regions. We have identified several limitations of the available methods and have highlighted areas requiring further research and development. The development, validation, and sharing of standardized methods for all genotypes and subtypes should be a priority. (Hepatology Communications 2017;1:379-390).

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