Virologic Tools for HCV Drug Resistance Testing

Fourati, Slim; Pawlotsky, Jean‐Michel

doi:10.3390/v7122941

Cited by 49 publications

(54 citation statements)

References 86 publications

(114 reference statements)

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“…Resistance testing relies on inhouse techniques based on populations sequencing (reporting resistance-associated substitutions, RASs, as "present" or "absent") or deep sequencing (only RASs that are present in more than 15% of sequences generated are considered) [B1] [34]. Because access to reliable HCV resistance testing is not universally available and there is no consensus on the techniques or the interpretation of these tests, SRGH does not recommend systematic assessment of HCV resistance prior treatment at this moment [B1] [35].…”

Section: Virusologic Assessmentmentioning

confidence: 99%

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Gheorghe

Sporea

Iacob

et al. 2017

JGLD

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Background & Aims: Hepatitis C Virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments became available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country.Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention has been created. These items were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the first of the two parts of our Society’s recommendations for chronic HCV infection treatment. An agreement was reached regarding the diagnostic tools, the assessment of severity and the up-dated therapy schedules.Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to the real-life conditions in this country.Abbreviations: DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESLD: End-stage liver disease; ESRD: End-stage renal disease; eGFR: Estimated glomerular filtration rate; EASL: European Association for the Study of the Liver; EMA: European Medicines Agency; FDA: US Food and Drug Administration; FDC: Fixed-dose combination; GT: Genotype; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; LLD: Lower limit of detection; MELD score: Mayo-Clinic End-Stage Liver Disease score; ANMDM: National Agency of Medicines and Medical Devices; PPIs: Proton pump inhibitors; PWID: People who inject drugs; RCT: Randomized controlled trial; RDT: Rapid diagnostic test; RAS: Resistance-associated substitution; SRGH: Romanian Society of Gastroenterology and Hepatology; SAE: serious adverse events; SPC: Summary of Product Characteristics; SVR: Sustained virologic response.

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Section: Virusologic Assessmentmentioning

confidence: 99%

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Gheorghe

Sporea

Iacob

et al. 2017

JGLD

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“…(2) Genotypic analysis (sequence analysis): used to detect the amino acids substitutes which cause drug resistance and treatment failure [17]. Clonal and deep sequencing technologies allow reliable detection of viral variants with a frequency down to 0.5-1% and commonly accepted level reached to 15% [18].…”

Section: Diagnosis Of Resistance In Clinical Practice Is Conducted Bymentioning

confidence: 99%

HCV Treatment Failure in the Era of DAAs

Hassany¹,

Elsharkawy²

2017

Advances in Treatment of Hepatitis C and B

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Hepatitis C virus (HCV) has six well-known genotypes in worldwide and has a very high genetic diversity. Introduction of DAAs leads to improvement of treatment results with SVR rates exceeding 95%. Development of HCV treatment resistance is a problematic issue that needs sufficient solutions. Many hosts, viral, and drug factors are implemented in the process of treatment resistance. Lack of clinical trials on treatment failure leads to lag in development of certain consensuses for retreatment.

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“…Large numbers of genetically distinct HCV viral variants are generated daily in infected individuals. Collectively, these variants can create unique "quasispecies," possibly resulting in reduced susceptibility to DAAs if polymorphisms are created in drug-targeted genes [7]. Viral resistance is an important factor associated with HCV treatment failure.…”

Section: Update On Hepatitis C 218mentioning

confidence: 99%

“…These small groups of resistance-associated substitutions (RASs) apparent before the initiation of treatment can become dominant in the presence of selective treatment with DAAs. This, in turn, may affect treatment outcomes, leading to virological breakthrough or more commonly, relapse after treatment cessation [7,11].…”

Section: Update On Hepatitis C 218mentioning

confidence: 99%

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The Molecular Basis of Anti-HCV Drug Resistance

Lynch¹,

Wu²

2017

Update on Hepatitis C

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Hepatitis C virus (HCV) is a significant medical problem and has become one of the leading causes of chronic liver disease. HCV replicates at a high rate, and due to inherently inaccurate nucleotide incorporation and lack of proofreading and post-replication repair, mutations are inevitable. In the era of direct acting antivirals (DAAs), treatment for HCV has become highly effective, but there are still about 5-10% of treated patients who do not achieve sustained virological response (SVR). There are many factors that affect SVR rates including the absorption and metabolism of DAAs, genetic make-up, the presence or absence of cirrhosis, and severity and resistance of HCV to DAAs. An important factor influencing treatment failure is HCV resistance. The majority of treatment failures while on DAAs are not due to on-treatment failures, but due to relapses. The exact mechanism for mutation-associated relapse is unclear, but possible theories include persistent intrahepatocytic viral replication and/or differences in the levels of host immune response.

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Virologic Tools for HCV Drug Resistance Testing

Cited by 49 publications

References 86 publications

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

Position Paper on Treatment of Hepatitis C in Romania, 2017. Part One

HCV Treatment Failure in the Era of DAAs

The Molecular Basis of Anti-HCV Drug Resistance

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