Is real‐life hepatitis C virus therapy as effective as in clinical trials?

Background: Advances in the development of Direct-Acting Antivirals (DAAs), particularly pangenotypic drugs, have led to a high rate of hepatitis C virus (HCV) eradication. Notably, real- world studies have confirmed the efficacy and safety of pangenotypic DAA combinations reported in registration trials. The aim of this study was to review the treatment recommendations, and the efficacy and safety data of anti-HCV pangenotypic drugs reported in registration clinical trials and in recent real-life cohort studies. Methods: We reviewed the efficacy and safety data of pangenotypic anti-HCV drug combinations reported in original articles and in online conference abstracts. Results: Current pangenotypic drug combinations resulted in very high rates of sustained virologic response and few adverse reactions in real-life settings. SVR12 rates in real-life studies ranged from 90-100% depending on the pangenotypic combination, the HCV genotype and the stage of liver disease. Most adverse reactions reported in real-life settings were mild in intensity and rarely led to treatment discontinuation. These results are in accordance with those of clinical trials. Conclusion: Pangenotypic DAAs result in very high rates of sustained virologic responses and are well tolerated. However, they are contraindicated in patients with decompensated cirrhosis or advanced chronic kidney disease who failed previous DDA-based treatment. Further research is required to customize treatment to “unpackage” current DAA combinations and to develop generic drugs against HCV.

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

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld.2014.1121.263.rom ◽

2017 ◽

Vol 26 (3) ◽

pp. 309-317 ◽

Cited By ~ 3

Author(s):

Liana Gheorghe ◽

Ioan Sporea ◽

Speranța Iacob ◽

Roxana Șirli ◽

Anca Trifan ◽

...

Keyword(s):

Hepatitis C Virus ◽

Liver Disease ◽

Hepatitis C ◽

Sustained Virologic Response ◽

Real Life ◽

Virologic Response ◽

Position Paper ◽

Hcv Infection ◽

End Stage Liver Disease ◽

End Stage

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 have become 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 was created and these were discussed and rated. Decisions were taken by consensus.Recommendations: We present here the second part of the Society’s recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure.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 real-life conditions in Romania. Abbreviations: CKD: Chronic kidney disease; DAAs: Direct-acting antivirals; DDIs: Drug-drug interactions; ESDL: End-stage liver disease; FCH: Fibrosing cholestatic hepatitis; GT: Genotype; HCV: Hepatitis C virus; HCC: Hepatocellular carcinoma; LT: Liver transplantation; MELD score: Mayo-Clinic End-Stage Liver Disease score; PDC: Premature discontinuation; PWID: Persons who inject drugs; RASs: Resistance associated substitutions; RBV: Ribavirin; RCT: Randomized controlled trial; SAE: Serious adverse events; SRGH: Romanian Society of Gastroenterology and Hepatology; SVR: Sustained virologic response.

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Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts

Advances in Therapy ◽

10.1007/s12325-021-01753-3 ◽

2021 ◽

Author(s):

Xavier Forns ◽

Jordan J. Feld ◽

Douglas E. Dylla ◽

Stanislas Pol ◽

Kazuaki Chayama ◽

...

Keyword(s):

Clinical Trials ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Real World

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829 EFFECTIVENESS OF HEPATITIS C VIRUS TREATMENT IN REAL-LIFE PRACTICE: A PROSPECTIVE OBSERVATIONAL MULTICENTER STUDY IN ITALY (PROBE)

Journal of Hepatology ◽

10.1016/s0168-8278(08)60831-4 ◽

2008 ◽

Vol 48 ◽

pp. S311 ◽

Cited By ~ 6

Author(s):

M. Rizzetto ◽

M. Colombo ◽

A. Ascione ◽

F. Piccinino ◽

A. Craxi ◽

...

Keyword(s):

Hepatitis C Virus ◽

Hepatitis C ◽

Multicenter Study ◽

Real Life

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Statin (3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor)-based therapy for hepatitis C virus (HCV) infection-related diseases in the era of direct-acting antiviral agents

F1000Research ◽

10.12688/f1000research.7970.2 ◽

2016 ◽

Vol 5 ◽

pp. 223 ◽

Cited By ~ 1

Author(s):

Sara Sobhy Kishta ◽

Reem El-Shenawy ◽

Sobhy Ahmed Kishta

Keyword(s):

Clinical Trials ◽

Hepatitis C Virus ◽

Hepatitis C ◽

Antiviral Agents ◽

Antiviral Agent ◽

Viral Clearance ◽

Hcv Infection ◽

Direct Acting Antiviral ◽

Direct Acting ◽

Direct Acting Antiviral Agents

Recent improvements have been made in the treatment of hepatitis C virus (HCV) infection with the introduction of direct-acting antiviral agents (DAAs). However, despite successful viral clearance, many patients continue to have HCV-related disease progression. Therefore, new treatments must be developed to achieve viral clearance and prevent the risk of HCV-related diseases. In particular, the use of pitavastatin together with DAAs may improve the antiviral efficacy as well as decrease the progression of liver fibrosis and the incidence of HCV-related hepatocellular carcinoma. To investigate the management methods for HCV-related diseases using pitavastatin and DAAs, clinical trials should be undertaken. However, concerns have been raised about potential drug interactions between statins and DAAs. Therefore, pre-clinical trials using a replicon system, human hepatocyte-like cells, human neurons and human cardiomyocytes from human-induced pluripotent stem cells should be conducted. Based on these pre-clinical trials, an optimal direct-acting antiviral agent could be selected for combination with pitavastatin and DAAs. Following the pre-clinical trial, the combination of pitavastatin and the optimal direct-acting antiviral agent should be compared to other combinations of DAAs (e.g., sofosbuvir and velpatasvir) according to the antiviral effect on HCV infection, HCV-related diseases and cost-effectiveness.

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