Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort

Calleja, José Luís; Crespo, Javier; Rincón, Diego; Ruíz-Antorán, Belén; Fernández, Inmaculada; Perelló, Christie; Gea, Francisco; Lens, Sabela; García-Samaniego, Javier; Sacristan, B.; García‐Eliz, María; Llerena, Susana; Pascasio, J.M.; Turnés, Juan; Torras, Xavier; Morillas, Rosa María; Llaneras, Jordi; Serra, Miguel; Diago, M.; Rodríguez, Conrado Fernández; Ampuero, Javier; Jorquera, Francisco; Simón, Miguel Ángel; Arenas, Juan; Navascués, C.A.; Bañares, Rafael; Muñoz, Raquel; Albillos, Agustı́n; Mariñó, Zoe

doi:10.1016/j.jhep.2017.01.028

Cited by 166 publications

(170 citation statements)

References 27 publications

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“…The findings were in line with other studies that evaluated the HCC risk of patients with an interferon-based regimen (3)(4)(5). Several prospective studies have evaluated the subsequent risk of HCC among patients who underwent DAA treatment (6)(7)(8). However, DAAs are recently developed regimens; therefore, the period of follow-up in studies of DAA-treated patients were relatively short compared with studies that analysed patients treated with interferon-based regimens.…”

supporting

confidence: 84%

“…The large study population and the existence of comprehensive electronic medical records were suitable for the study of HCV treatment outcomes in a realworld setting. Although 40% of patients already had liver cirrhosis, compared with other prospective studies aimed to estimate HCC risks among patients treated in tertiary centres (6)(7)(8), the veterans included in this study were relatively healthy. However, at least 96% of participants were male, which limited the study's generalizability.…”

mentioning

confidence: 99%

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Risk of hepatocellular carcinoma for patients treated with direct-acting antivirals: steps after hepatitis C virus eradication to achieve elimination

Lee¹

2018

Transl. Gastroenterol. Hepatol.

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supporting

confidence: 84%

mentioning

confidence: 99%

Risk of hepatocellular carcinoma for patients treated with direct-acting antivirals: steps after hepatitis C virus eradication to achieve elimination

Lee¹

2018

Transl. Gastroenterol. Hepatol.

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“…In a multicenter study from Spain with 70 patients with a prior diagnosis of HCC who had experienced a complete response before initiation of DAA therapy, HCC recurred in 21 (30%) within 12 months of starting DAA therapy, and two patients subsequently died. Comparatively, incident HCC was confirmed in 30/3233 (0.93%) patients without a prior diagnosis within 18 months of starting DAA therapy (Calleja et al 2017). By contrast, in a French prospective, multicenter ANRS cohort that included more than 6000 patients treated with DAAs, no increased risk of cancer recurrence was observed in patients with HCC successfully treated before DAA therapy.…”

Section: Clinical Consequences Of Immune Reconstruction During Treatmmentioning

confidence: 99%

Modulation of the Immune System in Chronic Hepatitis C and During Antiviral Interferon-Free Therapy

Urbanowicz

Zagożdżon

Ciszek

2018

Arch. Immunol. Ther. Exp.

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The treatment of patients with chronic hepatitis C virus (HCV) infection has changed tremendously over the past 2 years, with an increasing variety of all-oral direct-acting antiviral (DAA) treatment regimens available for different HCV genotypes and distinct clinical settings. These treatments have significantly improved safety in patients with advanced liver disease compared with interferon (IFN)-based regimens. HCV modifies the human immune system to escape immunosurveillance via several mechanisms. One of the basic mechanisms of HCV is the ability to “switch” the immune response by reducing the activity of cells responsible for the elimination of virus-infected cells. IFN-free DAA treatment regimens provide a unique opportunity to assess the effect of HCV elimination on the immune system. Abrupt changes in the immune system can in some cases be responsible for two alarming processes: viral reactivation in patients with chronic hepatitis B and recurrence of hepatocellular carcinoma in patients with previous successful cancer treatment.

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“…These recommendations are based on the results of the four phase III RCTs ION-1, ION-2, ION-3 and ION-4 [47][48][49], on several post-hoc analyses of pooled data from phase II and III RCTs [50,51], as well as on several real-world observational studies [52][53][54].…”

Section: Treatment Of Gt-1 Infected Patients Without or With Compensamentioning

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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Effectiveness, safety and clinical outcomes of direct-acting antiviral therapy in HCV genotype 1 infection: Results from a Spanish real-world cohort

Cited by 166 publications

References 27 publications

Risk of hepatocellular carcinoma for patients treated with direct-acting antivirals: steps after hepatitis C virus eradication to achieve elimination

Risk of hepatocellular carcinoma for patients treated with direct-acting antivirals: steps after hepatitis C virus eradication to achieve elimination

Modulation of the Immune System in Chronic Hepatitis C and During Antiviral Interferon-Free Therapy

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

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