Real life rates of sustained virological response (SVR) and predictors of relapse following DAA treatment in genotype 3 (GT3) patients with advanced fibrosis/cirrhosis

Autor: Natalia Terreni, Massimiliano Copetti, Ruggero Losappio, Vincenzo Palmieri, Domenico Potenza, Giovanni Cenderello, D. Bacca, Giulio De Stefano, Alessandra Mangia, Rosanna Santoro, Fernando Sogari, Michele Mazzola, Nicola Minerva, Valeria Piazzola
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Liver Cirrhosis
0301 basic medicine
European People
Pyrrolidines
Cirrhosis
Medical Doctors
Sustained Virologic Response
Sofosbuvir
Health Care Providers
lcsh:Medicine
Hepacivirus
Gastroenterology
0302 clinical medicine
Recurrence
Genotype
Medicine and Health Sciences
Ethnicities
Medical Personnel
Prospective Studies
Prospective cohort study
lcsh:Science
Multidisciplinary
Liver Diseases
Imidazoles
Anemia
Valine
Hematology
Hepatitis C
Italian People
Professions
Italy
Drug Therapy
Combination
030211 gastroenterology & hepatology
Research Article
medicine.drug
Genotyping
medicine.medical_specialty
Daclatasvir
Gastroenterology and Hepatology
Research and Analysis Methods
Antiviral Agents
03 medical and health sciences
Pharmacotherapy
Physicians
Internal medicine
Ribavirin
PEG ratio
medicine
Humans
Molecular Biology Techniques
Molecular Biology
Treatment Guidelines
Health Care Policy
Polymorphism
Genetic
business.industry
lcsh:R
Biology and Life Sciences
Hepatitis C
Chronic
medicine.disease
Fibrosis
Health Care
030104 developmental biology
People and Places
Population Groupings
lcsh:Q
Carbamates
business
Developmental Biology
Zdroj: PLoS ONE, Vol 13, Iss 7, p e0200568 (2018)
PLoS ONE
ISSN: 1932-6203
Popis: Background Treatment of GT3 remains challenging compared to other genotypes. Aims To explore real life SVR rates and to identify predictors of virological failure across the most recently used Direct acting antiviral (DAA) regimens in a large cohort of Italian patients with cirrhosis or advanced fibrosis (F3 or F4). Methods Between May 2015 and June 2017, the combinations of sofosbuvir (SOF) plus daclatasvir (DCV) ± RBV and SOF plus velpatasvir (VEL) ± RBV become available in our Country. Patients were treated following Italian guidelines within a protocol implemented by 11 centers working together on genetics. Results Of 336 patients, 38.1% were Peg/IFN-experienced. SOF/DCV was used in 65.1%, SOF/VEL in the remaining. Overall SVR12 was 90.2% ranging from 87.2% after SOF/DCV to 95.7% after SOF/VEL (p = 0.012). No additional benefits of RBV use were observed for both regimens. 155 patients (46.1%) had cirrhosis. SVR12 was 87.1% (135/155) for cirrhotic patients and 92.8% (169/182) for non-cirrhotic (p = 0.09). NS5A-RASs were present at baseline in 6.4% of patients, PNPLA3GG and IL28BCC genotypes in 7.3% and 33.0%, respectively. No association between favorable genetics and SVR12 was observed. Predictors of relapse were: history of Peg/IFN/RBV failure (OR = 6.34, 95% CI 2.04-19.66, P = .001), baseline NS5A-RASs (OR = 8.7, 95% CI 1.58-47.92, P = 0.013) and treatment regimen (OR = 5.57 95% CI 1.64-18.95.96, P = 0.006). Conclusions Our real-world results validate the efficacy of current GT3 IFN-free regimens suggesting that, among patients with severe disease, Peg/IFN/RBV experience and NS5A associated RASs are predictors of relapse. Their relevance can be expected to decline with the use of SOF/VEL. (250).
Databáze: OpenAIRE
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