Background Chronic hepatitis C (CHC) treatment has radically changed with the commercialisation of direct-acting antivirals (DAAs) for the hepatitis C virus (HCV) with high levels of safety and effectiveness. Available data from clinical trials reveal that baseline factors at the beginning of treatment that can influence treatment results are basically viral genotype, baseline viral load, degree of fibrosis and previous treatments (naive or pretreated).
Purpose To identify patient, virus or treatment baseline factors which can influence antiviral treatment effectiveness obtained with DAAs in real clinical practice.
Material and methods Prospective observational study of patients with CHC who initiated and completed antiviral treatment for 12 or 24 weeks, between 1 April 2015 and 1 January 2017. Exclusion criteria: patients from prisons. Main variable: sustained virological response (SVR). Covariates: sex, age, HIV coinfection, previous treatment, hepatic transplantation, cirrhosis, fibrosis, viral genotype, baseline viral load and antiviral treatment. Statistical method: descriptive analysis comparing patients with SVR and patients with relapse. Statistical significance was calculated with the Fisher exact test and Mann–Whitney U test. This study was authorised by the Health System Investigation Committee.
Results Seven hundred and ninety-eight patients included, mean age: 58±12 years; 63.4% males; 66.8% naives; 30.6% cirrosis; 14% HIV coinfected; 4.7% hepatic transplantation; HCV genotypes: 4.4% G1; 23.6% G1A; 42.9% G1B; 5.3% G2; 13.5% G3; 10.3% G4. Median basal viral load: 1,475,595 UI/mL. Median adherence to DDAs: 100%. Fibrosis degree: 9.5% F0–1, 33.1% F2, 27.4% F3 and 30% F4. Treatments: 50.7% sofosbuvir/ledipasvir; 25.3% paritaprevir/ombitasvir/ribavirin/dasabuvir; 14.1% sofosbuvir/daclatasvir; 11.7% others (five). Eighty-three per cent DAAs treatment for 12 weeks. Only nine patients relapsed to treatment, so SRV was 98.7%. The lowest SVR were obtained for genotype 3 (96.9%) and for sofosbubir/daclatasvir (95.9%). None of the analysed basal covariates significantly influences SVR, except sexr (p=0.03), since all the relapsers were males.
Conclusion This prospective study in a large population of patients demonstrates the high effectiveness of treatment with DAAs against HCV in real clinical practice. Neither genotype, nor baseline viral load, nor degree of fibrosis, nor previous treatments nor any other variable except sex, had influence on SRV.
References and/or Acknowledgements 1. Jacobsen JC. Direct-acting antivirals for chronic hepatitis C. Cochrane Database Syst Rev2017Sep 18;9:CD012143.
Conflict of interest: Corporate-sponsored research or other substantive relationships. Conference fees: Gilead, Bristol-Myers Squibb, Abbvie, Merck-Sharp-Dhome. Advisory Board: Gilead, Bristol-Myers Squibb.
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