title: Hepatitis C: efficacy and safety in real life.
abstract: Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis. In a number of recently published real-world studies evaluating ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV, the SVR rate was between 92% and 100%. The SVR rate of the 4260 patients included in the studies in this paper was 97% and the rate was the same in the 1647 patients with cirrhosis. Recently, data evaluating SOF/simeprevir±RBV showed an SVR rate >90%, while in combination with daclatasvir this rate reached approximately 95%. The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies. Because of the similar efficacy and safety, real-world data support the use of either the LDV/SOF±RBV or OBV/PTV/r±DSV±RBV regimen in patients with genotypes 1 or 4. There is still not enough real-world data in patients with genotype 3 and other genotypes.
authors.affiliation: Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
authors.forename: Robert
authors.initials: R
authors.lastname: Flisiak
authors.affiliation: Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Pogorzelska
authors.affiliation: Department of Pediatrics, Gastroenterology and Allergology, Medical University of Białystok, Białystok, Poland.
authors.forename: Marta
authors.initials: M
authors.lastname: Flisiak-Jackiewicz
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002219:Carbamates; D060085:Coinfection / Q000821:virology; D004359:Drug Therapy, Combination; D005838:Genotype; D015658:HIV Infections / Q000821:virology; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000150:complications; D011759:Pyrrolidines; D012254:Ribavirin / Q000627:therapeutic use; D012307:Risk Factors; D000069616:Simeprevir / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use; D000072230:Sustained Virologic Response; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D012254:Ribavirin; D000069616:Simeprevir; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: direct-acting antivirals; hepatitis C; real-world experience