title: Sofosbuvir-based regimens in clinical practice achieve SVR rates closer to clinical trials: results from ERCHIVES.
abstract: Sofosbuvir is widely prescribed for treatment of HCV infection. We compared the sustained virologic response rates (SVR12) and the haematologic toxicity of various sofosbuvir-based regimens in routine clinical practice.
  
  
  
  We used ERCHIVES (Electronically Retrieved Cohort of HCV infected Veterans) to identify HCV-infected persons initiated on sofosbuvir-based regimens. Treatment duration and regimen were defined as per labelling guidelines. We excluded persons with HIV, positive hepatitis-B surface antigen, hepatocellular carcinoma and missing HCV RNA.
  
  
  
  Among 4257 sofosbuvir-treated persons, sofosbuvir/simeprevir (30%), sofosbuvir/ledipasvir (29%) and sofosbuvir/ribavirin (23%) were the most common combinations prescribed. The mean age (SD) was 60.22 (6.3) years, 96% were male, 22.4% were black, 37.2% had cirrhosis, 29.7% were treatment-experienced; baseline mean HCV RNA was 6.73 log lIU/ml. Comorbidities included: 40.2% alcohol abuse or dependence, 39.7% drug abuse or dependence, 25.1% diabetes and 14.4% stage 3-5 chronic kidney disease. Overall, 86.7% completed a full course of treatment. Overall, SVR12 rates were 88-98% in the sofosbuvir/simeprevir group and 93-98% in the sofosbuvir/ledipasvir group and did not vary based on previous treatment history or cirrhosis at baseline. For genotype 2/3 patients treated with sofosbuvir/ribavirin, SVR12 rates ranged from 69 to 87% with lowest rates in treatment-experienced cirrhotics. For the sofosbuvir/simeprevir and sofosbuvir/ledipasvir groups, grade3/4 haematologic adverse events were uncommon; these trended back close to baseline values after completion of treatment.
  
  
  
  Sofosbuvir-based regimens in clinical practice are associated with SVR rates comparable to those seen in clinical trials and low rates of grade 3/4 haematological adverse events.
authors.affiliation: VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.|Hamad Healthcare Quality Institute, Doha, Qatar.|Hamad Medical Corporation, Doha, Qatar.|University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Adeel A
authors.initials: AA
authors.lastname: Butt
authors.affiliation: VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
authors.forename: Peng
authors.initials: P
authors.lastname: Yan
authors.affiliation: VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.|University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Obaid S
authors.initials: OS
authors.lastname: Shaikh
authors.affiliation: Massachusetts General Hospital, Boston, MA, USA.|Harvard Medical School, Boston, MA, USA.
authors.forename: Raymond T
authors.initials: RT
authors.lastname: Chung
authors.affiliation: University of Cincinnati College of Medicine/UC Health, Cincinnati, OH, USA.
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Sherman
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use; D015897:Comorbidity; D016208:Databases, Factual; D004359:Drug Therapy, Combination; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012254:Ribavirin / Q000627:therapeutic use; D000069616:Simeprevir / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use*; D000072230:Sustained Virologic Response; D014481:United States
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; C586541:ledipasvir; D012254:Ribavirin; D000069616:Simeprevir; D000069474:Sofosbuvir
keywords: DAA; ERCHIVES; SVR; Sofosbuvir; ledipasvir; real life; simeprevir