title: Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV).
abstract: BACKGROUND
  Clinical trials have demonstrated the efficacy of all-oral direct-acting antiviral (DAA) regimens in the treatment of patients infected with hepatitis C virus (HCV). This study assessed real-world effectiveness of two recently approved regimens; paritaprevir/ritonavir/ombitasvir; dasabuvir (3D), and sofosbuvir/ledipasvir (SOF/LDV) in patients with HCV genotype 1.
  
  
  METHODS
  A retrospective analysis of administrative claims data (IMS Health Patient-Centric Data Warehouse/Medivo database) from October 1, 2013 to August 14, 2015 was conducted. Patients ≥19 years of age with a HCV genotype 1 infection, a prescription fill for 3D or SOF/LDV, and ≥1 HCV viral load (VL) assessment from weeks 4-30 post-treatment were selected for analysis. Percentages of patients achieving sustained virologic response (SVR; defined as HCV RNA ≤43 IU/mL) were determined. Unadjusted SVR rates were compared between treatment groups using Fisher's exact tests. SVR rates were also assessed using multivariate regression with adjustment for age group, sex, and treatment history. Analyses were repeated for a subset of patients with VL assessment from 12 to 30 weeks post-treatment.
  
  
  RESULTS
  A total of 1707 (44 3D and 1663 SOF/LDV) patients were included. The majority (60%) were male, 49% were aged 55-64 years, and 97% were treatment-naïve 1 year prior to index. The unadjusted relative risk (RR) for achieving SVR in patients treated with SOF/LDV compared with 3D was 0.98%, 95% confidence interval (CI): 0.93-1.02. After adjusting for the baseline covariates, the RR was 0.98%, 95% CI: 0.94-1.03.
  
  
  CONCLUSIONS
  In this early view of real-world data, effectiveness of all-oral DAA regimens in HCV genotype 1 patients was concordant with results from registration trials. SVR rates were similar for the two regimens. Further studies are needed to confirm these results.
  
  
  BACKGROUND
  AbbVie, Inc.
authors.affiliation: AbbVie, Inc., North Chicago, IL, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Walker
authors.affiliation: AbbVie, Inc., North Chicago, IL, USA.
authors.forename: Marcos C
authors.initials: MC
authors.lastname: Pedrosa
authors.affiliation: AbbVie, Inc., North Chicago, IL, USA.
authors.forename: Shivaji R
authors.initials: SR
authors.lastname: Manthena
authors.affiliation: AbbVie, Inc., North Chicago, IL, USA.
authors.forename: Nikil
authors.initials: N
authors.lastname: Patel
authors.affiliation: AbbVie, Inc., North Chicago, IL, USA. steve.marx@abbvie.com.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Marx
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: Direct-acting antivirals; Hepatitis C; Infectious diseases; Real-world evidence; Sustained virologic response