title: Disease Burden, Early Discontinuation, and Healthcare Costs in Hepatitis C Patients with and without Chronic Kidney Disease Treated with Interferon-Free Direct-Acting Antiviral Regimens.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited.
  
  
  OBJECTIVE
  This study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Comorbidities, early discontinuation rates, and healthcare costs were compared between patients with and without CKD.
  
  
  METHODS
  Patients with HCV who were treated with oral DAAs between November 2013 and June 2015, and who were enrolled in a US health plan, were identified. Early discontinuation was calculated based on observed versus expected treatment duration, and expected treatment duration was based on genotype, initial treatment regimen, baseline cirrhosis, and prior treatments. Healthcare costs were calculated during the baseline, treatment, and post-treatment periods.
  
  
  RESULTS
  This study included 3438 patients receiving oral DAAs, of whom 6.9% had a CKD diagnosis. CKD patients were more often male (70.8 vs. 62.9%, p = 0.02) and older (mean age 62.0 vs. 58.8 years, p < 0.001) than non-CKD patients, and had a higher prevalence of most comorbidities. Among early discontinuers, CKD patients were more likely to experience anemia (19.4 vs. 7.7%, p = 0.028).
  
  
  CONCLUSIONS
  Few patients with CKD receive DAA treatment for HCV infections. HCV patients with CKD had significantly more comorbidities and higher baseline healthcare costs than patients without CKD. Compared with non-CKD patients, CKD patients were equally likely to discontinue DAA treatment early but had higher rates of anemia. This study highlights the need for more renal-friendly HCV therapies.
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co. Inc., 2000 Galloping Hill Rd, Kenilworth, NJ, 07033, USA.
authors.forename: Amy
authors.initials: A
authors.lastname: Puenpatom
authors.affiliation: Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN, 55344, USA. michael.hull@optum.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Hull
authors.affiliation: Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN, 55344, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: McPheeters
authors.affiliation: Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN, 55344, USA.
authors.forename: Kay
authors.initials: K
authors.lastname: Schwebke
mesh_terms: D000368:Aged; D000740:Anemia / Q000453:epidemiology; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D005838:Genotype; D017048:Health Care Costs; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000453:epidemiology*; D008103:Liver Cirrhosis / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology*; D012189:Retrospective Studies
chemical_list: D000998:Antiviral Agents