title: Real-World Drug Costs of Treating Hepatitis C Genotypes 1-4 with Direct-Acting Antivirals: Initiating Treatment at Fibrosis 0-2 and 3-4.
abstract: BACKGROUND
  Direct-acting antivirals (DAA) for the treatment of hepatitis C virus (HCV) have drastically improved outcomes but are also very costly. For this reason, priority for treatment is often given to patients with a higher fibrosis score at baseline by payers and providers rather than treating all eligible patients. Simulation studies have suggested that waiting to treat patients until fibrosis 3-4 may be more costly and result in worse outcomes; however, real-world implications are unknown.
  
  
  OBJECTIVE
  To determine drug costs and outcomes for treating hepatitis C in patients with fibrosis scores of 0-2 and 3-4 at baseline in a real-world ambulatory care setting.
  
  
  METHODS
  A total of 322 patients at 36 clinical sites in Massachusetts with HCV genotype 1-4 and a prescription for at least 1 DAA medication between May 2011 and October 2015 were included. Retrospective and prospective chart reviews were completed by the primary investigator. Data were collected through April 2016. The primary outcome for the study was to determine the mean drug cost per sustained virologic response (SVR) achieved for patients with fibrosis scores of 0-2 and 3-4. Drug costs were calculated using average wholesale price and only included the cost of HCV medications, not for adjunctive medications, blood work, hospitalizations, anticipated complications, or any other projected medical costs.
  
  
  RESULTS
  The mean ± SD (median) drug cost per patient was $130,391 ± 46,787 (113,400) and completed treatment duration was 15.0 ± 8.9 (12) weeks. The mean drug cost per SVR was $155,662 for all patients with a mean drug cost per SVR of $122,452 and $178,401 for patients with fibrosis scores of 0-2 and 3-4, respectively. SVR rates were 83.5% (269/322) for all patients and 92.2% (107/116) and 78.6% (162/206) for patients with fibrosis scores of 0-2 and 3-4, respectively. Ledipasvir/ sofosbuvir; sofosbuvir + ribavirin; ledipasvir/sofosbuvir + ribavirin; sofos-buvir + interferon + ribavirin; boceprevir + interferon + ribavirin; sofosbu-vir + simeprevir; and telaprevir + interferon + ribavirin had a mean drug cost per SVR of $123,559; $153,347; $157,969; $184,800; $248,640; $251,550; and $373,333; respectively.
  
  
  CONCLUSIONS
  Real-world knowledge about outcomes and drug costs may influence future decisions. Further studies are needed to evaluate emerging treatment options and to reflect changes in treatment guidelines.
  
  
  BACKGROUND
  No outside funding supported this study. The authors report no conflicts of interest. Data in this study were presented as a poster at the ASHP Midyear Clinical Meeting; New Orleans, Louisiana; December 9, 2015; at the Massachusetts Society of Health-System Pharmacists Annual Meeting; Newton, Massachusetts; April 12, 2016; and at Eastern States Conference for Pharmacy Residents and Preceptors; Hershey, Pennsylvania; May 2, 2016. Study concept and design was primarily contributed by Bach, along with Zaiken. Bach took the lead in data collection, data interpretation, and preparation of the manuscript, along with Zaiken.
authors.affiliation: 1 MCPHS University, Boston, Massachusetts.
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Bach
authors.affiliation: 1 MCPHS University, Boston, Massachusetts.
authors.forename: Kathy
authors.initials: K
authors.lastname: Zaiken
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics*; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000191:economics* / Q000453:epidemiology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000191:economics* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents