title: Present, old and future strategies for anti-HCV treatment in patients infected by genotype-1: estimation of the drug costs in the Calabria Region in the era of the directly acting antivirals.
abstract: BACKGROUND
  In Italy, anti-HCV drugs are provided free of charge by the National Health System. Since 2011, three drug regimens including a directly acting antiviral (DAA) are considered the gold standard for HCV treatment. However, these drugs add a significant cost (roughly €26,000) to the combination of pegylated-interferon-α/ribavirin (PEG-IFN/RBV), which before DAA represented the unique treatment. To provide the National Health System potential useful information, we estimated costs to provide anti-HCV drugs to treat a population experienced for PEG-INF/RBV.
  
  
  METHODS
  Genotype 1 HCV mono-infected or HIV/HCV co-infected individuals who were treated with PEG-IFN/RBV between 2008 and 2013 were included. The cost to treat these patients with PEG-IFN/RBV was calculated (cost 1). We also estimated costs if we had to treat these patients with a lead-in period of PEG-INF/RBV followed by PEG-IFN/RBV and a DAA in naïves (cost 2), in addition to cost 1 plus the estimated cost to re-treat with PEG-IFN/RBV and a DAA patients who had a relapse or a non response (cost 3). Moreover, all costs were normalized by SVR. Rates of foreseen response with DAA were obtained from literature data.
  
  
  RESULTS
  The overall study population consisted of 104 patients. The rate of sustained virological response (SVR) was 55%, while it was estimated that SVR would be obtained in 75% of patients with a lead-in period with PEG-IFN/RBV followed by a DAA combination, and in 78% if this treatment is used to re-treat experienced patients with a DAA. Drug costs associated with these treatments were: €1,214,283 for cost 1, €3,474,977 for cost 2 and €3,002,095 for cost 3. Costs per SVR achieved were: €22,284 for cost 1, €44,643 for cost 2 and €38,322 for cost 3.
  
  
  CONCLUSIONS
  Treatments including DAAs achieve a SVR in more patients than PEG-IFN/RBV but they cost around three times more than PEG-IFN/RBV alone regimens. Also, cost per SVR is almost twofold greater than PEG-IFN/RBV regimens. Therefore, it is mandatory to implement use of DAA in clinical practice, but the National Health System should allocate adequate resources to provide drugs, which challenges sustainability. Cost reduction for anti-HCV drugs should be pursued.
authors.forename: Alessio
authors.initials: A
authors.lastname: Strazzulla
authors.forename: Chiara
authors.initials: C
authors.lastname: Costa
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Pisani
authors.forename: Vincenzo
authors.initials: V
authors.lastname: De Maria
authors.forename: Francesca
authors.initials: F
authors.lastname: Giancotti
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Di Salvo
authors.forename: Saverio Giuseppe
authors.initials: SG
authors.lastname: Parisi
authors.forename: Monica
authors.initials: M
authors.lastname: Basso
authors.forename: Marzia Maria
authors.initials: MM
authors.lastname: Franzetti
authors.forename: Nadia
authors.initials: N
authors.lastname: Marascio
authors.forename: Maria Carla
authors.initials: MC
authors.lastname: Liberto
authors.forename: Giorgio Settimo
authors.initials: GS
authors.lastname: Barreca
authors.forename: Angelo Giuseppe
authors.initials: AG
authors.lastname: Lamberti
authors.forename: Emilia
authors.initials: E
authors.lastname: Zicca
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Postorino
authors.forename: Giovanni
authors.initials: G
authors.lastname: Matera
authors.forename: Alfredo
authors.initials: A
authors.lastname: Focà
authors.forename: Carlo
authors.initials: C
authors.lastname: Torti
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use; D016527:Drug Costs; D004359:Drug Therapy, Combination / Q000191:economics; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D006526:Hepatitis C / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000191:economics / Q000627:therapeutic use; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin