title: Minimum target prices for production of direct-acting antivirals and associated diagnostics to combat hepatitis C virus.
abstract: Combinations of direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-naïve patients. Mass treatment programs to cure HCV in developing countries are only feasible if the costs of treatment and laboratory diagnostics are very low. This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of sustained virological response across hepatitis C genotypes. For each DAA, molecular structures, doses, treatment duration, and components of retrosynthesis were used to estimate costs of large-scale, generic production. Manufacturing costs per gram of DAA were based upon treating at least 5 million patients per year and a 40% margin for formulation. Costs of diagnostic support were estimated based on published minimum prices of genotyping, HCV antigen tests plus full blood count/clinical chemistry tests. Predicted minimum costs for 12-week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir+daclatasvir; US$152 for sofosbuvir+ribavirin; US$192 for sofosbuvir+ledipasvir; and US$115 for MK-8742+MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping US$34 for two HCV antigen tests and US$22 for two full blood count/clinical chemistry tests.
  
  
  CONCLUSIONS
  Minimum costs of treatment and diagnostics to cure hepatitis C virus infection were estimated at US$171-360 per person without genotyping or US$261-450 per person with genotyping. These cost estimates assume that existing large-scale treatment programs can be established.
authors.affiliation: Division of Infectious Diseases, Imperial College London, London, United Kingdom.
authors.forename: Nikolien
authors.initials: N
authors.lastname: van de Ven
authors.forename: Joe
authors.initials: J
authors.lastname: Fortunak
authors.forename: Bryony
authors.initials: B
authors.lastname: Simmons
authors.forename: Nathan
authors.initials: N
authors.lastname: Ford
authors.forename: Graham S
authors.initials: GS
authors.lastname: Cooke
authors.forename: Saye
authors.initials: S
authors.lastname: Khoo
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
mesh_terms: D000998:Antiviral Agents / Q000191:economics* / Q000627:therapeutic use*; D003132:Commerce; D003955:Diagnostic Tests, Routine / Q000191:economics*; D060005:Genotyping Techniques / Q000191:economics; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000175:diagnosis* / Q000188:drug therapy*; D018936:Hepatitis C Antigens; D006801:Humans
chemical_list: D000998:Antiviral Agents; D018936:Hepatitis C Antigens