Because of the large proportion of Medicare patients that enter the program in advanced stages of disease, treatment prior to Medicare entry is likely to be more effective in mitigating the health consequences of HCV. Disclosures: David B. Rein – Grant/Research Support: Gilead Selleckchem PS 341 Sciences, Inc. The following people have nothing to disclose: John S. Wittenborn, Danielle Liffmann, Joshua M. Borton Background: Several combinations of Direct Acting Antivirals (DAAs) can cure Hepatitis C (HCV) in the majority of treat-ment-naïve patients, in a range of genotypes. Mass treatment programmes to cure HCV in developing countries are only feasible if the costs of treatment and monitoring are very low.
This analysis aimed to estimate minimum costs of DAA treatment and associated diagnostic monitoring. Methods: Clinical trials of HCV DAAs were reviewed to identify combinations with consistently high rates of Sustained Virological Response (SVR) in different genotypes. For each DAA, molecular structures, doses, treatment duration and components of retro-synthesis were used to estimate costs of mass production. Manufacturing
costs per gram of DAA were projected as formulated product cost, based upon treating at least 5 million patients/year (to arrive at volume demand) and a 40% margin for formulation. Costs of diagnostic support were estimated based on published developing country prices of genotyping, HCV antigen tests (to confirm infection pre-treatment and identify relapse/re-infection post-treatment), AZD8055 price plus full blood count/clinical chemistry.
Avelestat (AZD9668) Results: Predicted minimum costs for 12-week courses of HCV DAAs (patent expiry dates) were: US$50 for ribavirin 1200mg/day (generic), US$20 for daclatasvir 60mg/day (2027), US$102 for sofosbuvir 400mg/day (2029), US$90 for ledipasvir 90mg/day (2030), US$44 for MK-8742 (2028), and US$71 for MK-5172 (2030). Predicted minimum costs for 12 week courses of combination DAAs with the most consistent efficacy results were: US$122 per person for sofosbuvir+da-clatasvir, US$152 for sofosbuvir+ribavirin (US$304 for 24 weeks), US$192 for sofosbuvir+ledipasvir and US$115 for MK-8742+MK-5172. Diagnostic testing costs were estimated at US$90 for genotyping (if treatment not pan-genotypic), US$34 for two HCV antigen tests (lower detection limit 2000 IU/mL) and US$22 for two full blood count, ALT and creati-nine tests (before and during treatment). Conclusions: Minimum costs of treatment and diagnostics to cure HCV were estimated at US$171-360 per-person, without genotyping or US$261-450 per-person with genotyping. These cost estimates assume that similar large-scale treatment programmes for HIV/AIDS can be established for HCV. Treatments with proven pan-ge-notypic activity will be required to avoid expensive pre-treat-ment genotyping. Further reductions in price could be achieved through shorter durations of treatment, if efficacy is shown in future trials. Disclosures: Andrew M.