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Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in
Andrew Hill1, Saye Khoo, Joe Fortunak
1Department of Pharmacology and Therapeutics, Liverpool University, United Kingdom.
Summary
Large-scale manufacturing of hepatitis C virus (HCV) direct-acting antivirals (DAAs) could achieve low prices. This makes widespread HCV treatment accessible in low- and middle-income countries within 15 years.
Area of Science:
- Hepatology and Virology
- Pharmaceutical Manufacturing
- Global Health Equity
Background:
- Hepatitis C virus (HCV) direct-acting antivirals (DAAs) offer high cure rates for treatment-naive patients.
- DAAs share structural and mechanistic similarities with human immunodeficiency virus (HIV) antiretrovirals.
- Existing generic antiretrovirals demonstrate the potential for low-cost manufacturing.
Purpose of the Study:
- To project the manufacturing costs of key HCV DAAs.
- To assess the feasibility of large-scale production for widespread access.
- To estimate target prices for 12-week treatment courses.
Main Methods:
- Classified four HCV DAAs (daclatasvir, sofosbuvir, simeprevir, faldaprevir) and ribavirin by synthesis complexity, molecular weight, and dose.
- Projected manufacturing costs per gram based on synthesis complexity and volume demand (≥1 million patients/year).
- Compared projected costs with actual antiretroviral manufacturing costs.
Main Results:
- HCV DAAs' synthesis complexity ranked: ribavirin < daclatasvir < sofosbuvir < faldaprevir < simeprevir.
- Predicted 12-week treatment course costs ranged from $21-$63 (ribavirin) to $130-$270 (simeprevir).
- Antiretroviral manufacturing costs were US$0.2-$2.1 per gram.
Conclusions:
- Large-scale manufacturing of HCV DAAs is feasible within 15 years.
- Target prices for 12-week treatment courses are projected at $100-$250.
- Low projected prices can facilitate widespread HCV treatment access in resource-limited settings.
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