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Minimum costs for producing Hepatitis C Direct Acting Antivirals, for use in large-scale treatment access programs in developing countries
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AASLD: Minimum costs to produce Hepatitis C Direct Acting Antivirals for access programs in developing countries - (12/20/13)
Clinical Infectious Diseases Advance Access published January 6, 2014
Andrew Hill1, Saye Khoo1, Joe Fortunak2, Bryony Simmons3, Nathan Ford4 1Department of Pharmacology and Therapeutics, Liverpool University, UK 2Chemistry and Pharmaceutical Sciences, Howard University, Washington, DC, USA 3Imperial College London, London, UK 4Centre for Disease Epidemiology and Research, University of Cape Town, South Africa
"The high cost of drugs is often justified by the need to recover costs of research and development (R&D). In the case of antiretrovirals for HIV, many of these costs were assumed by the public sector, where parts of the drug discovery and development occurred.39 Several mechanisms have been used by originator companies to allow access to antiretrovirals in low-income settings. These include differential pricing (charging more in high-income countries) and voluntary licensing (allowing third party generic manufacture). Similar mechanisms could be employed for HCV DAAs to ensure these drugs are affordable, while also providing a financial return on the costs of research and development.40 Commitments by national governments to scale up antiretroviral therapy, with support from international donors, were also critical to leveraging prices by increasing the size and predictability of the HIV market. This will be an essential factor in lowering drug prices and increasing access to HCV DAAs.41.....Widespread access to HCV DAAs will also require fast regulatory approvals of new drugs, political will, establishment of national viral hepatitis programs, early access programs to start treating people who are most at risk, and accepted international HCV treatment guidelines."
Several combinations of two or three Direct Acting Antivirals (DAAs) can cure HCV in the majority of treatment-naïve patients. DAAs for HCV infection have similar mechanisms of action and chemical structures to antiretrovirals for HIV infection. Generic antiretrovirals are currently manufactured at very low prices, to treat 10 million people with HIV/AIDS in developing countries.
Methods. Four HCV DAAs, currently either in Phase III development or recent approval (daclatasvir, sofosbuvir, simeprevir, faldaprevir) and ribavirin were classified by chemical structure, molecular weight, total daily dose and complexity of synthesis. The likely range of manufacturing costs per gram of DAA were then projected as formulated product cost, based upon treating a minimum of one million patients annually (to arrive at volume demand) combined with an analysis of the complexity of synthesis and a 40% margin for formulation. Projections were then compared with actual costs of antiretrovirals with similar structures.
Results. Minimum manufacturing costs of antiretrovirals were US$0.2-2.1/g. The complexity of chemical synthesis for HCV DAAs was ranked from lowest to highest: ribavirin, daclatasvir, sofosbuvir, faldaprevir and simeprevir. Predicted manufacturing costs for 12-week courses of HCV DAAs were: US$21-63 for ribavirin, US$10-30 for daclatasvir, US$68-136 for sofosbuvir, US$100-210 for faldaprevir, and US$130-270 for simeprevir.
Conclusions. Within the next 15 years, large-scale manufacture of two or three drug combinations of HCV DAAs is feasible, with minimum target prices of US$100-250 per 12 week treatment course. These low prices could make widespread access to HCV treatment in low and middle income countries a realistic goal.
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