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Novel HCV DAAs could be mass-produced under $90 per person

If international donors place larger orders, novel direct-acting antivirals to treat hepatitis C could be mass-produced for under $90 per person, according to data presented at AIDS 2016.

“A course of treatment to cure hepatitis C could be mass produced for under $90 per person, if we can follow the same methods of production used to treat 17 million people with HIV/AIDS using antiretrovirals,” Andrew Hill, PhD, senior visiting research fellow in the pharmacology department at Liverpool University, told Infectious Disease News. “For this to happen, we need international donors or national health authorities to place large orders for treatment. We would need orders for at least 1 million courses of treatment to achieve the $90-unit price.”

Andrew Hill

Novel DAAs can achieve sustained viral response rates above 90%, according to Hill and colleagues. However, the lowest price for a 12-week course of Sovaldi (sofosbuvir, Gilead Sciences) is $324 and “access” prices are available in countries only covering 50% of the worldwide epidemic, they said.

To measure how prices for novel DAAs are beginning to fall, the researchers extracted data from the first half of 2016 on the per-kilogram prices of exported active pharmaceutical ingredient (API) and exported volumes and determined per-pill API costs according to daily dosage. They estimated a cost of $0.04 per pill for formulation and excipients, $0.35 a month for packaging and a 50% profit margin.

They found that the total exports from India during this period were 10.2 tons of sofosbuvir, which is equivalent to 303,000 12-week treatment courses; 5,443 kg of Daklinza (daclatasvir Bristol-Myers Squibb), which is equivalent to 1,080,000 courses; and 240 kg of ledipasvir (Gilead Sciences), which is equivalent to 32,000 courses.

API prices decreased during this period. At the end of May 2016, the API price was $1,094/kg for sofosbuvir, $998/kg for daclatasvir, $2,441/kg for ledipasvir and between $8,900 and $11,700/kg for velpatasvir. Prices in the United States were 1,355 times higher than the target price for sofosbuvir, 4,500 times higher for daclatasvir, 984 times higher for Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) and between 346 and 413 times higher for Epclusa (sofosbuvir/velpatasvir, Gilead Sciences).

Overall, 12-week treatments of sofosbuvir can be manufactured for $62, sofosbuvir plus ledipasvir for $96, daclatasvir for $14 and sofosbuvir plus velpatasvir for between $181 and $216, all of which include a 50% profit margin.

“Currently, less than 1 million people are being treated for hepatitis C worldwide, according to our analysis of exported raw materials,” Hill said. “By contrast there are an estimated 2 to 4 million new infections with hepatitis C each year. So unless we increase the numbers of people treated, the epidemic of hepatitis C will continue worldwide.” – by Will Offit

Reference:

Gotham D, et al. Abstract A-792-0516-01639. Presented at: AIDS 2016 Annual Meeting; July 18-22, 2016; Durban, South Africa.

Disclosure: The researchers report no relevant financial disclosures.