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Background: High prices to treat HIV, viral hepatitis and TB can limit treatment access. This analysis aimed to determine prices currently feasible for HIV, HBV, HCV, and first-line (1L) DS-TB treatment, assuming competitive generic manufacture.
Methods: Data on API exported from India were collected from an online database (www.infodriveindia.com) for July 2014-July 2016. Linear regression was used to plot API cost/kg versus export date, weighted by export volumes: the generated model was used to calculate current average cost/kg of API. Target prices were calculated based on the per-pill cost of API, plus costs of manufacture ($0.01/pill), 10% profit margin, and assumed 27% tax on profit. Current lowest global prices are from public reports and the Global Drugs Fund (TB), US prices from the Centers for Medicare & Medicaid Services. Patent protection expiry dates are from FDA Orange Book and Medicines Patent Pool Patent Status Database.
Results: The Table shows current prices of antiretrovirals for HIV, entecavir (ETV) for HBV (per person-year), HCV treatments (per 12-week course) and 1L DS-TB treatment (RHZE, per 6-month course). API costs/kg were $1189 for ATV, $182 for TDF, $241 for 3TC, $109 for EFV, $380,965 for ETV, $1224 for SOF, $4448 for LDV and $852 for DCV. EFV, 3TC, ETV, and RHZE are already generic in USA. The US substance patents on atazanavir expire in 2017, TDF 2018, sofosbuvir 2030, daclatasvir 2031. Sofosbuvir+ledipasvir combination patents expire in 2032.

DRUGUSAGLOBAL LOWESTTARGETPATENT EXPIRY
ATV$16,093$170$1512017
TDF/3TC/EFV$23,965$107$832018
ETV$5,915$409$82GENERIC
SOF/LDV$91,207$408$852032
SOF/DCV$142,710$66$522031
TB: RHZE$945$27$28GENERIC
PRICES: HIV&HBV - PER YEAR, HCV - PER 12 WEEK COURSE, TB - PER STANDARD 6 MONTH FIRST-LINE REGIMEN. USD.
[Prices and year of patent expiry]


Conclusions: Treatment of HIV, HBV, HCV, and TB could be achieved for < $90 per person globally, if robust generic competition is enabled. In most countries, generic TDF/3TC/EFV, TDF/3TC, ETV or 1L DS-TB treatment could be available for < $90 by early 2018, after patent expiry. Most HCV DAAs will remain on patent for ≥12 more years. Voluntary licensing or other mechanisms will be required to enable access to HCV DAAs at low prices.