Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries
نویسندگان
چکیده
BACKGROUND In 2013, an estimated 686,000 people died from hepatitis B virus (HBV) infection worldwide. Mass treatment programmes for hepatitis B will require very low drug costs. International treatment guidelines recommend first-line monotherapy with either entecavir or tenofovir disoproxil fumarate (TDF). While the basic patent on TDF expires in 2017/8, entecavir is already generic in several countries, including the US. The chemical structure of entecavir is related to abacavir, which costs <$200 per person-year in low-income countries. METHODS The clinical efficacy, chemical structures, daily doses, routes of chemical synthesis, costs of raw materials and patent expiry dates were analysed for entecavir and TDF. Costs of sustainable, generic production were calculated for entecavir, and compared with published originator and generic prices in high- and low-income countries. RESULTS With a daily dose of 0.5 mg, one year's supply of entecavir treatment requires <0.2 g of active pharmaceutical ingredient (API) per person, estimated to cost $4/year, based on quotations of API production from generic suppliers. With an additional $20 per year for formulation/packaging and a 50% profit margin, entecavir was estimated to cost a minimum of $36/person-year, substantially lower than current originator and generic prices. Entecavir is no longer under patent protection in the USA, China, Brazil and South Africa, with European expiry in 2017. Given differences in daily dosing, production volumes for entecavir would be 600 times lower than TDF (300 mg once daily) for treating the same numbers of patients. CONCLUSIONS Mass treatment for hepatitis B with generic entecavir could be achieved at very low cost in all countries, provided that important projections can be met in terms of pricing for the API and finished dosage form.
منابع مشابه
Strategies of Hepatitis B vaccine export to the Middle East and Central Asian countries
Introduction: This paper proposes an appropriate strategy for exporting Hepatitis B vaccine, manufactured by Pasteur Institute of Iran, to other countries. Methods: Eeffectiveness factors and their relative variables were found out by factor analysis method in SPSS software. Results: We could identify 6 main factors which can extremely affect the export of this product. We evaluated manufacture...
متن کاملAssociation between KIR Genes and Efficacy of Treatment of HBeAg-Positive Chronic Hepatitis B Patients with Entecavir
Background: Entecavir (ETV) is commonly used to treat chronic hepatitis B (CHB) in China. However, certain percentages of e-Antigen (HBeAg) positive CHB patients do not respond to ETV therapy. Objective: To investigate whether the killer immunoglobulin-like receptor (KIR) genes were associated with seroconversion in HBeAg positive CHB responder patients treated with ETV. Methods: Polymerase cha...
متن کاملPrevalence of hepatitis A in children in Yasuj city
Abstract Background: hepatitis A infection is prevalance in the worldwide but has different epidemiologic and transmittance pattern in different regions. The aim of this study was to determine the seroprevalence of hepatitis A and it’s associated risk factors in children,Yasuj,Iran. Methods & Materials: This descriptive cross-sectional study was done on 379 children whose aged from 1 year...
متن کاملMinimum Costs for Producing Hepatitis C Direct-Acting Antivirals for Use in Large-Scale Treatment Access Programs in Developing Countries
BACKGROUND Several combinations of 2 or 3 direct-acting antivirals (DAAs) can cure hepatitis C virus (HCV) in the majority of treatment-naive patients. DAAs for HCV infection have similar mechanisms of action and chemical structures to antiretrovirals for human immunodeficiency virus (HIV) infection. Generic antiretrovirals are currently manufactured at very low prices, to treat 10 million peop...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره 1 شماره
صفحات -
تاریخ انتشار 2015