Global Hepatitis B Epidemic Treatable at Cost of Just $36 per Patient per Year

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Large-scale production of generic entecavir (Baraclude) could cut the cost of first-line hepatitis B virus (HBV) therapy to just $36 per patient per year, according to a study published in the online edition of the Journal of Virus Eradication. The authors believe that this price could facilitate low-cost global therapy for hepatitis B. The cost of scaled-up generic production of entecavir was shown to be significantly cheaper than that associated with alternative therapies, including tenofovir (Viread).

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"Hepatitis B infection leads to approximately 686,000 deaths per year. This life-threatening viral infection could be controlled using entecavir treatment costing $36/person-year," comment the investigators. "Entecavir priced at $36/patient-year could allow expansion of chronic hepatitis B treatment in low- and middle-income countries, avoiding significant numbers of cases of cirrhosis and/or primary liver cancer, and massive savings in high-income countries."

Globally, an estimated 350 million individuals are living with chronic HBV infection. Prevalence rates are highest in low- and middle-income settings, including Central and Southeast Asia, central areas of South America, and sub-Saharan Africa.

The World Health Organization (WHO) recommended first-line therapy for HBV monoinfection is monotherapy with entecavir or tenofovir. Both these drugs are safe, highly effective, and have a high barrier to resistance.

The patent on entecavir has already expired in several countries, including the United States. Using the cheapest generic formulation of the drug, the current annual cost of hepatitis B treatment is $427 per patient per year. In contrast, the lowest price for tenofovir is just $38.

But only a very small amount of the active ingredient of entecavir is required in each pill, and Andrew Hill and an international team of investigators wanted to see if sustainable, generic production of the drug could be achieved at a price that would allow for its global use to treat HBV infection. Hill has previously looked at the cost of producing new direct-acting antiviral drugs for hepatitis C.

The researchers considered costs of manufacturing the active pharmaceutical ingredient, coformulation, and packaging, and their estimates also allowed manufacturers a 50% profit.

Total costs were estimated to be just $36 per patient per year.

"We estimated the target price conservatively, including a generous 50% profit margin on top of total production and shipping costs," write the authors. "Generic production at this cost would thus be highly sustainable, and attract competitors."

The cost of the pharmaceutical ingredient was estimated at $0.011 per tablet, a total of $4 per year. This was significantly lower than the $0.066 cost associated with the active ingredient in each tenofovir pill.

Production of entecavir at a cost of $36 per patient per year was significantly lower than the current lowest generic cost of $427; the annual per-patient cost of patented entecavir in the European Union is $7000.

"Encouraging widespread competitive generic production of entecavir would allow dramatic price reductions and rapid scale-up of HBV treatment globally, with a well-tolerated regimen that has a high barrier to resistance," conclude the authors. "Increasing the number of patients treated with entecavir rather than other drugs is both recommended by guidelines, and will allow further reductions in price by increasing purchase volume."

4/22/15

Reference

A Hill, Z Gotham, G Cooke, et al. Analysis of minimum target prices for production of entecavir to treat hepatitis B in high- and low-income countries. Journal of Virus Eradication 1:103-110. 2015.