production of generic entecavir could cut the cost of first-line hepatitis B
virus (HBV) therapy to just US$36 per patient per year, according to a study
published in the online version of the Journal
of Virus Eradication. The authors believe that this cost could facilitate low-cost
global therapy for HBV. The cost of scaled-up generic production of entecavir
was shown to be significantly cheaper than that associated with alternative
therapies, including tenofovir.
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.”
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
The World Health Organization (WHO)
recommended first-line therapy for HBV mono-infection is mono-therapy 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 HBV infection is $427 per patient per year. In contrast, the lowest
price for tenofovir is just $38.
But only a very
small amount of entecavir’s active ingredient is required in each pill, 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.
costs of manufacturing the active pharmaceutical ingredient, co-formulation,
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.
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 EU is $7000.
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.”