Researchers from the University of Liverpool have recently released results from a report in which they analyzed the factors that influence the cost of manufacturing drugs for the Hepatitis B Virus (HBV), such as the cost of the raw materials, the amount of drug needed and the patent status for each drug.  The report was published in the latest edition of Journal of Virus Eradication, and it demonstrated that the drug entecavir (Baraclude) could be mass-produced for approximately $36 (£24) per person per year, versus the current US price of over $15,000, and UK NHS price of £4,600.

Hepatitis B Virus

The HBV is a major risk factor for developing liver cancer (LC). LC is the second most common cancer worldwide, with 700,000 new cases diagnosed each year; approximately 33,000 of which will occur in the U.S. The virus is easily transmittable through blood and infected bodily fluids, as well as a high rate of perinatal (mother to child during birth) transmission. According to the CDC, the global burden of HBV includes 240 million people chronically infected and an estimated 786,000 deaths each year.

Report Findings

The report was conducted at the University’s Institute of Translational Medicine.  What the investigators found was quite an important discovery from a global economic and humanitarian standpoint. The fiscal evidence showed that it would be possible to mass produce as a generic drug entecavir (known as Baraclude, Bristol Myers Squibb, in the US and Canada), at a fraction of its current price.  This finding is of significant importance because it would mean that all countries, including developing countries, could afford to use it.

Entecavir is considered a very effective antiviral drug to treat HBV that produces very few side-effects and has low levels of resistance. Unfortunately, its current price is too high for most of the populations in the developing world, where HBV chronic infection rates are the highest.  The report found that it would be possible to mass produce entecavir at a low cost due to the following:

• The dose is only 0.5 milligrams per day, so only a fifth of a gram would need to be produced to provide a year’s supply.
• The drug’s patent expired in February of this year in the USA and other countries, so it can now be manufactured as a generic at a lower cost.
• The drug becomes a generic in the UK in 2017 .

In a University press release, Dr Andrew Hill, PhD, Senior Visiting Research Fellow in the University’s Department of Pharmacology, stated,  “We have shown that the Hepatitis B drug, entecavir, could be mass produced for only £24 ($36) per person per year. Combining mass vaccination with mass treatment would lead to huge reductions in the number of people being infected with Hepatitis B, and could significantly lower the death rates from the current 786,000 per year worldwide.”