Liverpool University. UK: Lowering the cost of hepatitis C drugs is possible and key to
achieving global access to treatment, according to new research by the
University of Liverpool and Imperial College London.
There are an estimated 185 million people infected with the hepatitis
C virus worldwide and 160,000 in Britain. Currently there is no vaccine
and, if left untreated, infection can lead to cirrhosis and liver
cancer, causing up to 500,000 related deaths globally per year.
Hepatitis C is particularly problematic in low to middle income countries; for example 12 million people are infected in Egypt.
A new and effective generation of direct-acting antiviral drugs
(DAAs) has been developed to treat hepatitis C. However, at present
these drugs are highly expensive. A 12-week course of the new drug
sofosbuvir in the US is priced at as much as $84,000 per person and
£55,440 in the UK. The NHS has recently delayed introduction of
sofosbuvir due to its high price.
The treatment of HIV provides a precedent for cutting the costs of
drugs on a large scale to make them available across the world. The
drugs that have been rolled out worldwide for HIV are similar in
chemical structure and mechanisms to the new generation of hepatitis C
drugs.
Monitoring costs
Researchers at Liverpool believe that it is feasible that global
hepatitis C treatment could be achieved if the manufacturing and
monitoring of costs of those drugs were minimised in the same way as
with HIV treatments, which involved the lifting of patents to allow
drugs to be made by generic manufacturers.
In the study, published in Hepatology,
the researchers used HIV drugs as a framework for the analysis to
explore what would be possible if drugs were produced at a large scale
with the removal of patents to enable generic versions of these DAAs to
be manufactured. This is feasible since India has recently filed a
patent opposition to sofosbuvir and, if successful, this would mean the
patent would no longer restrict the manufacture of the drug and generic
versions could be made by a range of manufacturers.
By taking a bottom-up approach using information on the drugs’ raw
materials, molecular structure and doses, the researchers estimated that
if production was done at a large enough scale, it may be possible to
dramatically reduce the cost of these news drugs. The study estimated
that to treat at least five million people with a combination of the two
DAAs sofosbuvir and daclatasvir could cost $122 per person.
Bringing down the price
Co-author, Dr Andrew Hill, from the University of Liverpool’s
Institute of Translational Medicine, said: “As hepatitis C drugs are so
similar to those used to treat HIV we assumed they have the potential to
be made in the same way; producing the drugs at economies of scale in
large factories and within a freely competitive market where patents
have been lifted to allow generic production.
“We know from the experience of HIV treatment that charitable funders
want to be able to donate a large sum of money and know it will treat a
large amount of people. Our results indicate that this is possible by
bringing down the price of hepatitis C drugs for a set target for the
number treated.”
Through a review of clinical trials, the study identified the four
most effective combination regimes of DAAs for a 12-week treatment
course for Hepatitis C. The study estimated the minimum costs of
treatment by this new generation of DAAs, assuming large scale
manufacture to treat at least five million patients per year, in a
freely competitive market without the limitations of current patents.
The analysis involved going back to the basic chemistry of the drugs to
ascertain the cost of the raw materials, synthesis and manufacture of
the drugs.
Barriers
Dr Graham Cooke, from the Department of Medicine at Imperial College
London, said: “We now have treatments to deal with hepatitis C, but
there are operational, legal and political barriers preventing us from
ensuring access for people on a global and national scale.
“To break down these barriers, we need to learn lessons from the
large-scale rollout of HIV treatment and accelerate the process. In this
study we have estimated the possible reduction in cost of these new
drugs if some of these barriers are removed and they can be produced at a
large scale with free competition and improved production efficiency. ”
The results showed that the combination of sofosbuvir and daclatasvir
to treat five million people could potentially cost $122 per person.
These two drugs are already licensed and considered to be the most
promising for large-scale programmes.