E-DRUG: MSF: WHO hep C guidelines - Global response to hangs on access to new oral drugs
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Global response to hepatitis C hangs on access to new oral drugs
MSF warns of countries' inability to scale up treatment in wake of
first-ever WHO guidelines, unless medicines are more affordable
Geneva/London, 9 April, 2014 With patent barriers on new oral drugs to
treat hepatitis C in developing countries, the high price of new treatment
could squander the opportunity governments now have to scale up diagnosis
and treatment for the disease, international medical humanitarian
organisation Medecins Sans Frontieres (MSF) warned today. The caution comes
as MSF welcomed the first-ever World Health Organization (WHO) guidelines
for hepatitis C virus (HCV).
'These guidelines give countries a road map for screening and treating a
disease which affects 150 million people worldwide, including some
marginalised populations', said Dr Jennifer Cohn, Medical Director for
MSF's Access Campaign. 'The critical aspect now is implementing them, and
this hinges on ensuring that access to new drugs and diagnostics is not
hampered by patent barriers that undermine low-cost generic supply'
Current hepatitis C treatment involves using pegylated interferon, which is
not only expensive, but is also complex for resource-limited settings and
can cause side effects so severe in some people it causes them to stop
treatment early and can deter other people from starting. The limitations
of current treatment mean countries have been reluctant to address HCV, and
have even hindered MSFâs ability to respond to the disease, with only a
small number of people on treatment in India.
'We welcome the release of these guidelines as they provide guidance on how
to start treatment in resource-limited settings but, equally as important,
is the registration of new oral drugs in middle-income countries like India',
said Dr Simon Janes, Medical Coordinator of MSF in India. 'Without
access to the newer treatments that are coming out of the pipeline, our
ability to implement effective treatment programs will be hampered'
New oral drugs sofosbuvir and simeprevir, known as direct-acting antivirals
(DAAs), have emerged on the market within the last six months, with
regulators approving sofosbuvir in late 2013. These new drugs and those
still in development have the potential to revolutionise treatment, with
studies showing cure rates higher than 90% for people with some genotypes
of the disease. The new guidelines strongly recommend treatment using
sofosbuvir for four of the six genotypes of the disease in regimens that
either eliminate or reduce the need for pegylated interferon, depending on
the genotype.
But the price of the DAAs is prohibitive. Sofosbuvir has been released in
the US with a price tag of US$84,000 for 12 weeks' treatment, which equates
to $1,000 per pill. Simeprevir costs around $45,000 for 12 week' treatment
in Russia and sofosbuvir could be priced as much as $5,000 in Thailand. At
these prices, access in middle-income countries - where 75% of the world's
poor actually live - is likely to be extremely limited.
'The price Gilead says it will charge for sofosbuvir in developing
countries is still far too high for people to afford', said Rohit Malpani,
Director of Policy and Advocacy for MSF's Access Campaign. 'When you're
starting from such an exorbitant price in the US, the price Gilead will
offer middle-income countries like Thailand and Indonesia may seem like a
good discount, but it will still be too expensive for many of these
countries to scale up treatment.'
DAAs can however be produced generically in India and marketed at very
affordable prices, just like antiretrovirals (ARVs) used in the treatment
of HIV. A study by researchers at Liverpool University however has found
that a twelve-week course of sofosbuvir could cost as low as $68-$136.
It's possible that diagnosis and treatment together could cost as little as
$500. Gold-standard diagnosis and first-line treatment for HIV today costs
under $200 per person per year; just over a decade ago, HIV treatment alone
cost as much as $10,000 per person per year.
'Bringing the price down will be critical to scaling up treatment, so if
the cost of drugs are unaffordable, countries should use all the legal
means available to ensure affordable access', said Leena Menghaney, India
Manager for MSF's Access Campaign. 'Already, civil society groups have
filed patent oppositions in India to ensure affordability and generic
production; with 12 million people estimated to be infected with chronic
hepatitis C in India, there's a lot at stake'.
At the same time, funding for HCV treatment must be ramped up both on a
national and on a global level, as countries face an epidemic on a scale
far larger than HIV.
'The guidelines give countries a clear signal to begin scaling up HCV
diagnosis and treatment; now we need them to commit to quickly do so. But
we need the money from domestic and international funders to back it upâ,
said Dr Cohn. âThe Global Fund to Fight AIDS, Tuberculosis and Malaria has
made some grants to treat hepatitis C, but this trend needs to continue,
and other donors like PEPFAR must contribute.'
Joanna Keenan
Press Officer
Medecins Sans Frontieres - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02
E: joanna.keenan[at]geneva.msf.org