E-DRUG: New HIV drug dolutegravir: MSF- will it be accessible in developing
As US FDA approves promising new HIV drug dolutegravir, MSF asks when
people in developing countries will have access
Geneva/New York, 13 August 2013 As the US Food and Drug Administration
approved the new HIV drug dolutegravir late yesterday, international
medical humanitarian organisation Médecins Sans Frontieres/Doctors Without
Borders (MSF) questioned when people in developing countries would be able
to access this promising new drug.
Studies have shown dolutegravir, a drug from the potent new integrase
inhibitor class of drugs, to be well-tolerated and extremely effective in
stopping replication of the HIV virus, with a high barrier to HIV
resistance. Given its advantages over drugs in the same class and those
widely used today, dolutegravir will likely become part of first-line
therapy in wealthy countries. However, it is still unclear whether people
across the developing world will have access to dolutegravir, as initial
indications from the drug's producer ViiV (Pfizer + GlaxoSmithKline +
Shionogi) to enable affordable access have not been encouraging.
'Based on studies to date, dolutegravir holds important advantages for use
in developing countries, but as treatment providers, our biggest concern is
what the price will be,' said Dr Manica Balasegaram, Executive Director of
MSF's Access Campaign. 'A promising new drug will only translate into more
lives saved if it is affordable, so that people who need it have access.'
But ViiV's position on access to dolutegravir in developing countries is
concerning, with the company indicating it would pursue a 'tiered-pricing'
strategy that will keep the drug out of reach for people who need it,
limiting the use and sale of generic versions to only 67 countries,
excluding many low- and middle-income countries where millions of people
with HIV live.
'We are deeply concerned that ViiV's business strategy will result in
dolutegravir being priced out of reach in countries excluded from ViiV's
licensing deals'�, said Rohit Malpani, director of Policy and Analysis at
MSF's Access Campaign. 'We have seen in the past that excluded countries
are left paying exorbitant prices.'
ViiV should take proactive steps to make sure dolutegravir will be
available and affordable for people in need, especially through
registration of the product and by allowing the availability of generic
versions in low- and middle-income countries. One way to improve access to
more affordable dolutegravir could be through a licence agreement with the
Medicines Patent Pool, which would need to include all low- and
middle-income countries and have no restrictions on where the drug can be
manufactured or active pharmaceutical ingredients can be sourced.
'Where dolutegravir is priced out of reach, the onus will be on countries
to overcome patent barriers by making full use of public health safeguards
and flexibilities in international trade rules, which allow for more
affordable versions to be produced or imported'�, said Malpani.
The availability of affordable HIV medicines has been crucial to making the
scale-up of antiretroviral therapy to nearly ten million people in
developing countries possible. Competition among generic producers of HIV
medicines, primarily in India, is what caused the price of treatment to
drop by a dramatic 99% over the last decade, from more than US$10,000 per
person per year to roughly $120 today. However, patents blocking generic
production have resulted in newer drugs remaining priced out of reach, with
a possible salvage regimen today costing, at best, more than $2,000 per
person, even in the poorest countries, nearly 15 times the price of today's
first-line therapy. Middle-income countries face prices that are far
MSF currently provides antiretroviral treatment to more than 285,000 people
in 21 countries.
Medecins Sans Frontieres - Access Campaign
P: +41 22 849 87 45
M: +41 79 203 13 02