[Ip-health] There's a new HIV drug - but you might not have it

Lotti Rutter lotti.rutter at mail.tac.org.za
Wed Aug 14 23:53:31 PDT 2013



There's a new HIV drug - but you might not have it

By Mara Kardas-Nelson


This week, the US Food and Drug Administration (FDA) announced its approval
of dolutegravir, a new HIV medicine made by ViiV, a joint venture between
pharmaceutical giants Pfizer and GlaxoSmithKlein and Japanese company
Shionogi. It will be sold under the brand name Tivicay. The drug forms part
of a class of antiretroviral drugs (ARVs) called integrase inhibitors, which
work by interfering with one of the enzymes the HI-virus needs to multiply.


The FDA says that a 50mg dose of the drug should be taken once or twice
daily, with or without food, and can be used in patients who have never been
treated before, as well as those who have developed resistance to other
ARVs. It can also be used in children over the age of 12 who weigh 40kgs or
more. According to Médecins Sans Frontières (MSF), the drug will likely be
used as a first-line HIV drug (the most effective treatment with the fewest
side effects) in the developed world. The Treatment Action Campaign said
dolutegravir "could potentially become a vital drug in the global struggle
against HIV". 


But in a statement released Tuesday, MSF warned that dolutegravir may not be
easily available in poorer countries. While David Daley, spokesperson for
GlaxoSmithKline, says that ViiV grants voluntary licenses to some generic
companies, allowing them to produce cheaper versions of their patented
products, these licenses only allow countries that are considered low-income
or least-developed, or located within sub-Saharan Africa, to access the
cheaper drugs.


Middle-income countries, on the other hand, are subject to "tiered-pricing"
of the patented product, with prices set on a sliding scale depending on a
country's gross domestic product and disease burden. As such, MSF says that
some may be unable to afford the drug. "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," says Rohit Malpani,
director of policy and analysis at MSF's Access Campaign
<http://www.msfaccess.org/> . "We have seen in the past excluded countries
are left paying exorbitant prices." 


As it is located in sub-Saharan African, South Africa will be able to source
a generic version of dolutegravir after a voluntary license agreement is
concluded between ViiV and a generic company, according to Daley. He said
that ViiV submitted an application to register dolutegravir in South Africa
with the country's Medicines Control Council in June of this year, but could
not offer an estimation of its price pending registration. According to the
Treatment Action Campaign, the drug could be available for as little as R300
per patient per year, but only if multiple generic versions are made.
Voluntary licenses often only allow one producer to make a generic version
of a product, and limit where these versions can be sold. 


Francois Venter, deputy executive director at the Reproductive Health and
HIV Institute at the University of the Witwatersrand, expects dolutegravir
to hit the South African market in one to two years. Calling it "amazingly
side-effect free in the short to medium term", he said that it could be used
instead of efavirenz, which has some side effects and is currently used in
first-line therapy. Most efavirenz side effects occur in the brain, and
result in dizziness, poor sleep, confusion, and abnormal thinking, among
others, according to the online HIV information source, Aidsmap.com.


In studies, dolutegravir has been shown to be more effective than
raltegravir, a competitor integrase inhibitor, when treating patients who
have already been on ARVs. According to Treatment Action Campaign,
raltegravir is currently used in third-line treatment in South Africa, which
is used when patients develop resistance to other ARVs. While developed
countries will likely use dolutegravir in first-line, it may be unaffordable
for South Africa to do so. Venter said South Africa would likely look at
data stemming from other countries who use dolutegravir to inform those
using it here.




Lotti Rutter

Senior Researcher

Policy, Communications and Research


Treatment Action Campaign

Tel: 021 422 1700

Cell: 081 818 8493

Skype: lotti.rutter

Twitter: @FixPatentLaw


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