In
this 2003 World AIDS Day, the 15th campaign since the
virus was first discovered 20 years ago, the World Health
Organisation has vowed to focus on the elimination of
stigma and discrimination surrounding HIV and AIDS. Ignorance,
denial, intolerance, fear and complacency create the
perfect conditions to unleash this opportunistic virus:
IMS takes a look at the dual roles of the pharmaceutical
industry as scapegoat and saviour in the war against
HIV.
Alarming
complacency in the West
In
the developed world, the industry has undoubtedly added
years as well as quality to the lives of infected individuals.
An alarming complacency has emerged, however, fuelling
rising numbers of new cases among certain groups. Between
1999 and 2002, infection rates rose by 15% in Western
Europe and 16% in North America, while in the UK, the
number of heterosexuals diagnosed as HIV+ has almost
doubled since 1998: overall infection rates soared by
20% over 2002.
The
availability of treatment options has brought with it
the false security that AIDS can be cured when it cannot
- the industry is in fact only transiently ahead of the
virus. A new campaign reiterating the "Don't Die of Ignorance" message
so unforgettably conveyed in the late 1980s is obviously
needed to clarify the facts surrounding risk behaviour.
Explosions
dormant in Russia and Asia
On
World AIDS Day 2003, WHO pledged to ensure that three
million HIV infected individuals will gain access to
the drugs they need by 2005. The latest figures released
by UNAIDS show that 40 million people are now living
with the virus; five million of those infections occurred
in 2002 alone, and it was a year that witnessed three
million deaths from AIDS.
The
pandemic is pursuing its grim march through sub-Saharan
Africa, which accounts for around two-thirds of total
infections, where the prevalence is as high as 39% in
the worst hit countries. Furthermore, an alarming explosion
of outbreaks lies dormant in the former Soviet Union
and parts of Asia, including China and India. The UN
estimates that China, where one million HIV infections
are recorded, will have 10 million cases by 2010, and
that India's will rise from four million to 20-25 million.
Quashing the barrage of criticism
Only around 75,000 Africans currently have access to antiretroviral
therapies, and the initial cocktails, supplied as generics
from India, cost $292 per patient per year, which rises
to $1,594 when patients move onto a second line of drugs,
including some under patent.
Industry launching new drug each year
Since the launch of the first antiviral in 1987, the global
pharmaceutical industry has contributed an average of one
drug per year, with Roche and
Trimeris' novel fusion inhibitor Fuzeon (enfuvirtide)
being the latest addition to the existing array of nucleotide
reverse transcriptase inhibitors (NRTIs), protease inhibitors
and non-nucleoside reverse transcriptase inhibitors (NNRTIs).
The global market is expected to double to $10 billion
by 2012 according to research by IMS
Therapy Forecaster .
HIV (J5C) Global Sales*
1993-2002 with forecast to 2012
*Global includes the USA, Canada, Germany,
France, Italy, Spain, the UK and Japan
Source: IMS Therapy Forecaster
According to IMS
World Review,
three companies (GlaxoSmithKline, Bristol-Myers Squibb
and Abbott) together dominated three-quarters of the
$5.4 billion total global sales of HIV antiretrovirals
generated in 2002. Combivir and Trizivir,
GSK's NRTI combination treatments, took the gold and
bronze positions in the class with 16.6% and 9.7% of
sales respectively, with Abbott's protease inhibitor
combination Kaletra in second place with 9.9%.
Reducing the pill burden has
become an increasingly important factor in HIV therapy,
and as such the industry is actively working on new molecules
such as atazanavir, emtricitabine and fosamprenivir,
which offer simpler dosing regimens, as well as simplifying
regimens of existing products.
Leading Corporations in Global J5C HIV Antiviral Market
12 months to March 2003
Source: IMS
MIDAS
A potential new class of
drugs is emerging, the integrase inhibitors; integrase
is the third enzyme (along with nucleoside reverse transcriptase
and protease) essential to HIV replication. Despite
considerable research in this area, however, Shionogi
and GSK’s S-1360 was the first to reach Phase II trials,
and analysis of resultant data led to discontinuation
of the product in July 2003. Nevertheless, Merck & Co
is entering Phase II trials with L870810, while other
potential compounds are in earlier stages of development.
Incorporating another novel limb of attack into combination
therapy could buy more time for infected individuals
who are beginning to run out of treatment options due
to viral resistance.
Vaccine pipeline or pipe
dream…
The most advanced stage vaccine, AIDSVAX from
VaxGen, failed to show any protection against HIV infection
in large trials in Thailand and the US. Many industry
observers had anticipated the coming failure, but the
confirmation has further enhanced doubts that vaccines
are likely to become available in the near future. The
majority of opinion leaders interviewed by IMS Therapy
Forecaster expressed pessimism over the prospects of
a vaccine within the next decade.
There are still many vaccines
in development however: according to IAVA, around a
dozen vaccine candidates are in human trials around
the world, and the availability of a prophylactic vaccine
may still be the best hope of controlling the spread
of HIV in the developing world.
Treatment empowers Africa
with hope
Education is key in the HIV
war, but as the income of families living with AIDS
in the developing world plummets, children are less
likely to remain in education, thus reducing their own
earning capacity and fuelling the terrifying cycle.
The resultant global economic implications of the ‘tab’ AIDS
is propelling, with spiralling welfare costs to care
for the sick and the orphaned as Africa's work force
is wiped out, is being warned of.
The availability of treatment
options, however, empowers Africa with the strength,
will and time to fight the HIV war, and replaces discrimination
and fear with awareness and hope. As richer western
countries drive innovation for novel HIV therapies,
resultant profits can balance those lost to poorer nations,
facilitating the industry to face its role as saviour
in slowing the tide of death through Africa.
This article was written by Angie Fraser, Deputy Managing
Editor of IMS
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