| ANTI-RETROVIRAL THERAPY
1. The Hesperian Foundation (www.hesperian.org)
has recently released a new book entitled HIV, Health and
Your Community: A Guide for Action by Reuben Granich and Jonathan
Mermin, Updated 2006, 248 pages, illustrated.
This comprehensive, easy-to-understand guide to combating
HIV is equally useful in a rural village in southern Africa,
a major city in Thailand, or a Peace Corps worker's backpack.
Designed for people confronting HIV in places with few medical
resources, it is easily accessible to those without advanced
technical knowledge and without prior training in the care
of people with AIDS or in the prevention of HIV. Interventions
and treatments emphasized are available to the majority of
the people in the world who have HIV, and focus on community-based
solutions that are possible in poor communities. Topics include:
biology of the virus, strategies for prevention, symptoms
and epidemiology of the disease, counseling for people with
HIV and their families, how to care for people with HIV, and
even writing grant proposals.
Chapter 13 and the Appendix of this easy to read book is entitled:
Treating advanced HIV disease-medicines for HIV and common
infections and their treatment.
2. Medecins san Frontieres (www.msf.org)
reports that Lopinavir/ritonavir (LPV/r) has been recognized
as an essential medicine by the WHO, as it is the only co-formulation
that consists of a protease inhibitor (lopinavir) and booster
(ritonavir) in the same pill. The WHO will include LPV/r in
its revised recommendations as part of a second-line therapy
once first-line treatment failure has occurred.
Abbott Laboratories has been marketing the old formulation
of LPV/r as Kaletra since 2000. But the old version of LPV/r
has some serious drawbacks, as it requires refrigeration,
comes with a high pill burden of six capsules per day and
needs to be taken with food.
Although second-line regimens including LPV/r are preferred
in developing countries, they have not been an option in many
places because of the refrigeration requirement of the old
formulation.
The 14th WHO Expert Committee on the Use of Essential Medicines
recommended the use of "fixed dose combinations and the
development of appropriate new FDCs, [which include] modified
dosage forms, non-refrigerated formulations ..."
The price for developing countries should be the same as,
or less than, the old version. Since May 2002, Abbott has
been selling the old formulation of LPV/r in Africa and Least
Developed Countries for $500 per patient per year on an FOB
basis (meaning that freight, insurance, customs handling,
taxes and duties paid by purchaser). However, unlike other
companies, Abbott does not offer differential prices in middle-income
countries even though in these countries millions live on
less than US $2 per day. As the chart below shows, middle-income
countries are paying dearly for access to the old formulation
of LPV/r.
The price of LPV/r in middle-income countries outside Africa
is on average 7.4 times more expensive than in low-income
countries (mean: $672 vs. $4,998). In some developing countries,
the price for the old version of LPV/r is nearly as high as
it was in the US ($6,944).
In Brazil, where the government has twice threatened to manufacture
the drug at a lower cost under a compulsory license, Abbott
Laboratories agreed to cut the price of old LPV/r formulation
from $2,562 to $1,379 per patient/year, starting in March
2006
Although this is an improvement, Brazil will still have to
pay nearly three times the price of the old formulation of
LPV/r in Africa and least-developed countries.
In the long run, alternate suppliers will be critical.
There is currently some generic production of the old formulation
of LPV/r, but the sources have not been internationally validated
yet, and patents on the combination could block companies
from marketing it in some countries. In addition, new patent
obstacles may prevent the development of generic versions
of the new formulation of LPV/r. Given the usual patenting
strategies of multinational pharmaceutical companies, the
new formulation of LPV/r is likely to be patent protected
in drug producing countries for a new 20 year period, preventing
generic competition.
Registration should be immediately sought for the new formulation.
The old formulation of LPV/r (133/33.3 mg soft gel capsules)
is registered in 54 countries and registration is pending
in 14 others, covering 68 of the 69 countries eligible for
Abbott's Access Program. But the new formulation of the drug
has not been registered in any country except for the US.
MSF calls on Abbott to register the new formulation of LPV/r
(200/50 mg tablets) promptly and replace the old version with
the new one in developing countries, as they have done in
the US.
The new formulation of LPV/r represents a significant improvement
in second-line options for ARV treatment in developing countries.
Abbott needs to make new LPV/r available throughout the developing
world at an affordable price without further delay.
Also at this site (www.msf.org)
you can read about a campaign to access essential medicines.
3. The Imperial College, London, recently
published an article entitled: Anti-HIV Drugs Unlikely To
Stop HIV Spread
Researchers believe antiretroviral therapy (ART) will not
be effective in stopping HIV epidemics even if it is made
universally available in poorer countries, and that widespread
use could even lead to an increase in the numbers infected
with HIV.
Research published today in PLoS Medicine by a team from
Imperial College London reveals a model which predicts how
different strategies for increasing access to ART might affect
HIV infection rates.
The modelling found that while ART reduces the viral load
of infected individuals, thus decreasing the risk of HIV transmission,
slowing disease progression allows patients to live longer,
increasing the number infected and potentially the number
of new infections they will cause.
Rebecca Baggaley, from Imperial College London, and one of
the authors of the paper, said: "This model demonstrates
that ongoing provision of prevention initiatives for stopping
the spread of HIV is vital. Although ART may prove effective
as part of an integrated treatment and prevention programme,
including increased education and promotion of safe sex practices,
it is unlikely to be effective alone.
"For a number of years, there has been significant debate
about access to antiretroviral drugs, and how the high cost
of these drugs has hindered many poorer countries' attempts
to combat HIV epidemics. While ART is undoubtedly effective
at treating AIDS patients, particularly in richer countries,
without public health interventions it will not prove effective
in stopping the spread of HIV in poorer countries."
The model also studied how ART treatment might affect behaviour.
The researchers believe it could result in a greater spread
of HIV by making infected individuals feel physically better,
and more likely to be sexually active, but counselling of
ART patients about risk behaviour could compensate for this
to some extent. Therefore prevention initiatives aiming to
decrease patients' risk taking behaviour are even more relevant.
Rebecca Baggaley added: "This study could be important
in helping to ensure that limited supplies of ART are used
most effectively."
4. FHI has recently released Delivering
Antiretroviral Therapy in Resource-Constrained Settings: Lessons
from Ghana, Kenya and Rwanda. The book is intended for governments,
development partners and private health facilities seeking
to integrate ART into existing HIV services. Throughout the
text, there are lessons learned which refer to experiences
that implementers consider valuable for initiating ART programmes.
The book has 9 chapters which include information on country,
community and site preparedness, referral systems and linkages,
patient preparation and adherence, health management information
systems and patient response to ART
5. Other websites with the latest information
on ART include:
- www.aidsmed.com.
This site has been developed and is managed by HIV+people
and has the answers to many questions about ART. They provided
simple to read and easy replies to complicated questions.
- www.hivinsite.com.
This website is developed by the University of California,
San Francisco and has a lot of information, fact sheets
and patient guidelines.
- www.atdn.org.
(AIDS Treatment Data Network)
- www.jama.ama-assn.org.
JAMA is the Journal of the American Medical Association.
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