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HIV/ AIDS MUST READS
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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