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Tackling HIV/AIDS in Resource Poor Settings James Nichols AIDS is one of the biggest killers in the world. Since 1995 survival rates in the developed world have improved dramatically as a range of new treatments have become available. However, applying these methods in countries with limited health systems has proved a problem, and some people have questioned if it is possible. Introduction One of the single greatest killers in the world today is the Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome, otherwise known as HIV/AIDS. It is also one of the greatest challenges that national and international health workers, organisations, governments and civil societies face, in the battle to provide treatment to an ever-expanding infected population – especially in the developing world, or as we like to say – in resource-poor settings. Médecins Sans Frontières (MSF) has spent the better half of the past decade coming to terms with issues around prevention, stigma, drugs, infrastructure, human resources, treatment regimens, and cost of treatment for HIV/AIDS – which all combined provide an incomplete account of the challenges, obstacles and successes in tackling this emerging disease. The AIDS Epidemic Update 2005 published by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organisation (WHO), reveals that indeed the number of people living with HIV has continued to rise in all regions of the world except the Caribbean, the report says. “There were an additional 5 million new infections in 2005. The number of people living with HIV globally has reached its highest level with an estimated 40.3 million people, up from an estimated 37.5 million in 2003.” Faced with these numbers, world health organisations and international medical aid organisations face an ongoing and uphill struggle to increase treatment in resource-poor settings. In Sub-Saharan Africa 3.2 million people were newly infected with HIV in 2005. In South and South East Asia there were 990,000 new infections, while in Australia there were just 820 new diagnoses of HIV in 2004. The divide between the affects of the disease on rich and poor societies is even more apparent considering that on our doorstep in Papua New Guinea (PNG), 10,000 HIV cases were diagnosed by the end of 2004, but the actual number of people living with HIV could be five times higher. In April 2005, The Economist magazine reported that in the capital Port Moresby, about 60% of hospital beds are now occupied by AIDS patients. Background At first little was known about the disease when it came to the world’s attention in the early 1980s and there was no treatment for it. The disease was more prevalent amongst the homosexual population in western countries, recognised then for practising ‘high-risk’ or unprotected sexual intercourse. Activist groups very quickly mobilised in Europe, Australia and in the United States calling for access to prevention and treatment, and immediately this surge of solidarity for people living with a disease linked to a specific group in society, enabled a rapid and aggressive approach to tackling this disease. The difference in the developing world was that the pattern of spread of the disease differed, affecting largely the heterosexual population for many reasons. There were and still are significant cultural, traditional as well as gender-based barriers to the implementation of strategies that could protect people in poor countries from contracting HIV, that were not as straightforward as those overcome in rich countries. Unfortunately the momentum for reaction seen in the western countries, did not translate into the same sort of action in poor countries, especially in Africa. Prevention campaigns, if any, were the main method of combating this debilitating disease, which also sometimes spread fear and exclusion – stigma was a side-effect keeping many people from accessing education, prevention and care - in fact, stigma caused more harm to these efforts. The discovery of powerful drugs in the second half of the 1990s made it possible to change the landscape of dealing with HIV/AIDS. By using antiretroviral drugs (ARVs), HIV/AIDS related mortality in developed countries was reduced by more than 85% within a very short period (1995-1997). This was good news however it has taken nearly five more years for those life-saving drugs to begin to reach those who need them in poorer countries. Even today, 95% of the drug market is in the developed world, yet 95% of patients live in Africa, Latin America and Asia. In the world today over one million people in low and middle-income countries are now receiving antiretroviral treatment (ART), while Médecins Sans Frontières (MSF) is currently providing ART to more than 60,000 patients in 29 countries. The need for more treatment however is huge, and MSF is only touching the tip of the iceberg. Of these 60,000 patients, 3,500 (6%) are children. This mere figure of 3,500 children currently under the ARV drug regimes of MSF, pales in comparison to the fact that more than half a million children around the world, died of AIDS-related diseases last year.
While MSF is not the only organisation in the world providing successful treatment programs for HIV/AIDS in developing countries, it was one of the first organisations to use ARVs in poor countries for treating HIV; and it was the first organisation to provide free of charge, large-scale treatment for the disease in poor countries. MSF was also one of the first international organisations to introduce governments of poor countries to the process, drugs, staffing, training and necessary modern medical techniques to combat HIV in their population. It was very much a learning exercise with the hope of demonstrating that high quality treatment was possible in resource-poor settings despite the obstacles. When MSF decided to provide treatment for its patients infected with HIV it had to adapt what is a fairly complex and expensive regime of testing, drugs supply and expertise; to resource-poor settings. MSF was directly involved in bringing down the prices of drugs by lobbying western-owned pharmaceutical companies, and the introduction of generic drugs provided the competition so bitterly needed for prices to plummet. Once this was possible and the drugs could be produced at affordable prices, MSF set about procurement, treating patients with these drugs and getting the drugs through the prequalification process with the WHO. Effective Antiretroviral treatment (ART) today involves starting a patient on three drugs, what is called Highly Active Antiretorviral Treatment (HAART). ARVs restore the immune system and prevent the reoccurrence of opportunistic infections, such as tuberculosis (TB), and certain forms of cancer which affect people who have compromised immune systems. Because of the nature of HIV, resistance will eventually develop about 3-8 years after treatment has been started. The first treatment projects began in 2000-2001 in Thailand, South Africa and Cameroon. These experiences led MSF to rapidly increase the number of treatment programs aimed at providing ARV treatment to those most severely affected. The challenge was operating in the context of a country whose health infrastructure was very weak and almost non-existent in some cases. For example in Malawi where there was a complete collapse of the public health infrastructure even to the point where the disease itself wiped out qualified health professionals. Uganda was another country where MSF decided to expand, a country where the government strongly recognised the need for it and thus political will seemed conducive for a comprehensive HIV/AIDS programme. Also, the broad objective of ‘treating those with the disease who need help most’ created problems, specifically: trying to address the needs of the large numbers of patients who arrived at the door step of MSF’s clinics asking for help. As a result, a second-generation programme developed which aimed at scaling up fast and effective treatment delivery to a maximum number of patients. MSF never aimed at treating everybody infected with HIV, however chose geographical areas often with vulnerable populations (such as the Mathare in Nairobi, one of the biggest slums in East Africa) to demonstrate to the international medical and civil society that it was possible to deliver good quality treatment where money, drugs and infrastructure were limited. In order for this to work MSF worked to adapt to the various contexts they were working in, for example bringing treatment to patients in rural areas. Challenges and successes to expanding treatment The Malawi Case Study Chiradzulu is a rural area where 90% of the population earn a living by farming while 25% of the adult population is HIV-positive. MSF began working in Chiradzulu in 1997 in collaboration with the Ministry of Heatlh, and primarily focused on prevention (education, communication, testing and counselling). HAART was introduced in 2001 and the most severely affected patients received treatment first. The programme was designed to demonstrate that HAART would prolong life and enhance the quality of life of patients, even to the point where they could earn a living once again. From just initiating a few patients per month the programme evolved to introduce treatment for 210 patients in March 2004, by which date there were 3,122 patients under care in 12 facilities. Today, 6,800 patients have been initiated on HAART (March 2006). The dramatic increase in the case load was attributed to change in the criteria for starting treatment and streamlining of the overall programme. Mandatory CD4 counts (indicating the level of immune suppression) and other laboratory tests were eliminated from this process and the training of nurses and clinical officers in treatment and monitoring HAART and providing the care closer to the communities in need (decentralisation) also contributed to the successful expansion. Adherence support and patient follow-up were also identified as necessary adjustments, increasing counselling via non-medical staff with Malawi High School Certificates to fill the role of nurses who counselled patients. A community support group of people living with HIV/AIDS assisted by MSF and MOHP (Ministry of Health and Population) counsellors also contributed to the further expansion of the programme. Expansion can be also credited to MSF’s adaptation to the context: by bringing treatment to patients who do not have time or money to travel to clinics was very significant; had the effect of reducing pressure on the District Hospital and improving the likelihood of adherence. However, there were, and still are major challenges to the Chiradzulu
success story, including: Positive results across MSF projects Paediatric problems Transmission Diagnosis The current strategy for diagnosing children using the current gold standard (assessing viral loads) is by using expensive equipment worth up to $140,000. This technology is not easily transferable to resource-poor settings. Complex procedures are required and political will is ultimately required to make it accessible to patients in need. Together with researchers and experts from the WHO, MSF is currently working on guidelines to enable infant diagnosis in resource limited settings. ARV formulations Generic Indian companies have developed quality paediatric FDCs but the process for prequalification has been incredibly slow, so that those drugs developed over one year ago, are still not available to most children in need.
Successful national AIDS programmes in Brazil and Thailand were possible because key pharmaceuticals were not patent protected and could be produced locally at much lower costs, fuelling generic competition. Local production in India, Thailand, and Brazil had effects far beyond the borders of those three countries. Second wave of the pricing crisis There is also questioning of the current pricing system based on companies giving voluntary discounts to some countries. A survey conducted in MSF projects, concludes that although it has some benefits, ‘differential pricing’ simply doesn’t work for all those who need ARVs. The survey MSF prepared for the IAS (International AIDS Society) conference in 2005 revealed that medicines available from only one producer were still very expensive, for example the differential price for abacavir produced by GlaxoSmithKline is over US$800 per patient per year. Another disconcerting finding form the survey was that prices often announced by pharmaceutical companies are not available in reality, because they have not registered or marketed the drugs in countries that have differential pricing – an obvious case is Gilead’s Viread (tenofovir) which only is fully registered in four of the 95 countries where the company offers it with a differential price. Finally, MSF’s survey found that some companies do not offer discounts to middle-income countries, case in point being lopinavir/ritonavir (Kaletra made by Abbott Laboratories) in Thailand, Latin America and Ukraine, where programmes pay US$4,000 to US$6,000 per patient per year for this one drug alone. To put this in perspective MSF pays less than US$250 per patient per year for WHO-prequalified first-line triple combinations from Indian generic producers. Abbott and Kaletra The CAME put public pressure on Abbott in March 2006 to register the drugs in poor countries in an effort to make this product available in MSF programmes at the price of the old formula. However despite Abbott’s recent declaration of its intention to do so, up until now Abbott made few steps in registering Kaletra in countries that are most in need, ie. South Africa. After a public lobbying campaign including collecting signatures from researchers and prescribers (including in Australia) Abbott is now starting registering the new Kaletra in South Africa. While it’s a small victory it did illustrate the difficulty in making second line treatments available in the fight against AIDS. The current system in force regarding intellectual property (20 year patents) means access to new drugs is difficult as they can not be legally copied by manufacturers of generic medicines. MSF has thus been forced to adopt a case-by-case, drug-by-drug approach when it comes to putting pressure on laboratories to make these treatments available at affordable prices. The battle still remains as the need for alternative second generation drugs will increase. Patents Patent rules also hamper the development of fixed dose combinations (FDCs): three-in-one pills that helped simplify patients’ lives in many MSF programmes. But their development is slowed when different companies hold patents on the different compounds in FDCs. MSF already uses FDCs for 70% of its patients on first-line treatment however patent rules in India will make such combinations difficult to produce, if at all, in the future. In light of these current challenges MSF is encouraging the countries that do have manufacturing capacity (for example Brazil, Thailand, India and China), to routinely use the safeguards (such as compulsory licenses and government use provisions) affirmed in the 2001 WTO Doha Declaration. It is clear that the effect of patents on medicines has an enormous affect on the ability of governments and international organisations to expand treatment to the millions of people living with HIV/AIDS in poor countries around the world.
However the more successes that MSF racks up it seems the more obstacles and problems it encounters along the way and present for future decades. Indeed the greatest challenge is the expansion of long term quality treatment. The long term plan for MSF is to become ‘not necessary’ or ‘invisible’ in the process of providing comprehensive care for people living with HIV/AIDS in resource-poor settings. The further challenges that the organisation has already identified for itself include diagnosing and treating opportunistic infections (such as HIV-TB co-infection; Kaposi Sarkoma – a cancer typically that immune-suppressed people contract; and Cytomegaly Virus or CMV – a viral infection that often leads to blindness in HIV-positive patients); cost of treatment; infrastructure and second-line drugs. We can say that already MSF is taking on some of these challenges head-on for instance the problems with paediatrics – diagnosing babies before 18 months – and ARV formulations lie ahead. MSF is currently involved in the development of a point-of-care diagnostic tool that involves testing children. In the meantime this may significantly change the diagnosing of babies and children, as well as therapeutic follow-up of all HIV patients, with the possibility of saving many lives and enabling more fulfilled lives. Acronyms first published in Issues Magazine, No. 75- June 2006 Read more articles on HIV/AIDS
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Clinical monitoring
(for example developing clinical algorithms for nurses working in isolated
locations);