· Trials of new antiretroviral treatments, particularly the triple combination therapies, have shown impressive short term results, prolonging life, reducing opportunistic infections, and resulting in the possibility of HIV/AIDS becoming a chronic infection requiring primarily outpatient care.
· Impressive results have also been obtained with monotherapy in pregnant women which reduces mother to child transmission of HIV infection by almost 70%.
· Although these advances represent the first real hope for people living with HIV/AIDS cautious optimism is warranted. Long term effectiveness has not yet been demonstrated and problems of resistance risk to appear. Nonetheless, in industrialized countries, triple combinations are widely prescribed and a reduction in AIDS hospitalization and mortality has been seen.
· The therapies are extremely expensive (US$1000-1500 per patient per month for triple therapy) - costs which are prohibitive in many settings, in particular in most low and middle income countries. Cost of the drugs is not the only constraint: rapid development of resistance and complex dosage regimens require strict patient compliance, trained practitioners, a functioning health and social system for monitoring, follow-up care and support, and a drug regulatory system to ensure reliable supplies of safe and quality products.
· In just over a decade, AIDS has evolved from a fulminant, rapidly fatal illness into a possibly chronic, albeit incurable disease. The good news coming from science and drug development is to be considered in the light of unequal access to care, and the uneven distribution of the epidemic - 90% of people with HIV/AIDS live in developing countries.
· The recent advances, particularly the new triple therapies, are widely perceived as a turning point in the history of treatment. People living with HIV/AIDS in all corners of the world are requesting the treatments and governments are seeking policy guidance on this issue. In response, WHO organized in April 1997 a consultation, with the support of UNAIDS, to review the state of the art of antiretroviral treatments and to examine the implications of providing them in low and middle income settings.
· The consultation brought together people living with HIV/AIDS, representatives from ministries of health, national AIDS Programmes, NGOs and the pharmaceutical industry, clinicians and researchers, to discuss the latest treatments, the problems of adherence to these complicated regimens, the risk of emergence of resistance to the drugs, the laboratory requirements, the prevention of mother to child transmission, the ethical implications and the need for support from a functioning health and social system.
· There was wide agreement on a large number of guiding principles, most importantly that:
Universal access to care and treatment, a principle which WHO promotes as a human right, is the aim. The fact that full access will not be achieved immediately and universally does not preclude the progressive introduction of antiretroviral treatments.
None of the drugs currently available is ideal; their efficacy depends upon adhering to a complicated and very strict regimen, and they can have unpleasant side effects. Funds must continue to be directed towards further basic science research to develop more user friendly treatments.
The provision of antiretrovirals must not lead to the diversion of resources from other essential health and development programmes, nor from HIV prevention activities such as condom promotion and other HIV/AIDS research priorities such as vaccines and microbicides.
Access to antiretrovirals must be integrated within a continuum of care between home, community and hospital, which includes clinical management, nursing, counselling and social support.
Quality assurance, supply, distribution and provision of antiretrovirals cannot be left to the private sector alone. Governments must have a regulatory and supervisory role and must take responsibility for issues such as price regulation, quality control, and the monitoring of safety and efficacy through a functioning laboratory system.
· Minimum requirements for the safe and effective use of antiretroviral treatments need to be identified, especially in settings where resources are very limited. For example, a functioning health and social system is important for safe and effective treatment with antiretrovirals, since missing as few as two doses a week may reduce efficacy by 50%.
· To appreciate the extent to which minimum requirements in terms of health and social support in the poorest countries can be met, one has only to reflect that to take 10-20 pills a day, one needs clean water and a nutritious and plentiful diet. Many people in the countries hardest hit by the AIDS pandemic do not have access to these basic commodities. Even HIV test kits may be unobtainable in certain regions, for months at a time due to stockouts.
· Laboratory facilities to monitor side effects and treatment effectiveness are not easily available to the majority of the worlds HIV infected people. The monitoring of adverse reactions (liver function test and bloodcount) is a prerequisite to safe treatment. The development of resistance is a major issue not solved as yet by triple combination therapy, and viral load measurement in particular for asymptomatic patients on treatment is essential for monitoring resistance patterns.
· Given a life saving treatment which is prohibitively expensive and hard to obtain, it is almost certain that a black market will develop in good quality, poor quality and counterfeit drugs. Unsupervised use invariably means incorrect use and will rapidly lead to emergence and transmission of resistant strains.
· Two assumptions underlie most of the discussions about antiretrovirals. One is that the therapy is complicated and has many side effects, and the other is that it needs to be continued indefinitely. However, easier drugs are in the pipeline and, theoretically, it might be possible to take triple combination therapies for 6 months to 3 years to reduce viraemia and then continue with a maintenance dose of only two drugs.
· WHO will produce and widely distribute the report of the consultation, develop technical and policy guidelines, and continue negotiations with industry on increasing access to the treatments, setting research priorities and ensuring good manufacturing practices.
For further information, please contact Health Communications and Public Relations, WHO, Geneva. Telephone (41 22) 7912535. Fax (41 22) 791 4858.
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© WHO/OMS, 1998