In April 1997, WHO and UNAIDS held an Informal Consultation on the Implications of Antiretroviral Treatments for HIV/AIDS, with the objective of providing policy guidance on major issues relating to the use and provision of antiretroviral drugs.¹ As a follow up activity to this consultation, a set of nine Guidance Modules on several aspects of antiretroviral treatments was produced.² Guidance Module number 4, entitled Safe and Effective use of Antiretroviral Therapies, provided guidance primarily to clinicians, counsellors, and managers of clinical services. Policy makers, people living with HIV/AIDS (PLHA) and decision-makers in national referral and district hospitals as well as training institutions have also found this guidance module very helpful. The module reflected the published standards of care and the consensus of participants at the time of the consultative meeting in 1997.

^1.The Implications of Antiretroviral Treatments. Informal Consultation - April 1997. WHO/ASD/97.2.

^2. Guidance Modules on Antiretroviral Treatments. WHO/ASD/98. 1; UNAIDS/98.7.

Treatment guidelines need to be regularly updated to take into account evolution in knowledge and experiences from different healthcare settings. There is today a much better understanding of the biological basis for antiretroviral therapy (ART) and clinical research has provided consistent data on its effectiveness. The adherence difficulties and adverse effects associated with some of the antiretroviral drug combinations are better understood and regimens that are easier to take are being developed. There is also an increasing body of knowledge on the therapeutic implications of antiretroviral drug resistance. A variety of international treatment guidelines have been developed to keep clinical practice as much as possible in pace with the data emerging from basic and clinical research.

Clinical guidance for the use of ART must take into account the profile of patients seeking care as well as the capacities of the healthcare setting in which this care is being delivered. Low and middle-income countries have requested recommendations for the provision and monitoring of ART that are more directly relevant to their resource limited settings than the published International Guidelines. In response to this requirement, WHO in collaboration with UNAIDS and the International Aids Society (IAS) organised a technical consultative meeting, in February 2000. This consultation brought together experts in HIV/AIDS care and HIV clinical research from industrialised countries and developing countries, to analyse available scientific evidence and discuss contextual issues relating to the safe and effective use of antiretroviral therapies in resource limited settings. This guide is a result of the discussions and recommendations of the February 2000 consultation.

In section one, the principles behind current use of antiretroviral drugs for the treatment of HIV-1 infection are outlined. This section refers to existing international recommendations.

Several factors that relate to the profile of patients seeking HIV care in resource limited countries may influence the choice and the outcome of antiretroviral therapy:

• the vast majority of patients are currently treatment naive because antiretroviral drugs are usually not available through the public sector and are poorly introduced into private markets.

• most patients have advanced stage HIV disease at the time treatment is initiated because in the absence of wide spread counselling and testing, diagnosis is often delayed.

• patients in resource poor countries are more likely to have co-existing morbidity such as anaemia, malnutrition as well as tuberculosis and other medical conditions, which may act in concert to affect the choice of therapy and the considerations on the potential spectrum of drug interactions and drug toxicity.

• the majority of patients are in a low-income bracket and because antiretroviral drugs are not usually provided free of charge, financial constraints are a common cause of treatment interruptions and of further delay in initiating therapy.

Within many resource limited countries there are “sites of excellence” where small scale ART programmes have been implemented. Nevertheless, inadequacy of healthcare services in terms of consistency of supplies and quality assurance of laboratory support as well as a scarcity of trained clinicians, are characteristic of most resource limited settings. Experiences with the use of ART in these settings, however, continue to accumulate and there are important lessons to be drawn from them.

In section two of this guide, some national ART programmes and some pilot initiatives from six low and middle income countries are described.

In section three, discussions and recommendations on the use of antiretroviral drugs in resource limited settings, for the treatment of HIV-1 infection, are presented.

The participation of patients in decision-making processes is crucial to the outcome of any treatment programme. People living with HIV/AIDS (PLHA), from resource limited countries participated in this consultation and their contributions on adherence issues and on the psychosocial support needs of patients form an important element of the contents of this guide.