Combination therapy is feasible in resource poor countries, and models already exist for its implementation, according to two articles from international expert groups published in today's edition of The Lancet.
In the first article, a group from Haiti and Harvard Medical School report on the experience of providing antiretroviral therapy in Central Haiti, the poorest region of the poorest country in the Carribean. The Clinique Bon Saveur began providing triple combination therapy in late 1998 to patients no longer responding to syndromic treatment for opportunistic infections, and has now treated more than 60 individuals with a triple regimen of either Combivir and indinavir or Combivir and efavirenz via directly observed therapy.
The author propose a basic minimum package for provision of HAART, and also describe the criteria used to identify patients who require treatment with HAART:
Basic minimum package for HIV in endemic settings : the Haiti experience
- HAART with DOT (initial regimen: non-PI containing triple therapy involving twice daily dosing)
- DOT using community health workers
- Monthly support meetings for people on therapy
- Social support to families, including financial assistance
- Antiretroviral therapy and milk substitutes to prevent mother to child transmission
- Post-exposure prophylaxis for professional accidents and rape
Criteria for inclusion in DOT-HAART project, Clinique Bon Saveur, Haiti
- Absence of active tuberculosis (TB is usually an early symptom of immunodeficiency, and can be effectively treated in the absence of antiretroviral therapy, with patients remaining free of HIV symptoms subsequently for several years)
- Recurrent opportunistic infections difficult to manage with antibacterials or antifungals
- Chronic enteropathy with wasting
- Otherwise unexplained and significant weight loss
- Severe neurologic complications attributable to HIV eg dementia, encephalopathy
- Severe leukopenia, anaemia or thrombocytopenia
In the second article, doctors from Malawi's national Tuberculosis Control Programme highlight the following steps for the establishment of an effective Directly Observed Therapy programme for antiretroviral therapy
- Government commitment
- Integrate HIV treatment programmes with national tuberculosis control programmes in order to:
- Avoid drug interactions
- Give highest chance of accessing HIV-infected individuals
- Use existing DOT providers and expertise, with understanding of adherence
- Reduce stigma of HIV infection by allowing people to access TB programme
- Standardise the antiretroviral regimens for first line, second line and subsequent therapy
- Establish a regular drug supply
- Introduce an examination system to ensure that only qualified individuals prescribe antiretrovirals
- Focus on patients with symptomatic disease
- Directly observed therapy, administered as close to the patient's home as possible
- Provide trained counsellors
- Ensure that all patients have a monitoring card similar to those used in the DOT TB programme, and institute quarterly reporting to a national programme monitoring unit, to accumulate reliable statistics for drug procurement etc
The group also makes the following critical points about how antiretroviral therapy might need to be rolled out during the coming years:
"A long-term programme development plan should be drawn up with all stakeholders laying out the vision, strategy, activities, reporting mechanisms, and above all the budget and sources of funding. Nationwide coverage cannot be done at once and a phased approach to antiretroviral therapy will be necessary. The chosen triple-combination therapy should be rigorously piloted in the first phase with intensive clinical and laboratory monitoring to ensure that the regimen is safe and well tolerated.
The aim will be to define simple and robust clinical management algorithms for the monitoring of treatment and complications, because in most districts laboratory monitoring will not be realistic. Additionally the difficult problem of defining antiretroviral treatment failure will be tackled.
While this study is taking place, the pilot districts earmarked for feasibility studies should be strengthening their infrastructure and expanding their staff to make a basic essential package of care for people living with AIDS available in preparation for the arrival of antiretroviral drugs. Once these pilot districts are ready, the feasibility of using antiretroviral drugs integrated into the national tuberculosis control programme structure and activities will have to be tested.
To test this integration will not be easy because the population will soon know where feasibility studies are taking place, and it is likely that there will be huge demand from patients outside the district. Strict criteria for including HIV-infected patients in district feasibility studies will be needed. These feasibility studies should include social science and health systems input to ensure that programmes are designed as equitably as possible and to monitor the social impact of taking these regimens long-term, especially on the poorest sectors of society. If the feasibility studies are successful, then the programme could be expanded and used throughout the country.
A resource-poor country itself will be unable to support an antiretroviral programme, and long-term donor support will be needed. This support is more likely to come if the AIDS control programme and the tuberculosis and antiretroviral therapy programme have developed a working, costed, development plan."
The International HIV/AIDS Alliance has produced a facilitator's guide for community needs assessment of treatment access needs. The primary aim of this toolkit, which is currently being field tested in Cambodia, India and Zambia, is to improve the ability of local NGOs to deal effectively with treatment access issues by assisting them to:
- Make decisions on involvement in treatment provision and drug supply, by providing a basic understanding of the main factors involved in HIV/AIDS treatment issues;
- Gain access to and make use of existing local and national drug supply systems where available; explore and use alternatives to these systems and drugs where necessary and useful; understand the uses of donated drugs and the constraints associated with their management and use;
- Work with the practical issues involved in drug supply and financing, with special regard to cost, quantification, quality and sustainability in the context of the development of the epidemic and in relation to other public health needs.
Farmer P et al. Community based approaches to HIV treatment in resource poor settings.The Lancet 358: 404-9, 2001.
Harries AD et al. Preventing antiretroviral anarchy in sub-Saharan Africa. The lancet 358: 410-14, 2001.