Research priorities
Simple rapid diagnostic tests and monitoring tools
Current research focuses on developing new high-tech methods to measure patients' virological outcomes (resistance genotyping, etc.). Many of these tools are inappropriate for use in developing countries. Operational research is needed to come up with means of improving clinical diagnosis (when to start treatment, when to switch treatment) for use in resource-poor settings. In the longer term, simple and inexpensive rapid test are needed that would, for example, clearly indicate from a drop of blood whether a patient has a CD4 below 200 or would show that a viral load is above 5,000 copies. In addition, research on how to most benefit from monitoring tools is essential.
Specific paediatric formulations
The lack of paediatric formulations makes determining and administering paediatric doses complex and burdensome and often leads to over- or under-dosing. Treating a child also costs five or six times more than treating an adult. Industry must begin producing paediatric formulations of ARVs, in particular paediatric fixed-dose combinations (several medicines in one tablet), and at lower prices. New diagnostic and monitoring devices and clearer treatment guidelines are also needed to assist clinicians in the task of starting children on ARV treatment.TB and HIV In some countries, up to 70% of people who have tuberculosis (TB) also have HIV/AIDS. Yet diagnosing TB in patients with HIV/AIDS is difficult: sputum smear microscopy only shows up positive results in about a third of patients, and clinical diagnosis is complicated by the many symptom similarities between AIDS and TB. Treatment is also problematic: nevirapine, a component of the most commonly used, WHO-recommended ARV treatment regimen, cannot be used at the same time as a key TB medicine, rifampicin. Switching to other compatible drugs means a much higher pill count for co-infected patients. There is a clear and urgent need for new diagnostic tools to detect all forms of TB in all patients - including people living with HIV/AIDS, children, and people with extrapulmonary TB - and for fixed-dose combinations of ARVs that can be taken at the same time as key TB drugs.
Affordable second-line drugs adapted to resource-poor settings We need access to low-cost, effective and easy-to-use second-line drugs, so that when patients fail their first-line treatment, they have another set of medicines to fall back on. Current second-line drugs are very expensive: annual treatment costs jump from US$250 a year to US$700-3,000 because there is no generic competition. They are also difficult to take: daily pill count increases from two for first-line to up to 16 for second-line. Drug companies, both originator and generic, must reduce their prices for second-line ARVs and develop new formulations adapted to resource-poor settings. MSF has serious concerns about supplies of affordable quality medicines in the future. On January 1st 2005, all members of the World Trade Organization (WTO) are required to be fully compliant with the WTO TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement and start granting 20 year patents for pharmaceutical products. Only the least developed countries can postpone this until 2016. This means that affordable sources of new medicines will gradually dry up as patents will be granted on all new medicines and some existing medicines produced by generic manufacturers in countries like India. It is unlikely that affordable generic sources of second-line ARVs will be available any time soon. In general, lack of competition between manufacturers will result in higher drug prices. Infrastructure and human resources
Staffing
National scale-up efforts have only started in a handful of countries, such as Brazil, Thailand, South Africa, Zambia and Malawi. In other countries, efforts to expand treatment are moving very slowly. The health infrastructure of many developing countries is weak, and there is often a critical shortage of medical professionals and lack of specialist knowledge to run national treatment programmes. For example, there is often little capacity to procure safe and effective antiretroviral drugs at the lowest affordable price.
Training
Training staff is an essential part of making ARV treatment programmes successful. Governments, international organisations and NGOs should put more effort into training new nurses, clinicians and other medical and non-medical professionals. Technical assistance should also be extended for matters such as procurement.