The overall objectives of treatment for HIV/AIDS, malaria and tuberculosis:

1. Safe, effective, quality treatment of three major communicable diseases, HIV/AIDS, TB and malaria, which together claim six million lives each year.

2. Formulations and packaging that help to ensure effective use, contain resistance and thereby keep existing medicines available for use for as long as possible.

3. Formulations and packaging that support massive scaling-up of treatment will make the best use of limited human and financial resources. At present, very few patients who would benefit from effective treatment of AIDS, TB and malaria actually receive optimal treatment.

Provisional observations concerning fixed-dose combinations

1. Combination therapy has become the standard for treating HIV/AIDS and TB, and is rapidly becoming the standard for malaria. Combination therapy has recognized benefits in slowing resistance, improving clinical outcomes and facilitating logistics. In the case of antiretroviral (ARV) triple therapy, fixed-dose combinations (FDCs) usually offer the most affordable option.

2. The key question for the meeting was: are there additional benefits in presenting combination therapy as FDCs or co-blistered combinations (CBCs)? This would enhance the likelihood that all active ingredients in the combination travel together from producer, through the supply system, to the prescriber, to the dispenser, and into the patient’s hands.

3. In response to this question, the following main observations were made:

a. FDCs/CBCs are very important tools for scaling-up treatment for HIV/AIDS, TB and malaria. FDCs remain the first choice when they are available, CBCs are a second choice and single products are a third, but least desirable choice.

b. FDCs/CBCs alone are not going to be enough; separate medicines will continue to be needed in specific circumstances, as discussed below.

c. FDCs/CBCs must be considered as one element in an effort to ensure adherence that also includes supportive counselling, appropriate information and other measures.

d. FDCs should be based on combinations of clinically proven safety and efficacy, and they must have demonstrated quality and bioequivalence. Where CBCs are used, the requirement is for a logical combination of products of proven safety, efficacy and assured quality.

e. To achieve “3 by 5”, many approaches will be needed. There will be a need for FDCs, CBCs and single products in differing circumstances.