1. The following medicines should be added to the core list of essential medicines under section 6.4.2 (Antiretroviral medicines):
• Nucleoside reverse transcriptase inhibitors: abacavir (ABC), didanosine (ddI), lamivudine (3TC), stavudine (d4T) and zidovudine (ZDV or AZT).
• Non-nucleoside reverse transcriptase inhibitors: efavirenz (EFV or EFZ) and nevirapine (NVP).
• Protease inhibitors: indinavir (IDV), lopinavir/low-dose ritonavir (LPV/r), nelfinavir (NFV), ritonavir (r) and saquinavir (SQV).
The following footnotes should also be added:
The antiretroviral medicines do not cure the HIV infection, they only temporarily suppress viral replication and improve symptoms. They have various adverse effects and patients receiving these medicines require careful monitoring by adequately trained health professionals. For these reasons, continued rigorous promotion of measures to prevent new infections is essential and the need for this has not been diminished in any way by the addition of antiretroviral medicines to the Model List. Adequate resources and trained health professionals are a prerequisite for the introduction of this class of medicines. Effective therapy requires commencement of three or four medicines simultaneously, and alternative regimens are necessary to meet specific requirements at start-up, to substitute for first-line regimens in the case of toxicity, or to replace failing regimens. The Committee strongly recommends the use of three- or four-medicine combinations as specifically recommended in the WHO clinical guidelines. The use of fixed-dose preparations for these combinations is also recommended, with assured pharmaceutical quality and interchangeability with the single products as approved by the relevant drug regulatory authority.
Selection of two or three protease inhibitors from the Model List will need to be determined by each country after consideration of local clinical guidelines and experience, as well as the comparative costs of available products. Ritonavir is recommended for use in combination with indinavir, lopinavir and saquinavir as a booster, and not as a medicine in its own right.
2. Artemether + lumefantrine (fixed-dose combination) should be added to the core list of essential medicines under section 6.5.3a (Antimalarial medicines - for curative treatment).
3. The dosage of meglumine antimoniate should be changed from “approximately 8.5%” to “approximately 8.1%”.