The Pharmaceutical Journal
Vol 269 No 7206 p45
13 July 2002

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JAMA (jama.ama-assn.org)
AIDS 2002 Conference (www.aids2002.org)

HIV: new guidelines but few new drugs

New recommendations for the treatment of HIV infection were published last week while participants at the XIV International AIDS Conference held in Barcelona heard that there had been "pitifully few" new drugs in this field over the past 20 years.

The new guidelines, written by the International AIDS Society USA panel (JAMA 2002;288:222), say that the threshold for initiation of antiretroviral therapy has shifted to later in the course of the disease.

In symptomatic disease and at CD4 levels under 200cells/ml, treatment is recommended, but at CD4 levels over 200cells/ml, treatment depends on various criteria such as CD4 count and rate of decline, viral load, patient motivation and risks of toxicity. The guidelines state that in patients with CD4 cell counts above 350/ml, concerns over treatment generally outweigh the benefits.

The choice of initial therapy is dependent on the individual patient, according to the new recommendations, with agents which have long half lives and less complicated administration being likely to have advantages. The criteria for initial therapy drugs are efficacy, durability, antiretroviral activity, tolerability, low incidence of adverse effects, convenience of drug regimen, low interaction potential and salvageability in case of failure. The three types of initial combination regimens recommended are shown in the Panel.

The guidelines say that protease inhibitors (PIs) are effective with nucleoside reverse transcriptase inhibitors (NRTIs) but are often difficult to adhere to. Low-dose ritonavir has been found to boost various PIs.

The recommendations advise against strategic treatment interruptions, though data presented at Barcelona last week suggest that this practice is safe (see below right). Various salvage regimens to follow failure of initial treatment are suggested with prompt intervention advocated to minimise the emergence of drug resistance.

The guideline authors call for still simpler, more effective and less toxic regimens. They describe new agents in development which may fulfil these needs. These include the NRTIs amdoxovir and emtricitabine, the non-nucleoside reverse transcriptase inhibitors DPC-083 and TMC-125 and the PIs atazanavir and tipranavir, as well as new classes of drugs such as entry inhibitors and integrase inhibitors.

Despite these developments, Brenda Lein, director, Immune Restoration Project, United States, said at the conference that there had been pitifully few new drugs or innovations in the field of HIV/AIDS over the past 20 years, compared with other conditions such as cancer and heart disease.

She added that this was due to inadequate funding for HIV/AIDS drug research and development plus deficiencies in leadership, planning and prioritisation of research and development.