Malarone®, a fixed-dose combination antimalarial of atovaquone and proguanil hydrochloride, was first registered in the United Kingdom in 1996 for the treatment of multidrug-resistant falciparum malaria. It has subsequently been registered for this indication in 32 other countries worldwide, including 7 in Western Europe. It has also been registered for prophylaxis in Denmark. Registration in the USA for both treatment and prophylaxis of falciparum malaria is pending. Its role in malaria control is being determined through public/private sector collaboration for policy and operational research in cooperation with the Global Partnership to Roll Back Malaria.

The role of atovaquone and proguanil in control programmes

There has been much discussion on whether this combination product should be introduced for treatment in malaria-endemic countries immediately or whether it should be held in reserve for the future when treatment options will be limited because of increased resistance to existing drugs. The application of a policy to withhold an effective drug is difficult, although there are clearly regions (such as West Africa) where there is little resistance to amodiaquine and sulfadoxine/pyrimethamine and the use of atovaquone/proguanil based solely on efficacy criteria would not be justified. However, it is always difficult to determine the optimal role of an antimalarial in areas of multidrug resistance. The issue of efficacy is only one of the factors that need to be considered when incorporating a new drug into a national drug policy and cost/effectiveness, sustainable delivery, access and the potential impact of changes on treatment policy will need to be evaluated.

To help countries consider these issues, Glaxo Wellcome, the manufacturers of Malarone®, have agreed not to market the product in malaria-endemic countries immediately. Instead, in collaboration with the Task Force for Child Survival and Development, they are working with the Ministries of Health in Kenya, the United Republic of Tanzania and Uganda to determine the usefulness of atovaquone/proguanil for patients who fail to respond to the standard treatment at the district hospital level. Thereafter, the product is provided free of charge to eligible patients through the "Malarone Donation Programme". The donation programme also aims to define the role of atovaquone/proguanil in reducing severe anaemia in children, morbidity and mortality in pregnant women and in patients with drug-resistant disease. Product information is set out on page 226.

The Programme is being implemented within the context of the Global Partnership to Roll Back Malaria and the objectives are fully supported by WHO. Once the role of atovaquone/proguanil in national drug policy is defined, and if anticipated demand for the drug exceeds the quantity which Glaxo Wellcome has offered to donate, the Global Partnership to Roll Back Malaria will seek ways to reduce the cost for public sector use.