14 January 2002, Today, PharmAccess International (PAI) announces the start of the CARE partnership pilot programme to deliver comprehensive HIV healthcare in four African centres. Together with support and funding from Roche, this programme is now providing access to HIV care for patients in Africa’s developing countries. The aim of the new programme is to widen access to HIV therapy in a sustainable way by focusing on disease education and building-up vital local medical infrastructures. The first step of this pilot programme will run for two years and if successfully implemented, could serve as a best practice model that will inspire the expansion of this and similar initiatives across Africa. Marking the official start of the initiative, the first patient was welcomed to an HIV care centre in Dakar, just one of many patients that will receive care in Senegal, signaling hope for the millions of people with HIV living in Africa today.

The programme, run by the not-for-profit Dutch organisation PAI, is being initiated in major urban treatment centres in Côte d’Ivoire, Kenya, Senegal and Uganda. Funding as well as anti-retroviral agents, diagnostic monitoring tests and the technical support for the training of healthcare professionals is being provided for by Roche. Over the last 6 months the educational element of the programme has been very successful, particularly in the delivery of HIV healthcare training to over 100 African healthcare professionals. Local physicians, pharmacists, laboratory staff and counselors in treatment centres are now able to offer together a comprehensive holistic treatment programme for patients with HIV.

"In environments with limited resources, partnerships are needed to provide holistic comprehensive HIV/AIDS care, since effective HIV treatment is not solely based upon the supply of drugs," said Professor Joep Lange, Academic Medical Center, University of Amsterdam (Chairman, PAI). "Creating working partnerships is the only way to ensure a sustainable healthcare infrastructure and we are all 100% committed to making this partnership a great success, one that can bring lasting benefits to the local HIV infected patients. This programme embraces numerous aspects required for the successful implementation of Highly Active Antiretroviral Therapy (HAART). These range from the initial testing and ongoing diagnostic monitoring of the patient, to the treatment and prophylaxis of opportunistic infections associated with AIDS, to patient education, prevention and counseling programmes, to specialized training and education of local healthcare professionals. We're delighted to have Roche as our partner in the establishment of this programme. Their dedication and commitment in helping to implement this initiative rapidly will allow us to benefit the health of many HIV infected people living in developing countries".

The programme, structured as a cohort access programme, is intended to be a first step in widening access to HIV therapy in a clinically sound and sustainable manner by focussing on patient monitoring and HIV counseling, the improvement / build-up of local medical infrastructure in addition to providing controlled access to antiretroviral and related medication. This pilot phase of the programme will run for two years following which the participating patients will continue to receive the medication, while the scope of the programme will be expanded into other centres and countries. Both PAI and Roche believe that the programme, if successfully implemented, could serve as a model that in turn will inspire other donors to contribute to its expansion.

The programme will be coordinated and implemented by PharmAccess International, a not-for-profit organization closely linked with the International Antiviral Therapy Evaluation Center (IATEC) at the Academic Medical Center, University of Amsterdam. The mission of PharmAccess International is to create and expand access to drugs for patients in developing countries in a clinically justified way and at a sustainable cost.

The treatment provided combines the use of FortovaseÒ (saquinavir) with a low dose of ritonavir and the nucleoside analogues zidovudine and lamivudine on a twice daily basis. The choice of the HAART regimen has been based upon a combination of drugs that have a simple dosage regime with a limited number of pills.

ENDS

The access programme of PAI contains the following components: educational programmes for health-care providers, pharmacists and laboratory technicians, patient education and counseling, HIV awareness programmes and prevention strategies, comprehensive technical support according to a study protocol (data management, logistics, drug supply management, and overall quality control). The goal of PAI is to eventually be able to provide treatment in a clinically justified way for 1 million patients in developing countries.

The approach of utilising low dose ritonavir to boost the drug levels of other members of the protease inhibitors class is commonly used in routine clinical practice and is recommended by the US Department of Health and Human Services (*see below). The advantages of ritonavir boosted protease inhibitor regimens, such as the Fortovase/ritonavir combination used in this access programme, include reduced pill burden, dietary requirements, frequency of dosing in addition to reduced drug acquisition costs.

Roche is also supplying Amplicor HIV-1 MonitorÒ v.1.5 viral load kits.

* Related text from the DHHS guidelines: "The use of ritonavir to increase plasma concentrations of other protease inhibitors (PIs) has rapidly evolved from an investigational concept to widespread practice. Standard doses of individual PIs result in trough drug levels that are often only slightly higher than the effective antiviral concentration; this may afford an opportunity for viral replication. In contrast, protease "boosting" or "enhancement" by ritonavir increases the trough levels of other

protease inhibitors well above the IC50 or IC95, minimizing opportunities for viral replication, and potentially allowing for drug activity even against moderately resistant strains of virus. In addition, these dual PI combinations often lead to more convenient regimens in terms of pill burden, scheduling, and elimination of food restrictions. "