28 February 2001, PharmAccess International (PAI), a not-for-profit Dutch-American organization announces a new initiative to create access to anti-HIV drugs for patients in four African countries. The program will be initiated in major urban treatment centres in Côte d'Ivoire, Kenya, Senegal and Uganda with funding, anti-retroviral agents, diagnostic and monitoring tests as well as technical support for training of healthcare professionals and education for patients provided for by F. Hoffmann-La Roche Ltd. The program, structured as a cohort access program, is intended to be a first step in widening access to HIV therapy in a clinically sound and sustainable manner by focussing on the improvement / build-up of local medical infrastructure in addition to providing controlled access to medication. The initial phase of the program will run for two years, following which the participating patients will continue to receive the medication under the same conditions while the scope of the program will be expanded into other centers and countries.
" In environments with limited resources, partnerships are needed to provide holistic 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). "This program 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 programs, to specialized training of local healthcare professionals. We're delighted to have Roche as a partner for this program. Their dedication and commitment in helping to implement this initiative rapidly has been very beneficial".
The patients who will benefit from the cohort access program are those who would otherwise have no access to highly active antiretroviral therapy. "The choice of anti-HIV drugs includes a combination of two protease inhibitors, which provide HAART in a simple dosage regime as well as in a cost effective manner" explained Dr. Richard Hoetelmans, Board of Directors, PAI. The treatment combines the use of FortovaseÒ (saquinavir) on a once-daily basis (1600mg) with a low dose of ritonavir (100mg) and the nucleoside analogues zidovudine and 3TC (lamivudine).
Dr. Marie Charles, Managing Director of PAI, reinforced that this pilot initiative is only a first step in widening access. "In developing this program, time was spent in understanding how to best implement this from all aspects of care, access, delivery, prevention, and especially sustainability. While the program design and quality control is organized at the central level by a small project team, its implementation focuses on building local capacity and resources which will ensure long term sustainability. We intend to have the first patients receiving medication by September 2001."
This PAI initiative is just the beginning and provides the framework for the initial program to be broadened over time by the addition of more patients and new centers. Both PAI and Roche believe that the program, if successfully implemented, could serve as a model that in turn will inspire other donors to contribute to its expansion. Dr. Charles commented that "successfully expanding the project will not only require ongoing supply of test kits and drugs but also increased support in order to be able to continue the build up of local medical infrastructure and patient education which are vital elements of delivering comprehensive care in a clinically justified way."
" At Roche, we are acutely aware of the magnitude of the challenge of alleviating the suffering that people living with HIV/AIDS in Africa and other developing countries face " said Christopher Murray, head of Roche's Pharma International unit. "This initiative has the capability and potential to provide long term and sustainable HIV healthcare to increasing numbers of people across Africa. It is fully aligned within the principles of the UNAIDS accelerating access initiative and while this is only a first step we see it as a step in the right direction and we are delighted to be partnering with PAI to make a real difference to the lives of people living with HIV". The program 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.
Notes for Editors:
The access program of PAI contains the following components: medical training and patient education programs, HIV prevention programs, comprehensive clinical care 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.
Roche is providing financial support, drugs, diagnostic monitoring tests and technical expertise to assist in the training of local staff to ensure they are equipped to deliver the highest standards of HIV related care. The choice of anti-HIV drugs has been based upon a combination of two protease inhibitors, which provide HAART in a simple dosage regime as well as in a cost effective manner.
The Fortovase/r regimen uses 44% of the recommended dose of Fortovase, but due to the 'boosting' effect from the ritonavir component of the regimen, this dose provides drug levels for the patient that are at least equivalent to those achieved with the standard Fortovase regimen. This approach of utilising ritonavir to increase the levels of other protease inhibitors is now recommended in the USA Department of Health and Human Services guidelines for antiretroviral therapy in HIV infected adults and adolescents (*see below). Such an approach will further increase the affordability of the regimen, a benefit not only in the African environment.
Roche is also supplying Amplicor HIV-1 Monitor® 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."
"The dose of ritonavir that is used for PI "boosting" also appears to be important for some protease inhibitors but not others. With saquinavir and amprenavir, increases in the ritonavir dose above 100 mg BID do not significantly increase the PI levels further."
For information (technical details of the access program) please contact:
PAI: Prof. Joep Lange, M.D., Ph.D.
Tel.:: +31 20 566 44 79
For information (global outline of the access program) please contact:
PAI: Marie Charles, M.D., M.I.A.
Tel: +31 651 822 810
To create and expand access to therapy
For patients in developing countries
In a clinically justified way and at a sustainable cost.