AEGiS-14IAC: Implementation of an antiretroviral access program (CARE) in HIV-1 infected individuals in resource poor settings: initial experiences.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Implementation of an antiretroviral access program (CARE) in HIV-1 infected individuals in resource poor settings: initial experiences.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPp2209)

van Leeuwen R, Sow PS, Bissagnene E, Kityo C, Waweru H, Waalberg E, Lange J; PharmAccess International, Amsterdam, The Netherlands

ISSUES: One of the key debates after the previous World AIDS meeting was how to scale-up access to antiretroviral (ARV) therapy in resource poor settings. The WHO estimates that 6 million people are in direct need of ARV treatment but only a fraction has access to it. CARE (Cohort program to evaluate Access to anti-Retroviral therapy and Education) is a pilot program designed to provide ARVs along with comprehensive clinical care in 4 African countries. We describe the first experiences from this project.

DESCRIPTION: This a single-arm, 96 week, open-label cohort program in 200 subjects in Kenya, Uganda, Senegal and Cote d'Ivoire. ARV- naïve HIV-1 infected patients, who are unable to afford ARVs, with a CD4-count < 350/mm³ are treated with SQV/r 1600/100 mg od plus AZT 300 mg bid and 3TC 150 mg bid. Educational programs to increase general knowledge of HIV/AIDS, HIV awareness, prevention strategies, and treatment adherence are offered to patients and healthcare providers. The program also includes pharmacoeconomic and pharmacokinetic substudies. The results of the program will be used to determine the feasibility and cost-effectiveness of providing access to ARVs in developing countries.

ISSUES: Prior to initiation of patients on ARV, there were considerable logistical and administrative challenges, including establishment of suitable local infrastructure (computer, refrigerator, OPD clinic rooms), ethical approval, GCP consensus, transfer of funds, shipment, importation and storage of drugs. Comprehensive educational resource material was generated by an international faculty at multidisciplinary onsite workshops.

RECOMMENDATIONS: It took 12 months to overcome all hurdles, which was longer than anticipated. Patients are now being enrolled quickly. These first experiences from the CARE project may facilitate implementation of other access programs. The CARE program could serve as a model for access to ARVs and healthcare in a resource poor setting.

Keywords: AEGIS, HIV-1, HIV Infections, Health Resources, Acquired Immunodeficiency Syndrome, CD4 Lymphocyte Count, Poverty, Developing Countries, Cote d'Ivoire, Kenya, Senegal, Uganda, Human

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