NACCAP ART-A - Programme for developing an Affordable HIV drug Resistance Test for Africa.

Background HIV drug resistance (HIVDR) occurs when viral replication continues in the presence of the selective pressure of antiretroviral (ARV) drug exposure and can be transmitted to newly infected patients. HIVDR is likely to have a great influence on the long-term success of treatment programs, undermining the current investments made in large-scale HAART programs in Africa. HIVDR patterns in Africa, where most HIV-1 viruses are non-B subtypes, may be different from subtype B. Information on the occurence of HIVDR in Africa is important for public health decision makers to make informed choices for 1st and 2nd line HAART. Development of specific technology to support this process is indicated. The use of commercial plasma-based kits for HIVDR genotyping is extremely costly and incurs serious logistical difficulties, rendering application in the resource-limited setting impossible. Dried Fluid Spot (DFS) technology offers a solution, enabling easy, cheap and cold-chain independent transportation of the non-infectious spots to central laboratories by regular mail. Sample collection using DFS is a recognized technology for viral load quantification and initial results demonstrate that it is also a valid method for HIVDR genotyping. The PharmAccess Studies to Evaluate Resistance (PASER) Program is key to leveraging the current NACCAP grant application (ART-A program), since it provides the clinical, laboratory, logistical and managerial framework for embedding the novel affordable HIVDR test and interpretation system into the African setting (clinical and laboratory network). ART-A program specifics: Objectives - Development of an affordable genotypic HIVDR protocol for testing and interpretation, using a convenient sample collection device, for Africa. - Technology transfer to Africa and capacity building, including ongoing assistance and comprehensive laboratory and clinical training program. - Dissemination of information to various audiences. Setting Collaboration between complementary international partners: PharmAccess/CPCD, UMCU-Virology, CRP-Santé, WITS-MM&H, Virco and CLS. Implementation in reference laboratories, peripheral laboratories and clinics throughout Africa, using the PASER networks. Overview ART-A projects 1. Development of a convenient sample collection device and extraction protocol to facilitate HIVDR testing in resource-limited settings. 2. Development of affordable genotypic applications. 3. Implementation and optimization of genotypic interpretation systems. 4. Technology transfer and Training Work Package. 5. Dissemination and communication. Long term perspectives The affordable and convenient HIV-1 subtype independent HIVDR test and interpretation system can be used in national HIVDR surveillance and monitoring programs in resource-poor settings, relevant for health pplicy makers, and the will be avialable to clinicians in the clinical management of individual patients on HAART. For the first time, the availability of real-time, affordable HIVDR testing, embedded in ongoing assistance in the responsible interpretation of test results, will become a realistic option, thus greatly improving HIV care in Africa.