Evaluation of a rescue treatment program from Argentina's Ministry of Health
V. Curras, C. Balleri, E. Bissio, D. Martinez Madrid, C. Falistocco
Ministerio de Salud de la Nación (National Ministry of Health), Buenos Aires, Argentina
Background: Since late 2008, enfuvirtide, darunavir and tipranavir have been incorporated into the list of drugs provided by the “Dirección Nacional de Sida y ETS” of Argentina´s Ministry of Health (DSyETS). Although these drugs have been extensively evaluated in multiple clinical trials, it´s necessary to evaluate their clinical effectiveness in population terms and in real scenarios.
Objective: To describe and evaluate the effectiveness of a rescue program from the DSyETS of Argentina´s Ministry of Health that provides darunavir, tipranavir and/or enfuvirtide to HIV(+) patients with multiple treatment failures or no other treatment options.
Methods: Retrospective cohort study. Demographic variables, information about HIV infection, treatment history and efficacy measures (CD4, viral load) were collected at baseline and at regular intervals after starting rescue treatment.
Results: The program enrolled 114 patients so far; 76 were male, mean (±SD) age was 42.2 years (±8.65; range:18-62), median of time since HIV infection diagnosis was 10.7 years. Median number of previous regimens was 4 (IQR: 2-5). Most patients (52%) were at CDC stage C3. Median viral load before starting rescue treatment was 21000 copies/mL (IQR: 5287-100000); and median CD4 count, 163 cells/mm3 (60-264). According to resistance tests, 47.6% had extensive resistance to 3 drug classes, 43% to 2 drug classes. Darunavir was prescribed to 80% of the patients, tipranavir to 10.5% and enfuvirtide to 35% (25% received enfuvirtide PLUS darunavir or tipranavir as part of the regimen)Regarding follow-up, we could recover data for only 50 patients (44%). After a median follow-up time of 7 months (4-10), median viral load decreased to 50 copies/mL (50-150).
Conclusions: This rescue program seems to be effective, at least regarding short-term viral load control. Strategies are needed to improve recovery of follow-up information from the hospitals in order to improve evaluation of the program.
Partially supported by Fogarty-AITRP Grant#5D43TW001037
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