The objective of the study is to evaluate the impact of the new highly active antiretroviral biotechnology medicines (tenofovir disoproxil, emtricitabin and darunavir) on the clinical centre health care budget for AIDS in 2011 for a one year time horizon. A computer simulated budget impact model is created to calculate the budget impact of the new biotechnology medicines as a difference among the cost of illness based on current practice monus the cost of illness based on new practice after the new medicines inclusion in the clinic. The cost of therapy is calculated as a sum of mean annual medicines cost for all patients on the therapeutic regime, yearly cost of physician's consultation, and laboratory tests. Two scenarios have been considered depending on the line of therapy - 1st line (140 patients in the current state and 20 in the new state) and IInd line (2 patients in the current state and 26 in the new state). The yearly cost per patient in the current state on 1st line therapy, which did not involve the use of the new biotechnology products varied between 3000 and 12 000 euro. In the new state the budget impact varies from 8000 to 13000 euro for treatment naive patient, and for the switched - therapy patients it varies between 5000 and 13 000 euro. Thus the addition of the new medicines let to the increase in the yearly budget per patient with 1000 to 5000 euro. The IInd line therapy is usually started when adverse drug events or resistance against the first line therapy is observed. The addition of the new medicines increases total budget more evidently for the patients on first line therapy, than for the patients on find line. The budget impact of the new highly active antiretroviral therapy depends mainly on the new biotechnology medicines cost. Biotechnol. & Biotechnol. Eq. 2011, 25(3), 2547-2554