Patients failing saquinavir therapy require an early change to indinavir before HIV-1 viral load reaches high levels

Sequential use of antiretroviral therapy with protease inhibitors (PI) is f requently prescribed owing to failure or intolerance of the first selected agent. Controversial data exist about the virological and immunological out come of patients in whom a change to a second PI regimen is needed. A prosp ective study of 113 HIV-positive patients (male, 84%; mean age 36 years; pr evious AIDS-defining event, 35%; previous antiretroviral therapy with nucle oside analogues, 94%) who started a saquinavir-containing regimen between M arch 1996 and March 1997 and had to change to indinavir (n = 79) owing to i ntolerance, failure or medical criteria was performed. At the time of the s witch, median CD4 cell count was 221 cells/mm(3) and the HIV RNA level was 3.98 log(10) copies/ml. The rate of viral suppression (HIV RNA levels below 200 copies/ml) was 40% at 3 months and 28% at month 6 after indinavir was instituted. In a logistic regression analysis, only the baseline viral load [relative risk (RR), 2.85; 95% confidence interval (CI), 1.31-6.05; P = 0. 007] was statistically associated with the lack of viral suppression on ind inavir. Although there are not sufficient data about the best therapeutic o ption if a change in PI-containing regimens therapy is considered, this stu dy supports the recommendation of an early change of the PI-containing regi mens, before the HIV-1 viral load reaches high levels.