Clinical outcome among HIV-infected patients starting saquinavir hard gel compared to ritonavir or indinavir

Objective: To compare the clinical response among patients who initiate pro tease inhibitor therapies with different virological potency. Design: We analysed patients who started indinavir, ritonavir or saquinavir hard gel capsule (hgc) as part of at least triple therapy during prospecti ve follow-up within the EuroSIDA study. Methods: Changes in plasma viral load (pVL) and CD4 cell count from baselin e were compared between treatment groups. Time to new AIDS-defining events and death were compared in Kaplan-Meier models, and Cox models were establi shed to further assess differences in clinical progression (new AIDS/death) . Adjustment was made for differences in baseline parameters, in particular pVL, CD4 cell count, and region of Europe. Results: A total of 2708 patients (median follow-up: 30 months) were includ ed, of which 556 started ritonavir (21%), 1342 indinavir (50%), and 810 saq uinavir hgc (30%). The three groups were fairly evenly balanced at baseline regarding CD4 count, previous diagnosis of AIDS and pVL, After 12 months, the median changes in CD4 cell count were 90, 96 and 74 x 10(6) cells/l, re spectively; P < 0.001, the proportions of patients with pVL < 500 copies/ml were 47, 54 and 41%; P < 0.001, and the proportions with clinical progress ion were 11.9, 9.2 and 11.9%, respectively; P = 0.20 (log-rank lest). In mu ltivariate models the relative risk of clinical progression for indinavir c ompared with saquinavir hgc was: 0.77 (0.60-0.99); P = 0.043, and for riton avir 0.83 (0.62-1.11); P = 0.20. Conclusions: Saquinavir hgc was associated with an inferior long-term clini cal response relative to indinavir, which was consistent with the observed differences in virological and immunological responses. (C) 2001 Lippincott Williams & Wilkins.