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Objective: To assess the clinical and economic consequences of the use of protease inhibitors in the treatment of HIV infection.

Design: Multicentric, observational, retrospective cohort study.

Setting: Ten AIDS reference centres in France.

Patients: All patients followed in each centre from September 1995 through October 1996.

Main outcome measures: AIDS-defining events, death, health-care resources use, administration of antiretroviral therapy.

Results: Data from 7749 patients in 10 centres showed a drop in hospitalization days by 35%, new AIDS cases by 35%, and deaths by 46%. In the same period, the proportion of patients receiving antiretrovirals rose from 36 to 53% including highly active antiretroviral therapy (HAART), which rose from 0.3 to 18%. Overall cost evaluation showed a slight increase of monthly treatment cost of US$ 12 per patient. Comparison of the three centres that used HAART earliest to the three centres that used it latest showed a clear benefit to early HAART with a drop in hospitalization days by 41%, new AIDS cases by 41% and deaths by 69%. The proportion of patients with HAART rose to 27% and monthly health-care cost decreased by US$ 248 852 (i.e., by US$ 101 per patient per month). Late prescribing centres experienced a less marked effect with a drop in hospitalization days by 22%, new AIDS cases by 31%, and deaths by 32.5%. Proportion of patients with HAART rose to 12% and monthly health-care costs increased by US$ 113 578 (i.e., by US$ 38 per patient per month).

Conclusions: This study supports the extensive use of HAART in HIV-infected patients.

(C) Lippincott-Raven Publishers.