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participating institutions:
Johns Hopkins University AIDS Service, New York State DOH AIDS Institute, The CORE Center, Cook County Hospital



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Incidence of Adverse Reactions in HIV Patients Treated with Protease Inhibitors: A Cohort Study [P Bonfanti, et al. JAIDS 2000;23:236]: This multi-center study from northern Italy is based on a systematic evaluation of 1,207 patients who initiated PI therapy and were followed through April 1999 to determine the frequency of adverse reactions. The results, which are expressed as incidence/100 patient-years for all reactions, hepatic reactions (abnormal liver function tests with >2 x increase in transaminase), metabolic changes (lipodystrophy with fat redistribution), or renal toxicity, are summarized in the table below:

Toxicity of Protease Inhibitors Incidence/100 pt.-years
  IDV RTV SQV NFV SQV/RTV
All reactions 78 145 39 105 113
GI 12 45 10 24 34
Hepatic 6 12 6 8 10
Metabolic 17 44 11 32 31
Renal 13 1 1 2 3

Comment: The authors claim that this is the first prospective survey of the frequency of adverse reactions to protease inhibitors. The overall frequency of reactions was 36%, and 10% had reactions severe enough to be considered serious. The frequency of adverse reactions as a reason to discontinue treatment at 12 months was 15%. With respect to the individual drugs, ritonavir was associated with a high rate of reactions, particularly GI and metabolic. Nelfinavir had the best overall tolerance in that only 6% had grade 3-4 toxicities, and it was associated with the least number of discontinuations due to ADR. The frequency of renal stones due to indinavir was 2%. posted 6/6/2000





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