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