Prevalence of Adverse Events Associated with Potent Antiretroviral Treatment: Swiss HIV Cohort Study [Fellay J et al. Lancet 2001;358:1322] Potent Antiretroviral Treatment: Swiss HIV Cohort Study [Fellay J et al. Lancet 2001;358:1322]: This is a prospective study of adverse reactions among 1,160 patients receiving antiretroviral agents. Physicians completed a questionnaire concerning adverse reactions, which were classified by the AACTG criteria [http://aactg.s-3.com]. Symptoms were based on history for the past 30 days. Lipodystrophy was evaluated according to criteria established by Carr and colleagues [AIDS 1998;12:F51] and probability of association with ART according to WHO criteria [http://www.who-umc.org/defs.html]. Laboratory studies that were performed included CBC, LFTs, lipids, and lactate. The results showed clinical or laboratory abnormalities in 78%, including severe abnormalities (grade 3 or 4) that were clinical in 9% and laboratory in 16%. About 6% of outpatient visits were prompted by the adverse event, and 8 (0.6%) were hospitalized due to the complication. Specific associations that are statistically significant according to logistic regression analysis are summarized below:

Clinical
Diarrhea	RTV (2.4)*, SQV (2.1), NFV (3.1)
Mood	3TC (1.7), EFV (1.5)
Sleep disorder	EFV (2.1)
Rash	IDV (2.0)
Nephrolithiasis	IDV (11.3)
Lipodystrophy	3TC (1.6), d4T (1.8)
Laboratory**
Neutropenia	AZT (2.4), 3TC (2.4)
ITP	SQV (4.9)
ALT	NVP (2.2)
Bilirubin	RTV (2.5), IDV (18.3)
CPK	d4T (1.8), ABC (2.9)
Lactate	d4T (1.7), ddI (1.8)
Cholesterol & triglyceride	d4T (1.5), RTV (2.4)
*Associations that are statistically significant by logistic regression analysis (p < 0.05); number in parenthesis is odds-ratio. **Indicates increases in lab values except for neutropenia and ITP.

Comment: There are relatively few surprises here concerning either the frequency of these side effects or the specific associations observed by the authors.
posted 11/9/2001

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