James Kahn
Publication Details
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Evidence for risk-stratification when monitoring for toxicities following initiation of combination antiretroviral therapy.
AIDS. 2013
OBJECTIVE:: Laboratory monitoring is recommended during combination antiretroviral therapy (cART), but the pattern of detected abnormalities and optimal monitoring are unknown. We assessed laboratory abnormalities during initial cART in 2000-2010 across the United States. DESIGN:: Observational study in the Centers for AIDS Research Network of Integrated Clinical Systems Cohort METHODS:: Among patients with normal results within a year prior to cART initiation, time to first significant abnormality was assessed by Kaplan-Meier curves stratified by event type, with censoring at first of regimen change, loss to follow-up, or 104 weeks. Incidence rates of first events were estimated using Poisson regression; multivariable analyses identified associated factors. Results were stratified by time (16 weeks) from therapy initiation. RESULTS:: 3,470 individuals contributed 3,639 person-years. Median age, pre-cART CD4 and follow-up duration were 40 years, 206 cells/mm and 51 weeks, respectively. Incidence rates for significant abnormalities (per 100 person-years) in the first 16 weeks post cART initiation were: lipid = 49 (95% Confidence Interval [CI]: 41-58); hematologic = 44 (40-49); hepatic = 24 (20-27); and renal = 9 (7-11), dropping substantially during weeks 17-104 of cART to lipid = 23 (18-29); hematologic = 5 (4-6); hepatic = 6 (5-8); and renal = 2 (1-3) (all p < 0.05). Among patients receiving initial cART with no prior abnormality (N = 1889), strongest associations for hepatic abnormalities after 16 weeks were hepatitis B and C, hazard ratios (HR) = 2.3 (95%CI: 1.2-4.5) and HR = 3.0 (1.9-4.5), respectively. The strongest association for renal abnormalities was hypertension, HR = 2.8 (1.4-5.6). CONCLUSION:: New abnormalities decreased after week 16 of cART. For abnormalities not present by week 16, subsequent monitoring should be guided by co-morbidities.
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