Guidance for Monitoring Toxicities After Starting ART

Keith Henry, MD

The high rate of significant lipid, hematologic, hepatic, and renal abnormalities decreased within 16 weeks after ART initiation.

Although Department of Health and Human Services guidelines recommend regular laboratory monitoring after antiretroviral therapy (ART) initiation, information is limited on the risk/benefit of long-term regular testing. To explore this issue, researchers using data from the Centers for AIDS Research Network of Integrated Clinical Systems cohort assessed laboratory abnormalities among HIV-infected adults who started ART between January 1, 2000, and January 31, 2010, in the U.S. Patients were included if they had normal baseline laboratory studies (lipid, hematologic, hepatic, and renal) and had at least one lab result after starting their first ART regimen. Modern ART was defined as a ritonavir-boosted protease inhibitor (PI), a nonnucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor, together with at least two nucleoside reverse transcriptase inhibitors.

A total of 3470 patients were included in the analysis (median age, 40; median pre-ART CD4 count, 206 cells/mm3; median follow-up, 51 weeks). During the first 16 weeks of ART, incidence rates (per 100 patient-years) for significant lipid, hematologic, hepatic, and renal abnormalities were 49, 44, 24, and 9. For weeks 17 through 104, these rates decreased to 23, 5, 6, and 2. The strongest predictors of hepatic and renal abnormalities after week 16 were hepatitis B or C coinfection (hazard ratios, 2.3 and 3.0) and preexisting hypertension (HR, 2.8), respectively. Compared with NNRTI-based regimens, boosted-PI–based regimens were associated with greater risk for delayed hematologic (HR, 1.8), hepatic (HR, 1.8) and renal (HR, 2.1) abnormalities.

Citation(s):

Taiwo B et al. Evidence for risk stratification when monitoring for toxicities following initiation of combination antiretroviral therapy. AIDS 2013 Jun; 27:1593.