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LIVER TOXICITY OF LOPINAVIR/RITONAVIR-CONTAINING REGIMENS IN HIV-INFECTED PATIENTS WITH OR WITHOUT HEPATITIS C VIRUS (HCV) CO-INFECTION
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Reported by Jules Levin
9th European AIDS Conference (October 2003, Warsaw, Poland)
Vincent Soriano and colleagues. Hospital Carlos III, Madrid, Spain
Liver toxicity is a common side effect of antiretroviral therapy, particularly in subjects with HCV. Overall, it leads to treatment discontinuation in 10-15% of patients who initiate HAART.
The incidence of severe liver toxicity after initiation of LPV/rit (Kaletra 400/100mg) and its possible association with LPV plasma levels were assessed in all consecutive HIV+ patients attended at our institution during 2002.
A total of 120 patients were analyzed. Mean features: 92% men; 52% coinfected with HCV; mean age 38-years-old; mean CD4 count 287 cells/ul; and mean plasma HIV-RNA 73,041 cop/ml.
The incidence of grade 3-4 liver toxicity (>5-fold elevation in liver enzymes) at 3 months was 1.7% and the cumulative incidence at 12 months was 4%. All cases occurred among patients with HCV, and all had liver enzyme elevations at baseline. Among HCV-pos patients, the cumulative incidence of LPV/rit severe liver toxicity was 8%, which was significantly greater (p=0.027) than among HCV-neg individuals (0%).
Mean (range) LPV plasma trough levels were 5.9 (0.01-17.7) _g/ml. There was no association between LPV levels and severe hepatotoxicity (OR, 0.72 [95% CI 0.44-1.19]; p=0.21). On the other hand, mean (range) LPV levels were similar when comparing HCV-pos and HCV-neg patients (6.33 vs 6.11 _g/ml; p=0.79).
The authors concluded that the incidence of severe liver toxicity attributable to LPV/rit is low, although this complication may be more frequent among HCV+ patients. In contrast with other side effects associated to PI use, Kaletra liver toxicity does not seem to be related with LPV plasma levels.
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