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Predictive
Factors of Lopinavir/Ritonavir Discontinuation for Drug-related
Toxicity in Highly Pretreated HIV Patients
The objective of this study was to find predictive factors
of lopinavir/ritonavir/
LPV/r (Kaletra) discontinuation for drug-related toxicities
in highly pre-treated HIV patients.
The study was an observational study of HIV patients starting
LPV/r with HIV RNA >3log(10) copies/mL and a follow-up >/=6
months. Parameters studied were HIV
RNA, CD4+
cell counts, metabolic parameters and drug-related
adverse events. AIDS-defining
events and deaths
were recorded. The Kaplan-Meier (KM) model was used to estimate
time-dependent probability, and the multivariable Cox model to identify
predictors of LPV/r discontinuation for adverse events.
Results
·
The
study evaluated 416 HIV-infected patients.
·
Seventy-seven
patients (18.5%) discontinued LPV/r for toxicities.
·
Adverse
events leading to LPV/r discontinuation were gastrointestinal
(GI) symptoms in 40 cases, hyperlipidemia
in 27 and increase of aspartate aminotransferase (AST)/alanine
aminotransferase (ALT) in 10 patients.
·
Nineteen
patients (4.6%) developed an AIDS event during observation and 15
(3.6%) died.
The
KM probability of LPV/r discontinuation for toxicities was 5.3%
at month 12 and 15.7% at month 24. Subjects with hepatitis C virus
(HCV)-HIV co-infection and receiving LPV/r plus nucleoside
reverse transcriptase inhibitors (NRTIs) and protease
inhibitor (PI)/non-nucleoside
reverse transcriptase inhibitor (NNRTI) versus LPV/r
plus only NRTIs showed a higher risk of LPV/r discontinuation by
a Cox analysis, whereas non-intravenous drug abusers (IVDUs) had
a lower risk.
The
rate of discontinuation for toxicity decreased by 17% for each additional
month of LPV/r exposure.
The
authors conclude, “LPV/r was substantially well tolerated. Diarrhea
was the most frequent adverse event leading to discontinuation.
HCV-HIV co-infected patients and patients with a short exposure
to LPV/r have a higher risk of discontinuing LPV/r and should be
strictly monitored.”
Institute of Infectious and Tropical Diseases, Ospedale Luigi Sacco, University
of Milan, Milan, Italy.
05/13/05
Reference
M
Bongiovanni and others. Predictive factors of lopinavir/ritonavir
discontinuation for drug-related toxicity: results from a cohort
of 416 multi-experienced HIV-infected individuals. International
Journal of Antimicrobial Agents. May 3, 2005 [Epub ahead of
print].
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