Use of Lopinavir/Ritonavir in HIV-infected Patients Failing First-line Protease Inhibitor-based HAART

Database of Antiretroviral
Drug Interactions
    Search by:
    • Antiretroviral Drug
    • Interacting Drug
    • Interacting Drug Class

The long-term virological efficacy of lopinavir/ritonavir (Kaletra)-containing HAART in HIV-infected patients failing a first-line protease inhibitor (PI)-based regimen is still unclear. An observational study was carried out from December 2000-December 2002 on 111 consecutive patients starting lopinavir/ritonavir.

The primary end-point was virological success (HIV RNA <50 copies/mL in two consecutive determinations). CD4 outcome, lipid levels and adverse events were recorded. The Kaplan-Meier method and log-rank test were used to estimate the time-dependent probability of reaching the end-point using intention-to-treat and on-treatment approaches.

Results

· Ninety-six patients obtained virological success during follow-up;

· Kaplan-Meier analysis showed that the time-dependent probability of obtaining this end-point was 78.4% at month 12 and 85.8% at month 24.

· The median CD4+cell count increased by 118 cells/mm(3) from baseline to month 12 and by 153 cells/mm(3) to month 24.

· Thirty-one patients discontinued lopinavir/ritonavir: 16 because of drug-related toxicities, six for simplification, five because of virological failure, one patient was lost at follow-up and three died.

· An elevation in lipid parameters was observed, but only a minority of patients developed a grade 3 or higher hypertriglyceridaemia and/or hypercholesterolaemia.

· Among the 15 patients not reaching virological success, five had </=5 mutations in the protease region known to reduce susceptibility to lopinavir/ritonavir (one discontinued lopinavir/ritonavir because of gastrointestinal intolerance), five had no mutations (two discontinued lopinavir/ritonavir because of gastrointestinal intolerance) and five showed >/=6 mutations (all discontinued lopinavir/ritonavir);

· Of the patients who discontinued lopinavir/ritonavir none achieved HIV RNA <50 copies/mL on subsequent regimens.

The authors conclude, “Lopinavir/ritonavir was highly effective and well tolerated in HIV-infected patients failing a first-line PI-based HAART.”

Institute of Infectious and Tropical Diseases, Ospedale Luigi Sacco, University of Milan.

04/20/05

Reference
Bongiovanni and others. Use of lopinavir/ritonavir in HIV-infected patients failing a first-line protease-inhibitor-containing HAART. Journal of Antimicrobial Chemotherapy April 11, 2005