13th Annual Conference of the British HIV Association 29 March–1 April 2007, Brighton, UK

ANALYSIS OF PLASMA LOPINAVIR (LPV) LEVELS WHEN KALETRA^® (LOPINAVIR 400 mg/RITONAVIR 100 mg) TABLETS ARE ADMINISTERED WITH AND WITHOUT AN NNRTI (NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR)

HIV Med 2007; 8(Suppl. 1):12 (abstract no. P11)

Martin Lechelt, Emma Hull, Claire Richardson, Venita Hardweir, Heather Leake Date, Duncan Churchill and Martin Fisher
Royal Sussex County Hospital, Brighton, UK

AIMS AND OBJECTIVES: The clinical significance of the pharmacokinetic interaction between Kaletra^® tablets and NNRTIs is unclear; the optimum dose of the tablets when used in this combination is yet to be established, especially in a PI-experienced population. The aims of this project were: to examine plasma drug levels achieved with Kaletra^® tablets in the presence and absence of co-administered NNRTIs, and to establish a dose recommendation for Kaletra^® tablets with co-administered NNRTIs.

METHODS: Plasma LPV trough levels were collected from patients receiving Kaletra^® tablet-containing ARV regimens, with or without NNRTIs, between 01/ 01/2006 and 31/12/2006. Data on LPV levels and drug regimens were obtained from pharmacy databases.

RESULTS: Median trough concentration (C_t) for all tablet samples was 6140 ng/ mL (n=47). For all doses of Kaletra^®, median C_t without NNRTI was 6620 ng/ mL (n=21) and with NNRTI 5939.5 ng/mL (n=26). When comparing various doses, two tablets bd: median C_t without NNRTI 6620 ng/mL (n=13) and with NNRTI 5308 ng/mL (n=8); three tablets bd: median C_t without NNRTI 3400 ng/mL (n=3) and with NNRTI C_t 9154 ng/mL (n=7); three tablets am and 2 pm, median C_t without NNRTI 7378 ng/mL (n=5) and with NNRTI 5751.5 ng/mL (n=8). Three patients were on OD Kaletra^® (5 OD n=1, 6 OD n=2), all were co-administered with an NNRTI and all patients had C_t < 1000 ng/mL.

CONCLUSION: Low plasma LPV levels were observed when OD Kaletra^® was co-administered with NNRTIs and is not recommended. Our data suggest standard dose Kaletra^® with NNRTIs in PI naïve subjects may be safe, but higher doses and TDM should be considered in PI-experienced patients.

2007-03-29
P11

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