Sixth International Congress Drug Therapy in HIV Infection 17-21 November, 2002 Glasgow, UK

The ABT-378/r European Early Access Program was initiated in Hungary in November 2000 and between this date and December 2001 22 patients (pts), heavily pretreated with antiretrovirals (ARs) limited treatments options with viral failure were included. The mean viral load was 118500 copies/ml (581 - 553000), mean CD4+ count was 246,6 /µl (21 - 612), previously diagnosed AIDS was 67% and the mean time on antiretroviral treatment was 6,1 years (3,2 - 10,5) at baseline. The previous AR treatments were as follows, mean numbers of nucleoside reverse transcriptase inhibitors (NRTI), protease inhibitors (PI) were 4,2 (2 -5) and 2,4 (2 -4) respectively and 9 patients were non-nucleoside reverse transcriptase (NNRTI) experienced. NRTI keymutations were determined in 12 pts by INNOLiPA method. Regarding the new lopinavir/ritonavir containing AR regiments treatment history, keymutations were taken into consideration and NNRT was offered for naïve pts where it was possible.

All patients completed week 48. The viral efficacy was determined as effective, HIV-RNS < 50 copies/ml and as moderate, a decrease in HIVRNS copies > 1 log with the new lopinavir/ritonavir containing AR treatment at week 12, 24, 36 and 48 were 64 %, 59 %, 54 %, 45 % and 36 %, 32 %, 32 %, 27 % respectively. The immunological efficacy was determined as a rise of CD4 cells > 50/ µl at week 12 and > 100/ µl at week 48, these were 83 % and 74% respectively. The treatment was well tolerated severe hypersensitive reaction probably due to nevirapine was observed in one case. Other severe adverse reactions either clinical or laboratory were not observed.

The excellent inhibitory quotient of lopinavir/ritonavir makes it capable that even after failing other PIs and/or NNRTIs containing regimens provides durable antiviral activity in new AR combinations with a good safety profile.

Presenting author: D Bánhegyi

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1 Saint László Hospital, Budapest, Hungary.

2002-11-17
P7

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