9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland

Background: We previously reported our experience with lopinavir/r (L/r) alone for treatment of HIV infection in 15 patients.

Objectives: To update and extend the observations in this original cohort of patients on L/r alone.

Methods: The charts of patients previously reported on L/r alone were reviewed. Dates and reason for treatment with L/r, previous antiviral treatment, resistance tests, CD4 counts and HIV-RNA levels before and after L/r were noted.

Results: This original cohort of 15 patients had received L/r alone for more than 8 weeks. 2 of the 15 patients are no longer on L/r alone. 13 of 15 patients continue on L/r alone for a mean of 68 weeks (range 39-104 weeks). 12/15 (80%) of the cohort continue to demonstrate HIV-RNA levels < 400 copies/mL and 10 of 12 have HIV-RNA levels <75 copies/mL. 3 patients had resistance testing after viral rebound on or following L/r alone. One had an HIV-RNA level of 1470 copies/mL at week 22 and genotypic testing showed the L63C gene mutation. The second patient had a genotype done after temporary discontinuation of L/r alone and had L63A and V77I mutations (currently at week 47 with HIV-RNA < 50 copies/mL). The third patient had documented non-adherence and had L63A and V77I mutations.

Conclusions: Follow up observations in this small cohort of patients suggest that L/r alone has potent and durable antiviral activity. No evidence of viral resistance has been observed. Prospective trials of L/r alone are warranted.

Presenting Author: M.D. Gerald Pierone, AIDS Research and Treatment Center of the Treasure Coast, 3715 7th Terrace, 32960, Vero Beach, United States, Phone: (772) 978-9556

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