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Lopinavir/r (Kaletra) As Sole Therapy for HIV
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Reported by Jules Levin
Pierone and colleagues (AIDS Research & Treatment Center of the Treasure Coast, Vero Beach, FL) reported at the 9th European AIDS Conference (Oct 2003) an update on a pilot study using Kaletra as a sole therapy for HIV without any other accompanying HIV ART drugs. Here is his abstract. He previously reported their experience with lopinavir/r (L/r) alone for treatment of HIV infection in 15 patients. This report updates and extends the observations in this original cohort of patients on L/r alone.
The charts of patients previously reported on LPV/r alone were reviewed. Dates and reason for treatment with LPV/r, previous antiviral treatment, resistance tests, CD4 counts and HIV-RNA levels before and after LPV/r were noted.
This original group of 15 patients had received LPV/r alone for more than 8 weeks. 2 of the 15 patients are no longer on LPV/r alone. 13 of 15 patients continue on LPV/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 LPV/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 LPV/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.
The authors concluded that follow up observations in this small cohort of patients suggest that LPV/r alone has potent and durable antiviral activity. No evidence of viral resistance has been observed. Prospective trials of L/r alone are warranted.
Reference: 9TH EUROPEAN AIDS CONFERENCE (EACS). 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP. October 25 - 29, 2003 Warsaw, Poland. Abstract F1/5 - LOPINAVIR/R AS SOLE THERAPY FOR HIV-INFECTION. Pierone G. (1), Mieras J. (2), Kantor C. (2), Bulgin-Coleman D. (1), Shearer J. (1), McCabe J. (2). (1) AIDS Research and Treatment Center of the Treasure Coast, Vero Beach, FL., USA, (2) Treasure Coast Infectious Disease Consultants, Vero Beach, FL, USA
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