AEGiS-9CROI: TMC125 Monotherapy for 1 Week Results in a Similar Initial Rate of Decline of HIV-1 RNA as Therapy with a 5-Drug Regimen

9th Conference on Retroviruses and Opportunistic Infections

Seattle, Washington - February 24 -February 28, 2002

TMC125 Monotherapy for 1 Week Results in a Similar Initial Rate of Decline of HIV-1 RNA as Therapy with a 5-Drug Regimen

Conf Retroviruses Opportunistic Infect 2002 Feb 24-28;9:abstract no. 5
S. Sankatsing¹, G. Weverling¹, G. van't Klooster², J. Prins¹, and J. Lange¹
¹Univ. of Amsterdam, The Netherlands, and ²Tibotec-Virco NV, Mechelen, Belgium

BACKGROUND: We have previously demonstrated that a 5-drug regimen (ERA study), including drugs from all 3 currently licensed classes, provides a faster initial decline of plasma HIV-1 RNA than standard triple antiretroviral therapy (ART). We here compare the initial rate of decline of plasma HIV-1 RNA of the ERA regimen (zidovudine, lamivudine, abacavir, indinavir, nevirapine), with that obtained with monotherapy with TMC125, a novel, highly potent, non-nucleoside reverse transcriptase inhibitor (NNRTI).

METHODS: Data from the ERA study were compared with recent TMC125 data. TMC125 was administered to 12 HIV-1 ART-naïve patients during 1 week in a dosage of 900 mg BID as monotherapy. The virion clearance rate constant (first order elimination) was calculated for this regimen and for the first week of treatment with the ERA-regimen (n = 13), based on at least 4 measurements.

RESULTS: Mean ages were 25 and 39 years for TMC125 and ERA patients, respectively (p<0.05). Median baseline plasma HIV-1 RNA levels were 4.2 and 4.8 log₁₀ copies/mL (p=0.001). Median baseline CD4 counts 458 and 310 cells/mm³(p=0.047). The median virion clearance rate constant was 0.68 per day in TMC125-treated patients, and 0.54 per day in ERA participants (p=0.13). The median decline in HIV-1 RNA was 1.92 and 1.55 log₁₀ copies (p=0.40). Respective median CD4 increases were 119 and 60 cells/mm³ after 1 week (NS).

CONCLUSIONS: Monotherapy with the TMC125 in ART-naïve, HIV-1-infected individuals results in a similar initial rate of decline of plasma HIV-1 during the first week of therapy as a 5-drug regimen. These results demonstrate that TMC125 is a highly potent NNRTI.

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Copyright © 2002 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.