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

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Session 4 Oral Abstract Session
Antiretroviral Chemotherapy: New Agents
Session Time: Monday, 10 am - 12:30 pm
Room 6A-B

11:00 5.

TMC125 Monotherapy for 1 Week Results in a Similar Initial Rate of Decline of HIV-1 RNA as Therapy with a 5-Drug Regimen
S. Sankatsing¹, G. Weverling¹, G. van't Klooster², J. Prins¹, and J. Lange*¹
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-naďve 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-naďve, 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.

Š2002 9^th Conference on Retroviruses and Opportunistic Infections