3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

TIPRANAVIR/RITONAVIR (TPV/R) 500 MG/200 MG BID DRIVES WEEK 24 VIRAL LOAD (VL) BELOW 400 COPIES/ML WHEN COMBINED WITH A SECOND ACTIVE DRUG (T-20) IN PROTEASE INHIBITOR EXPERIENCED HIV+ PATIENTS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeOa0205

Valdez H., McCallister S., Kohlbrenner V., Mayers D.
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, United States of America

BACKGROUND: TPV is a new non-peptidic protease inhibitor (PI) with activity against multidrug resistant HIV-1. The combination of TPV with a high Inhibitory Quotient (IQ) against PI-resistant viruses and T-20 as a second active drug could be very potent in patients with limited treatment options.

METHODS: Phenotypic testing was performed on 450 randomly selected baseline samples from participants in the RESIST trials. Trough TPV concentrations were determined at weeks 2 and 4. Using TPV drug susceptibility and geometric mean TPV plasma concentrations the TPV IQ was calculated. Week 24 virologic responses were analyzed according to TPV IQ and T-20 use.

RESULTS: RESIST patients had previously received a median of 12 antiretrovirals including 4 PIs. Median baseline CD4 and VL were 155 cells/mm³ and 4.8 log₁₀ copies/mL. 58% of patients who used TPV + T-20 achieved a ≥1 log₁₀ VL reduction at week 24. 70% of patients who were naïve to T-20 and received TPV/r achieved a 1 log₁₀ VL reduction at week 24, while only 31% of patients who received TPV and T-20 – but were T-20 experienced – had a ≥1 log₁₀ VL reduction. 99 patients on TPV and T-20 had IQ determinations: 42% (42/99) had a TPV IQ <60 and 57.6% (57/99) an IQ ≥60. Week 24 VL responses for patients who used T-20 and had a TPV IQ ≥60 were ≥1 log₁₀ in 80.7% (46/57) of patients; VL <400 copies/mL in 59.6%% (34/57) and VL <50 copies/mL in 36.8% (21/57).

CONCLUSIONS: Most PI-experienced patients who received a TPV/r-containing regimen achieved an IQ ≥60. With this IQ, 81% of patients who also included a new class of drug in the regimen achieved a week 24 viral load reduction of 1 log₁₀ or more. Nearly 60% of these hard-to-treat patients achieved a week 24 VL <400 copies/mL.

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050724
Clinical | WeOa0205 | H Valdez
Treatment failure and salvage therapy

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