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Abstract
IMPACT OF TREATMENT GUIDED BY PHENOTYPIC OR GENOTYPIC RESISTANCE TESTS ON THE RESPONSE TO ANTIRETROVIRAL THERAPY (ART): FINAL ANALYSIS OF THE NARVAL TRIAL (ANRS 088)
MEYNARD J, VRAY M, MORAND-JOUBERT L, PEYTAVIN G, BRUN-VEZINET F, CLAVEL F, GIRARD P
Objective:To evaluate the respective value of phenotype (P) and genotype (G) for choosing optimal ART vs by standard of care (SOC) in patients (pts) failing protease inhibitor (PI) containing regimen with VL<1000 cp/ml.
Methods:Pts failing PI regimen were randomized into 3 arms with treatment choice at screening based on 1)P results, 2)G results, 3)SOC.Pts were stratified at baseline according to VL and previous ART received.P and G were performed at W12 for pts with virologic failure (decrease in VL less than 1 log copies/ml). P was performed using a recombinant virus assay;G was a complete reverse transcriptase and protease sequencing using the TruGeneTM HIV1 genotypic test and interpreted using the ANRS algorithm.
Results:541 pts were enrolled between April and November 1999:190 in P,192 in G 159 in SOC.Baseline median CD4 (280/mm3),VL (4.3 log cp/ml),number of drugs previously received (n=7) were comparable between the 3 groups.More pts in SOC received at least 3 new drugs (55% vs 20% in P and G:p<0.001). Percentages of pts with VL<200 cp/ml at W12 (primary end point) were 33% in P,41% in G and 34% in SOC (P/SOC: p=0.918; G/SOC p=0.120).The mean fold decreases in plasma VL(log10) from baseline to W12 were 0.93±1.06 in P, 0.94±1.03 in G and 0.75±1.01 in SOC (P/SOC: p=0.274, G/SOC p=0.215). A benefit was observed in favor of genotyping/SOC (31% vs 22%;p=0.052) on the percentage of pts with VL<200 cp/ml both at W12 and W24 but this advantage wasn’t sustained at W36 (25% vs 19%; p=0.270). Impact of the number of PI previously received on the comparison of the response between the 3 groups was explored and showed that,for pts who had received only one PI,65% in G and 45% in SOC had < 200 cp/ml at W12 (p=0.022).
Conclusion:In this population of pts, P and G did not significantly improve the response to a next treatment regimen.The role of P and G for sparing new drugs will be investigated.Multivariate analysis of predictive factors of response will be presented.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
126
Suggested Citation
"MEYNARDJ, et al.
IMPACT OF TREATMENT GUIDED BY PHENOTYPIC OR GENOTYPIC RESISTANCE TESTS ON THE RESPONSE TO ANTIRETROVIRAL THERAPY (ART): FINAL ANALYSIS OF THE NARVAL TRIAL (ANRS 088).
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
126"
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