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Low level of the K103N HIV-1 above a threshold is associated with virological failure in treatment-naive individuals undergoing efavirenz-containing therapy

BACKGROUND:: Study GS-01-934 was a randomized open-label phase III study comparing efavirenz and tenofovir/emtricitabine to efavirenz and zidovudine/lamivudine in treatment-naive HIV-1-infected individuals. Through 144 weeks, 50 of 487 participants without baseline nonnucleoside reverse transcriptas... Full description

Journal Title: AIDS 2011, Vol.25(3), pp.325-333
Main Author: Goodman, D, Derrick
Other Authors: Zhou, A, Yun , Margot, J, Nicolas , Mccoll, D, Damian , Zhong, S, Lijie , Borroto-Esoda, S, Katyna , Miller, S, Michael , Svarovskaia, S, Evguenia
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ID: ISSN: 0269-9370 ; DOI: 10.1097/QAD.0b013e3283427dcb
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recordid: ovid10.1097/QAD.0b013e3283427dcb
title: Low level of the K103N HIV-1 above a threshold is associated with virological failure in treatment-naive individuals undergoing efavirenz-containing therapy
format: Article
creator:
  • Goodman, D, Derrick
  • Zhou, A, Yun
  • Margot, J, Nicolas
  • Mccoll, D, Damian
  • Zhong, S, Lijie
  • Borroto-Esoda, S, Katyna
  • Miller, S, Michael
  • Svarovskaia, S, Evguenia
subjects:
  • Efavirenz
  • Non-Nucleoside Reverse Transcriptase Inhibitors
  • Emtricitabine
  • Subpopulations
  • Abundance
  • Regression Analysis
  • Polymerase Chain Reaction
  • Zidovudine
  • Lamivudine
  • Tenofovir
  • Acquired Immune Deficiency Syndrome
  • Acquired Immune Deficiency Syndrome
  • Subpopulations
  • Subpopulations
  • Mutants
  • Mutants
  • Abundance
  • Abundance
  • Human Immunodeficiency Virus 1
  • General: Models, Forecasting
  • General: Models, Forecasting
  • Microorganisms & Parasites
  • AIDS and HIV
ispartof: AIDS, 2011, Vol.25(3), pp.325-333
description: BACKGROUND:: Study GS-01-934 was a randomized open-label phase III study comparing efavirenz and tenofovir/emtricitabine to efavirenz and zidovudine/lamivudine in treatment-naive HIV-1-infected individuals. Through 144 weeks, 50 of 487 participants without baseline nonnucleoside reverse transcriptase inhibitor resistance by population sequencing (efavirenz/tenofovir/emtricitabine, n = 19; efavirenz/zidovudine/lamivudine, n = 31) experienced virologic failure (>400 copies/ml). Here, we analyzed whether the presence of low levels of K103N at baseline correlated with virologic failure. METHODS:: Available baseline plasma samples (n = 485) were amplified and tested for K103N using an allele-specific PCR (AS-PCR) assay with a lower detection cut-off of 0.5%. RESULTS:: Sixteen of 476 (3.4%) evaluable participants had low-level K103N at baseline by AS-PCR (0.8–15%). The abundance of the K103N subpopulation at baseline distinguished individuals with virologic failure from those who responded durably to efavirenz-containing therapy. Among six participants with at least 2000 K103N copies/ml before treatment, five experienced virologic failure, compared with only one virologic failure among 10 who had less than 2000 K103N copies/ml (P = 0.008). Multivariate logistic regression analysis showed that K103N viral load at least 2000 copies/ml increased the risk of virologic failure with an odds ratio of 47.4 (95% confidence interval 5.2–429.2, P = 0.0006). CONCLUSION:: The presence of K103N mutant virus in plasma above 2000 copies/ml prior to therapy in treatment-naive individuals correlated with increased risk of virologic failure of these efavirenz-containing triple-drug regimens.
language:
source:
identifier: ISSN: 0269-9370 ; DOI: 10.1097/QAD.0b013e3283427dcb
fulltext: fulltext
issn:
  • 0269-9370
  • 02699370
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titleLow level of the K103N HIV-1 above a threshold is associated with virological failure in treatment-naive individuals undergoing efavirenz-containing therapy
creatorGoodman, D, Derrick ; Zhou, A, Yun ; Margot, J, Nicolas ; Mccoll, D, Damian ; Zhong, S, Lijie ; Borroto-Esoda, S, Katyna ; Miller, S, Michael ; Svarovskaia, S, Evguenia
ispartofAIDS, 2011, Vol.25(3), pp.325-333
identifierISSN: 0269-9370 ; DOI: 10.1097/QAD.0b013e3283427dcb
descriptionBACKGROUND:: Study GS-01-934 was a randomized open-label phase III study comparing efavirenz and tenofovir/emtricitabine to efavirenz and zidovudine/lamivudine in treatment-naive HIV-1-infected individuals. Through 144 weeks, 50 of 487 participants without baseline nonnucleoside reverse transcriptase inhibitor resistance by population sequencing (efavirenz/tenofovir/emtricitabine, n = 19; efavirenz/zidovudine/lamivudine, n = 31) experienced virologic failure (>400 copies/ml). Here, we analyzed whether the presence of low levels of K103N at baseline correlated with virologic failure. METHODS:: Available baseline plasma samples (n = 485) were amplified and tested for K103N using an allele-specific PCR (AS-PCR) assay with a lower detection cut-off of 0.5%. RESULTS:: Sixteen of 476 (3.4%) evaluable participants had low-level K103N at baseline by AS-PCR (0.8–15%). The abundance of the K103N subpopulation at baseline distinguished individuals with virologic failure from those who responded durably to efavirenz-containing therapy. Among six participants with at least 2000 K103N copies/ml before treatment, five experienced virologic failure, compared with only one virologic failure among 10 who had less than 2000 K103N copies/ml (P = 0.008). Multivariate logistic regression analysis showed that K103N viral load at least 2000 copies/ml increased the risk of virologic failure with an odds ratio of 47.4 (95% confidence interval 5.2–429.2, P = 0.0006). CONCLUSION:: The presence of K103N mutant virus in plasma above 2000 copies/ml prior to therapy in treatment-naive individuals correlated with increased risk of virologic failure of these efavirenz-containing triple-drug regimens.
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subjectEfavirenz ; Non-Nucleoside Reverse Transcriptase Inhibitors ; Emtricitabine ; Subpopulations ; Abundance ; Regression Analysis ; Polymerase Chain Reaction ; Zidovudine ; Lamivudine ; Tenofovir ; Acquired Immune Deficiency Syndrome ; Acquired Immune Deficiency Syndrome ; Subpopulations ; Subpopulations ; Mutants ; Mutants ; Abundance ; Abundance ; Human Immunodeficiency Virus 1 ; General: Models, Forecasting ; General: Models, Forecasting ; Microorganisms & Parasites ; AIDS and HIV;
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6Miller, S, Michael
7Svarovskaia, S, Evguenia
titleLow level of the K103N HIV-1 above a threshold is associated with virological failure in treatment-naive individuals undergoing efavirenz-containing therapy
descriptionBACKGROUND:: Study GS-01-934 was a randomized open-label phase III study comparing efavirenz and tenofovir/emtricitabine to efavirenz and zidovudine/lamivudine in treatment-naive HIV-1-infected individuals. Through 144 weeks, 50 of 487 participants without baseline nonnucleoside reverse transcriptase inhibitor resistance by population sequencing (efavirenz/tenofovir/emtricitabine, n = 19; efavirenz/zidovudine/lamivudine, n = 31) experienced virologic failure (>400 copies/ml). Here, we analyzed whether the presence of low levels of K103N at baseline correlated with virologic failure. METHODS:: Available baseline plasma samples (n = 485) were amplified and tested for K103N using an allele-specific PCR (AS-PCR) assay with a lower detection cut-off of 0.5%. RESULTS:: Sixteen of 476 (3.4%) evaluable participants had low-level K103N at baseline by AS-PCR (0.8–15%). The abundance of the K103N subpopulation at baseline distinguished individuals with virologic failure from those who responded durably to efavirenz-containing therapy. Among six participants with at least 2000 K103N copies/ml before treatment, five experienced virologic failure, compared with only one virologic failure among 10 who had less than 2000 K103N copies/ml (P = 0.008). Multivariate logistic regression analysis showed that K103N viral load at least 2000 copies/ml increased the risk of virologic failure with an odds ratio of 47.4 (95% confidence interval 5.2–429.2, P = 0.0006). CONCLUSION:: The presence of K103N mutant virus in plasma above 2000 copies/ml prior to therapy in treatment-naive individuals correlated with increased risk of virologic failure of these efavirenz-containing triple-drug regimens.
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authorGoodman, D, Derrick ; Zhou, A, Yun ; Margot, J, Nicolas ; Mccoll, D, Damian ; Zhong, S, Lijie ; Borroto-Esoda, S, Katyna ; Miller, S, Michael ; Svarovskaia, S, Evguenia
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abstractBACKGROUND:: Study GS-01-934 was a randomized open-label phase III study comparing efavirenz and tenofovir/emtricitabine to efavirenz and zidovudine/lamivudine in treatment-naive HIV-1-infected individuals. Through 144 weeks, 50 of 487 participants without baseline nonnucleoside reverse transcriptase inhibitor resistance by population sequencing (efavirenz/tenofovir/emtricitabine, n = 19; efavirenz/zidovudine/lamivudine, n = 31) experienced virologic failure (>400 copies/ml). Here, we analyzed whether the presence of low levels of K103N at baseline correlated with virologic failure. METHODS:: Available baseline plasma samples (n = 485) were amplified and tested for K103N using an allele-specific PCR (AS-PCR) assay with a lower detection cut-off of 0.5%. RESULTS:: Sixteen of 476 (3.4%) evaluable participants had low-level K103N at baseline by AS-PCR (0.8–15%). The abundance of the K103N subpopulation at baseline distinguished individuals with virologic failure from those who responded durably to efavirenz-containing therapy. Among six participants with at least 2000 K103N copies/ml before treatment, five experienced virologic failure, compared with only one virologic failure among 10 who had less than 2000 K103N copies/ml (P = 0.008). Multivariate logistic regression analysis showed that K103N viral load at least 2000 copies/ml increased the risk of virologic failure with an odds ratio of 47.4 (95% confidence interval 5.2–429.2, P = 0.0006). CONCLUSION:: The presence of K103N mutant virus in plasma above 2000 copies/ml prior to therapy in treatment-naive individuals correlated with increased risk of virologic failure of these efavirenz-containing triple-drug regimens.
pub© 2011 Lippincott Williams & Wilkins, Inc.
doi10.1097/QAD.0b013e3283427dcb
eissn14735571
date2011-01