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Genotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients.

Results from 2 placebo-controlled intensification trials of tenofovir disoproxil fumarate (DF) in treatment-experienced human immunodeficiency type 1 (HIV-1)-infected patients (n = 332) were integrated to determine the effects of resistance at baseline on HIV-1 RNA response. In these trials, there w... Full description

Journal Title: The Journal of infectious diseases March 1, 2004, Vol.189(5), pp.837-846
Main Author: Miller, Michael D
Other Authors: Margot, Nicolas , Lu, Biao , Zhong, Lijie , Chen, Shan-Shan , Cheng, Andrew , Wulfsohn, Michael
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 0022-1899
Link: http://search.proquest.com/docview/80173142/?pq-origsite=primo
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title: Genotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients.
format: Article
creator:
  • Miller, Michael D
  • Margot, Nicolas
  • Lu, Biao
  • Zhong, Lijie
  • Chen, Shan-Shan
  • Cheng, Andrew
  • Wulfsohn, Michael
subjects:
  • Acquired Immunodeficiency Syndrome–Drug Therapy
  • Adenine–Genetics
  • Anti-HIV Agents–Analogs & Derivatives
  • Cd4 Lymphocyte Count–Therapeutic Use
  • Double-Blind Method–Therapeutic Use
  • Genotype–Drug Therapy
  • HIV Infections–Genetics
  • HIV Reverse Transcriptase–Genetics
  • HIV-1–Enzymology
  • Humans–Genetics
  • Multivariate Analysis–Therapeutic Use
  • Mutation–Genetics
  • Organophosphonates–Isolation & Purification
  • Organophosphorus Compounds–Analogs & Derivatives
  • Phenotype–Genetics
  • Placebos–Genetics
  • Predictive Value of Tests–Genetics
  • RNA, Viral–Genetics
  • Regression Analysis–Genetics
  • Tenofovir–Genetics
  • Thymidine–Genetics
  • Abridged
  • Anti-HIV Agents
  • Organophosphonates
  • Organophosphorus Compounds
  • Placebos
  • RNA, Viral
  • Tenofovir
  • HIV Reverse Transcriptase
  • Adenine
  • Thymidine
ispartof: The Journal of infectious diseases, March 1, 2004, Vol.189(5), pp.837-846
description: Results from 2 placebo-controlled intensification trials of tenofovir disoproxil fumarate (DF) in treatment-experienced human immunodeficiency type 1 (HIV-1)-infected patients (n = 332) were integrated to determine the effects of resistance at baseline on HIV-1 RNA response. In these trials, there was a high prevalence of HIV-1 resistance mutations, with 94% of patients having nucleoside-associated mutations and 71% having thymidine analogue-associated mutations (TAMs). Statistically significant HIV-1 RNA reductions associated with tenofovir DF treatment, relative to placebo (P < 0.001), were observed for patients without TAMs (n = 97) or for patients with 1-2 (n = 88) or greater than or equal to 3 TAMs (n = 147). Response to tenofovir DF was reduced among patients with HIV-1 with greater than or equal to 3 TAMs inclusive of either the M41L or L210W mutation (n = 86) or patients who had a preexisting K65R mutation (n = 6). Slightly increased treatment responses were observed when the M184V mutation was present. Phenotypic cutoffs were established at 1.4-fold and 4-fold, respectively, for the beginning of reduced response to tenofovir DF and for a strongly reduced response. The results from these controlled clinical trials provide guidance for the use of tenofovir DF for treatment-experienced patients.
language: eng
source:
identifier: ISSN: 0022-1899
fulltext: fulltext
issn:
  • 00221899
  • 0022-1899
url: Link


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titleGenotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients.
creatorMiller, Michael D ; Margot, Nicolas ; Lu, Biao ; Zhong, Lijie ; Chen, Shan-Shan ; Cheng, Andrew ; Wulfsohn, Michael
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ispartofThe Journal of infectious diseases, March 1, 2004, Vol.189(5), pp.837-846
identifierISSN: 0022-1899
subjectAcquired Immunodeficiency Syndrome–Drug Therapy ; Adenine–Genetics ; Anti-HIV Agents–Analogs & Derivatives ; Cd4 Lymphocyte Count–Therapeutic Use ; Double-Blind Method–Therapeutic Use ; Genotype–Drug Therapy ; HIV Infections–Genetics ; HIV Reverse Transcriptase–Genetics ; HIV-1–Enzymology ; Humans–Genetics ; Multivariate Analysis–Therapeutic Use ; Mutation–Genetics ; Organophosphonates–Isolation & Purification ; Organophosphorus Compounds–Analogs & Derivatives ; Phenotype–Genetics ; Placebos–Genetics ; Predictive Value of Tests–Genetics ; RNA, Viral–Genetics ; Regression Analysis–Genetics ; Tenofovir–Genetics ; Thymidine–Genetics ; Abridged ; Anti-HIV Agents ; Organophosphonates ; Organophosphorus Compounds ; Placebos ; RNA, Viral ; Tenofovir ; HIV Reverse Transcriptase ; Adenine ; Thymidine
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descriptionResults from 2 placebo-controlled intensification trials of tenofovir disoproxil fumarate (DF) in treatment-experienced human immunodeficiency type 1 (HIV-1)-infected patients (n = 332) were integrated to determine the effects of resistance at baseline on HIV-1 RNA response. In these trials, there was a high prevalence of HIV-1 resistance mutations, with 94% of patients having nucleoside-associated mutations and 71% having thymidine analogue-associated mutations (TAMs). Statistically significant HIV-1 RNA reductions associated with tenofovir DF treatment, relative to placebo (P < 0.001), were observed for patients without TAMs (n = 97) or for patients with 1-2 (n = 88) or greater than or equal to 3 TAMs (n = 147). Response to tenofovir DF was reduced among patients with HIV-1 with greater than or equal to 3 TAMs inclusive of either the M41L or L210W mutation (n = 86) or patients who had a preexisting K65R mutation (n = 6). Slightly increased treatment responses were observed when the M184V mutation was present. Phenotypic cutoffs were established at 1.4-fold and 4-fold, respectively, for the beginning of reduced response to tenofovir DF and for a strongly reduced response. The results from these controlled clinical trials provide guidance for the use of tenofovir DF for treatment-experienced patients.
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titleGenotypic and phenotypic predictors of the magnitude of response to tenofovir disoproxil fumarate treatment in antiretroviral-experienced patients.
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