Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT

Kimberly Y. Smith, Winkler G. Weinberg, Edwin DeJesus, Margaret A Fischl, Qiming Liao, Lisa L. Ross, Gary E. Pakes, Keith A. Pappa, C. Tracey Lancester

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Background: Once-daily (QD) ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100) or atazanavir 300 mg (ATV/r100), plus tenofovir/ emtricitabine (TDF/FTC) 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT) in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3) randomly assigned to the FPV/r100 or ATV/r100 regimens. Results: At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both]), CD4+ count (mean, 176 vs 205 cells/mm3). At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA < 50 copies/mL: 75% (40/53) vs 83% (44/53), p = 0.34 [Cochran-Mantel-Haenszel test]); mean CD4+ count change-from-baseline: +170 vs +183 cells/mm3, p = 0.398 [Wilcoxon rank sum test]). Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL). FPV/ r100-treated patients experienced fewer treatment-related grade 2-4 adverse events (15% vs 57%), with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to <50 mL/min. Conclusion: The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/ HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2-4 adverse events.

Original languageEnglish
Article number5
JournalAIDS Research and Therapy
Volume5
DOIs
StatePublished - Mar 28 2008

Fingerprint

Tenofovir
Ritonavir
HIV Infections
CD4 Lymphocyte Count
HIV-1
Fasting
RNA
Nonparametric Statistics
LDL Cholesterol
HDL Cholesterol
Therapeutics
Hyperbilirubinemia
fosamprenavir
Atazanavir Sulfate
Emtricitabine

ASJC Scopus subject areas

  • Virology
  • Molecular Medicine
  • Pharmacology (medical)

Cite this

Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection : 48-week results of ALERT. / Smith, Kimberly Y.; Weinberg, Winkler G.; DeJesus, Edwin; Fischl, Margaret A; Liao, Qiming; Ross, Lisa L.; Pakes, Gary E.; Pappa, Keith A.; Lancester, C. Tracey.

In: AIDS Research and Therapy, Vol. 5, 5, 28.03.2008.

Research output: Contribution to journalArticle

Smith, Kimberly Y. ; Weinberg, Winkler G. ; DeJesus, Edwin ; Fischl, Margaret A ; Liao, Qiming ; Ross, Lisa L. ; Pakes, Gary E. ; Pappa, Keith A. ; Lancester, C. Tracey. / Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection : 48-week results of ALERT. In: AIDS Research and Therapy. 2008 ; Vol. 5.
@article{39020366f72844c1998d956532734987,
title = "Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT",
abstract = "Background: Once-daily (QD) ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100) or atazanavir 300 mg (ATV/r100), plus tenofovir/ emtricitabine (TDF/FTC) 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT) in 106 antiretroviral-na{\"i}ve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3) randomly assigned to the FPV/r100 or ATV/r100 regimens. Results: At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both]), CD4+ count (mean, 176 vs 205 cells/mm3). At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA < 50 copies/mL: 75{\%} (40/53) vs 83{\%} (44/53), p = 0.34 [Cochran-Mantel-Haenszel test]); mean CD4+ count change-from-baseline: +170 vs +183 cells/mm3, p = 0.398 [Wilcoxon rank sum test]). Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL). FPV/ r100-treated patients experienced fewer treatment-related grade 2-4 adverse events (15{\%} vs 57{\%}), with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to <50 mL/min. Conclusion: The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/ HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2-4 adverse events.",
author = "Smith, {Kimberly Y.} and Weinberg, {Winkler G.} and Edwin DeJesus and Fischl, {Margaret A} and Qiming Liao and Ross, {Lisa L.} and Pakes, {Gary E.} and Pappa, {Keith A.} and Lancester, {C. Tracey}",
year = "2008",
month = "3",
day = "28",
doi = "10.1186/1742-6405-5-5",
language = "English",
volume = "5",
journal = "AIDS Research and Therapy",
issn = "1742-6405",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection

T2 - 48-week results of ALERT

AU - Smith, Kimberly Y.

AU - Weinberg, Winkler G.

AU - DeJesus, Edwin

AU - Fischl, Margaret A

AU - Liao, Qiming

AU - Ross, Lisa L.

AU - Pakes, Gary E.

AU - Pappa, Keith A.

AU - Lancester, C. Tracey

PY - 2008/3/28

Y1 - 2008/3/28

N2 - Background: Once-daily (QD) ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100) or atazanavir 300 mg (ATV/r100), plus tenofovir/ emtricitabine (TDF/FTC) 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT) in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3) randomly assigned to the FPV/r100 or ATV/r100 regimens. Results: At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both]), CD4+ count (mean, 176 vs 205 cells/mm3). At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA < 50 copies/mL: 75% (40/53) vs 83% (44/53), p = 0.34 [Cochran-Mantel-Haenszel test]); mean CD4+ count change-from-baseline: +170 vs +183 cells/mm3, p = 0.398 [Wilcoxon rank sum test]). Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL). FPV/ r100-treated patients experienced fewer treatment-related grade 2-4 adverse events (15% vs 57%), with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to <50 mL/min. Conclusion: The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/ HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2-4 adverse events.

AB - Background: Once-daily (QD) ritonavir 100 mg-boosted fosamprenavir 1400 mg (FPV/r100) or atazanavir 300 mg (ATV/r100), plus tenofovir/ emtricitabine (TDF/FTC) 300 mg/200 mg, have not been compared as initial antiretroviral treatment. To address this data gap, we conducted an open-label, multicenter 48-week study (ALERT) in 106 antiretroviral-naïve, HIV-infected patients (median HIV-1 RNA 4.9 log10 copies/mL; CD4+ count 191 cells/mm3) randomly assigned to the FPV/r100 or ATV/r100 regimens. Results: At baseline, the FPV/r100 or ATV/r100 arms were well-matched for HIV-1 RNA (median, 4.9 log10 copies/mL [both]), CD4+ count (mean, 176 vs 205 cells/mm3). At week 48, intent-to-treat: missing/discontinuation = failure analysis showed similar responses to FPV/r100 and ATV/r100 (HIV-1 RNA < 50 copies/mL: 75% (40/53) vs 83% (44/53), p = 0.34 [Cochran-Mantel-Haenszel test]); mean CD4+ count change-from-baseline: +170 vs +183 cells/mm3, p = 0.398 [Wilcoxon rank sum test]). Fasting total/LDL/HDL-cholesterol changes-from-baseline were also similar, although week 48 median fasting triglycerides were higher with FPV/r100 (150 vs 131 mg/dL). FPV/ r100-treated patients experienced fewer treatment-related grade 2-4 adverse events (15% vs 57%), with differences driven by ATV-related hyperbilirubinemia. Three patients discontinued TDF/FTC because their GFR decreased to <50 mL/min. Conclusion: The all-QD regimens of FPV/r100 and ATV/r100, plus TDF/FTC, provided similar virologic, CD4+ response, and fasting total/LDL/ HDL-cholesterol changes through 48 weeks. Fewer FPV/r100-treated patients experienced treatment-related grade 2-4 adverse events.

UR - http://www.scopus.com/inward/record.url?scp=43149106498&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=43149106498&partnerID=8YFLogxK

U2 - 10.1186/1742-6405-5-5

DO - 10.1186/1742-6405-5-5

M3 - Article

C2 - 18373851

AN - SCOPUS:43149106498

VL - 5

JO - AIDS Research and Therapy

JF - AIDS Research and Therapy

SN - 1742-6405

M1 - 5

ER -