A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study

H. G. Sprenger; N. Langebeek; P. G. H. Mulder; C. H. H. ten Napel; R. Vriesendorp; A. I. M. Hoepelman; J. C. Legrand; P. P. Koopmans; B. Bravenboer; R. W. ten Kate; P. H. P. Groeneveld; W. F. W. Bierman; T. S. van der Werf; E. H. Gisolf; C. Richter

doi:10.1111/hiv.12186

A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study

H. G. Sprenger^*, N. Langebeek, P. G. H. Mulder, C. H. H. ten Napel, R. Vriesendorp, A. I. M. Hoepelman, J. C. Legrand, P. P. Koopmans, B. Bravenboer, R. W. ten Kate, P. H. P. Groeneveld, W. F. W. Bierman, T. S. van der Werf, E. H. Gisolf, C. Richter

^*Corresponding author for this work

Microbes in Health and Disease (MHD)

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

ObjectivesThe aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI).

MethodsAn open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naive patients with CD4 count 350 cells/L and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNA

ResultsFor the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm.

ConclusionsA single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.

Original language	English
Pages (from-to)	122-131
Number of pages	10
Journal	HIV Medicine
Volume	16
Issue number	2
DOIs	https://doi.org/10.1111/hiv.12186
Publication status	Published - Feb-2015

Keywords

abacavir
lamivudine
zidovudine
antiretroviral therapy
dyslipidaemia
induction maintenance
nucleoside reverse transcriptase inhibitors
REVERSE-TRANSCRIPTASE INHIBITORS
IMMUNODEFICIENCY-VIRUS-INFECTION
ACUTE MYOCARDIAL-INFARCTION
HIV-1-INFECTED PATIENTS
PROTEASE INHIBITORS
HIV-1 INFECTION
NAIVE PATIENTS
ABACAVIR USE
INITIAL TREATMENT
RISK

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A randomized controlled trial of single-class maintenance therapy with abacavir
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Sprenger, H. G., Langebeek, N., Mulder, P. G. H., ten Napel, C. H. H., Vriesendorp, R., Hoepelman, A. I. M., Legrand, J. C., Koopmans, P. P., Bravenboer, B., ten Kate, R. W., Groeneveld, P. H. P., Bierman, W. F. W., van der Werf, T. S., Gisolf, E. H., & Richter, C. (2015). A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study. HIV Medicine, 16(2), 122-131. https://doi.org/10.1111/hiv.12186

@article{c7a1617e77224a7b97beb09e30c5fafd,

title = "A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study",

abstract = "ObjectivesThe aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI).MethodsAn open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naive patients with CD4 count 350 cells/L and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNAResultsFor the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm.ConclusionsA single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.",

keywords = "abacavir, lamivudine, zidovudine, antiretroviral therapy, dyslipidaemia, induction maintenance, nucleoside reverse transcriptase inhibitors, REVERSE-TRANSCRIPTASE INHIBITORS, IMMUNODEFICIENCY-VIRUS-INFECTION, ACUTE MYOCARDIAL-INFARCTION, HIV-1-INFECTED PATIENTS, PROTEASE INHIBITORS, HIV-1 INFECTION, NAIVE PATIENTS, ABACAVIR USE, INITIAL TREATMENT, RISK",

author = "Sprenger, {H. G.} and N. Langebeek and Mulder, {P. G. H.} and {ten Napel}, {C. H. H.} and R. Vriesendorp and Hoepelman, {A. I. M.} and Legrand, {J. C.} and Koopmans, {P. P.} and B. Bravenboer and {ten Kate}, {R. W.} and Groeneveld, {P. H. P.} and Bierman, {W. F. W.} and {van der Werf}, {T. S.} and Gisolf, {E. H.} and C. Richter",

year = "2015",

month = feb,

doi = "10.1111/hiv.12186",

language = "English",

volume = "16",

pages = "122--131",

journal = "HIV Medicine",

issn = "1464-2662",

number = "2",

}

Sprenger, HG, Langebeek, N, Mulder, PGH, ten Napel, CHH, Vriesendorp, R, Hoepelman, AIM, Legrand, JC, Koopmans, PP, Bravenboer, B, ten Kate, RW, Groeneveld, PHP, Bierman, WFW , van der Werf, TS, Gisolf, EH & Richter, C 2015, 'A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study', HIV Medicine, vol. 16, no. 2, pp. 122-131. https://doi.org/10.1111/hiv.12186

A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study. / Sprenger, H. G.; Langebeek, N.; Mulder, P. G. H. et al.
In: HIV Medicine, Vol. 16, No. 2, 02.2015, p. 122-131.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy

T2 - final 96-week results from the FREE study

AU - Sprenger, H. G.

AU - Langebeek, N.

AU - Mulder, P. G. H.

AU - ten Napel, C. H. H.

AU - Vriesendorp, R.

AU - Hoepelman, A. I. M.

AU - Legrand, J. C.

AU - Koopmans, P. P.

AU - Bravenboer, B.

AU - ten Kate, R. W.

AU - Groeneveld, P. H. P.

AU - Bierman, W. F. W.

AU - van der Werf, T. S.

AU - Gisolf, E. H.

AU - Richter, C.

PY - 2015/2

Y1 - 2015/2

N2 - ObjectivesThe aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI).MethodsAn open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naive patients with CD4 count 350 cells/L and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNAResultsFor the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm.ConclusionsA single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.

AB - ObjectivesThe aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI).MethodsAn open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naive patients with CD4 count 350 cells/L and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNAResultsFor the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm.ConclusionsA single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.

KW - abacavir

KW - lamivudine

KW - zidovudine

KW - antiretroviral therapy

KW - dyslipidaemia

KW - induction maintenance

KW - nucleoside reverse transcriptase inhibitors

KW - REVERSE-TRANSCRIPTASE INHIBITORS

KW - IMMUNODEFICIENCY-VIRUS-INFECTION

KW - ACUTE MYOCARDIAL-INFARCTION

KW - HIV-1-INFECTED PATIENTS

KW - PROTEASE INHIBITORS

KW - HIV-1 INFECTION

KW - NAIVE PATIENTS

KW - ABACAVIR USE

KW - INITIAL TREATMENT

KW - RISK

U2 - 10.1111/hiv.12186

DO - 10.1111/hiv.12186

M3 - Article

SN - 1464-2662

VL - 16

SP - 122

EP - 131

JO - HIV Medicine

JF - HIV Medicine

IS - 2

ER -

A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study

Abstract

Keywords

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