Efficacy of etravirine combined with darunavir or other ritonavir-boosted protease inhibitors in HIV-1-infected patients: An observational study using pooled European cohort data

J. Vingerhoets, V. Calvez, P. Flandre, A. G. Marcelin, F. Ceccherini-Silberstein, C. F. Perno, M. Mercedes Santoro, R. Bateson, M. Nelson, A. Cozzi-Lepri, J. Grarup, J. Lundgren, F. Incardona, R. Kaiser, A. Sonnerborg, B. Clotet, R. Paredes, Hf Günthard, B. Ledergerber, A. HoogstoelS. Nijs, L. Tambuyzer, L. Lavreys, M. Opsomer

Research output: Contribution to journalArticle

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Abstract

Objectives: This observational study in antiretroviral treatment-experienced, HIV-1-infected adults explored the efficacy of etravirine plus darunavir/ritonavir (DRV group; n=999) vs. etravirine plus an alternative boosted protease inhibitor (other PI group; n=116) using pooled European cohort data. Methods: Two international (EuroSIDA; EUResist Network) and five national (France, Italy, Spain, Switzerland and UK) cohorts provided data (collected in 2007-2012). Stratum-adjusted (for confounding factors) Mantel-Haenszel differences in virological responses (viral load <50 HIV-1 RNA copies/mL) and odds ratios (ORs) with 95% confidence intervals (CIs) were derived. Results: Baseline characteristics were balanced between groups except for previous use of antiretrovirals (≥ 10: 63% in the DRV group vs. 49% in the other PI group), including previous use of at least three PIs (64% vs. 53%, respectively) and mean number of PI resistance mutations (2.3 vs. 1.9, respectively). Week 24 responses were 73% vs. 75% (observed) and 49% vs. 43% (missing=failure), respectively. Week 48 responses were 75% vs. 73% and 32% vs. 30%, respectively. All 95% CIs around unadjusted and adjusted differences encompassed 0 (difference in responses) or 1 (ORs). While ORs by cohort indicated heterogeneity in response, for pooled data the difference between unadjusted and adjusted for cohort ORs was small. Conclusions: These data do not indicate a difference in response between the DRV and other PI groups, although caution should be applied given the small size of the other PI group and the lack of randomization. This suggests that the efficacy and virology results from DUET can be extrapolated to a regimen of etravirine with a boosted PI other than darunavir/ritonavir.

Original languageEnglish
Pages (from-to)297-306
Number of pages10
JournalHIV Medicine
Volume16
Issue number5
DOIs
Publication statusPublished - May 1 2015

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etravirine
Ritonavir
Protease Inhibitors
Observational Studies
HIV-1
Odds Ratio
Confidence Intervals
Virology
Random Allocation
Viral Load
Switzerland
Spain
Italy
France
RNA
Mutation
Darunavir

Keywords

  • Darunavir/ritonavir
  • Efficacy
  • Etravirine
  • HIV-1
  • Protease inhibitor

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Health Policy
  • Medicine(all)

Cite this

Efficacy of etravirine combined with darunavir or other ritonavir-boosted protease inhibitors in HIV-1-infected patients : An observational study using pooled European cohort data. / Vingerhoets, J.; Calvez, V.; Flandre, P.; Marcelin, A. G.; Ceccherini-Silberstein, F.; Perno, C. F.; Mercedes Santoro, M.; Bateson, R.; Nelson, M.; Cozzi-Lepri, A.; Grarup, J.; Lundgren, J.; Incardona, F.; Kaiser, R.; Sonnerborg, A.; Clotet, B.; Paredes, R.; Günthard, Hf; Ledergerber, B.; Hoogstoel, A.; Nijs, S.; Tambuyzer, L.; Lavreys, L.; Opsomer, M.

In: HIV Medicine, Vol. 16, No. 5, 01.05.2015, p. 297-306.

Research output: Contribution to journalArticle

Vingerhoets, J, Calvez, V, Flandre, P, Marcelin, AG, Ceccherini-Silberstein, F, Perno, CF, Mercedes Santoro, M, Bateson, R, Nelson, M, Cozzi-Lepri, A, Grarup, J, Lundgren, J, Incardona, F, Kaiser, R, Sonnerborg, A, Clotet, B, Paredes, R, Günthard, H, Ledergerber, B, Hoogstoel, A, Nijs, S, Tambuyzer, L, Lavreys, L & Opsomer, M 2015, 'Efficacy of etravirine combined with darunavir or other ritonavir-boosted protease inhibitors in HIV-1-infected patients: An observational study using pooled European cohort data', HIV Medicine, vol. 16, no. 5, pp. 297-306. https://doi.org/10.1111/hiv.12218
Vingerhoets, J. ; Calvez, V. ; Flandre, P. ; Marcelin, A. G. ; Ceccherini-Silberstein, F. ; Perno, C. F. ; Mercedes Santoro, M. ; Bateson, R. ; Nelson, M. ; Cozzi-Lepri, A. ; Grarup, J. ; Lundgren, J. ; Incardona, F. ; Kaiser, R. ; Sonnerborg, A. ; Clotet, B. ; Paredes, R. ; Günthard, Hf ; Ledergerber, B. ; Hoogstoel, A. ; Nijs, S. ; Tambuyzer, L. ; Lavreys, L. ; Opsomer, M. / Efficacy of etravirine combined with darunavir or other ritonavir-boosted protease inhibitors in HIV-1-infected patients : An observational study using pooled European cohort data. In: HIV Medicine. 2015 ; Vol. 16, No. 5. pp. 297-306.
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abstract = "Objectives: This observational study in antiretroviral treatment-experienced, HIV-1-infected adults explored the efficacy of etravirine plus darunavir/ritonavir (DRV group; n=999) vs. etravirine plus an alternative boosted protease inhibitor (other PI group; n=116) using pooled European cohort data. Methods: Two international (EuroSIDA; EUResist Network) and five national (France, Italy, Spain, Switzerland and UK) cohorts provided data (collected in 2007-2012). Stratum-adjusted (for confounding factors) Mantel-Haenszel differences in virological responses (viral load <50 HIV-1 RNA copies/mL) and odds ratios (ORs) with 95{\%} confidence intervals (CIs) were derived. Results: Baseline characteristics were balanced between groups except for previous use of antiretrovirals (≥ 10: 63{\%} in the DRV group vs. 49{\%} in the other PI group), including previous use of at least three PIs (64{\%} vs. 53{\%}, respectively) and mean number of PI resistance mutations (2.3 vs. 1.9, respectively). Week 24 responses were 73{\%} vs. 75{\%} (observed) and 49{\%} vs. 43{\%} (missing=failure), respectively. Week 48 responses were 75{\%} vs. 73{\%} and 32{\%} vs. 30{\%}, respectively. All 95{\%} CIs around unadjusted and adjusted differences encompassed 0 (difference in responses) or 1 (ORs). While ORs by cohort indicated heterogeneity in response, for pooled data the difference between unadjusted and adjusted for cohort ORs was small. Conclusions: These data do not indicate a difference in response between the DRV and other PI groups, although caution should be applied given the small size of the other PI group and the lack of randomization. This suggests that the efficacy and virology results from DUET can be extrapolated to a regimen of etravirine with a boosted PI other than darunavir/ritonavir.",
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T1 - Efficacy of etravirine combined with darunavir or other ritonavir-boosted protease inhibitors in HIV-1-infected patients

T2 - An observational study using pooled European cohort data

AU - Vingerhoets, J.

AU - Calvez, V.

AU - Flandre, P.

AU - Marcelin, A. G.

AU - Ceccherini-Silberstein, F.

AU - Perno, C. F.

AU - Mercedes Santoro, M.

AU - Bateson, R.

AU - Nelson, M.

AU - Cozzi-Lepri, A.

AU - Grarup, J.

AU - Lundgren, J.

AU - Incardona, F.

AU - Kaiser, R.

AU - Sonnerborg, A.

AU - Clotet, B.

AU - Paredes, R.

AU - Günthard, Hf

AU - Ledergerber, B.

AU - Hoogstoel, A.

AU - Nijs, S.

AU - Tambuyzer, L.

AU - Lavreys, L.

AU - Opsomer, M.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Objectives: This observational study in antiretroviral treatment-experienced, HIV-1-infected adults explored the efficacy of etravirine plus darunavir/ritonavir (DRV group; n=999) vs. etravirine plus an alternative boosted protease inhibitor (other PI group; n=116) using pooled European cohort data. Methods: Two international (EuroSIDA; EUResist Network) and five national (France, Italy, Spain, Switzerland and UK) cohorts provided data (collected in 2007-2012). Stratum-adjusted (for confounding factors) Mantel-Haenszel differences in virological responses (viral load <50 HIV-1 RNA copies/mL) and odds ratios (ORs) with 95% confidence intervals (CIs) were derived. Results: Baseline characteristics were balanced between groups except for previous use of antiretrovirals (≥ 10: 63% in the DRV group vs. 49% in the other PI group), including previous use of at least three PIs (64% vs. 53%, respectively) and mean number of PI resistance mutations (2.3 vs. 1.9, respectively). Week 24 responses were 73% vs. 75% (observed) and 49% vs. 43% (missing=failure), respectively. Week 48 responses were 75% vs. 73% and 32% vs. 30%, respectively. All 95% CIs around unadjusted and adjusted differences encompassed 0 (difference in responses) or 1 (ORs). While ORs by cohort indicated heterogeneity in response, for pooled data the difference between unadjusted and adjusted for cohort ORs was small. Conclusions: These data do not indicate a difference in response between the DRV and other PI groups, although caution should be applied given the small size of the other PI group and the lack of randomization. This suggests that the efficacy and virology results from DUET can be extrapolated to a regimen of etravirine with a boosted PI other than darunavir/ritonavir.

AB - Objectives: This observational study in antiretroviral treatment-experienced, HIV-1-infected adults explored the efficacy of etravirine plus darunavir/ritonavir (DRV group; n=999) vs. etravirine plus an alternative boosted protease inhibitor (other PI group; n=116) using pooled European cohort data. Methods: Two international (EuroSIDA; EUResist Network) and five national (France, Italy, Spain, Switzerland and UK) cohorts provided data (collected in 2007-2012). Stratum-adjusted (for confounding factors) Mantel-Haenszel differences in virological responses (viral load <50 HIV-1 RNA copies/mL) and odds ratios (ORs) with 95% confidence intervals (CIs) were derived. Results: Baseline characteristics were balanced between groups except for previous use of antiretrovirals (≥ 10: 63% in the DRV group vs. 49% in the other PI group), including previous use of at least three PIs (64% vs. 53%, respectively) and mean number of PI resistance mutations (2.3 vs. 1.9, respectively). Week 24 responses were 73% vs. 75% (observed) and 49% vs. 43% (missing=failure), respectively. Week 48 responses were 75% vs. 73% and 32% vs. 30%, respectively. All 95% CIs around unadjusted and adjusted differences encompassed 0 (difference in responses) or 1 (ORs). While ORs by cohort indicated heterogeneity in response, for pooled data the difference between unadjusted and adjusted for cohort ORs was small. Conclusions: These data do not indicate a difference in response between the DRV and other PI groups, although caution should be applied given the small size of the other PI group and the lack of randomization. This suggests that the efficacy and virology results from DUET can be extrapolated to a regimen of etravirine with a boosted PI other than darunavir/ritonavir.

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KW - Efficacy

KW - Etravirine

KW - HIV-1

KW - Protease inhibitor

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