Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: A prospective cohort study

Josep M. Llibre, Alessandro Cozzi-Lepri, Court Pedersen, Matti Ristola, Marcelo Losso, Amanda Mocroft, Viktar Mitsura, Karolin Falconer, Fernando Maltez, Marek Beniowski, Vincenzo Vullo, Gamal Hassoun, Elena Kuzovatova, János Szlavik, Anastasiia Kuznetsova, Hans Jürgen Stellbrink, Claudine Duvivier, Simon Edwards, Kamilla Laut, Roger ParedesM. Losso, M. Kundro, N. Vetter, R. Zangerle, I. Karpov, A. Vassilenko, V. M. Mitsura, D. Paduto, N. Clumeck, S. De Wit, M. Delforge, E. Florence, L. Vandekerckhove, V. Hadziosmanovic, K. Kostov, J. Begovac, L. Machala, D. Jilich, D. Sedlacek, G. Kronborg, T. Benfield, J. Gerstoft, T. Katzenstein, N. F. Møller, M. Zaccarelli, Andrea Antinori, Rosa Antonietta Acinapura, Maria Maddalena Plazzi, A. Lazzarin, N. Gianotti, EuroSIDA Study

Research output: Contribution to journalArticle

Abstract

Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant. We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50copies/mL. We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50copies/mL. The third drug in the previous regimen was ritonavir-boosted atazanavir (ATV/r) in 79 (28%), and another ritonavir-boosted protease inhibitor (PI/r) in 29 (10%). Ninety (32%) had previously failed with a PI. Proportions of people with virological success at 48/96/144 weeks were 90%/87%/88% (TLOVR) and 74%/67%/59% (snapshot analysis), respectively. The rates of VF were 8%/8%/6%. Rates of adverse events leading to study discontinuation were 0.4%/1%/2%. The multivariable adjusted analysis showed an association between VF and nadir CD4+ (hazard ratio [HR] 0.63 [95% confidence interval [CI]: 0.42-0.93] per 100 cells higher), time with pVL ≤50copies/mL (HR 0.87 [95% CI: 0.79-0.96] per 6 months longer), and previous failure with a PI (HR 2.78 [95% CI: 1.28-6.04]). Resistance selection at failure was uncommon. A switch to ATV + ABC/3TC in selected subjects with suppressed viremia was associated with low rates of VF and discontinuation due to adverse events, even in subjects not receiving ATV/r. The strategy might be considered in those with long-term suppression and no prior PI failure.

Original languageEnglish
Article numbere5020
JournalMedicine (United States)
Volume95
Issue number40
DOIs
Publication statusPublished - 2016

Fingerprint

Cohort Studies
Lamivudine
Prospective Studies
Viral Load
HIV-1
Ritonavir
Confidence Intervals
Viremia
Protease Inhibitors
Atazanavir Sulfate
lamivudine drug combination abacavir
Pharmaceutical Preparations

Keywords

  • Atazanavir
  • HIV-1
  • Protease inhibitors: abacavir
  • Simplification antiretroviral therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression : A prospective cohort study. / Llibre, Josep M.; Cozzi-Lepri, Alessandro; Pedersen, Court; Ristola, Matti; Losso, Marcelo; Mocroft, Amanda; Mitsura, Viktar; Falconer, Karolin; Maltez, Fernando; Beniowski, Marek; Vullo, Vincenzo; Hassoun, Gamal; Kuzovatova, Elena; Szlavik, János; Kuznetsova, Anastasiia; Stellbrink, Hans Jürgen; Duvivier, Claudine; Edwards, Simon; Laut, Kamilla; Paredes, Roger; Losso, M.; Kundro, M.; Vetter, N.; Zangerle, R.; Karpov, I.; Vassilenko, A.; Mitsura, V. M.; Paduto, D.; Clumeck, N.; De Wit, S.; Delforge, M.; Florence, E.; Vandekerckhove, L.; Hadziosmanovic, V.; Kostov, K.; Begovac, J.; Machala, L.; Jilich, D.; Sedlacek, D.; Kronborg, G.; Benfield, T.; Gerstoft, J.; Katzenstein, T.; Møller, N. F.; Zaccarelli, M.; Antinori, Andrea; Acinapura, Rosa Antonietta; Plazzi, Maria Maddalena; Lazzarin, A.; Gianotti, N.; EuroSIDA Study.

In: Medicine (United States), Vol. 95, No. 40, e5020, 2016.

Research output: Contribution to journalArticle

Llibre, JM, Cozzi-Lepri, A, Pedersen, C, Ristola, M, Losso, M, Mocroft, A, Mitsura, V, Falconer, K, Maltez, F, Beniowski, M, Vullo, V, Hassoun, G, Kuzovatova, E, Szlavik, J, Kuznetsova, A, Stellbrink, HJ, Duvivier, C, Edwards, S, Laut, K, Paredes, R, Losso, M, Kundro, M, Vetter, N, Zangerle, R, Karpov, I, Vassilenko, A, Mitsura, VM, Paduto, D, Clumeck, N, De Wit, S, Delforge, M, Florence, E, Vandekerckhove, L, Hadziosmanovic, V, Kostov, K, Begovac, J, Machala, L, Jilich, D, Sedlacek, D, Kronborg, G, Benfield, T, Gerstoft, J, Katzenstein, T, Møller, NF, Zaccarelli, M, Antinori, A, Acinapura, RA, Plazzi, MM, Lazzarin, A, Gianotti, N & EuroSIDA Study 2016, 'Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: A prospective cohort study', Medicine (United States), vol. 95, no. 40, e5020. https://doi.org/10.1097/MD.0000000000005020
Llibre, Josep M. ; Cozzi-Lepri, Alessandro ; Pedersen, Court ; Ristola, Matti ; Losso, Marcelo ; Mocroft, Amanda ; Mitsura, Viktar ; Falconer, Karolin ; Maltez, Fernando ; Beniowski, Marek ; Vullo, Vincenzo ; Hassoun, Gamal ; Kuzovatova, Elena ; Szlavik, János ; Kuznetsova, Anastasiia ; Stellbrink, Hans Jürgen ; Duvivier, Claudine ; Edwards, Simon ; Laut, Kamilla ; Paredes, Roger ; Losso, M. ; Kundro, M. ; Vetter, N. ; Zangerle, R. ; Karpov, I. ; Vassilenko, A. ; Mitsura, V. M. ; Paduto, D. ; Clumeck, N. ; De Wit, S. ; Delforge, M. ; Florence, E. ; Vandekerckhove, L. ; Hadziosmanovic, V. ; Kostov, K. ; Begovac, J. ; Machala, L. ; Jilich, D. ; Sedlacek, D. ; Kronborg, G. ; Benfield, T. ; Gerstoft, J. ; Katzenstein, T. ; Møller, N. F. ; Zaccarelli, M. ; Antinori, Andrea ; Acinapura, Rosa Antonietta ; Plazzi, Maria Maddalena ; Lazzarin, A. ; Gianotti, N. ; EuroSIDA Study. / Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression : A prospective cohort study. In: Medicine (United States). 2016 ; Vol. 95, No. 40.
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abstract = "Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant. We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50copies/mL. We included 285 subjects, 67{\%} male, with median baseline CD4 530 cells, and 44 months with pVL ≤50copies/mL. The third drug in the previous regimen was ritonavir-boosted atazanavir (ATV/r) in 79 (28{\%}), and another ritonavir-boosted protease inhibitor (PI/r) in 29 (10{\%}). Ninety (32{\%}) had previously failed with a PI. Proportions of people with virological success at 48/96/144 weeks were 90{\%}/87{\%}/88{\%} (TLOVR) and 74{\%}/67{\%}/59{\%} (snapshot analysis), respectively. The rates of VF were 8{\%}/8{\%}/6{\%}. Rates of adverse events leading to study discontinuation were 0.4{\%}/1{\%}/2{\%}. The multivariable adjusted analysis showed an association between VF and nadir CD4+ (hazard ratio [HR] 0.63 [95{\%} confidence interval [CI]: 0.42-0.93] per 100 cells higher), time with pVL ≤50copies/mL (HR 0.87 [95{\%} CI: 0.79-0.96] per 6 months longer), and previous failure with a PI (HR 2.78 [95{\%} CI: 1.28-6.04]). Resistance selection at failure was uncommon. A switch to ATV + ABC/3TC in selected subjects with suppressed viremia was associated with low rates of VF and discontinuation due to adverse events, even in subjects not receiving ATV/r. The strategy might be considered in those with long-term suppression and no prior PI failure.",
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TY - JOUR

T1 - Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression

T2 - A prospective cohort study

AU - Llibre, Josep M.

AU - Cozzi-Lepri, Alessandro

AU - Pedersen, Court

AU - Ristola, Matti

AU - Losso, Marcelo

AU - Mocroft, Amanda

AU - Mitsura, Viktar

AU - Falconer, Karolin

AU - Maltez, Fernando

AU - Beniowski, Marek

AU - Vullo, Vincenzo

AU - Hassoun, Gamal

AU - Kuzovatova, Elena

AU - Szlavik, János

AU - Kuznetsova, Anastasiia

AU - Stellbrink, Hans Jürgen

AU - Duvivier, Claudine

AU - Edwards, Simon

AU - Laut, Kamilla

AU - Paredes, Roger

AU - Losso, M.

AU - Kundro, M.

AU - Vetter, N.

AU - Zangerle, R.

AU - Karpov, I.

AU - Vassilenko, A.

AU - Mitsura, V. M.

AU - Paduto, D.

AU - Clumeck, N.

AU - De Wit, S.

AU - Delforge, M.

AU - Florence, E.

AU - Vandekerckhove, L.

AU - Hadziosmanovic, V.

AU - Kostov, K.

AU - Begovac, J.

AU - Machala, L.

AU - Jilich, D.

AU - Sedlacek, D.

AU - Kronborg, G.

AU - Benfield, T.

AU - Gerstoft, J.

AU - Katzenstein, T.

AU - Møller, N. F.

AU - Zaccarelli, M.

AU - Antinori, Andrea

AU - Acinapura, Rosa Antonietta

AU - Plazzi, Maria Maddalena

AU - Lazzarin, A.

AU - Gianotti, N.

AU - EuroSIDA Study

PY - 2016

Y1 - 2016

N2 - Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant. We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50copies/mL. We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50copies/mL. The third drug in the previous regimen was ritonavir-boosted atazanavir (ATV/r) in 79 (28%), and another ritonavir-boosted protease inhibitor (PI/r) in 29 (10%). Ninety (32%) had previously failed with a PI. Proportions of people with virological success at 48/96/144 weeks were 90%/87%/88% (TLOVR) and 74%/67%/59% (snapshot analysis), respectively. The rates of VF were 8%/8%/6%. Rates of adverse events leading to study discontinuation were 0.4%/1%/2%. The multivariable adjusted analysis showed an association between VF and nadir CD4+ (hazard ratio [HR] 0.63 [95% confidence interval [CI]: 0.42-0.93] per 100 cells higher), time with pVL ≤50copies/mL (HR 0.87 [95% CI: 0.79-0.96] per 6 months longer), and previous failure with a PI (HR 2.78 [95% CI: 1.28-6.04]). Resistance selection at failure was uncommon. A switch to ATV + ABC/3TC in selected subjects with suppressed viremia was associated with low rates of VF and discontinuation due to adverse events, even in subjects not receiving ATV/r. The strategy might be considered in those with long-term suppression and no prior PI failure.

AB - Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant. We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50copies/mL. We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50copies/mL. The third drug in the previous regimen was ritonavir-boosted atazanavir (ATV/r) in 79 (28%), and another ritonavir-boosted protease inhibitor (PI/r) in 29 (10%). Ninety (32%) had previously failed with a PI. Proportions of people with virological success at 48/96/144 weeks were 90%/87%/88% (TLOVR) and 74%/67%/59% (snapshot analysis), respectively. The rates of VF were 8%/8%/6%. Rates of adverse events leading to study discontinuation were 0.4%/1%/2%. The multivariable adjusted analysis showed an association between VF and nadir CD4+ (hazard ratio [HR] 0.63 [95% confidence interval [CI]: 0.42-0.93] per 100 cells higher), time with pVL ≤50copies/mL (HR 0.87 [95% CI: 0.79-0.96] per 6 months longer), and previous failure with a PI (HR 2.78 [95% CI: 1.28-6.04]). Resistance selection at failure was uncommon. A switch to ATV + ABC/3TC in selected subjects with suppressed viremia was associated with low rates of VF and discontinuation due to adverse events, even in subjects not receiving ATV/r. The strategy might be considered in those with long-term suppression and no prior PI failure.

KW - Atazanavir

KW - HIV-1

KW - Protease inhibitors: abacavir

KW - Simplification antiretroviral therapy

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