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 Paredes; M. 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; C. Pedersen; U. B. Dragsted; L. N. Nielsen; K. Zilmer; Jelena Smidt; M. Ristola; I. Aho; J. P. Viard; P. M. Girard; L. Cotte; C. Pradier; E. Fontas; F. Dabis; D. Neau; C. Duvivier; J. Rockstroh; R. Schmidt; O. Degen; H. J. Stellbrink; C. Stefan; J. Bogner; G. Fätkenheuer; N. Chkhartishvili; J. Kosmidis; P. Gargalianos; G. Xylomenos; P. Lourida; H. Sambatakou; J. Szlávik; M. Gottfredsson; F. Mulcahy; I. Yust; D. Turner; M. Burke; E. Shahar; G. Hassoun; H. Elinav; M. Haouzi; D. Elbirt; Z. M. Sthoeger; A. D'Arminio Monforte; R. Esposito; I. Mazeu; C. Mussini; F. Mazzotta; A. Gabbuti; V. Vullo; M. Lichtner; M. Zaccarelli; A. Antinori; R. Acinapura; M. Plazzi; A. Lazzarin; A. Castagna; N. Gianotti

doi:10.1097/MD.0000000000005020

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, C. Pedersen, U. B. Dragsted, L. N. Nielsen, K. Zilmer, Jelena Smidt, M. Ristola, I. Aho, J. P. Viard, P. M. Girard, L. Cotte, C. Pradier, E. Fontas, F. Dabis, D. Neau, C. Duvivier, J. Rockstroh, R. Schmidt, O. Degen, H. J. Stellbrink, C. Stefan, J. Bogner, G. Fätkenheuer, N. Chkhartishvili, J. Kosmidis, P. Gargalianos, G. Xylomenos, P. Lourida, H. Sambatakou, J. Szlávik, M. Gottfredsson, F. Mulcahy, I. Yust, D. Turner, M. Burke, E. Shahar, G. Hassoun, H. Elinav, M. Haouzi, D. Elbirt, Z. M. Sthoeger, A. D'Arminio Monforte, R. Esposito, I. Mazeu, C. Mussini, F. Mazzotta, A. Gabbuti, V. Vullo, M. Lichtner, M. Zaccarelli, A. Antinori, R. Acinapura, M. Plazzi, A. Lazzarin, A. Castagna, N. Gianotti

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

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Abstract

Copyright © 2016 the Author(s). Published by Wolters Kluwer Health, Inc. All rights reserved. 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 language	English
Article number	e5020
Journal	Medicine (United States)
Volume	95
Issue number	40
DOIs	https://doi.org/10.1097/MD.0000000000005020
Publication status	Published - 1 Jan 2016

Keywords

Atazanavir
HIV-1
Protease inhibitors: abacavir
Simplification antiretroviral therapy

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1097/MD.0000000000005020

Cite this

Llibre, J. M., 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, H. J., Duvivier, C., Edwards, S., Laut, K., ... Gianotti, N. (2016). Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: A prospective cohort study. Medicine (United States), 95(40), [e5020]. https://doi.org/10.1097/MD.0000000000005020

@article{aaf15025a0064e46973c811d5144d658,

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

abstract = "Copyright {\textcopyright} 2016 the Author(s). Published by Wolters Kluwer Health, Inc. All rights reserved. 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.",

keywords = "Atazanavir, HIV-1, Protease inhibitors: abacavir, Simplification antiretroviral therapy",

author = "Llibre, {Josep M.} and Alessandro Cozzi-Lepri and Court Pedersen and Matti Ristola and Marcelo Losso and Amanda Mocroft and Viktar Mitsura and Karolin Falconer and Fernando Maltez and Marek Beniowski and Vincenzo Vullo and Gamal Hassoun and Elena Kuzovatova and J{\'a}nos Szlavik and Anastasiia Kuznetsova and Stellbrink, {Hans J{\"u}rgen} and Claudine Duvivier and Simon Edwards and Kamilla Laut and Roger Paredes and M. Losso and M. Kundro and N. Vetter and R. Zangerle and I. Karpov and A. Vassilenko and Mitsura, {V. M.} and D. Paduto and N. Clumeck and {De Wit}, S. and M. Delforge and E. Florence and L. Vandekerckhove and V. Hadziosmanovic and K. Kostov and J. Begovac and L. Machala and D. Jilich and D. Sedlacek and G. Kronborg and T. Benfield and J. Gerstoft and T. Katzenstein and M{\o}ller, {N. F.} and C. Pedersen and Dragsted, {U. B.} and Nielsen, {L. N.} and K. Zilmer and Jelena Smidt and M. Ristola and I. Aho and Viard, {J. P.} and Girard, {P. M.} and L. Cotte and C. Pradier and E. Fontas and F. Dabis and D. Neau and C. Duvivier and J. Rockstroh and R. Schmidt and O. Degen and Stellbrink, {H. J.} and C. Stefan and J. Bogner and G. F{\"a}tkenheuer and N. Chkhartishvili and J. Kosmidis and P. Gargalianos and G. Xylomenos and P. Lourida and H. Sambatakou and J. Szl{\'a}vik and M. Gottfredsson and F. Mulcahy and I. Yust and D. Turner and M. Burke and E. Shahar and G. Hassoun and H. Elinav and M. Haouzi and D. Elbirt and Sthoeger, {Z. M.} and {D'Arminio Monforte}, A. and R. Esposito and I. Mazeu and C. Mussini and F. Mazzotta and A. Gabbuti and V. Vullo and M. Lichtner and M. Zaccarelli and A. Antinori and R. Acinapura and M. Plazzi and A. Lazzarin and A. Castagna and N. Gianotti",

year = "2016",

month = jan,

day = "1",

doi = "10.1097/MD.0000000000005020",

language = "English",

volume = "95",

number = "40",

}

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, Pedersen, C, Dragsted, UB, Nielsen, LN, Zilmer, K, Smidt, J, Ristola, M, Aho, I, Viard, JP, Girard, PM, Cotte, L, Pradier, C, Fontas, E, Dabis, F, Neau, D, Duvivier, C, Rockstroh, J, Schmidt, R, Degen, O, Stellbrink, HJ, Stefan, C, Bogner, J, Fätkenheuer, G, Chkhartishvili, N, Kosmidis, J, Gargalianos, P, Xylomenos, G, Lourida, P, Sambatakou, H, Szlávik, J, Gottfredsson, M, Mulcahy, F, Yust, I, Turner, D, Burke, M, Shahar, E, Hassoun, G, Elinav, H, Haouzi, M, Elbirt, D, Sthoeger, ZM, D'Arminio Monforte, A, Esposito, R, Mazeu, I, Mussini, C, Mazzotta, F, Gabbuti, A, Vullo, V, Lichtner, M, Zaccarelli, M, Antinori, A, Acinapura, R, Plazzi, M, Lazzarin, A, Castagna, A & Gianotti, N 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

TY - JOUR

T1 - Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: 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 - Pedersen, C.

AU - Dragsted, U. B.

AU - Nielsen, L. N.

AU - Zilmer, K.

AU - Smidt, Jelena

AU - Ristola, M.

AU - Aho, I.

AU - Viard, J. P.

AU - Girard, P. M.

AU - Cotte, L.

AU - Pradier, C.

AU - Fontas, E.

AU - Dabis, F.

AU - Neau, D.

AU - Duvivier, C.

AU - Rockstroh, J.

AU - Schmidt, R.

AU - Degen, O.

AU - Stellbrink, H. J.

AU - Stefan, C.

AU - Bogner, J.

AU - Fätkenheuer, G.

AU - Chkhartishvili, N.

AU - Kosmidis, J.

AU - Gargalianos, P.

AU - Xylomenos, G.

AU - Lourida, P.

AU - Sambatakou, H.

AU - Szlávik, J.

AU - Gottfredsson, M.

AU - Mulcahy, F.

AU - Yust, I.

AU - Turner, D.

AU - Burke, M.

AU - Shahar, E.

AU - Hassoun, G.

AU - Elinav, H.

AU - Haouzi, M.

AU - Elbirt, D.

AU - Sthoeger, Z. M.

AU - D'Arminio Monforte, A.

AU - Esposito, R.

AU - Mazeu, I.

AU - Mussini, C.

AU - Mazzotta, F.

AU - Gabbuti, A.

AU - Vullo, V.

AU - Lichtner, M.

AU - Zaccarelli, M.

AU - Antinori, A.

AU - Acinapura, R.

AU - Plazzi, M.

AU - Lazzarin, A.

AU - Castagna, A.

AU - Gianotti, N.

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Copyright © 2016 the Author(s). Published by Wolters Kluwer Health, Inc. All rights reserved. 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 - Copyright © 2016 the Author(s). Published by Wolters Kluwer Health, Inc. All rights reserved. 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

U2 - 10.1097/MD.0000000000005020

DO - 10.1097/MD.0000000000005020

M3 - Article

VL - 95

IS - 40

M1 - e5020

ER -

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

Abstract

Keywords

UN SDGs

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