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 & 1 andre EuroSIDA Study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

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 <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/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 ≤50 copies/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.

OriginalsprogEngelsk
Artikelnummere5020
TidsskriftMedicine
Vol/bind95
Udgave nummer40
ISSN0025-7974
DOI
StatusUdgivet - okt. 2016

Fingeraftryk

Cohort Studies
Lamivudine
Prospective Studies
Viral Load
HIV-1
Ritonavir
Confidence Intervals
Protease Inhibitors
Atazanavir Sulfate
Pharmaceutical Preparations

Citer dette

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 ; EuroSIDA Study. / Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression : A prospective cohort study. I: Medicine. 2016 ; Bind 95, Nr. 40.
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title = "Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: A prospective cohort study",
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 <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67{\%} male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/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 ≤50 copies/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.",
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 Hans-J{\"u}rgen Stellbrink and Claudine Duvivier and Simon Edwards and Kamilla Laut and Roger Paredes and {EuroSIDA Study}",
year = "2016",
month = "10",
doi = "10.1097/MD.0000000000005020",
language = "English",
volume = "95",
journal = "Medicine",
issn = "0025-7974",
publisher = "Wolters Kluwer Health, Inc.",
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, H-J, Duvivier, C, Edwards, S, Laut, K, Paredes, R & EuroSIDA Study 2016, 'Long-term effectiveness of unboosted atazanavir plus abacavir/lamivudine in subjects with virological suppression: A prospective cohort study', Medicine, bind 95, nr. 40, e5020. https://doi.org/10.1097/MD.0000000000005020

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; EuroSIDA Study.

I: Medicine, Bind 95, Nr. 40, e5020, 10.2016.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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 - EuroSIDA Study

PY - 2016/10

Y1 - 2016/10

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 <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/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 ≤50 copies/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 <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/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 ≤50 copies/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.

U2 - 10.1097/MD.0000000000005020

DO - 10.1097/MD.0000000000005020

M3 - Journal article

VL - 95

JO - Medicine

JF - Medicine

SN - 0025-7974

IS - 40

M1 - e5020

ER -