Efficacy and Safety of Switching From Boosted Lopinavir to Boosted Atazanavir in Patients With Virological Suppression Receiving a LPV/r-Containing HAART: The ATAZIP Study

Mallolas, Josép; Podzamczer, Daniel; Milinkovic, Ana; Domingo, Peré; Clotet, Bonaventura; Ribera, Esteban; Gutiérrez, Félix; Knobel, Hernando; Cosin, Jaime; Ferrer, Elena; Arranz, J. A.; Roca, Víctor; Vidal, Francesc; Murillas, Javier; Pich, Judit; Pedrol, Enric; Llibre, Josep M; Dalmau, David; García, I Beltrán; Aranda, Miquel; Cruceta, Ana; Martínez, Estebán; Blanco, José Luis Santiago; Lazzari, Elisa de; Gatell, José M.

doi:10.1097/qai.0b013e31819a226f

Cited by 78 publications

(60 citation statements)

References 14 publications

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Section: Jansen Et Alsupporting

confidence: 73%

“…6,7 These longterm outcomes confirm and extend the efficacy findings from ATV/r clinical trials in treatment-experienced patients. 6,7 ATV/r-based regimens were generally well tolerated with a favorable rate of discontinuation over time when compared with other cohort studies examining discontinuation rates with several different first-line ARV regimens. 11,12 For example, among the seven first-line ARV regimens compared in the Swiss HIV Cohort Study, treatment modification rates at 1 year were lowest for tenofovir-emtricitabine combined with ATV/r (24.1%) and highest for zidovudine-lamivudine combined with ritonavir-boosted lopinavir (70.7%).…”

Section: Jansen Et Alsupporting

confidence: 73%

“…While adverse events were the main known reason for discontinuation, the long-term safety profile in this real-life study was consistent with that observed previously in clinical trials of up to 2 years duration, [5][6][7] with no new or unexpected adverse events identified.…”

Section: Jansen Et Alsupporting

confidence: 69%

“…2 In clinical trials, convenient once-daily ritonavir-boosted atazanavir (ATV/r)-based regimens have proven efficacy and safety in both treatment-naive [3][4][5] and -experienced patients. 6,7 These regimens are recommended as a preferred therapeutic option for initiation of therapy in treatment-naive patients by the current treatment guidelines in both the United States 8,9 and Europe. 10 In clinical settings, ATV/r-based regimens are associated with sustained virologic suppression and favorable rates of treatment discontinuation when compared with other ARV regimens.…”

mentioning

confidence: 99%

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Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Jansen

Sönnerborg

Brockmeyer

et al. 2013

AIDS Research and Human Retroviruses

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Atazanavir-based regimens have established efficacy and safety in both antiretroviral (ARV)-naive and -experienced patients. However, data evaluating effectiveness beyond 2 years is sparse. Therefore, we assessed the long-term outcomes of ritonavir-boosted atazanavir (ATV/r)-containing regimens in ARV-experienced patients in a clinical setting in a noncomparative, retrospective, observational study collecting data from three European HIV databases on ARV-experienced adults with HIV-1 infection starting an ATV/r-based regimen. Data were extracted every 6 months (maximum follow-up 5 years). Primary outcome was the proportion of patients remaining on ATV/r by baseline HIV-1 RNA ( < 500 or ‡ 500 copies/ml). Secondary outcomes included time to virologic failure, reasons for discontinuation, and long-term safety profile. The duration of treatment and time to virologic failure were analyzed using the Kaplan-Meier method. Data were analyzed for 1,294 ARV-experienced patients (male 74%; mean ART exposure 5.7 years). After 3 years, 56% (95% CI: 52%, 60%) of patients with baseline HIV-1 RNA < 500 copies/ml and 53% (95% CI: 49%, 58%) of those with HIV-1 RNA ‡ 500 copies/ml remained on ATV/r. After 3 years, 75% (95% CI: 69%, 80%) of patients with baseline HIV-1 RNA < 50 copies/ml remained suppressed and 51% (95% CI: 47%, 55%) of those with baseline HIV-1 RNA ‡ 50 copies/ml achieved and maintained virologic suppression. Although adverse events (AEs) were the main known reason for discontinuation, no unexpected AEs were observed. In a real-life setting ATV/r-based regimens demonstrated sustained virologic suppression in ARV-experienced patients. After long-term therapy the majority of patients remained on treatment and no unexpected AEs were observed.

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Section: Jansen Et Alsupporting

confidence: 73%

Section: Jansen Et Alsupporting

confidence: 73%

Section: Jansen Et Alsupporting

confidence: 69%

mentioning

confidence: 99%

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Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Jansen

Sönnerborg

Brockmeyer

et al. 2013

AIDS Research and Human Retroviruses

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“…Regarding safety, the suspension of treatment was higher in patients in the control group (21% vs. 34%, p<0,01) and lipid profile was improved in the group simplified to ATV. SIMPATAZ and ATAZIP studies confirm the safety and efficacy of this strategy of simplification, in this case changing LPV/r by ATV/r 32,33 . The REAL study from which data were presented at 48 weeks, a clinical trial that includes patients in stable antiretroviral therapy for at least 12 weeks that contains a given BID PI, CVP undetectable and lipohypertrophy, which were randomized to continue the same treatment or change the PI to ATV / r 300/100 mg. Inmuno-virologic control was maintained, showed improved lipid profile in the field of ATC but no differences were observed in body composition.…”

Section: Simplification To Atazanavirmentioning

confidence: 56%

Simplification of Antiretroviral Therapy (ART)

Martinez¹

2011

Recent Translational Research in HIV/AIDS

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Recent Translational Research in HIV/AIDS 238 reintroducing the previously recalled. The data at 96 weeks confirmed the durability and safety of this estrategia 3 . After this study, is performed OK04 study including 205 patients with undetectable VL for at least 6 months (median 28), who were taking HAART including LPV/r associated with two NA. Is a randomized, open, non-inferiority comparing the strategy of continuation of triple therapy compared to monotherapy with LPV/r, followed by reinduction with 2 NA if viral rebound appeared. At 48 weeks the percentage of patients without virologic failure was 90 and 94% respectively (difference, -4%, upper limit 95% CI for difference 3.4%, meeting the criteria for noninferiority). The percentage of patients with VL <;50 copies/mL at 48 weeks (ITT), considering as failures reinduction was 85% in the monotherapy group and 90% in the continuation (p = 0.31). Episodes of low-level viremia between 50 and 500 copies / mL were more frequent in patients treated with monotherapy (4 vs. none) 4 . With patients in these two studies performed a multivariate analysis of predictors of loss of virologic response in the group treated with LPV/r monotherapy. Virologic failure was associated with lack of grip, low haemoglobin levels and nadir CD4 <100 cells/μL 5 . In another study of simplification to monotherapy with LPV/r was somewhat different strategy. We included 155 previously untreated patients who were randomized 2:1 to treatment with ZDV/3TC start with LPV / r (n = 104) or EFV (n = 51). Within 24 weeks of treatment and after at least 3 controls with VL < 50 copies / mL, patients taking LPV maintenance came to LPV/r monotherapy. Whereas failure to any positive viremia at 96 weeks of follow up, 48% of patients treated with LPV / r and 61% with EFV had CVP < 50 copies / mL (p = 0.17, 95% of the difference, -29% to 4%). In a new analysis that included patients as responders to reintroduce them after getting back NA CVP < 50 copies / mL, 60% of patients on LPV/r and EFV 63% responded to treatment ( p = 0.73, CI 95% -19% 13%). Have been observed low viral loads in patients on monotherapy. As for security, lipoatrophy was observed in 5% of the monotherapy arm, compared to 34% of the EFV group. There were no differences in lipohypertrophy. Grade 3-4 lipid abnormalities were more frequent in the group of LPV/r. In these two studies highlights the importance of the period during which the CVP remains undetectable prior to the step alone. This same strategy is being explored and DRV/r 6,7 ATV/r 8,10 . They have published the results at 48 weeks of a pilot study, single-arm open-simplification to ATV / r, the ACTG 5201. Were included in the same 34 patients who started treatment with 2 NA and IP, who were with undetectable viral load (<50 copies / mL) for at least 48 weeks, had not been treated with NN or prior virologic failure were HBsAg negative. Upon entering the study were switched to IP they were taking on ATV / r and 6 weeks after suspending the AN. The primary endpoint was time to ...

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The Nutritional Management of Complications Associated with HIV and Antiretroviral Therapy

Duncan¹,

Klassen²

2010

Nutrition and HIV

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Efficacy and Safety of Switching From Boosted Lopinavir to Boosted Atazanavir in Patients With Virological Suppression Receiving a LPV/r-Containing HAART: The ATAZIP Study

Abstract: Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].

Cited by 78 publications

References 14 publications

Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Long-Term Efficacy and Safety of Atazanavir/Ritonavir Treatment in a Real-Life Cohort of Treatment-Experienced Patients with HIV Type 1 Infection

Simplification of Antiretroviral Therapy (ART)

The Nutritional Management of Complications Associated with HIV and Antiretroviral Therapy

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