96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures

Johnson, Margaret; Grinsztejn, Beatriz; Rodríguez, Claudia; Coco, Jeffrey; DeJesus, Edwin; Lazzarin, Adriano; Lichtenstein, Kenneth A.; Wirtz, Victoria; Rightmire, Anna; Odeshoo, L; McLaren, Colin

doi:10.1097/01.aids.0000216371.76689.63

Cited by 194 publications

(145 citation statements)

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“…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: 88%

Section: Jansen Et Alsupporting

confidence: 70%

“…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: 70%

“…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: 88%

Section: Jansen Et Alsupporting

confidence: 70%

Section: Jansen Et Alsupporting

confidence: 70%

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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“…Therefore, an unmet medical need exists for additional recommended third agents for use during pregnancy. Atazanavir (ATV) is a potent, well-tolerated, once-daily (qd) HIV protease inhibitor, with established efficacy in both treatment-naïve and treatment-experienced adult, nonpregnant HIV-infected patients [11,12] and is included as a preferred treatment option for nonpregnant HIVinfected patients [2]. HIV protease inhibitor drug levels are generally reduced during pregnancy [13][14][15][16], especially during the third trimester, because of metabolic and physiological changes associated with pregnancy [17].…”

Section: Introductionmentioning

confidence: 99%

Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women

et al. 2011

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ObjectiveThere are limited antiretroviral options for use in the treatment of HIV infection during pregnancy. The purpose of this study was to assess the safety, efficacy and appropriate dosing regimen for ritonavir (RTV)-boosted atazanavir in HIV-1-infected pregnant women. MethodsIn this nonrandomized, open-label study, HIV-infected pregnant women were dosed with either 300/ 100 mg (n 5 20) or 400/100 mg (n 5 21) atazanavir/RTV once-daily (qd) in combination with zidovudine (300 mg) and lamivudine (150 mg) twice daily in the third trimester. Pharmacokinetic parameters [maximum observed plasma concentration (C max ), trough observed plasma concentration 24 hour post dose (C min ) and area under concentration-time curve in one dosing interval (AUC t )] were determined and compared with historical values (300/100 mg atazanavir/RTV) for HIV-infected nonpregnant adults (n 5 23). ResultsAt or before delivery, all mothers achieved HIV RNA o50 HIV-1 RNA copies/mL and all infants were HIV DNA negative at 6 months of age. The third trimester AUC t for atazanavir/RTV 300/100 mg was 21% lower than historical data, but the C min values were comparable. The C min value for atazanavir/RTV 400/100 mg was 39% higher than the C min for atazanavir/RTV 300/100 mg in historical controls, but the AUC t values were comparable. Twice as many patients in the 400/100 mg group (62%) had an increase in total bilirubin (42.5 times the upper limit of normal) as in the 300/100 mg group (30%). Atazanavir (ATV) was well tolerated with no unanticipated adverse events. ConclusionsIn this study, use of atazanavir/RTV 300/100 mg qd produced C min comparable to historical data in nonpregnant HIV-infected adults. When used in combination with zidovudine/lamivudine, it suppressed HIV RNA in all mothers and prevented mother-to-child transmission of HIV-1 infection. During pregnancy, the pharmacokinetics, safety and efficacy demonstrated that a dose adjustment is not required for ATV.Keywords: atazanavir, HIV, pregnancy, prevention of mother-to-child transmission, protease inhibitor IntroductionTreatment guidelines for HIV-1 infection in pregnant women recommend highly active antiretroviral (ARV) therapy (HAART) with two nucleoside reverse transcriptase inhibitors (zidovudine and lamivudine) plus the nonnucleoside reverse transcriptase inhibitor nevirapine [1][2][3]. Some guidelines also recommend the ritonavir (RTV)-boosted protease inhibitor lopinavir as an optional third agent [1], although others recommend several boosted protease inhibitors as optional agents [2]. All other ARV DOI: 10.1111/j.1468-1293.2011.00927.x HIV Medicine (2011 r 2011 British HIV Association 570 drugs are alternative agents or for use in special circumstances [1,4]. However, there are questions and concerns regarding the two most frequently recommended third agents: treatment initiation with nevirapine is associated with an increased risk of symptomatic liver toxicity, often accompanied by a rash, which is potentially fatal [1,5]. Concerns with RTV-boosted lopinavir inclu...

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Regimen Simplification to Atazanavir-Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

Swindells

DiRienzo

Wilkin

et al. 2006

JAMA

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96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologic failures

Cited by 194 publications

References 17 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

Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women

Regimen Simplification to Atazanavir-Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression

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