Efficacy and Safety of Atazanavir-Based Highly Active Antiretroviral Therapy in Patients with Virologic Suppression Switched from a Stable, Boosted or Unboosted Protease Inhibitor Treatment Regimen: The SWAN Study (AI424-097) 48-Week Results

Gatell, José M.; Ceron, Dominique Salmon; Lazzarin, Adriano; Wijngaerden, Eric Van; Antunes, F; Leen, Clifford; Horban, Andrzéj; Wirtz, Victoria; Odeshoo, L; Dungen, M Van den; Gruber, Christian J.; Ledesma, Emilio

doi:10.1086/517497

Cited by 137 publications

(103 citation statements)

References 12 publications

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“…Altogether, over 264 extendedly discontinuous treatment years, HIV escaped control in 18 instances, amounting to 7 escapes per 100 highly discontinuous treatment years, within the range of viral escapes noted in a number of 7 days per week combinations (34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44), yet lower than on unremitting PI monotherapy (45)(46)(47)(48). Congruent with the tentative exploratory nature of our prescriptions, 14 of the 18 escapes could reasonably be linked to unfitting prescriptions or EA (Table 3).…”

Section: Iccarre 4 Day Per Week Treatment: Not a Single Hiv Escapementioning

confidence: 67%

“…Yet, not just any medicinal treatment simplification will do; the alleviation of triplecombination therapy with 2 drugs as maintenance therapy, 7 days per week, once failed radically (65)(66)(67)(68), and ritonavirboosted PI monotherapies, 7 days per week, have yet to match (45-48) current triple combination standards virologically (34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44).…”

Section: Treatment Outcomes Following Viral Escapesmentioning

confidence: 99%

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Four days a week or less on appropriate anti‐HIV drug combinations provided long‐term optimal maintenance in 94 patients: the ICCARRE project

et al. 2015

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Short, intraweekly cycles of anti‐HIV combinations have provided intermittent, effective therapy (on 48 patients) (1). The concept is now extended to 94 patients on treatment, 4 days per week or less, over a median of 2.7 discontinuous treatment years per patient. On suppressive combinations, 94 patients volunteered to treatment, 5 and 4 days per week, or reduced stepwise to 4,3,2, and 1 days per week in 94, 84, 66, and 12 patients, respectively, on various triple, standard, antiviral combinations, or nonregistered, quadruple, antiviral combinations. Ninety‐four patients on treatment 4 days per week aggregated 165 intermittent treatment years; no viral breakthrough was observed over 87 average treatment weeks per patient, 63 of 94 having passed 2.5 intermittent treatment years on any of the antiviral combinations prescribed. On the hyperintermittent treatment of 3, 2, and 1 days per week, HIV RNA surged >50 copies, 4 weeks apart, in 18 instances (6.8 viral escapes/100 hyperdiscontinuous maintenance years). Viral escapes could have been a result of erratic adherence (EA) to regimen or follow‐up (3 patients)—drug taken at half of the daily recommended dosage (8 patients) and/or overlooked archival‐resistant HIVs from antecedent treatment failures (6 patients). Aside from the above circumstances, HIV unexpectedly rebounded in 3 patients on 2 days per week treatment and 1 patient on 1 day per week treatment, posting 2.2 intrinsic viral escapes/100 highly discontinuous treatment years. All 18 escapes were eventually reversed by 7 days per week salvage combinations, and 11 of 18 patients have been back for a second course of intermittent therapy, 4 days per week or less. Both cell‐activation markers on the surface of T lymphocytes and cell‐bound HIV DNA levels remained stable or declined. CD4/CD8 ratios rose to ≤1 in 35% of patients, whereas CD4 counts went ≤500/μl in 75%. These values were previously 7 and 40%, respectively, on 7 days per week therapy. In our aging, long, HIV‐enduring, multitreated patient cohort, treatment 4 days per week and less over 421 intermittent treatment years reduced prescription medicines by 60%—equivalent to 3 drug‐free/3 virus‐free remission year per patient—actually sparing €3 million on just 94 patients at the cost of 2.2 intrinsic viral failure/100 hyperintermittent treatment years. At no risk of viral escape, maintenance therapy, 4 days per week, would quasiuniversally offer 40% cuts off of current overprescriptions.—Leibowitch, J., Mathez, D., de Truchis, P., Ledu, D., Melchior, J. C., Carcelain, G., Izopet, J., Perronne, C., David, J. R. Four days a week or less on appropriate anti‐HIV drug combinations provided long‐term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 29, 2223‐2234 (2015). http://www.fasebj.org

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Section: Iccarre 4 Day Per Week Treatment: Not a Single Hiv Escapementioning

confidence: 67%

Section: Treatment Outcomes Following Viral Escapesmentioning

confidence: 99%

Four days a week or less on appropriate anti‐HIV drug combinations provided long‐term optimal maintenance in 94 patients: the ICCARRE project

et al. 2015

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“…8,16,18 Another notable benefit of ATV may be the potential adherence advantage because ATV/r administration is once daily rather than the twice daily for IDV/r. 38 Moreover, due to its higher genetic barrier to ARV mutations, ATV/r is one of the PIs recommended by the US Department of Health and Human Services (DHHS) and International AIDS Society as a possible first-line choice (GuidelineREF).…”

Section: Visits (In Months)mentioning

confidence: 99%

Comparison of the Effectiveness of Low-Dose Indinavir/Ritonavir (IDV/r)- versus Atazanavir/Ritonavir (ATV/r)-Based Generic Antiretroviral Therapy in NNRTI-Experienced HIV-1-Infected Patients in India

Patel

Naik

et al. 2011

Journal of the International Association of Physicians in AIDS

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Background: Currently, data on the effectiveness of second-line antiretroviral regimens using indinavir/ritonavir (IDV/r) and atazanavir/ritonavir (ATV/r) along with 2 nucleoside reverse transcriptase inhibitor (NRTI) in resource-poor settings is limited. Methods: Observational follow-up study on 441 patients who experienced treatment failure to first-line nonnucleoside reverse transcriptase inhibitor (NNRTI)-based treatment. Multivariate Cox Proportional Hazards Model was used to assess comparative effectiveness of treatment regimens. Results: A total of 63 patients (14.8%) had failed second line treatments, of which 53 patients (17.2%) were using IDV/r while 10 patients (8.5%) were on ATV/r. After adjusting for age, weight, gender, and baseline CD4 count, patients who took IDV/r were more than twice as likely to experience treatment failure as compared to those who were on ATV/r (hazard ratio [HR] 2.18; 95% confidence interval [CI] 1.14, 4.15). Successful response to second-line therapy was not different between the 2 treatment groups when patients weighed less than 55 kg at baseline (log rank P value ¼ 1.00) in contrast to the individuals weighing 55 kg (P < .0001). Conclusion: We found that successful response to second-line therapy was twice as likely in the ATV/r group; however, this difference was eliminated in patients less than 55 kg.

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“…46 Patients (n = 419) were randomized 2:1 to switch to ATV (400 mg od) or, if they were receiving TFV, to ATV/r (300/100 mg od), or to continue to receive their existing PI. They concluded that in patients with virological suppression who were receiving …”

Section: Patient-focused Perspectivesmentioning

confidence: 99%

Clinical utility and long-term use of atazanavir in the treatment of HIV-1 infection

Rampling¹,

Nelson²

2011

VAAT

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Abstract:The protease inhibitor atazanavir (ATV) now forms an integral component of many combination antiretroviral regimens. It has been shown to have a favorable side effect profile, and it does not negatively affect plasma lipids as some other protease inhibitors can. ATV also has a long half-life, which allows for a once-daily dosing schedule. Coadministration of ATV with low-dose ritonavir (RTV) potentiates the effect of ATV ("RTV boosting"), allowing for lower doses of ATV than those prescribed without RTV. ATV boosted with RTV (ATV/r) has shown noninferiority to RTV-boosted lopinavir (LPV/r), and it has been shown to be effective as a simplification strategy in switch studies. ATV/r-based regimens have also shown promise as a rescue strategy for patients failing other regimens. Several important adverse events and drug interactions have been identified, and care must be taken when administering ATV with other medications. The most commonly reported adverse effect is unconjugated hyperbilirubinemia, which occurs as a result of the metabolic pathway by which it is excreted. Resistance to ATV has been described in both treatment-experienced and treatment-naïve patients.

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Efficacy and Safety of Atazanavir-Based Highly Active Antiretroviral Therapy in Patients with Virologic Suppression Switched from a Stable, Boosted or Unboosted Protease Inhibitor Treatment Regimen: The SWAN Study (AI424-097) 48-Week Results

Cited by 137 publications

References 12 publications

Four days a week or less on appropriate anti‐HIV drug combinations provided long‐term optimal maintenance in 94 patients: the ICCARRE project

Four days a week or less on appropriate anti‐HIV drug combinations provided long‐term optimal maintenance in 94 patients: the ICCARRE project

Comparison of the Effectiveness of Low-Dose Indinavir/Ritonavir (IDV/r)- versus Atazanavir/Ritonavir (ATV/r)-Based Generic Antiretroviral Therapy in NNRTI-Experienced HIV-1-Infected Patients in India

Clinical utility and long-term use of atazanavir in the treatment of HIV-1 infection

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