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Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study).
J Antimicrob Chemother. 2013 Jun; 68(6):1364-72.JA

Abstract

OBJECTIVES

To explore 48 week safety and efficacy of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression on a stable atazanavir/ritonavir-based standard triple regimen.

METHODS

This was a single-arm pilot study, enrolling 40 patients on atazanavir/ritonavir + two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), without previous treatment failure, with HIV-RNA <50 copies/mL for >3 months and CD4 >200 cells/mm(3). At baseline, patients were switched to 300/100 mg of atazanavir/ritonavir + 300 mg of lamivudine once daily. Laboratory parameters, atazanavir plasma levels, self-reported adherence, quality of life, neurocognitive performance, bone composition and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/mL on two consecutive determinations or a single level >1000 copies/mL.

RESULTS

After 48 weeks, 4/40 (10%) regimen discontinuations occurred: 1 death (brain haemorrhage), 1 study withdrawal (inadequate atazanavir plasma levels), 1 re-induction with two NRTIs due to pregnancy and 1 virological failure without development of resistance. Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients. At week 48, increases in total (mean change +17 mg/dL, P = 0.001), high-density lipoprotein (+6 mg/dL, P < 0.001) and low-density lipoprotein (+8 mg/dL, P = 0.052) cholesterol were observed. The glomerular filtration rate improved (+7 mL/min/1.73 m(2), P < 0.001), as did scores exploring self-reported physical and mental health (+11, P = 0.009 and +13, P < 0.001 on a 0-100 scale), neuropsychological performance (-1 pathological task, P = 0.002) and total bone mineral density (+0.03 g/cm(2), P = 0.026). There were no significant changes in CD4 cell count, bilirubin, atazanavir plasma levels, adherence and body fat distribution over time.

CONCLUSIONS

Simplification to atazanavir/ritonavir + lamivudine was apparently safe and associated with rare virological failure, without resistance selection. This strategy deserves further investigation in a randomized trial.

Authors+Show Affiliations

Institute of Clinical Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23372058

Citation

Di Giambenedetto, Simona, et al. "Safety and Feasibility of Treatment Simplification to Atazanavir/ritonavir + Lamivudine in HIV-infected Patients On Stable Treatment With Two Nucleos(t)ide Reverse Transcriptase Inhibitors + Atazanavir/ritonavir With Virological Suppression (Atazanavir and Lamivudine for Treatment Simplification, AtLaS Pilot Study)." The Journal of Antimicrobial Chemotherapy, vol. 68, no. 6, 2013, pp. 1364-72.
Di Giambenedetto S, Fabbiani M, Colafigli M, et al. Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study). J Antimicrob Chemother. 2013;68(6):1364-72.
Di Giambenedetto, S., Fabbiani, M., Colafigli, M., Ciccarelli, N., Farina, S., Sidella, L., D'Avino, A., Mondi, A., Cingolani, A., Tamburrini, E., Murri, R., Navarra, P., Cauda, R., & De Luca, A. (2013). Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study). The Journal of Antimicrobial Chemotherapy, 68(6), 1364-72. https://doi.org/10.1093/jac/dkt007
Di Giambenedetto S, et al. Safety and Feasibility of Treatment Simplification to Atazanavir/ritonavir + Lamivudine in HIV-infected Patients On Stable Treatment With Two Nucleos(t)ide Reverse Transcriptase Inhibitors + Atazanavir/ritonavir With Virological Suppression (Atazanavir and Lamivudine for Treatment Simplification, AtLaS Pilot Study). J Antimicrob Chemother. 2013;68(6):1364-72. PubMed PMID: 23372058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients on stable treatment with two nucleos(t)ide reverse transcriptase inhibitors + atazanavir/ritonavir with virological suppression (Atazanavir and Lamivudine for treatment Simplification, AtLaS pilot study). AU - Di Giambenedetto,Simona, AU - Fabbiani,Massimiliano, AU - Colafigli,Manuela, AU - Ciccarelli,Nicoletta, AU - Farina,Salvatore, AU - Sidella,Letizia, AU - D'Avino,Alessandro, AU - Mondi,Annalisa, AU - Cingolani,Antonella, AU - Tamburrini,Enrica, AU - Murri,Rita, AU - Navarra,Pierluigi, AU - Cauda,Roberto, AU - De Luca,Andrea, Y1 - 2013/01/30/ PY - 2013/2/2/entrez PY - 2013/2/2/pubmed PY - 2013/12/16/medline KW - combined antiretroviral therapy KW - dual therapy KW - long-term tolerability KW - switch SP - 1364 EP - 72 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 68 IS - 6 N2 - OBJECTIVES: To explore 48 week safety and efficacy of treatment simplification to atazanavir/ritonavir + lamivudine in HIV-infected patients with virological suppression on a stable atazanavir/ritonavir-based standard triple regimen. METHODS: This was a single-arm pilot study, enrolling 40 patients on atazanavir/ritonavir + two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), without previous treatment failure, with HIV-RNA <50 copies/mL for >3 months and CD4 >200 cells/mm(3). At baseline, patients were switched to 300/100 mg of atazanavir/ritonavir + 300 mg of lamivudine once daily. Laboratory parameters, atazanavir plasma levels, self-reported adherence, quality of life, neurocognitive performance, bone composition and body fat distribution were monitored. Virological failure was defined as HIV-RNA >50 copies/mL on two consecutive determinations or a single level >1000 copies/mL. RESULTS: After 48 weeks, 4/40 (10%) regimen discontinuations occurred: 1 death (brain haemorrhage), 1 study withdrawal (inadequate atazanavir plasma levels), 1 re-induction with two NRTIs due to pregnancy and 1 virological failure without development of resistance. Seven moderate to severe adverse events were recorded (including four renal colics, possibly treatment-related) in six patients. At week 48, increases in total (mean change +17 mg/dL, P = 0.001), high-density lipoprotein (+6 mg/dL, P < 0.001) and low-density lipoprotein (+8 mg/dL, P = 0.052) cholesterol were observed. The glomerular filtration rate improved (+7 mL/min/1.73 m(2), P < 0.001), as did scores exploring self-reported physical and mental health (+11, P = 0.009 and +13, P < 0.001 on a 0-100 scale), neuropsychological performance (-1 pathological task, P = 0.002) and total bone mineral density (+0.03 g/cm(2), P = 0.026). There were no significant changes in CD4 cell count, bilirubin, atazanavir plasma levels, adherence and body fat distribution over time. CONCLUSIONS: Simplification to atazanavir/ritonavir + lamivudine was apparently safe and associated with rare virological failure, without resistance selection. This strategy deserves further investigation in a randomized trial. SN - 1460-2091 UR - https://www.unboundmedicine.com/medline/citation/23372058/Safety_and_feasibility_of_treatment_simplification_to_atazanavir/ritonavir_+_lamivudine_in_HIV_infected_patients_on_stable_treatment_with_two_nucleos_t_ide_reverse_transcriptase_inhibitors_+_atazanavir/ritonavir_with_virological_suppression__Atazanavir_and_Lamivudine_for_treatment_Simplification_AtLaS_pilot_study__ DB - PRIME DP - Unbound Medicine ER -