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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
immunology and microbiology
Simplification to atazanavir/ritonavir monotherapy for HIV-1 treated individuals on virological suppression: 48-week efficacy and safety results
AIDS, Volume 28, No. 15, Year 2014
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Description
Objectives: The objective of this study was to assess the 48-week virological efficacy of atazanavir/ritonavir (ATV/r) monotherapy vs. ATV/r along with two nucleoside reverse transcriptase (NRTIs) in HIV-1 treated individuals with HIV-RNA less than 50 copies/ml. Methods: A multicentre, randomized, open-label, noninferiority trial. HIV-1 treated individuals on ATV/r 300/100mg along with two NRTIs were randomized to receive ATV/r monotherapy or to maintain their antiretroviral regimen. The primary endpoint was the confirmed viral rebound (CVR: Two consecutive HIV-RNA >50 copies/ml) or treatment discontinuation for any reason. Individuals who experienced CVR on ATV/r monotherapy reintroduced NRTIs and discontinued the study if HIV-RNA was more than 50 copies/ml after 12 weeks since reintensification. Results: One hundred and three patients enrolled. By week 48, 11 patients in ATV/r arm and two in ATV/r along with twoNRTIs experienced CVR; four (8%) patients in ATV/r and eight (15%) in ATV/r along with twoNRTIs discontinued. At the 48-week primary efficacy analysis (re-intensification=failure), treatment success was73%inATV/r armand85%in ATV/r along with two NRTIs [difference 12.1%, 95% confidence interval (95% CI)27.8 to 2.1]. According to the analysis considering re-intensification is equal to success, treatment success was 92%in ATV/r armand 85%in the ATV/r along with twoNRTIs arm (difference 7.5%, 95%CI4.7 to 19.8). At CVR, no mutation was observed in ATV/r arm and reintensification with NRTIs was effective in all individuals. Overall, Grade 3-4 (P=0.003) and grade 3-4 drug-related (P=0.027) adverse events were less frequent in ATV/r arm. A significant increase in total and low-density lipoprotein (LDL)-cholesterol was observed as well as a significant improvement in high-density lipoprotein (HDL)- cholesterol, fasting glucose, liver fibrosis and alkaline phosphatase was observed in ATV/r monotherapy in comparison with ATV/r along with two NRTIs. Conclusion: ATV/r monotherapy treatment simplification showed lower virological efficacy in comparison with maintaining triple therapy; NRTIs reintroduction was effective in all the individuals. © 2014 Wolters Kluwer Health-Lippincott Williams & Wilkins.
Authors & Co-Authors
Castagna, Antonella
Italy, Milan
Irccs Ospedale San Raffaele
Spagnuolo, Vincenzo
Italy, Milan
Irccs Ospedale San Raffaele
Italy, Milan
Università Degli Studi Di Milano
Galli, Laura
Italy, Milan
Irccs Ospedale San Raffaele
Nozza, Silvia
Italy, Milan
Irccs Ospedale San Raffaele
Monforte, Antonella D’Arminio
Italy, Milan
Ospedale San Paolo
Montella, Francesco
Italy, Turin
Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista Di Torino
Antinori, Andrea
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Di Biagio, Antonio
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Rusconi, Stefano
Italy, Milan
Università Degli Studi Di Milano
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Lazzarin, Adriano
Italy, Milan
Irccs Ospedale San Raffaele
Italy, Milan
Università Degli Studi Di Milano
Viscoli, Claudio
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Parisini, Andrea
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Prinapori, Roberta
Italy, Genoa
Irccs San Martino Polyclinic Hospital
Mazzotta, Francesco
Italy, Florence
Azienda Sanitaria Di Firenze
Lo Caputo, Sergio
Italy, Florence
Azienda Sanitaria Di Firenze
D'Arminio Monforte, Antonella D.
Italy, Milan
Ospedale San Paolo
Tincati, Camilla
Italy, Milan
Ospedale San Paolo
Bini, Teresa
Italy, Milan
Ospedale San Paolo
Puoti, Massimo
Italy, Milan
Asst Grande Ospedale Metropolitano Niguarda
Di Sora, Fiorella
Italy, Rome
Complesso Ospedaliero San Giovanni - Addolorata
Ammassari, Adriana
Italy, Rome
Irccs Istituto Nazionale Malattie Infettive Lazzaro Spallanzani
Cauda, Roberto
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Di Giambenedetto, Simona D.
Italy, Rome
Università Cattolica Del Sacro Cuore, Campus Di Roma
Galli, Massimo
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Rizzardini, Giuliano
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Capetti, Amedeo Ferdinando
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Gianotti, Nicola
Italy, Milan
Irccs Ospedale San Raffaele
Mussini, Cristina
Italy, Modena
Università Degli Studi Di Modena e Reggio Emilia
Guaraldi, Giovanni
Italy, Modena
Università Degli Studi Di Modena e Reggio Emilia
Statistics
Citations: 24
Authors: 29
Affiliations: 12
Identifiers
Doi:
10.1097/QAD.0000000000000407
ISSN:
02699370
Research Areas
Cancer
Infectious Diseases