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J Antimicrob Chemother. 2017 Apr 1;72(4):1163-1171. doi: 10.1093/jac/dkw557.

Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M).

Author information

1
Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, Rome, Italy.
2
University Division of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy.
3
Infectious Dermatology and Allergology Unit, IFO S. Gallicano Institute (IRCCS), Rome, Italy.
4
Department of Infectious Diseases, 'La Sapienza' University, Rome, Italy.
5
National Institute for Infectious Diseases 'Lazzaro Spallanzani' IRCCS, Rome, Italy.
6
Department of Infectious and Tropical Diseases, Vita-Salute San Raffaele University, San Raffaele Hospital, Milan, Italy.
7
Infectious and Tropical Diseases Unit, Amedeo di Savoia Hospital, Torino, Italy.
8
Infectious Diseases Clinic, University of Perugia, Perugia, Italy.
9
Systemic Infections and Immunodeficiency Unit, National Institute for Infectious Diseases 'Lazzaro Spallanzani' IRCCS, Rome, Italy.
10
Department of Clinical and Experimental Medicine, University of Sassari, Sassari, Italy.
11
Infectious Disease Unit, 'S. Caterina Novella' Hospital, Galatina, Italy.
12
Infectious Diseases Unit, DIBIC Luigi Sacco, University of Milan, Milan, Italy.
13
Unit of Infectious Diseases, S.M. Annunziata Hospital, Florence, Italy.
14
UOC Malattie Infettive, Azienda Ospedaliera Universitaria Senese, Siena, Italy.
15
Department of Medical Biotechnologies, University of Siena, Siena, Italy.

Abstract

Background:

Combination ART (cART)-related toxicities and costs have prompted the need for treatment simplification. The ATLAS-M trial explored 48 week non-inferior efficacy of simplification to atazanavir/ritonavir  +  lamivudine versus maintaining three-drug atazanavir/ritonavir-based cART in virologically suppressed patients.

Methods:

We performed an open-label, multicentre, randomized, non-inferiority study, enrolling HIV-infected adults on atazanavir/ritonavir + two NRTIs, with stable HIV-RNA <50 copies/mL and CD4 + >200 cells/mm 3 . Main exclusion criteria were hepatitis B virus coinfection, past virological failure on or resistance to study drugs, recent AIDS and pregnancy. Patients were randomly assigned 1:1 to either switch to 300 mg of atazanavir/100 mg of ritonavir once daily and 300 mg of lamivudine once daily (atazanavir/ritonavir + lamivudine arm) or to continue the previous regimen (atazanavir/ritonavir + two NRTIs arm). The primary study outcome was the maintenance of HIV-RNA <50 copies/mL at week 48 of the ITT-exposed (ITT-e) analysis with switch = failure. The non-inferiority margin was 12%. This study is registered at ClinicalTrials.gov, number NCT01599364.

Results:

Between July 2011 and June 2014, 266 patients were randomized (133 to each arm). After 48 weeks, the primary study outcome was met by 119 of 133 patients (89.5%) in the atazanavir/ritonavir + lamivudine arm and 106 of 133 patients (79.7%) in the atazanavir/ritonavir + two NRTIs arm [difference atazanavir/ritonavir + lamivudine versus atazanavir/ritonavir + two NRTIs arm: +9.8% (95% CI + 1.2 to + 18.4)], demonstrating non-inferiority and superior efficacy of the atazanavir/ritonavir + lamivudine arm. Virological failure occurred in two (1.5%) patients in the atazanavir/ritonavir + lamivudine arm and six (4.5%) patients in the atazanavir/ritonavir + two NRTIs arm, without resistance selection. A similar proportion of adverse events occurred in both arms.

Conclusions:

Treatment simplification to atazanavir/ritonavir + lamivudine showed non-inferior efficacy (superiority on post-hoc analysis) and a comparable safety profile over continuing atazanavir/ritonavir + two NRTIs in virologically suppressed patients.

PMID:
28093483
DOI:
10.1093/jac/dkw557
[Indexed for MEDLINE]

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