The 48-week interim analysis of the MODAT study showed that confirmed virologic failure (CVF) was more frequent in patients simplifying to ATV/r monotherapy compared to maintaining ATV/r-based triple therapy. The DSMB recommended stopping study enrollment but continuing follow-up of enrolled patients. We present the 96-week efficacy analysis

Antinori, Andrea

Bigoloni, Alba

Castagna, Antonella

Di Biagio, Antonio

Di Giambenedetto, Simona

Galli, Laura

Guaraldi, Giovanni

Lazzarin, Adriano

Monforte, Antonella d'Arminio

Nozza, Silvia

Rusconi, Stefano

Spagnuolo, Vincenzo

Journal of the International AIDS Society

English

PubMed

Vincenzo Spagnuolo

Laura Galli

Alba Bigoloni

Silvia Nozza

Antonella d'Arminio Monforte

Andrea Antinori

Antonio Di Biagio

Stefano Rusconi

Giovanni Guaraldi

Simona Di Giambenedetto

Adriano Lazzarin

Antonella Castagna

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Atazanavir/ritonavir monotherapy as maintenance strategy in HIV-1 treated subjects with viral suppression: 96-week analysis results of the MODAT study

Archivio istituzionale della ricerca - Università di Modena e Reggio Emilia

Poster Sessions  Abstract P274Atazanavir/ritonavir monotherapy as maintenance strategy inHIV-1 treated subjects with viral suppression: 96-week analysisresults of the MODAT studySpagnuolo, Vincenzo1; Galli, Laura1; Bigoloni, Alba1; Nozza, Silvia1; d’Arminio Monforte, Antonella2;Antinori, Andrea3; Di Biagio, Antonio4; Rusconi, Stefano5; Guaraldi, Giovanni6; Di Giambenedetto, Simona7;Lazzarin, Adriano1 and Castagna, Antonella11Department of Infectious Diseases, IRCCS San Raffaele Hospital, Milan, Italy. 2Clinic of Infectious and Tropical Diseases, S Paolo Hospital, University of Milan, Milan,Italy. 3Clinical Department, National Institute for Infectious Diseases IRCCS Lazzaro Spallanzani, Rome, Italy. 4Division of Infectious Diseases, Azienda Ospedaliera SanMartino, Genoa, Italy. 5Division of Infectious Diseases, Ospedale Luigi Sacco, University of Milan, Milan, Italy. 6Department of Medical and Surgical Sciences,University of Modena and Reggio Emilia, Modena, Italy. 7Institute of Clinical Infectious Diseases, Catholic University of the Sacred Heart, Rome, Italy.Introduction: The 48-week interim analysis of the MODAT study showed that confirmed virologic failure (CVF) was morefrequent in patients simplifying to ATV/r monotherapy compared to maintaining ATV/r-based triple therapy. The DSMBrecommended stopping study enrollment but continuing follow-up of enrolled patients. We present the 96-week efficacyanalysis.Materials and Methods: Multicentre, randomized, open-label, non-inferiority trial (non-inferiority margin 10%). Treatmentfailure (TF) was defined as CVF (two consecutive HIV-RNA 50 cp/mL) or discontinuation for any cause. In the monotherapyarm, patients with CVF re-introduced their previous NRTIs and remained in the study if HIV-RNA B50 copies/mL within 12weeks of re-intensification.Results: 101 patients evaluated (Figure 1): 85% males, 21% HCV-positive, median (IQR) age of 42 (3648) years, baseline CD4576 (447743) cells/mL. In the 96-week analysis (ITT; TFfailure), efficacy was 64% (32/50) in the monotherapy arm and 63%(32/51) in the triple-therapy arm (difference 1.3%, 95% CI 17.520.1). Fourteen patients in monotherapy and two in triple-therapy arm had CVF; median HIV-RNA was 136 (72376) copies/mL. In monotherapy arm, no PI or NRTI associated resistancemutations were observed at CVF. All patients who re-intensified re-suppressed. In monotherapy arm, TF was more frequent inHCV-co-infected patients (64% vs 28%; p0.041). In the secondary analysis (ITT; re-intensificationsuccess), 82% (41/50) inmonotherapy arm and 63% (32/51) in triple-therapy arm were on study at week 96 (difference 19.3%, 95% CI 2.236.3). SAEsoccurred in four (8%) patients in the monotherapy arm (one left basal pneumonia, one acute coronary stenosis, one traumaticlesion, one nephrolithiasis) and two (4%) in the triple therapy arm (one sepsis, one renal failure). Drug-related adverse events(AEs) leading to discontinuation were three (6%) in the monotherapy arm (two AEs occurred in patients after successful re-intensification) and 12 (23.5%) in the triple-therapy (p0.023).Conclusions: Despite the small sample size, the primary 96-week analysis showed that simplification to ATV/r monotherapyshowed inferior efficacy to maintaining ATV/r triple-therapy but appeared to be superior when re-intensification was consideredsuccess.Published 2 November 2014Copyright: – 2014 Spagnuolo V et al; licensee International AIDS Society. This is an Open Access article distributed under the terms of the Creative CommonsAttribution 3.0 Unported (CC BY 3.0) License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in anymedium, provided the original work is properly cited.Abstracts of the HIV Drug Therapy Glasgow Congress 2014Spagnuolo V et al. Journal of the International AIDS Society 2014, 17(Suppl 3):19806http://www.jiasociety.org/index.php/jias/article/view/19806 | http://dx.doi.org/10.7448/IAS.17.4.198061Figure 1. The MODAT trial: 96-week patients disposition.Abstracts of the HIV Drug Therapy Glasgow Congress 2014Spagnuolo V et al. Journal of the International AIDS Society 2014, 17(Suppl 3):19806http://www.jiasociety.org/index.php/jias/article/view/19806 | http://dx.doi.org/10.7448/IAS.17.4.198062 17582652, 2014, 4S3, Downloaded from https://onlinelibrary.wiley.com/doi/10.7448/IAS.17.4.19806 by University Modena, Wiley Online Library on [29/03/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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Atazanavir/ritonavir monotherapy as maintenance strategy in HIV-1 treated subjects with viral suppression: 96-week analysis results of the MODAT study

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Archivio istituzionale della ricerca - Università di Modena e Reggio Emilia