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Volume 15
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10.3390/v15051123
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Article

Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients

by
Massimiliano Fabbiani
1,*,
Melissa Masini
2,
Barbara Rossetti
3,
Arturo Ciccullo
4,5,
Vanni Borghi
6,
Filippo Lagi
7,
Amedeo Capetti
8,
Manuela Colafigli
9,
Francesca Panza
1,10,
Gianmaria Baldin
4,5,
Cristina Mussini
6,
Gaetana Sterrantino
11,
Damiano Farinacci
4,5,
Francesca Montagnani
1,10,
Mario Tumbarello
1,10 and
Simona Di Giambenedetto
4,5
1
UOC Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Senese, 53100 Siena, Italy
2
UOC Malattie Infettive, Azienda USL Toscana Sud Est, PO San Donato, 52100 Arezzo, Italy
3
Division of Infectious Diseases, AUSL Toscana Sud Est, Grosseto Hospital, 58100 Grosseto, Italy
4
Dipartimento di Sicurezza e Bioetica Sezione Malattie Infettive, Università Cattolica del Sacro Cuore, 00168 Rome, Italy
5
UOC Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy
6
Clinica Malattie Infettive e Tropicali, Azienda Ospedaliero Universitaria di Modena, 41100 Modena, Italy
7
SOD Malattie Infettive e Tropicali, Azienda Ospedaliero-Universitaria Careggi, 50134 Firenze, Italy
8
Divisione di Malattie Infettive, Dipartimento di Malattie Infettive, Ospedale Universitario Luigi Sacco, 20157 Milano, Italy
9
Unità di Dermatologia Infettiva e Allergologia, Istituto S. Gallicano IRCCS, 00144 Rome, Italy
10
Dipartimento di Biotecnologie Mediche, Università degli Studi di Siena, 53100 Siena, Italy
11
Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy
 
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*
Author to whom correspondence should be addressed.
Viruses 2023, 15(5), 1123; https://doi.org/10.3390/v15051123
Submission received: 7 April 2023 / Revised: 1 May 2023 / Accepted: 5 May 2023 / Published: 8 May 2023
(This article belongs to the Special Issue Efficacy and Safety of Antiviral Therapy)
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Abstract

Background: Since limited data are available, we aimed to compare the efficacy and durability of dolutegravir and darunavir in advanced naïve patients. Methods: Retrospective multicenter study including AIDS- or late-presenting (def. CD4 ≤ 200/µL) HIV-infected patients starting dolutegravir or ritonavir/cobicistat-boosted darunavir+2NRTIs. Patients were followed from the date of first-line therapy initiation (baseline, BL) to the discontinuation of darunavir or dolutegravir, or for a maximum of 36 months of follow-up. Results: Overall 308 patients (79.2% males, median age 43 years, 40.3% AIDS-presenters, median CD4 66 cells/µL) were enrolled; 181 (58.8%) and 127 (41.2%) were treated with dolutegravir and darunavir, respectively. Incidence of treatment discontinuation (TD), virological failure (VF, defined as a single HIV-RNA > 1000 cp/mL or two consecutive HIV-RNA > 50 cp/mL after 6 months of therapy or after virological suppression had been achieved), treatment failure (the first of TD or VF), and optimal immunological recovery (defined as CD4 ≥ 500/µL + CD4 ≥ 30% + CD4/CD8 ≥ 1) were 21.9, 5.2, 25.6 and 1.4 per 100 person-years of follow-up, respectively, without significant differences between dolutegravir and darunavir (p > 0.05 for all outcomes). However, a higher estimated probability of TD for central nervous system (CNS) toxicity (at 36 months: 11.7% vs. 0%, p = 0.002) was observed for dolutegravir, whereas darunavir showed a higher probability of TD for simplification (at 36 months: 21.3% vs. 5.7%, p = 0.046). Conclusions: Dolutegravir and darunavir showed similar efficacy in AIDS- and late-presenting patients. A higher risk of TD due to CNS toxicity was observed with dolutegravir, and a higher probability of treatment simplification with darunavir.
Keywords: HIV-1; antiretroviral therapy; integrase inhibitors; protease inhibitors; advanced naïve; virological failure; treatment discontinuation HIV-1; antiretroviral therapy; integrase inhibitors; protease inhibitors; advanced naïve; virological failure; treatment discontinuation

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MDPI and ACS Style

Fabbiani, M.; Masini, M.; Rossetti, B.; Ciccullo, A.; Borghi, V.; Lagi, F.; Capetti, A.; Colafigli, M.; Panza, F.; Baldin, G.; et al. Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients. Viruses 2023, 15, 1123. https://doi.org/10.3390/v15051123

AMA Style

Fabbiani M, Masini M, Rossetti B, Ciccullo A, Borghi V, Lagi F, Capetti A, Colafigli M, Panza F, Baldin G, et al. Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients. Viruses. 2023; 15(5):1123. https://doi.org/10.3390/v15051123

Chicago/Turabian Style

Fabbiani, Massimiliano, Melissa Masini, Barbara Rossetti, Arturo Ciccullo, Vanni Borghi, Filippo Lagi, Amedeo Capetti, Manuela Colafigli, Francesca Panza, Gianmaria Baldin, and et al. 2023. "Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients" Viruses 15, no. 5: 1123. https://doi.org/10.3390/v15051123

APA Style

Fabbiani, M., Masini, M., Rossetti, B., Ciccullo, A., Borghi, V., Lagi, F., Capetti, A., Colafigli, M., Panza, F., Baldin, G., Mussini, C., Sterrantino, G., Farinacci, D., Montagnani, F., Tumbarello, M., & Di Giambenedetto, S. (2023). Efficacy and Durability of Dolutegravir- or Darunavir-Based Regimens in ART-Naïve AIDS- or Late-Presenting HIV-Infected Patients. Viruses, 15(5), 1123. https://doi.org/10.3390/v15051123

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