Durability and effectiveness of dual vs. triple therapy and tablet simplification in ART: findings from the Italian MOSAICO study

Durability and effectiveness of dual vs. triple therapy and tablet simplification in ART: findings from the Italian MOSAICO study

IntroductionTreatment optimization in people with HIV (PWH) has increasingly focused on reducing drug burden and improving regimen simplicity. However, comparative real-world evidence on dual therapy (DT) vs. triple therapy (TT), and single-tablet regimens (STR) vs. multi-tablet regimens (MTR), rema...

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Main Authors: Daniele Mengato, Giacomo Berti, Andrea Francavilla, Silvia Michielan, Linda Cappellazzo, Laura Agnoletto, Maria Chiara Silvani, Marco Chiumente, Dario Gregori, Maria Mazzitelli, Francesca Venturini, Anna Maria Cattelan, the SIFaCT MOSAICO Study Group, Salvatore Agosta, Marina Allegrini, Marina Assirelli, Maria Rita Badagliacca, Giuliana Battagin, Giorgia Bo, Jenny Bolcato, Cristina Bitello, Raffaella Binazzi, Arianna Cadeddu, Marila Camboni, Francesca Cammalleri, Anila Corja, Marta Cappellini, Claudia Ciraldo, Nicolò de Gennaro, Maria Dell'Aera, Silvia Enisci, Giuseppina Emanuela Fassari, Sara Ferrari, Gabriele Fabbri, Michela Falciani, Roberta Fraccaroli, Anna Gagliardi, Giovanna Gandini, Veronica Gonzi, Giuseppe Greco, Clara La Bruna, Stefano Loiacono, Kety Luzi, Eleonora Magistrelli, Marina Malena, Paola Marini, Andrea Misin, Valentina Mureddu, Arianna Orcesi, Simonetta Palazzini, Clara Palmieri, Giulia Piazza, Mariantonietta Piccoli, Fabio Pieraccini, Francesco Pomarico, Giovanna Rametta, Roberta Rampazzo, Lucia Rossi, Aurora Scazzina, Chiara Scolamacchia, Martina Tegon, Sara Tordi, Dario Ventura, Salvatore Vitale, Anastasia Zoffoli
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-08-01
Series:Frontiers in Pharmacology
Subjects:
people with HIV
single tablet regimen
dual therapy
HIV treatment
switch therapy
optimization
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1633968/full
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Summary:IntroductionTreatment optimization in people with HIV (PWH) has increasingly focused on reducing drug burden and improving regimen simplicity. However, comparative real-world evidence on dual therapy (DT) vs. triple therapy (TT), and single-tablet regimens (STR) vs. multi-tablet regimens (MTR), remains limited.MethodsThe MOSAICO study is a multicenter, retrospective observational analysis conducted across 20 centers, including people with HIV on a stable virological suppression who switched antiretroviral therapy between 2017 and 2019. People were followed-up up to 48 months post-switch. Comparative analyses assessed virological suppression (HIV-RNA <50 copies/mL), CD4+ T cell count, CD4/CD8 ratio, and treatment discontinuation. Propensity score weighting was applied to adjust for baseline differences.ResultsFour hundred ninety-one PWH were included. Both DT and triple therapy groups maintained high levels of virological suppression over 48 months (12 months: 97.1% vs. 91.6%; 24 months: 100% vs. 95.6%; 36 months: 100% vs. 96.9%; 48 months: 100% vs. 100%). From 24 months onward, all persons living with HIV remaining on their respective regimens achieved full virological suppression. Immunological recovery (CD4+ count and CD4/CD8 ratio) was comparable across groups, although TT and MTR groups showed greater increases from lower baselines. STRs demonstrated significantly greater treatment durability than MTRs (aHR = 0.56, 95% CI: 0.32–0.97; p = 0.039), while no significant difference in persistence was found between DT and TT. INSTI-based regimens were predominant in DT and MTR arms (DT vs. TT: 84% vs. 46.52%, p < 0.01; MTR vs. STR: 59.38% vs. 47.14%, p < 0.01).DiscussionThe real-world effectiveness of both dual and triple therapies when tailored to appropriate person profiles. STRs offer enhanced long-term persistence compared to MTRs, supporting treatment simplification strategies. These results reinforce the importance of individualized treatment approaches balancing clinical effectiveness with person-centered considerations such as pill burden and tolerability. Limitations include the retrospective design and the lack of quality-of-life data, which may affect interpretation of patient-centered outcomes. Future efforts should expand access to dual-agent STR to further improve Antiretroviral Therapy outcomes.
ISSN:1663-9812

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