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. 2023 Jul 23;15(7):1612.
doi: 10.3390/v15071612.

Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting

Paolo Maggi  1 , Elena Delfina Ricci  2 , Canio Vito Martinelli  3 , Giuseppe Vittorio De Socio  4 , Nicola Squillace  5 , Chiara Molteni  6 , Addolorata Masiello  1 , Giancarlo Orofino  7 , Barbara Menzaghi  8 , Rita Bellagamba  9 , Francesca Vichi  10 , Benedetto Maurizio Celesia  11 , Giordano Madeddu  12 , Giovanni Francesco Pellicanò  13 , Maria Aurora Carleo  14 , Antonio Cascio  15 , Andrea Parisini  16 , Lucia Taramasso  17 , Laura Valsecchi  18 , Leonardo Calza  19 , Stefano Rusconi  20 , Eleonora Sarchi  21 , Salvatore Martini  22 , Olivia Bargiacchi  23 , Katia Falasca  24 , Giovanni Cenderello  25 , Sergio Ferrara  26 , Antonio Di Biagio  17 , Paolo Bonfanti  5   27 ; CISAI Study Group
Affiliations

Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting

Paolo Maggi et al. Viruses. .

Abstract

Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor (NNRTI). We aimed to investigate, in a real-life setting, how switching to a DOR-based regimen rather than a rilpivirine (RPV)-based regimen impacted metabolic and hepatic safety. The analysis included 551 antiretroviral treatment (ART)-experienced people living with HIV (PLWH), starting RPV-based or DOR-based regimens with viral load < 200 copies/mL, baseline (T0), and at least one control visit (6-month visit, T1). We enrolled 295 PLWH in the RPV and 256 in the DOR cohort. At T1, total cholesterol (TC), low-density lipoprotein-C (LDL-C), and triglycerides significantly decreased in both DOR and RPV cohorts, while high-density lipoprotein-C (HDL-C) only decreased in RPV-treated people. Consistently, the TC/HDL-C ratio declined more markedly in the DOR (-0.36, p < 0.0001) than in the RPV cohort (-0.08, p = 0.25) (comparison p = 0.39). Similar trends were observed when excluding the PLWH on lipid-lowering treatment from the analysis. People with normal alanine aminotransferase (ALT) levels showed a slight ALT increase in both cohorts, and those with baseline ALT > 40 IU/L experienced a significant decline (-14 IU/L, p = 0.008) only in the DOR cohort. Lipid profile improved in both cohorts, and there was a significant reduction in ALT in PLWH with higher-than-normal baseline levels on DOR-based ART.

Keywords: ART-experienced; HIV infection; adverse events; doravirine; hepatic safety; metabolic safety; rilpivirine.

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Conflict of interest statement

The following authors served as a consultant or advisory-board member and/or received speaker’s fees and/or received research grants for their institutions, outside the present work: PM, GM, and GFP from Gilead Science, ViiV Healthcare, Janssen, and Merck Sharp & Dohme; PB from Gilead Science, ViiV Healthcare, Janssen, Merck Sharp & Dohme, and Pfizer; LT and ADB from Gilead Science, ViiV Healthcare, and Janssen; RB from Gilead Science, ViiV Healthcare, and Merck Sharp & Dohme; AC from Gilead Science, Janssen, and Merck Sharp & Dohme; NS from ViiV Healthcare and Janssen; BMC from Gilead Science, Bristol Myers Squibb, AbbVie, ViiV Healthcare, Janssen, Mylan, and Merck Sharp & Dohme. All remaining authors have no potential conflict of interest.

Figures

Figure 1
Figure 1
Survival analysis in strata of DOR and RPV regimens. (a) Treatment interruptions for any reason and (b) treatment interruptions for adverse events. Numbers show the study participants at risk in the doravirine and rilpivirine cohorts.
See this image and copyright information in PMC

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