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

Author:

Maggi Paolo1ORCID,Ricci Elena Delfina2ORCID,Martinelli Canio Vito3,De Socio Giuseppe Vittorio4ORCID,Squillace Nicola5ORCID,Molteni Chiara6ORCID,Masiello Addolorata1,Orofino Giancarlo7,Menzaghi Barbara8,Bellagamba Rita9,Vichi Francesca10,Celesia Benedetto Maurizio11ORCID,Madeddu Giordano12ORCID,Pellicanò Giovanni Francesco13ORCID,Carleo Maria Aurora14,Cascio Antonio15ORCID,Parisini Andrea16ORCID,Taramasso Lucia17,Valsecchi Laura18,Calza Leonardo19,Rusconi Stefano20ORCID,Sarchi Eleonora21,Martini Salvatore22ORCID,Bargiacchi Olivia23,Falasca Katia24ORCID,Cenderello Giovanni25,Ferrara Sergio26,Di Biagio Antonio17ORCID,Bonfanti Paolo527ORCID

Affiliation:

1. Infectious Diseases Unit, AORN Sant’Anna e San Sebastiano, 81100 Caserta, Italy

2. Fondazione ASIA Onlus, 20090 Buccinasco, Italy

3. AOU Infectious and Tropical Diseases, Careggi Hospital, 50134 Florence, Italy

4. Unit of Infectious Diseases, Santa Maria Hospital,06156 Perugia, Italy

5. Infectious Diseases Unit, Fondazione IRCCS San Gerardo dei Tintori, 20900 Monza, Italy

6. Unit of Infectious Diseases, A. Manzoni Hospital, 23900 Lecco, Italy

7. Division I of Infectious and Tropical Diseases, ASL Città di Torino, 10149 Torino, Italy

8. Unit of Infectious Diseases, ASST della Valle Olona, 21052 Busto Arsizio, Italy

9. National Institute for Infectious Diseases Lazzaro Spallanzani Institute for Hospitalization and Care Scientific, Lazio, 00161 Roma, Italy

10. SOC 1 USLCENTRO Firenze, Unit of Infectious Diseases, Santa Maria Annunziata Hospital, 50012 Florence, Italy

11. Unit of Infectious Diseases, Garibaldi Hospital, 95124 Catania, Italy

12. Unit of Infectious Diseases, Department of Medicine, Surgery and Pharmacy, University of Sassari, 07100 Sassari, Italy

13. Unit of Infectious Diseases, Department of Human Pathology of the Adult and the Developmental Age ‘G. Barresi’, University of Messina, 98125 Messina, Italy

14. Infectious Diseases and Gender Medicine Unit, Cotugno Hospital, AO dei Colli, 80131 Naples, Italy

15. Unit of Infectious Diseases, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, 90127 Palermo, Italy

16. Department of Infectious Diseases, Galliera Hospital, 16128 Genoa, Italy

17. Clinic of Infectious Diseases, IRCCS Policlinico San Martino Hospital, University of Genoa, 16132 Genoa, Italy

18. 1st Department of Infectious Diseases, ASST Fatebenefratelli Sacco, 20157 Milan, Italy

19. Infectious Diseases Unit, IRCCS Policlinico Sant’ Orsola, Department of Medical Surgical Science, University of Bologna, 40138 Bologna, Italy

20. Infectious Diseases Unit, Ospedale Civile di Legnano, ASST Ovest Milanese, and DIBIC Luigi Sacco, Università degli Studi di Milano, 20025 Legnano, Italy

21. Infectious Diseases Unit, Santi Antonio e Biagio e Cesare Arrigo Hospital, 15121 Alessandria, Italy

22. Infectious Disease Unit, University Hospital Luigi Vanvitelli, 80138 Naples, Italy

23. Unit of Infectious Diseases, Ospedale Maggiore della Carità, 28100 Novara, Italy

24. Clinic of Infectious Diseases, Department of Medicine and Science of Aging, G. D’Annunzio University, Chieti-Pescara, 66100 Chieti, Italy

25. Department of Infectious Diseases, Sanremo Hospital, 18038 Sanremo, Italy

26. Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, University of Foggia, 71122 Foggia, Italy

27. School of Surgery and Medicine, University of Milano-Bicocca, 20126 Milan, Italy

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.

Publisher

MDPI AG

Subject

Virology,Infectious Diseases

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