Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).

Autor: Lim ZC; Department of Pharmacy, Ng Teng Fong General Hospital, Singapore, Singapore., Hoo GS; Department of Pharmacy, National Centre of Infectious Diseases, Singapore, Singapore. grace_sr_hoo@ttsh.com.sg.; Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore. grace_sr_hoo@ttsh.com.sg., Ang JH; Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore., Teng CB; Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore.; Department of Pharmacy, National University of Singapore, Singapore, Singapore., Ang LW; National Public Health and Epidemiology Unit, National Centre for Infectious Diseases, Singapore, Singapore., Lee CC; National Centre for Infectious Diseases, Singapore, Singapore.; Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore.; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore., Leo YS; National Centre for Infectious Diseases, Singapore, Singapore.; Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore.; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.; Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore., Law HL; Department of Pharmacy, National Centre of Infectious Diseases, Singapore, Singapore.; Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore.; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore., Ng OT; National Centre for Infectious Diseases, Singapore, Singapore.; Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore.; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore., Wong CS; National Centre for Infectious Diseases, Singapore, Singapore.; Department of Infectious Diseases, Tan Tock Seng Hospital, Singapore, Singapore.; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Jazyk: angličtina
Zdroj: AIDS research and therapy [AIDS Res Ther] 2021 Nov 01; Vol. 18 (1), pp. 80. Date of Electronic Publication: 2021 Nov 01.
DOI: 10.1186/s12981-021-00402-7
Abstrakt: Background: The efficacy and tolerability of an antiretroviral regimen are important considerations for selection of HIV-1 infection maintenance therapy. Abacavir/lamivudine plus rilpivirine (ABC/3TC + RPV) has been shown in international studies to be effective and well-tolerated in virologically suppressed individuals. This study evaluated the effectiveness and safety of switching to ABC/3TC + RPV as maintenance therapy in virologically suppressed HIV-1 infected individuals in Singapore.
Methods: In this retrospective, single-centre study, we included individuals who were prescribed ABC/3TC + RPV, had HIV-1 viral load (VL) < 50 copies/ml immediately pre-switch, and had no documented history of resistance mutations or virologic failure to any of the components. The follow-up period was 48 ± 12 weeks. The primary outcome was the proportion of individuals who maintained virologic suppression of HIV-1 VL < 50 copies/ml at the end of follow-up period based on on-treatment analysis. The secondary outcomes were the resistance profiles associated with virologic failure, changes in immunologic and metabolic parameters, and the safety profile of ABC/3TC + RPV.
Results: A total of 222 individuals were included in the study. The primary outcome was achieved in 197 individuals [88.8%, 95% confidence interval: 83.7-92.4%]. There were 21 individuals (9.5%) who discontinued treatment for non-virologic reasons. The remaining 4 individuals experienced virologic failure, of whom, 3 of these individuals had developed emergent antiretroviral resistance and had HIV-1 VL > 500 copies/ml at the end of the 48 ± 12 weeks follow-up period. The remaining individual experienced sustained low level viremia and subsequently achieved viral suppression without undergoing resistance testing. A total of 49 adverse events were observed in 31 out of 222 individuals (14.0%), which led to 13 individuals discontinuing therapy. Neuropsychiatric adverse events were most commonly observed (53.1%). A statistically significant increase in CD4 was observed (p < 0.01), with a median absolute change of 31 cells/uL (interquartile range: - 31.50 to 140.75). No significant changes in lipid profiles were detected.
Conclusion: ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore.
(© 2021. The Author(s).)
Databáze: MEDLINE