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| Efficacy and safety of combination of two enzyme inhibitors in newly treated HIV patients |
| ZHANG Yiyao, MA Ping |
| Department of Infectious Diseases,Tianjin Second People's Hospital, Tianjin 300192, China |
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Abstract Objective To evaluate the efficacy and safety of albuvirtide therapy (ABT) combined with antiretroviral therapy (ART)in newly treated HIV patients. Methods A total of 163 patients with ART initiated in Tianjin Second People's Hospital from March 2021 to March 2022 were retrospectively analyzed and divided into compound monolithic integrase inhibitors (INSTIs) treatment group and the group of INSTIs combined with ABT. Virological inhibition, immune recovery, and safety were evaluated in the two groups of newly treated HIV patients treated with baseline age, sex, and CD4 count-matched combined monolithic integrase inhibitors (INSTIs) and ABT combined with combined INSTIs. Results A total of 57 patients with ABT plus INSTIs and 106 patients with INSTIs were included. The rate of virological inhibition in the combined treatment group was higher than that in the monotherapy group at week 4 and 12, but there was no significant difference (61.1% vs. 53.1% at week 4, P=0.618; 87.8% vs. 81.5% at 12 weeks, P=0.801), and virological inhibition rates were comparable between the two groups through 48 weeks of follow-up. CD4 count in the combination treatment group was higher than that in the monotherapy group at week 4 (median 358 vs. 194, P=0.042) and week 12 (median 331 vs. 249, P=0.044). CD4/CD8 ratios were also higher in the combined treatment group at week 4 (median 0.28 vs. 0.17, P=0.036) and week 12 (median 0.33 vs. 0.19, P=0.049) than in the monotherapy group, and CD4 counts were higher in both groups until 48 weeks of follow-up. There was no significant difference in CD4/CD8 ratio at each follow-up point. During 12 weeks of ABT treatment, only 1 patient developed mild atopic dermatitis, and no other adverse events occurred. Conclusions ABT combined with INSTIs is safe and well tolerated in patients with initial treatment of HIV, which can rapidly increase CD4 and decrease viral load within 12 weeks of treatment.
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Received: 15 January 2024
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| [1] |
Nachega J B, Musoke P, Kilmarx P H, et al. Global HIV control: is the glass half empty or half full? [J]. Lancet HIV,2023, 10(9): e617-e622.
|
| [2] |
Bekker L G. The HIV epidemic 40 years on [J]. Nat Rev Microbiol,2023, 21(12): 767-768.
|
| [3] |
Ford N, Ehrenkranz P, Jarvis J. Advanced HIV as a neglected disease [J]. N Engl J Med,2024, 390(6): 487-489.
|
| [4] |
He N. Research progress in the epidemiology of HIV/AIDS in China [J]. China CDC Wkly,2021, 3(48): 1022-1030.
|
| [5] |
Liu X J, Mcgoogan J M, Wu Z Y. Human immunodeficiency virus/acquired immunodeficiency syndrome prevalence, incidence, and mortality in China, 1990 to 2017: a secondary analysis of the global burden of disease study 2017 data [J]. Chin Med J (Engl),2021, 134(10): 1175-1180.
|
| [6] |
Smiley C L, Rebeiro P F, Cesar C, et al. Estimated life expectancy gains with antiretroviral therapy among adults with HIV in Latin America and the Caribbean: a multisite retrospective cohort study [J]. Lancet HIV,2021, 8(5): e266-e273.
|
| [7] |
Marcus J L, Leyden W A, Alexeeff S E, et al. Comparison of overall and comorbidity-free life expectancy between Insured adults with and without HIV infection, 2000-2016 [J]. JAMA Netw Open,2020, 3(6): e207954.
|
| [8] |
Collaborators G H. Global, regional, and national sex-specific burden and control of the HIV epidemic, 1990-2019, for 204 countries and territories: the global burden of diseases study 2019 [J]. Lancet HIV,2021, 8(10): e633-e651.
|
| [9] |
Agrahari V, Anderson S M, Peet M M, et al. Long-acting HIV pre-exposure prophylaxis (PrEP) approaches: recent advances, emerging technologies, and development challenges [J]. Expert Opin Drug Deliv,2022, 19(10): 1365-1380.
|
| [10] |
Azzman N, Gill MSA, HassanS S, et al. Pharmacological advances in anti-retroviral therapy for human immunodeficiency virus-1 infection: a comprehensive review [J]. Rev Med Virol,2024, 34(2): e2529.
|
| [11] |
Piscaglia M, Cossu M V, Passerini M, et al. Emerging drugs for the treatment of HIV/AIDS: a review of 2019/2020 phase II and III trials [J]. Expert Opin Emerg Drugs,2021, 26(3): 219-230.
|
| [12] |
Rana A I, Castillo-Mancilla J R, Tashima KT, et al. Advances in long-acting agents for the treatment of HIVinfection [J]. Drugs,2020, 80(6): 535-545.
|
| [13] |
Xie D, Yao C, Wang L, et al. An albumin-conjugated peptide exhibits potent anti-HIV activity and long in vivo half-life [J]. Antimicrob Agents Chemother,2010, 54(1): 191-196.
|
| [14] |
Chong H, Yao X, Zhang C, et al. Biophysical property and broad anti-HIV activity of albuvirtide, a 3-maleimimidopropionic acid-modified peptide fusion inhibitor [J]. PLoS One,2012, 7(3): e32599.
|
| [15] |
Xiao T, Cai Y, Chen B. HIV-1 entry and membrane fusion inhibitors [J]. Viruses,2021, 13(5).
|
| [16] |
Qin H, Yao C, Zhang W, et al. Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection [J]. Naunyn Schmiedebergs Arch Pharmacol,2024, 397(2): 913-922.
|
| [17] |
Su B, Yao C, Zhao Q X, et al. Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority talent study [J]. Chin Med J (Engl),2020, 133(24): 2919-2927.
|
| [18] |
Su B, Yao C, Zhao Q X, et al. Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority talent study [J]. J Infect,2022, 85(3): 334-363.
|
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2024, Vol. 35 
