Generic placeholder image

Current HIV Research

Editor-in-Chief

ISSN (Print): 1570-162X
ISSN (Online): 1873-4251

Research Article

Dolutegravir Plus Lamivudine as Initial Therapy for HIV-1 Infected and ARV-naïve Patients in West China, 24-Weeks Results of a Preliminary Real-world Study

Author(s): Xia Hui, Xinrong Gan, Qian Li and Wei Sun*

Volume 20, Issue 3, 2022

Published on: 09 June, 2022

Page: [222 - 227] Pages: 6

DOI: 10.2174/1570162X20666220514165728

Price: $65

Abstract

Introduction: This preliminary real-world study (RWS) was designed to evaluate the antiviral efficacy, safety, and feasibility of the 2-drug regimen (2DR), dolutegravir plus lamivudine as the initial antiretroviral therapy (ART) among antiretroviral (ARV)-naïve adults with HIV-1 in West China.

Methods: This RWS included the treatment of treatment-naïve adults applying 2DR of dolutegravir 50 mg once daily (QD) plus lamivudine 300mg QD with negative HBsAg from one single center of People’s Hospital of Chongqing Banan District in West China. Viral load (VL), CD4+ T-cell count, and laboratory indicators were collected at baseline; weeks 4, 12, and 24, and thereafter every 24 weeks up to 144 weeks. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at week 24.

Results: A total of 54 ART-naïve patients were treated with the 2-drug regimen of DTG plus 3TC and were enrolled in this study since April 1st, 2020. Twenty-one patients received 24-week VL tests at screening as required by inclusion criteria. Median HIV-1 RNA at entry was 95,700 copies/ mL (interquartile range (IQR): 28,300-310,000) and the median baseline CD4+ cell count was 249 per cubic millimetre(IQR: 118-310). At week 24, 15 (71.4%) of 21 participants achieved virological success, defined as HIV-1 RNA < 50 copies/mL, while 10 (90.9%) of 11 participants with a baseline HIV-1 RNA < 100,000 copies/mL achieved virological success compared with 5 (50%) of 10 participants with a baseline HIV-1 RNA ≥100,000 copies/mL [Relative Risk (RR) 1.818; 95% CI 1.018-1.927]. In participants with CD4+ cell counts ≥ 200 cells/mm3, 9 (75%) of 12 participants achieved virological success compared with 6 (66.7%) of 9 participants with baseline CD4+ cell count < 200 cells/mm3 achieved it (RR 1.124; 95% CI 0.641-1.970). No major tolerability/toxicity issues were observed.

Conclusion: This real-world study suggested that the 2-drug regimen of DTG plus 3TC could be considered as an alternative for ART-naïve patients in West China, especially with HIV-1 RNA less than 100,000 copies/mL at baseline, regarding the limits of viral load test frequency and the absence of HIV genotypic testing of viral resistance.

Keywords: HIV, integrase strand transfer inhibitor, dolutegravir plus lamivudine, 2-drug regimen, effectiveness, simplification.

Graphical Abstract
[1]
Trickey A, May MT, Vehreschild J-J, et al. Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: A collaborative analysis of cohort studies. Lancet HIV 2017; 4(8): e349-56.
[http://dx.doi.org/10.1016/S2352-3018(17)30066-8] [PMID: 28501495]
[2]
Scott LJ. Dolutegravir/lamivudine single-tablet regimen: A review in HIV-1 infection. Drugs 2020; 80(1): 61-72.
[http://dx.doi.org/10.1007/s40265-019-01247-1] [PMID: 31865558]
[3]
Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 Recommendations of the international antiviral society-USA panel. JAMA 2020; 324(16): 1651-69.
[http://dx.doi.org/10.1001/jama.2020.17025] [PMID: 33052386]
[4]
Cihlar T, Fordyce M. Current status and prospects of HIV treatment. Curr Opin Virol 2016; 18: 50-6.
[http://dx.doi.org/10.1016/j.coviro.2016.03.004] [PMID: 27023283]
[5]
Baril J-G, Angel JB, Gill MJ, et al. Dual therapy treatment strategies for the management of patients infected with HIV: A systematic review of current evidence in ARV-naive or ARV-experienced, virologically suppressed patients. PLoS One 2016; 11(2): e0148231.
[http://dx.doi.org/10.1371/journal.pone.0148231] [PMID: 26849060]
[6]
Cahn P, Andrade-Villanueva J, Arribas JR, et al. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lop-inavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naive adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis 2014; 14(7): 572-80.
[http://dx.doi.org/10.1016/S1473-3099(14)70736-4] [PMID: 24783988]
[7]
Cahn P, Madero JS, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naïve adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr 2020; 83(3): 310-8.
[http://dx.doi.org/10.1097/QAI.0000000000002275] [PMID: 31834000]
[8]
European AIDS Clinical Society. EACS guidelines version 10.0 November 2019 2019. Available from: http://eacso ciety.org (Accessed on 10 Dec 2019).
[9]
Taiwo BO, Zheng L, Stefanescu A, et al. ACTG A5353: A pilot study of dolutegravir plus lamivudine for initial treatment of human im-munodeficiency virus-1 (HIV-1)-infected participants with HIV-1 RNA <500 000 copies/mL. Clin Infect Dis 2018; 66(11): 1689-97.
[http://dx.doi.org/10.1093/cid/cix1083] [PMID: 29253097]
[10]
Ciccullo A, Baldin G, Cossu MV, et al. Dolutegravir plus lamivudine as first-line regimen in a multicenter cohort of HIV-1-infected pa-tients: Preliminary data from clinical practice. AIDS Res Hum Retroviruses 2020; 36(1): 4-5.
[http://dx.doi.org/10.1089/aid.2019.0147] [PMID: 31476877]
[11]
Rolle CP, Berhe M, Singh T, et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS 2021; 35(12): 1957-65.
[http://dx.doi.org/10.1097/QAD.0000000000002979] [PMID: 34115650]
[12]
Ritchwood TD, Bishu KG, Egede LE. Trends in healthcare expenditure among people living with HIV/AIDS in the United States: Evidence from 10 Years of nationally representative data. Int J Equity Health 2017; 16(1): 188.
[http://dx.doi.org/10.1186/s12939-017-0683-y] [PMID: 29078785]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy