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For medical professionals only
Provide an important reference
for jump-start ART's clinical practice in China, and watch the wonderful pop-up video!
Since zidovudine was approved for the treatment of human immunodeficiency virus (HIV) in 1987, antiretroviral therapy (ART) has been used for more than three decades, ART has saved the lives of large numbers of people living with HIV, and The understanding of the composition and timing of ART solutions is also constantly evolving
.
Early ART drugs were highly toxic, weighing the risks against the benefits, and at that time only infected patients with low CD4 cell counts were recommended to receive ART
.
With the accumulation of research evidence and the deepening of clinical understanding, the threshold of ART-initiated CD4 cells continues to increase
.
At present, it has become a general consensus in the field of HIV treatment that patients diagnosed with HIV should start ART immediately regardless of the level of CD4 cells [1,2], but there is no uniform recommendation for the specific time threshold of the timing of ART
.
Based on the findings of a systematic review and meta-analysis of three randomized controlled trials, 11 observational studies, and five qualitative studies [3], in 2017, the World Health Organization (WHO) issued guidelines for "rapid start ART", recommending rapid start ART (defined as within seven days of diagnosis) for all people with confirmed infection and same-day start of ART for those who are ready for treatment [4].
]
。
Multiple studies have demonstrated multiple benefits of rapid initiation of ART, including increasing the proportion of infected people initiating ART, shortening the time to reach virological suppression, increasing virological inhibition, improving treatment retention, reducing patient dropout, and reducing mortality, hence the European Clinical Society of AIDS (EACS) [5] and the US Department of Health and Human Services (DHHS) [6].
and other international guidelines have also recommended
rapid start ART.
The Guidelines for the Diagnosis and Treatment of AIDS in China (2021 Edition) also mentions for the first time that "people with conditions of infection may consider rapid initiation or start ART on the day of diagnosis" [7].
Several studies confirm the benefits of fast-starting ART [8-15].
Although rapid start ART has increasingly gained recognition in the field of HIV treatment, there is no uniform recommendation
for the specific time threshold for the timing of ART.
The clinical research evidence of rapid start ART in China is still relatively limited
.
of efaviren + lamivudine + tenofovir disoproxil fumarate (EFV+3TC+TDF) and bic teigravir/emtricitabine/tenofovir propofovir (B/F/TAF) regimens for rapid start-up.
The interim results of the study were presented on October 24 at the 30th International Congress on Drug Treatment for HIV Infection (HIVGlasgow 2022) with an oral presentation [16].
In this issue, we specially invited Professor Dai Lili from Beijing You'an Hospital affiliated to Capital Medical University to interpret
this research.
was started within 14 days after HIV diagnosis 。 Baseline HIV RNA, CD4 cell count, and CD4/CD8 ratios were comparable in both groups, with ART initiation times of 6 (3.
0-8.
0) days and 5 (2.
0-7.
0) days
, respectively.
The primary endpoint of the study was the proportion of participants who achieved virologic suppression (HIV RNA<50 copies/mL) 24 weeks after ART initiation, and secondary endpoints were viral load at 12, 24, 36, and 48 weeks, CD4 cell count, changes in body weight and lipids, and cohort retention, among others<b10>.
In terms of efficacy, intention-to-treat population (ITT) analysis showed that at 24 weeks, the virologic inhibition rates in the EFV+3TC+TDF group and the B/F/TAF group were 74.
7% and 93.
5% (p-< 0.
001), respectively, and the time to achieve virologic suppression was shorter<b10> in the B/F/TAF group.
Figure ITT analysis, virologic inhibition rate of EFV+3TC+TDF group and B/F/TAF group at 24 weeks
Figure Time to virologic suppression of participants with different baseline viral loads in the EFV+3TC+TDF and B/F/TAF groups
In terms of immune recovery, the CD4 cell count in the B/F/TAF group increased from 338.
3/μL at baseline to 476.
0/μL, and the median increase was greater than that in the EFV+3TC+TDF group (127.
5 vs.
91.
5/μL, p=0.
131).
In terms of safety, there was no significant difference in the incidence of total adverse events (AEs) between the two groups, but the incidence of AEs that may be related to the study drug was 13.
9% (15/108) in the B/F/TAF group, which was significantly lower than 31.
9% (29/91, p=0.
002) in the EFV+3TC+TDF group, and there were no AEs leading to discontinuation in the B/F/TAF group, compared with 6 cases (6.
6%, p=0.
008) in the EFV+3TC+TDF group
。
This study shows that among newly diagnosed adult HIV-infected patients, rapid initiation of B/F/TAF within 14 days after diagnosis has a higher rate of virologic inhibition, faster virological inhibition and better safety
than EFV+3TC+TDF.
The study will continue to be followed up to 48 weeks, and the results will be reported
further in future academic conferences.
This is the first pilot study on rapid start ART in China, which provides an important reference and reference
for the clinical practice of rapid start ART in China from the perspective of protocol selection and start-up time.
Rapid start of ART can not only improve the prognosis of HIV-infected patients, but also reduce the transmission of HIV, which is of great significance to China's HIV prevention and treatment, and will help promote the "four 95%" 2025 phased goals and the realization
of the 2030 ultimate goal of eliminating the HIV epidemic.
Past Highlights
1.
The Lancet HIV: An in-depth discussion of the benefits and risks of using HIV PrEP in HBV-infected patientsExpert review
2.
20 years of HIV ART changes! The data of more than 10,000 people in the United States reveals that the second-generation INSTI and TAF-containing programs are currently the mainstream
3.
Asian population data: conversion B/F/TAF can sustainably suppress the virus at a high level, safe and well tolerated!
with AI medical assistant "Xiaozhi"Welcome to "Jizhi Doctor"
References:
[1] Song A, Liu X, Huang X, et al.
From CD4-based initiation to treating all HIV-infected adults immediately: an evidence-based meta-analysis[J].
Frontiers in immunology, 2018, 9: 212.
[2] Ho Na.
New progress in AIDS epidemiology in China[J].
Chinese Journal of Disease Control and Prevention, 2021, 25(12): 1365-480.
[3] Ford N, Migone C, Calmy A, et al.
Benefits and risks of rapid initiation of antiretroviral therapy[J].
AIDS (London, England), 2018, 32(1): 17.
[4] World Health Organization.
Guidelines for the Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy.
Available at: Accessed: July 2017.
[5] EACS.
Guidelines for treatment of people living with HIV version 10.
1.
Available at: www.
eacsociety.
org/files/guidelines-10.
1_30032021_1.
pdf.
Accessed: October 2020.
[6] DHHS.
Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.
Available at: https://clinicalinfo.
hiv.
gov/sites/default/files/guidelines/documents/guidelines-adult-adolescent-arv.
pdf.
Accessed: January 2022.
[7] Hepatitis C Group, AIDS and Hepatitis C, Chinese Center for Disease Control and Prevention, Chinese Society for Infectious Diseases.
Guidelines for the diagnosis and treatment of HIV/AIDS in China (2021 edition)[J].
China AIDS Venereal Diseases, 2021, 27(11): 1182-1201.
[8] Girometti N, et al.
EACS 2019.
Basel, Switzerland.
PE33/4.
[9] Dijkstra M, et al.
IAS 2019.
Mexico City, Mexico.
Oral WEAB0101.
[10] Rosen S, Maskew M, Fox M P, et al.
Initiating antiretroviral therapy for HIV at a patient’s first clinic visit: the RapIT randomized controlled trial[J].
PLoS medicine, 2016, 13(5): e1002015.
[11] Koenig S P, Dorvil N, Dévieux J G, et al.
Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: a randomized unblinded trial[J].
PLoS medicine, 2017, 14(7): e1002357.
[12] Seekaew P, et al.
AIDS 2018.
Amsterdam, NL.
THAC0403.
[13] Zhao Y, Wu Z, McGoogan J M, et al.
Immediate antiretroviral therapy decreases mortality among patients with high CD4 counts in China: a nationwide, retrospective cohort study[J].
Clinical Infectious Diseases, 2018, 66(5): 727-734.
[14] Rosen S, et al.
AIDS 2018.
Amsterdam, NL.
PLBPEE0049.
[15] Maskew M, et al.
CROI 2018.
Boston, MA.
P1106.
[16] Shiyun Lv, et al.
HIV Glasgow 2022.
Oral abstract 024.
This information is for medical and scientific reference only and is not recommended for use in any manner inconsistent with the prescribed information approved in your country.
