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At the beginning of the new year, take stock of the top ten important research results in the field of AIDS cure in 2022

 Last Update: 2023-02-02
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Although there are currently four cured cases worldwide, their success is not universal.

As a result, the scientific community is still tirelessly searching for strategies
for a cure for AIDS.
In general, there are five main types of strategies that may be used for cure (or functional cure), namely ultra-early antiretroviral therapy (ART), gene modification or editing, "shock and kill", "block and lock" and immunotherapy, most of these strategies are currently in the laboratory stage, and some research strategies have begun clinical trials.
This article cleans up the results of the ten most influential clinical trials published in this field in 2022 as follows: 1.
Use broad-spectrum neutralizing antibody therapy + ART treatment model:

improve and maintain HIV-specific cellular immune response
Danish scientists have found that ART therapy followed by broad-spectrum neutralizing antibody therapy can improve and maintain HIV-specific cellular immune responses, and the results were published in Nature Communications
in October 2022.

The study randomized four groups of patients, namely ART alone, ART+3BNC117 (a monoclonal antibody targeting the HIV spike protein CD4 binding site), ART+RMD (Romidepsin, romedisin, histone deacetylase inhibitor), ART+3BNC117+RMD, and longitudinal follow-up detected HIV-specific CD8 in these patients T cell immune response
.
It was found that a sustained HIV-1 Gag and Pol-specific CD8 T cell immune response
could be observed in the group of patients treated with 3BNC117.

By comparing patients with baseline 3BNC117-sensitive and drug-resistant groups, it was found that this increase in immunological effect only occurred in the antibody-sensitive group, and Gag-specific CD8 T cell immune response was associated with
viral control after ART interruption.
One of the patients was able to maintain viral suppression below detection levels and maintain a high Gag-specific CD8 T cell immune response
4 years after discontinuation of treatment.

The study suggests that the combination of neutralizing antibody therapy after initiation of ART therapy can enhance HIV-specific cellular immune response, and the mechanism may be related to the activation of antigen-presenting cells after antigen-antibody complex formation, thereby enhancing HIV-1 antigen presentation to
T cells.

2.
A variety of anti-HIV-1 broad-spectrum neutralizing antibody combination therapy mode is used to prolong the suppression time
of the virus at Marina of Rockefeller University Caskey et al.
published in Nature in April 2022 the results
of a Phase I clinical trial using the anti-HIV broad-spectrum neutralizing antibody 3BNC117 (a monoclonal antibody targeting the CD4 binding site of the HIV spike protein) and 10-1074 (targeting the V3 loop).

This is an open-label, randomized Phase 1b clinical trial that included two groups of patients who had received ART to maintain viral suppression for more than 12 months, with a total of seven neutralizing antibody injections over a 20-week period, with the first three two weeks apart and the last four four weeks
apart.

The first group of patients discontinued ART 3 days after receiving the first antibody injection (enrollment, 18 patients), the other group received both ART and neutralizing antibody therapy (enrolled, 8 patients), and discontinued ART at week 26, and both groups were followed up to 48 weeks
.
Neither group was screened
for antibody sensitivity prior to enrollment.

The results showed that repeated injections of 3BNC117 and 10-1074 antibodies were generally safe and well tolerated
.
76% (13/17) of patients maintained viral suppression 20 weeks after discontinuation of ART therapy
.
When the concentration of one of the and antibodies in plasma is less than 10 μg/ml, maintaining viral suppression for greater than 20 weeks, the patient begins to experience viral rebound
.
Two of the patients who received 7 antibody injections maintained viral suppression
1 year after discontinuation of ART.
Reservoir analysis also showed that antibody therapy changed the size of the reservoir and the composition of the
intact proviral reservoir after 6 months.

3.
The combined use of two broad-spectrum neutralizing antibodies can maintain virological inhibition without rebound, making ATI possible
This study is also a clinical trial of BNC117 and 10-1074, two neutralizing antibodies, by Michael C of the NIH Sneller was published
in Nature in June.

The study consisted of two parts: the first was a randomized, double-blind, placebo-controlled clinical trial of patients starting ART in the early/acute phase of HIV, and the second part was an open-label, single-arm study that enrolled mainly patients
who could control viremia without ART.
Combined injections of 8 neutralizing antibodies
over 24 weeks.
All patients tolerated these drugs well and did not develop serious injection site-related adverse effects
.

If no antibody-resistant HIV was found at baseline compared with placebo, this combined neutralizing antibody therapy strategy can maintain complete virologic suppression for up to 43 weeks
after Analytical treatment interruption (ATI).
Similarly, if the baseline carries an antibody-sensitive strain, a potent antiviral inhibitory effect can be observed in people who have not been treated with ART
.

Studies suggest that intermittent combination therapy with two broad-spectrum neutralizing antibodies targeting different regions of the HIV Env protein can make it possible
for HIV-infected patients to maintain long-term viral suppression without ART.

4.
The vaccine can induce the production of HIV broad-spectrum neutralizing antibody progenitor cells, which can be used for HIV prevention and treatment
, and the production of broad-spectrum neutralizing antibodies by the vaccine can protect the human body from HIV infection, but the obstacle to the production of vaccine-induced neutralizing antibodies is that it is difficult to promote rare neutralizing antibody progenitor B cells
。 e OD-GT8 is a B-cell germline (germline) targeted initial immune candidate vaccine designed by William R.
Schief et al.
, aiming to target and stimulate VRC01 antibody to produce progenitor B cells
.
These cells are characterized by the use of heavy chains VH1-2*02/VH1-2*04 and can use any 5-amino acid CDR-L3
.

IAVI001 is the first Phase I clinical trial of e OD-GT8 in humans and is also a randomized, double-blind, placebo-controlled trial
。 The experimental vaccine was e OD-GT8 60 polymer nanoparticles supplemented with ASO1B adjuvant, and a total of 48 healthy adults were enrolled in the study, vaccinated twice eight weeks apart, and two dose groups were set up with 20μg e OD-GT8+50ug ASO1B adjuvant (N=18) and 100ug e OD-GT8+50μg ASO1B adjuvant (N=18), and the remaining 12 people were vaccinated with normal saline as a placebo control group
。 The researchers collected lymphocytes from the peripheral blood and lymphoid tissue, performed epitope-specific B cell sorting, BCR sequencing and bioinformation analysis, and isolated monoclonal antibodies and vaccine antigens for affinity analysis
.

The results showed that the overall safety of e OD-GT8 vaccine was well tolerated, and it could induce VRC01 B cell response in 97% (35/36) of vaccinated patients, VRC01 B cell response accounted for 0.
1% of the median frequency of IgG memory B cells in peripheral blood, and vaccine-induced Archaeopteryx B cells had multiple characteristics of neutralizing antibody lineage.
It has the potential to undergo high-frequency mutation and affinity maturation of somatic cells after enhanced inoculationForce
.

The results of this study, which have been published in Science, are also a clinical proof-of-concept for initial immunity of targeted germline vaccines, which will help to develop an immune-boosting strategy that produces broad-spectrum neutralizing antibodies such as VRC01 for the prevention and treatment
of HIV.
and supports the use of this strategy in vaccine design for HIV and other pathogens
.

5.
On the basis of very early treatment, combining antibodies and therapeutic vaccines to make patients long-term non-progression is an important research strategy
in the field of functional cure AELIX-002 is a randomized, placebo-controlled Phase I clinical trial (NTC03204671) from Spain that used HIVACAT T cell immunogen (HTI), a novel immunogen
that induces a highly effective HIV-specific T cell immune response to kill infected cells.

The primary objective of the study was to evaluate the safety of
HTI in DNA vector (DNA.
HTI), poxvirus vaccine vector (MVA.
HTI), and adenovirus vector (ChAdOx1.
HTI) in 45 patients (44 men, 1 female) who received antiviral therapy at an early stage.
The secondary objective of the study was to assess the immunogenicity of HTIs and the safety of intention-to-treat discontinuation therapy (ATI), the gold standard for evaluating functional cures, and the effects of
delaying viral rebound.
Most of the adverse events in the studies were mild and transient, and no serious adverse events
were observed.

HTI vaccination given to patients treated with early ART can induce a strong broad-spectrum multifunctional CD4 and CD8 T cell immune response
in patients 。 Patients who were given to stop antiviral drugs entered the ATI phase were found to have viral rebound in all patients during the 24-week ATI trial phase, but 40% of patients with therapeutic vaccination achieved a low-amplitude viral rebound (< 10,000 copies) that remained without antivirals, compared to only 8% in the placebo group, and plasma viral load at the end of ATI was positively correlated
with vaccine-induced HTI-specific T cell responses at ART discontinuation.

Although the vaccine did not prevent the virus from rebounding, the study suggests that the strong T-cell immune response induced by the HTI vaccine will hopefully achieve a functional cure
in combination with other healing strategies.

6.
Phase I clinical trial
on safety and immunogenicity of the innovative HIV vaccine Trimer4571 Trimer4571 (BG505DS-SOSIP.
664) is a stable Env trimeric protein vaccine before HIV fusion, and the most important HIV antigen in the field of HIV and the entire field of structure-based rational antigen design, its invention set off a revolution in the field of HIV vaccines, and also led to the discovery
of a series of neutralizing antibodies.
Therefore, it is important
to use Trimer4571 directly as the first clinical trial of an HIV vaccine.

NCT03783130 is a randomized, open-label, dose-escalation Phase I clinical trial
.
Sixteen healthy volunteers (6 males, 10 females) received an increasing dose of 100 or 500 mg Trimer4571 (500 mg aluminum as an adjuvant) by subcutaneous or intramuscular injection at 0, 7, and 20 weeks, and the overall safety and tolerability of the vaccine was good, and the main common adverse reaction was pain
at the vaccination site.
In 44% of the patients in the study, HIV-binding antibodies were positive, but all but one subject gradually turned negative
.
However, vaccine-induced binding antibodies cannot bind to other SOSIP epitopes, nor to gp120 or gp41, because the induced antibodies mainly bind to the base of the glycosylation site, suggesting that the vaccine-induced antibodies lack broad spectrum
.

The results of the study were published in June 2022 in the Lancet sub-journal eClinicalMedicine
.

7.
Gilead's blockbuster long-acting capsid inhibitor Lenacapavir is a
new drug from Gilead and another blockbuster drug for the treatment of HIV after integrase inhibitors
。 Lenacapavir is the first innovative drug to inhibit HIV-1 capsid function, which can inhibit viral replication
in the early and late stages of the viral life cycle by interfering with the nuclear uptake of capsid protein-mediated pre-integration complexes and impairing the production of virions.

In vitro studies have shown that Lenacapavir can produce antiviral effects against resistant virus strains resistant to major antiviral drug species, and in clinical studies of 1b, Lenacapavir showed potential antiviral effects
.
As a result, Lenacapavir is currently the most promising next-generation anti-HIV therapeutical
.
In this CAPELLA Phase 3 clinical study, a total of 72 patients with multidrug-resistant HIV-1 infection were enrolled in two cohorts
.

Queue 1 follows 2: 1 Patients were randomly assigned to either Lenacapavir or placebo for 14 days on the basis of the original failed ART, and from day 15, both groups received an optimized ART regimen, with Lenacapavir given subcutaneous injection of Lenacapavir every 6 months, and oral Lenacapavir sequentially administered subcutaneously Lenacapavir
in the placebo group.

All patients in cohort 2 received open-label optimized ART + Lenacapavir from oral to semi-annual
injection after 14 days.
The primary endpoint was the proportion of patients in cohort 1 with a viral load decrease greater than 0.
5l og₁₀copies/ml at 15 days; The secondary endpoint was the proportion of
patients in cohorts 1 and 2 with viral load less than 50 copies/ml at 26 weeks.

It was found that 88% (21/24) of patients receiving lenacapavir in Cohort 1 had a reduction in viral load of at least 0.
5l og1₀copies/ml after 14 days of treatment.
This compares with only 17% (2/12) in the placebo group, with an absolute difference of 71%
between the two groups.
After 26 weeks of treatment, 81% of patients in cohort 1 and 83% in cohort 2 achieved virological treatment success with viral load less than 50 copies/ml
.
Patients in cohorts 1 and 2 had a mean CD4 cell count rise of 75 and 104 cells/^m3
.
Studies found no adverse events
associated with treatment with lenacapavir.
During the maintenance phase, 8 patients developed decreased drug sensitivity, and 6 of them developed selective M66I mutations
.

At present, the results of this phase 3 clinical trial have been published in the international top journal NEJM, and the drug has also been approved for marketing
in the United States and Europe.

8.
Clinical research
based on adenovirus vector AAV8 delivery of broad-spectrum neutralizing antibodies, adenovirus vector-mediated broad-spectrum neutralizing antibody encoding DNA superplacement provides an alternative method for attempting to induce immune protection by vaccine or repeated injection of neutralizing antibody
。 In May, the first human Phase 1 study on AAV vector delivery expressing neutralizing antibodies was published
in Nature Medicine.

In this study, a recombinant double cis- and transverson-associated viral vector AAV8
encoding the ultra-broad-spectrum neutralizing antibody VRC07 was used on a total of 8 adult HIV-infected patients.
All participants maintained effective antiviral therapy (viral load < 50 copies/ml)
in this Phase 1 dose-escalation clinical trial.
AAV-VRC07 is administered
intramuscularly at 5×10 10, 5×10 ¹¹, and 2.
5×10 ¹² vector genomes/kg doses.

The primary endpoints were to evaluate the safety and tolerability of AAV-VRC07, the pharmacokinetics and immunogenicity of VRC07 production in vivo, and the immune response
against AAV8-VRC07 vectors and products.
Secondary endpoints were to assess the clinical effect of AAV8-VRC07 on CD4 cell count and viral load, and the persistence of
VRC07 production.

In the selected cohort, intramuscular injection of AAV8-VRC07 was safe and well tolerated
.
At 1 to 3 years of follow-up, CD4 cell count and viral load did not change
significantly.
In subjects receiving AAV8-VRC07, VRC07 concentrations increased significantly at 6 weeks and 52 weeks after intramuscular injection
.
All 8 subjects produced measurable serum VRC07, 3 of whom had a maximum VRC07 concentration greater than 1 ug/ml, and 4 subjects were able to maintain stable serum VRC07 concentration near maximum concentration at up to 3 years of follow-up
.
In exploratory analyses, the neutralizing activity of VRC07 generated in vivo was similar
to VRC07 generated in vitro.
Three out of eight participants developed an anti-drug antibody (ADA) response
against the VRC07 Fab fragment.
This ADA response appeared to reduce serum VRC07 concentrations
in two of the subjects.

These data conceptually demonstrate that adeno-associated viral vectors can permanently produce biologically active, difficult-to-induce, broad-spectrum neutralizing antibodies in vivo, providing a new strategy
for HIV prevention and treatment.

9.
Clinical study
NCT03041012 in the early combination of broad-spectrum neutralizing monoclonal antibody (3BNC117) and histone deacetylase inhibitor (Romidepsin) in patients infected with HIV acutely is an open-label, randomized controlled phase 1b/2a clinical trial, Conducted
in 5 hospitals in Denmark and 2 hospitals in the UK.
A total of 55 (5 women, 50 men) patients with early HIV infection who had just been diagnosed (antibody positive) were enrolled in the study, divided into four groups: ART only (15), ART+3BNC117(15), ART+RMD (13), ART+3BNC117+RMD (16).

The primary endpoints of the study were changes in the decay kinetics of initial viral load and CD4 T cell frequency containing intact proviruses from initiation of ART therapy to day 365
.
Secondary endpoints included changes in frequency of CD4 T cell infection and virus-specific CD8 T cells, sensitivity, safety, and tolerability of pre-ART plasma HIV-1 3BNC117, and time
to virological rebound after initiation of ATI at day 400.
All adverse events that occurred in the study were mild to moderate and similar
across groups.
Early 3BNC117 treatment with or without RMD significantly accelerates plasma HIV RNA decay rates
compared with ART alone.

In addition, 3BNC117 treatment accelerated clearance
of HIV-1 p24+ infected cells.
The frequency of CD4 T cells containing intact HIV-1 provirus was significantly reduced
in all patients, including controls.
After 365 days of treatment, HIV-1 Gag-specific CD8 T cells with 3BNC117+RMD were more immune than in the ART group
.
The virological and immunological effects observed above are more pronounced
in patients whose plasma HIV-1 Env sequence is sensitive to antibodies before ART.
During the 12-week ATI phase, patients with antibody-sensitive strains were more likely to maintain viral load without rebound
after receiving 3BNC711.

This study suggests that the use of 3BNC711 at the start of ART enhances clearance of plasma virus and infected cells, enhances HIV-1-specific CD8 T cell immune responses, and is associated with
virologic control in patients with 3BNC711-sensitive virus.
These findings strongly support the use of 3BNC711 for intervention at the start of ART as a therapeutic strategy to limit the long-term persistence of HIV-1, findings that have been published in
Nature Medicine.

10.
Clinical studies
using three broad-spectrum neutralizing antibodies in combination for the treatment of HIV-1 infection In this study, a total of 3 HIV-neutralizing antibodies were tested, including V2 glycosylated antibody PGDM1400, V3 glycosylated antibody PGTT121, CD4bs antibody VRC07-523LS.

The Phase 1 clinical trial tested three antibodies because, in many previous clinical trials, one or two neutralizing antibody treatments predisposed to the development
of HIV-resistant mutations.

The study was divided into two parts: Cohort 1 was a single-center, randomized, double-blind, placebo-controlled clinical trial involving a total of 24 healthy subjects for PK/PD testing, and it was also the first human trial of PGDM1400 alone or in combination with PGTT121; Cohort 2 was a multicenter, open-label study of five HIV-infected patients without ART on the combination of three monoclonal antibodies
, PGDM1400, PGTT121, and VRC07-523LS.
The primary endpoints were safety, tolerability, and pharmacokinetics in patients in two cohorts; Cohort 2 performed antiviral efficacy assessment, while monitoring CD4 T cell counts and 3 HIV-1 mutations
associated with antibody resistance.

The results showed that GDM1400 was safe and tolerated well whether used alone or in combination with PGTT121 and VRC07-523LS, and remained so
at a high dose of 30 mg/ml.
A single intravenous infusion of any of the three antibodies at 20 mg/kg reduced viral load by up to 2.
04log₁₀copies/ml
。 However, at a median of 20 days after the lowest viral load, all subjects experienced viral rebound, with rebound virus showing partial to complete resistance to GDM1400 and PGTT121 in vitro, while VRC07-523LS did not show significant resistance mutations
.
Despite the mean serum concentration of 93 μg/ml for VRC07-523LS, the virus rebounded
.
As a drug resistance exploratory study, the trial met a pre-set endpoint
.

The study suggests that HIV therapeutic antibody combinations may need to achieve broad-spectrum antiviral activity while maintaining high serum concentrations for effective virologic control, and the results have been published in Nature Medicine
.

epilogue

Although there is still no effective treatment strategy to achieve an HIV cure or a functional cure, the above clinical trial results give us a glimpse of a functional cure
.
In the future, it is highly likely that the goal of functional cure will be achieved through a combination of
strategies.

Author of this article

Peng Qiaoli

Deputy Chief Physician of AIDS Zone, Shenzhen Third People's Hospital
Ph.
D.
candidate at the University of Hong Kong
Visiting scholar at the AIDS Research Institute, Li Ka Shing Faculty of Medicine, The University of Hong Kong
He has rich research experience on AIDS and SARS-CoV-2
He has published more than 20 SCI papers in internationally renowned journals such as Nature Communications, CMI, eBioMedicine, and Science Advances
.

Mentor experts

Professor Lu Hongzhou

Shenzhen Third People's Hospital
Chief physician, second-level professor; Doctoral supervisor in internal medicine, public health management and nursing
Deputy Secretary of the Party Committee and President of Shenzhen Third People's Hospital; Academician of the American Academy of Microbiology, leader of the first public health expert group for epidemic prevention and control in Shenzhen; Minister of Education Jiang Scholar, National Millions of Talents Project, "young and middle-aged experts with outstanding contributions", enjoy the special allowance
of the State Council.
Selected into the list of the world's top 2% scientists in 2021 and 2022 and the "Lifetime Science Impact Ranking" of Stanford University

Academic appointments

Director of the World Health Organization Collaborating Center for Clinical Diagnosis and Treatment of Emerging Infectious Diseases
Member of the National Expert Committee for Disease Prevention and Control, expert of the National Health and Construction Commission Quality Control Center for AIDS, Influenza, Ebola Virus Disease and Infectious Diseases, and member of the rear support team of the National Expert Group for the Treatment of New Coronavirus Disease and the Overseas Anti-epidemic Expert Group
Vice President and Tuberculosis Group Leader of China STD AIDS Prevention and Control Association, Vice President of AIDS Professional Group of Infectious Diseases Branch of Chinese Medical Association, former Chairman of Tropical Diseases and Parasites Branch of Chinese Medical Association and leader of AIDS Group, Chairman of Infectious Diseases Branch of Physicians Association of European and American Alumni Association (China Association of Overseas Students), Chairman of Infectious Diseases Branch of Shanghai Medical Association

Scientific research

He has undertaken 54 scientific research projects such as national major science and technology projects (4 projects), "863", National Natural Science Foundation of China (7 projects), Gates Fund of the United States, and national key clinical specialties
As the first author or corresponding author, he has published more than 480 papers at home and abroad, including 300 papers in SCI journals including Nature and Science Translational Medicine, and has edited 14 professional reference books

Awards

He has won more than 10 national, provincial and ministerial scientific and technological achievement awards such as the French National Academy of Sciences: "Chabunker-Dubose" Award (2020), the National Science and Technology Special Prize, the first prize of Shanghai Scientific and Technological Achievements, and the first prize of Shanghai Medical Science and Technology, and obtained 7 patents; In 2022, he won the "People's Famous Doctor, Outstanding Achievements" award

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