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AIDS is a deadly infectious disease caused by the human immunodeficiency virus (HIV)
.
HIV mainly attacks CD4+ T lymphocytes.
As a result, the body's immune mechanism has suffered severe trauma.
Pathological manifestations such as progressive decrease in the number of lymphocytes, impaired cell function, and abnormal activation of the immune system are endless
.
In addition, HIV is very cunning.
It can copy its own genetic code and integrate it into the human genetic code.
In this process, virus mutation will occur, which can be said to be very difficult to deal with
.
Image source: "Elite controllers" in the course of UNAIDS fight against AIDS.
Since AIDS was first recorded in human history in 1981, there have also been a handful of "chosen sons" in the 40-year history of fighting AIDS.
They are called "elite controllers" in academic circles.
"Their immune system can suppress the HIV virus without the need for drugs.
Although these people still have a virus reservoir that can produce more HIV, the immune cell-killing T cells in their body can suppress and kill the virus, thus making They do not need medication
.
At present, the most well-known "elite controllers" include three people: the "San Francisco patient" who healed without treatment, the "Berlin patient" and the "London patient" who recovered after treatment
.
Among them, the "San Francisco patient" is considered to be the world's first patient who can heal itself without treatment.
The research team of Professor YuXu of the Massachusetts Institute of Technology put the results of the study as "Distinct viral reservoirs inindividuals with" on August 26, 2020.
"spontaneous control of HIV-1" was published in the top international issue of "Nature".
In this study, the San Francisco patient had never been treated with antiretroviral drugs during more than 23 years of follow-up.
When 1.
5 billion peripheral blood mononuclear cells were tested, no complete HIV virus sequence was found.
His immune system completely eliminated the HIV virus reservoir in the body
.
The "Berlin patients" and "London patients" were accidentally cured of AIDS because they received hematopoietic stem cell transplants from donors with deletion mutations in the CCR5 gene
.
Just recently, scientists once again turned their attention to "elite controllers.
" Research teams from the Lagan Institute, Massachusetts Institute of Technology, and Harvard University published a paper in "Annals of Internal Medicine", reporting the world’s second case.
HIV-infected persons who have achieved sterilizing cure after treatment are referred to as "Esperanza patients" and the research topic is "A Possible Sterilizing Cure of HIV-1 Infection Without Stem Cell Transplantation"
.
https://doi.
org/10.
7326/L21-0297 According to the research, the "Esperanza patient" was diagnosed with AIDS in 2013, only received 6 months of antiretroviral treatment when pregnant, and gave birth in 2020 The healthy baby did not continue to receive treatment
.
In this study, the researchers analyzed a large number of cells in their blood and tissues.
After analyzing a total of 1.
188 billion peripheral blood mononuclear cells and 503 million placental mononuclear cells, no complete HIV was detected.
The researchers believe that the virus sequence indicates that the patient’s immune system may have eliminated the HIV virus pool.
This self-healing is called scavenging cure or sterilization cure by scientists, and the immune mechanism needs to be further studied in detail
.
Where are we from curing HIV? Today, there have been two cases of self-healing of HIV patients and two cases of HIV patients who have recovered after treatment.
This also makes people start to re-examine AIDS.
Is it really an incurable disease? At present, more scientists are willing to treat AIDS as a chronic disease, and therapies for AIDS are undergoing innovation and research and development
.
Previously, antiretroviral therapy (ART) was considered to be a major means to slow down the AIDS epidemic under the current status of unsuccessful development of HIV prevention vaccines
.
However, due to lower drug compliance and the increasing rate of drug resistance, ART therapy seems to have reached a deadlock.
More long-term HIV therapies and combination therapies have given AIDS patients new hope
.
In early 2021, Cabenuva, developed by Janssen Pharmaceuticals, a subsidiary of the global pharmaceutical giant Johnson & Johnson, and ViiV Healthcare, a well-known AIDS treatment company, was approved by the U.
S.
Food and Drug Administration (FDA) to replace traditional antiretroviral solutions for the treatment of infections Adult patients with human immunodeficiency virus type 1 (HIV-1)
.
This is the first complete injection program approved by the FDA for adult HIV patients.
Patients only need to receive treatment once a month to achieve the effect of suppressing the virus
.
This is also a milestone in the history of HIV treatment, which means the birth of a new and more convenient treatment
.
Subsequently, the long-acting HIV therapy layout of well-known pharmaceutical companies such as Gilead and Merck has gradually become clear
.
In October of this year, Gilead and Merck announced that they will start a phase II clinical study to evaluate the weekly islatravir/lenacapavir oral combination therapy among HIV-infected patients who are virologically suppressed after antiretroviral therapy.
Effectiveness
.
Lenacapavir is Gilead’s potential first-of-its-kind research long-acting HIV-1 capsid inhibitor, and islatravir (MK-8591) is Merck’s research nucleoside reverse transcriptase translocation inhibitor, both of which have a long half-life.
And it has shown low-dose activity in independent clinical studies, which supports its development as an investigative combination of oral and injectable long-acting preparations, and its clinical efficacy needs further verification
.
Regarding the independent clinical study of lenacapavir, Gilead announced the additional results of its Phase 2/3 CAPELLA trial at the 2021 Retroviral and Opportunistic Infection Conference (CRIO)
.
The new mid-term efficacy results show that in a group of refractory patients with limited treatment options and unmet medical needs, lenacapavir was injected subcutaneously every 6 months to maintain a high virological inhibition rate within 26 weeks
.
In this analysis of the continuous maintenance period of CAPELLA, the combination of lenacapavir and the optimized background plan were evaluated.
From the first subcutaneous injection of lenacapavir to the 26th week, 73% (n=19/26) of the subjects were unable to achieve The detected viral load (<50 copies/mL)
.
In addition, new HIV combination therapies are also underway.
Also in October this year, Merck announced the combination of innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir and approved non-nucleoside reverse transcriptase inhibitor doravirine.
Therapy, two pivotal phase 3 trials in adult patients with HIV-1 infection yield positive top-line results
.
Both trials reached the primary efficacy endpoint.
At week 48, the doravirine/islatravir combination showed comparable antiviral efficacy regardless of whether it was compared with the ART therapy group or the BIC/FTC/TAF therapy group
.
To date, the safety and tolerability characteristics of doravirine/islatravir during the trial period are consistent with the previously reported Phase 2 studies
.
On the other hand, the treatment of AIDS in China has also created new breakthroughs.
On July 21, 2021, the real biological class 1 innovative drug Azivudine tablets was approved for the market, with nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptases.
Combination of inhibitors to treat adult HIV-1 infected patients with high viral load
.
Azivudine has also become the world's first anti-HIV dual-target marketed innovative drug
.
According to the comments given by the Food and Drug Administration at that time, "the listing of this variety provides a new treatment option for people infected with HIV-1
.
"
Azvudine is a novel nucleoside reverse transcriptase and accessory protein Vif inhibitor, which can selectively enter CD4 cells or CD14 cells in the peripheral blood mononuclear cells of HIV-1 target cells to inhibit HIV, HCV, The function of RNA virus replication such as EV71
.
In addition to the real biological azvudine, in the domestic oral anti-AIDS category 1 new drug, Aidi Pharmaceutical's Enovirin is also attracting attention
.
Ainovirin is a non-nucleoside reverse transcriptase inhibitor with a brand-new structure.
It is the first class 1 anti-AIDS new drug of Addie Pharmaceuticals and has been included in the national 13th Five-Year Plan for the creation of major new drugs
.
At present, according to the statistics of China Business Industry Research, the market size of anti-AIDS drugs in China has increased from 790 million yuan in 2013 to 2.
02 billion yuan in 2018.
It is estimated that the market will be close to 5 billion yuan in 2023.
The average compound growth rate is 18.
6%, and the market potential is huge
.
In the field of domestic anti-HIV therapeutic drugs, original imported products from Gilead, GlaxoSmithKline, Merck and other multinational pharmaceutical companies have long occupied the market
.
It was not until 2018 that Abvette for injection brought by Frontier Biotech was successfully launched, becoming the first long-acting new AIDS drug in China, and the domestic AIDS treatment field ushered in new changes
.
In terms of domestically produced oral anti-AIDS innovative drugs, Enovirin and Azivudine are leading the way
.
Other products include ACC008 from Aidi Pharmaceuticals, Sifuvirtide from Tianjin Fusu Biology, Seravino from Shanghai Institute of Materia Medica and Kunming Institute of Zoology, Hengrui Pharmaceutical SHR2150, etc.
Among them, ACC008 with the fastest progress will be launched this year.
The listing application has been submitted in China for half a year, and most of the other products are in the early clinical stage, and there is still a period of time before the listing
.
2021 seems to usher in a revolutionary era of HIV therapy.
Let us expect more therapies to bring surprises and hopes to patients, and we also expect that the distance between humans and the cure of AIDS will continue to shorten
.
In order to facilitate you to continue to receive our articles, you are welcome to set us as a "star" so that you can see our news in the future
.
End Reference: [1]Distinct viral reservoirs in individuals with spontaneous control of HIV-1[2]A Possible Sterilizing Cure of HIV-1 Infection Without Stem Cell Transplantation[3]https://mp.
weixin.
qq.
com/ s/LdZ3KJxR4gyjMQz1-W1yNw[4]https://mp.
weixin.
qq.
com/s/N_MRbprhwTEHAlujzoTe0w[5]https://mp.
weixin.
qq.
com/s/taVXpXhta4pTm1S6BDUbWg[6]https://www.
cn-healthcare.
com/articlewm/20210124/content-1183803.
html[7]https://
.
HIV mainly attacks CD4+ T lymphocytes.
As a result, the body's immune mechanism has suffered severe trauma.
Pathological manifestations such as progressive decrease in the number of lymphocytes, impaired cell function, and abnormal activation of the immune system are endless
.
In addition, HIV is very cunning.
It can copy its own genetic code and integrate it into the human genetic code.
In this process, virus mutation will occur, which can be said to be very difficult to deal with
.
Image source: "Elite controllers" in the course of UNAIDS fight against AIDS.
Since AIDS was first recorded in human history in 1981, there have also been a handful of "chosen sons" in the 40-year history of fighting AIDS.
They are called "elite controllers" in academic circles.
"Their immune system can suppress the HIV virus without the need for drugs.
Although these people still have a virus reservoir that can produce more HIV, the immune cell-killing T cells in their body can suppress and kill the virus, thus making They do not need medication
.
At present, the most well-known "elite controllers" include three people: the "San Francisco patient" who healed without treatment, the "Berlin patient" and the "London patient" who recovered after treatment
.
Among them, the "San Francisco patient" is considered to be the world's first patient who can heal itself without treatment.
The research team of Professor YuXu of the Massachusetts Institute of Technology put the results of the study as "Distinct viral reservoirs inindividuals with" on August 26, 2020.
"spontaneous control of HIV-1" was published in the top international issue of "Nature".
In this study, the San Francisco patient had never been treated with antiretroviral drugs during more than 23 years of follow-up.
When 1.
5 billion peripheral blood mononuclear cells were tested, no complete HIV virus sequence was found.
His immune system completely eliminated the HIV virus reservoir in the body
.
The "Berlin patients" and "London patients" were accidentally cured of AIDS because they received hematopoietic stem cell transplants from donors with deletion mutations in the CCR5 gene
.
Just recently, scientists once again turned their attention to "elite controllers.
" Research teams from the Lagan Institute, Massachusetts Institute of Technology, and Harvard University published a paper in "Annals of Internal Medicine", reporting the world’s second case.
HIV-infected persons who have achieved sterilizing cure after treatment are referred to as "Esperanza patients" and the research topic is "A Possible Sterilizing Cure of HIV-1 Infection Without Stem Cell Transplantation"
.
https://doi.
org/10.
7326/L21-0297 According to the research, the "Esperanza patient" was diagnosed with AIDS in 2013, only received 6 months of antiretroviral treatment when pregnant, and gave birth in 2020 The healthy baby did not continue to receive treatment
.
In this study, the researchers analyzed a large number of cells in their blood and tissues.
After analyzing a total of 1.
188 billion peripheral blood mononuclear cells and 503 million placental mononuclear cells, no complete HIV was detected.
The researchers believe that the virus sequence indicates that the patient’s immune system may have eliminated the HIV virus pool.
This self-healing is called scavenging cure or sterilization cure by scientists, and the immune mechanism needs to be further studied in detail
.
Where are we from curing HIV? Today, there have been two cases of self-healing of HIV patients and two cases of HIV patients who have recovered after treatment.
This also makes people start to re-examine AIDS.
Is it really an incurable disease? At present, more scientists are willing to treat AIDS as a chronic disease, and therapies for AIDS are undergoing innovation and research and development
.
Previously, antiretroviral therapy (ART) was considered to be a major means to slow down the AIDS epidemic under the current status of unsuccessful development of HIV prevention vaccines
.
However, due to lower drug compliance and the increasing rate of drug resistance, ART therapy seems to have reached a deadlock.
More long-term HIV therapies and combination therapies have given AIDS patients new hope
.
In early 2021, Cabenuva, developed by Janssen Pharmaceuticals, a subsidiary of the global pharmaceutical giant Johnson & Johnson, and ViiV Healthcare, a well-known AIDS treatment company, was approved by the U.
S.
Food and Drug Administration (FDA) to replace traditional antiretroviral solutions for the treatment of infections Adult patients with human immunodeficiency virus type 1 (HIV-1)
.
This is the first complete injection program approved by the FDA for adult HIV patients.
Patients only need to receive treatment once a month to achieve the effect of suppressing the virus
.
This is also a milestone in the history of HIV treatment, which means the birth of a new and more convenient treatment
.
Subsequently, the long-acting HIV therapy layout of well-known pharmaceutical companies such as Gilead and Merck has gradually become clear
.
In October of this year, Gilead and Merck announced that they will start a phase II clinical study to evaluate the weekly islatravir/lenacapavir oral combination therapy among HIV-infected patients who are virologically suppressed after antiretroviral therapy.
Effectiveness
.
Lenacapavir is Gilead’s potential first-of-its-kind research long-acting HIV-1 capsid inhibitor, and islatravir (MK-8591) is Merck’s research nucleoside reverse transcriptase translocation inhibitor, both of which have a long half-life.
And it has shown low-dose activity in independent clinical studies, which supports its development as an investigative combination of oral and injectable long-acting preparations, and its clinical efficacy needs further verification
.
Regarding the independent clinical study of lenacapavir, Gilead announced the additional results of its Phase 2/3 CAPELLA trial at the 2021 Retroviral and Opportunistic Infection Conference (CRIO)
.
The new mid-term efficacy results show that in a group of refractory patients with limited treatment options and unmet medical needs, lenacapavir was injected subcutaneously every 6 months to maintain a high virological inhibition rate within 26 weeks
.
In this analysis of the continuous maintenance period of CAPELLA, the combination of lenacapavir and the optimized background plan were evaluated.
From the first subcutaneous injection of lenacapavir to the 26th week, 73% (n=19/26) of the subjects were unable to achieve The detected viral load (<50 copies/mL)
.
In addition, new HIV combination therapies are also underway.
Also in October this year, Merck announced the combination of innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir and approved non-nucleoside reverse transcriptase inhibitor doravirine.
Therapy, two pivotal phase 3 trials in adult patients with HIV-1 infection yield positive top-line results
.
Both trials reached the primary efficacy endpoint.
At week 48, the doravirine/islatravir combination showed comparable antiviral efficacy regardless of whether it was compared with the ART therapy group or the BIC/FTC/TAF therapy group
.
To date, the safety and tolerability characteristics of doravirine/islatravir during the trial period are consistent with the previously reported Phase 2 studies
.
On the other hand, the treatment of AIDS in China has also created new breakthroughs.
On July 21, 2021, the real biological class 1 innovative drug Azivudine tablets was approved for the market, with nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptases.
Combination of inhibitors to treat adult HIV-1 infected patients with high viral load
.
Azivudine has also become the world's first anti-HIV dual-target marketed innovative drug
.
According to the comments given by the Food and Drug Administration at that time, "the listing of this variety provides a new treatment option for people infected with HIV-1
.
"
Azvudine is a novel nucleoside reverse transcriptase and accessory protein Vif inhibitor, which can selectively enter CD4 cells or CD14 cells in the peripheral blood mononuclear cells of HIV-1 target cells to inhibit HIV, HCV, The function of RNA virus replication such as EV71
.
In addition to the real biological azvudine, in the domestic oral anti-AIDS category 1 new drug, Aidi Pharmaceutical's Enovirin is also attracting attention
.
Ainovirin is a non-nucleoside reverse transcriptase inhibitor with a brand-new structure.
It is the first class 1 anti-AIDS new drug of Addie Pharmaceuticals and has been included in the national 13th Five-Year Plan for the creation of major new drugs
.
At present, according to the statistics of China Business Industry Research, the market size of anti-AIDS drugs in China has increased from 790 million yuan in 2013 to 2.
02 billion yuan in 2018.
It is estimated that the market will be close to 5 billion yuan in 2023.
The average compound growth rate is 18.
6%, and the market potential is huge
.
In the field of domestic anti-HIV therapeutic drugs, original imported products from Gilead, GlaxoSmithKline, Merck and other multinational pharmaceutical companies have long occupied the market
.
It was not until 2018 that Abvette for injection brought by Frontier Biotech was successfully launched, becoming the first long-acting new AIDS drug in China, and the domestic AIDS treatment field ushered in new changes
.
In terms of domestically produced oral anti-AIDS innovative drugs, Enovirin and Azivudine are leading the way
.
Other products include ACC008 from Aidi Pharmaceuticals, Sifuvirtide from Tianjin Fusu Biology, Seravino from Shanghai Institute of Materia Medica and Kunming Institute of Zoology, Hengrui Pharmaceutical SHR2150, etc.
Among them, ACC008 with the fastest progress will be launched this year.
The listing application has been submitted in China for half a year, and most of the other products are in the early clinical stage, and there is still a period of time before the listing
.
2021 seems to usher in a revolutionary era of HIV therapy.
Let us expect more therapies to bring surprises and hopes to patients, and we also expect that the distance between humans and the cure of AIDS will continue to shorten
.
In order to facilitate you to continue to receive our articles, you are welcome to set us as a "star" so that you can see our news in the future
.
End Reference: [1]Distinct viral reservoirs in individuals with spontaneous control of HIV-1[2]A Possible Sterilizing Cure of HIV-1 Infection Without Stem Cell Transplantation[3]https://mp.
weixin.
qq.
com/ s/LdZ3KJxR4gyjMQz1-W1yNw[4]https://mp.
weixin.
qq.
com/s/N_MRbprhwTEHAlujzoTe0w[5]https://mp.
weixin.
qq.
com/s/taVXpXhta4pTm1S6BDUbWg[6]https://www.
cn-healthcare.
com/articlewm/20210124/content-1183803.
html[7]https://
