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▎The content team editor of WuXi AppTec recently, Gilead Sciences announced at the 11th International AIDS Society (IAS) Conference that its long-acting HIV-1 capsid inhibitor lenacapavir is in the Phase 2/3 clinical trial The latest results obtained in CAPELLA
.
The results of the test showed that lenacapavir was injected subcutaneously every 6 months in combination with other antiretroviral drugs.
Among HIV-infected patients who developed resistance to multiple drugs, 81% (n=29/ 36) Subjects reached the standard of undetectable viral load (<50 copies/ml)
.
Lenacapavir is a potential "first-in-class" capsid inhibitor developed by Gilead Sciences.
It can interfere with the assembly and disassembly of the HIV virus capsid protein and play a role in multiple stages of the HIV-1 life cycle
.
Lenacapavir was granted a breakthrough therapy designation by the U.
S.
FDA in May 2019 and is used in combination with other antiretroviral drugs to treat patients with multiple drug resistance and severely treated HIV-1 infection
.
The advantage of Lenacapavir is that patients may only need to receive an injection every 6 months to maintain its effectiveness
.
However, it still needs to be combined with other daily antiretroviral drugs
.
Prior to this, Gilead has reached a cooperation agreement with Merck & Co.
(MSD) to jointly develop a complete long-acting HIV combination therapy based on lenacapavir and Merck’s innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir
.
At the end of June this year, Gilead has submitted a new drug application (NDA) for lenacapavir to the FDA
.
▲Introduction to Lenacapavir therapy (picture source: Gilead Sciences official website) After 81% of the CAPELLA test subjects reached an undetectable viral load level at the 26th week, the subjects' CD4-positive T cell technology increased by an average of 81 cells / Microliter
.
Previously published results showed that compared with baseline, patients treated with lenacapavir had a reduction in viral load of 1.
93 log10 copies/ml, which was significantly better than the placebo group (0.
29 log10 copies/ml)
.
At the same time, more patients achieved a viral load reduction of more than 0.
5 log10 copies/ml (88% vs.
17%, p<0.
0001)
.
In addition, Gilead also announced the Phase 2 clinical trial of lenacapavir orally or subcutaneously in combination with oral emtricitabine/tenofovir alafenamide (F/TAF) for the treatment of newly-treated HIV-1 infected patients.
The result
.
The results of the trial showed that this combination allowed 94% of newly-treated patients to obtain viral suppression at week 28
.
"Lenacapavir is a breakthrough innovation in HIV research
.
If approved, it may become the cornerstone of long-term HIV treatment in the future," said Frank Duff, head of the field of virology treatment at Gilead Sciences.
"Scientific progress is to help end the HIV epidemic.
The key to this
.
Our researchers are committed to addressing the unmet needs of people living with HIV
.
"Reference: [1] New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor.
Retrieved July 17, 2021, from https:// /20210717005010/en Note: The purpose of this article is to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.
.
The results of the test showed that lenacapavir was injected subcutaneously every 6 months in combination with other antiretroviral drugs.
Among HIV-infected patients who developed resistance to multiple drugs, 81% (n=29/ 36) Subjects reached the standard of undetectable viral load (<50 copies/ml)
.
Lenacapavir is a potential "first-in-class" capsid inhibitor developed by Gilead Sciences.
It can interfere with the assembly and disassembly of the HIV virus capsid protein and play a role in multiple stages of the HIV-1 life cycle
.
Lenacapavir was granted a breakthrough therapy designation by the U.
S.
FDA in May 2019 and is used in combination with other antiretroviral drugs to treat patients with multiple drug resistance and severely treated HIV-1 infection
.
The advantage of Lenacapavir is that patients may only need to receive an injection every 6 months to maintain its effectiveness
.
However, it still needs to be combined with other daily antiretroviral drugs
.
Prior to this, Gilead has reached a cooperation agreement with Merck & Co.
(MSD) to jointly develop a complete long-acting HIV combination therapy based on lenacapavir and Merck’s innovative nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir
.
At the end of June this year, Gilead has submitted a new drug application (NDA) for lenacapavir to the FDA
.
▲Introduction to Lenacapavir therapy (picture source: Gilead Sciences official website) After 81% of the CAPELLA test subjects reached an undetectable viral load level at the 26th week, the subjects' CD4-positive T cell technology increased by an average of 81 cells / Microliter
.
Previously published results showed that compared with baseline, patients treated with lenacapavir had a reduction in viral load of 1.
93 log10 copies/ml, which was significantly better than the placebo group (0.
29 log10 copies/ml)
.
At the same time, more patients achieved a viral load reduction of more than 0.
5 log10 copies/ml (88% vs.
17%, p<0.
0001)
.
In addition, Gilead also announced the Phase 2 clinical trial of lenacapavir orally or subcutaneously in combination with oral emtricitabine/tenofovir alafenamide (F/TAF) for the treatment of newly-treated HIV-1 infected patients.
The result
.
The results of the trial showed that this combination allowed 94% of newly-treated patients to obtain viral suppression at week 28
.
"Lenacapavir is a breakthrough innovation in HIV research
.
If approved, it may become the cornerstone of long-term HIV treatment in the future," said Frank Duff, head of the field of virology treatment at Gilead Sciences.
"Scientific progress is to help end the HIV epidemic.
The key to this
.
Our researchers are committed to addressing the unmet needs of people living with HIV
.
"Reference: [1] New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor.
Retrieved July 17, 2021, from https:// /20210717005010/en Note: The purpose of this article is to introduce the progress of medical and health research, not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital for treatment
.