Recently, at the 51st Multidisciplinary Conference on Antimicrobial Pathogens and Chemotherapy held in Chicago, Merck announced the results of a clinical trial named REALMRK: In a single, ungrouped, open-group phase III trial, After 48 weeks of combined treatment for patients infected with HIV-1, the efficacy and tolerability of latilavir potassium tablets are similar to those of other phase III clinical trials. Data from this Phase III clinical trial include untreated HIV-infected adult patients, and HIV-1 infected adult patients who have received treatment but are ineffective or tolerant to current antiviral (ARV) therapy .
Latravavir potassium is currently the only integrase inhibitor approved for the treatment of HIV-1 infection and was used as part of a combination therapy to treat adults with HIV-1 infection who have not been treated and who have received treatment. Ratlavir Potassium inhibits HIV-1 DNA insertion into human DNA by integrase and has the ability to restrict virus replication and infect new cells, and its rapid antiviral activity has been demonstrated.
"The results of the REALMRK trial reflect the efficacy of latilavir combination therapy in different patient populations." Kathleen Squires, Director, Department of Infectious Diseases and Environmental Medicine, Thomas Jefferson School of Medicine, Thomas Jefferson University, and Chief Experimental Investigator Kathleen Squires Dr. pointed out that "in real life, the proportion of blacks and women infected with HIV is the highest."
Test plan
This Phase III clinical, multicenter, open-ended single-arm observation trial recruited a total of 209 adult patients infected with HIV-1, including adults who had not received treatment for HIV-1 (n=22), and had been infected with HIV-1. Patients who were treated but had no effect (n=98) and patients who were intolerant of current treatment (n=89). Among them, black patients accounted for 74.6% (156/209) and female patients accounted for 46.9% (98/209).
All patients received a combination of 400 mg lativavir potassium twice daily for 48 weeks. Other anti-HIV drugs in the combination therapy program are limited to approved, licensed drugs. Of the 209 patients enrolled in the trial, 3 were randomized but not treated. Patients participating in the trial came from North America, South America, the Caribbean, and South Africa.
The primary endpoint of this trial was the proportion of patients with a viral load below 50 copies/mL at week 48. The secondary end points included the proportion of patients with viral load levels below 400 copies/mL, the mean difference between CD4 cell counts and baseline, and viral load. The amount of change from baseline and the time at which the virological response was lost.
test results
According to the definition of treatment-related discontinuation that was ineffective, 11 patients who were randomized to treatment were excluded from the primary analysis because 48 weeks prior to treatment discontinued due to reasons unrelated to treatment.
The results of the study showed that after 48 weeks of combined therapy with latatevir potassium, in HIV-1-infected adult patients, 70.3% (137/195) of patients with HIV-1 viral load dropped to 50 copies/mL. Among them, 67.8% (61/90) of female patients and 72.4% (76/105) of male patients had viral load levels below 50 copies/mL, 67.6% (98/145) of black patients and 78.0% (39%). /50) The viral load level of non-black patients dropped below 50copies/mL.
The overall average CD4 cell count increase in patients was 111 cells/mm3 (95% CI) compared to baseline.
The overall rate of patients who received latilavir therapy was 14.8%. In women and men, the rates of arrest were 17.3% and 12.6%, respectively.
The trial found that 69.1% of female patients and 75.2% of male patients had clinical adverse events (AEs). In women and men, the incidence of drug-related clinical adverse events was 26.8% and 14.7%, respectively, and 3.1% of women and 0.9% of men stopped treatment due to clinical adverse events. 69.9% of black patients and 79.2% of non-black patients had clinical adverse events. The incidence of drug-related clinical adverse events was 21.6% in black patients and 17.0% in non-black patients. 2.6% of black patients stopped treatment due to clinical adverse events.
The common drug-related clinical adverse events that occurred in the trial (the proportion that occurred in all populations was greater than or equal to 2%) included abdominal stomach upset, diarrhea, nausea, vomiting, myalgia, and headache.
Extended reading
HIV refers to human immunodeficiency virus, which is divided into HIV-1 type and HIV-2 type. HIV-1 is the main HIV strain that is currently globally prevalent.
HIV-1 targets the most important T4 lymphoid tissue in the human immune system, destroys T4 lymphoid tissue in large numbers, and produces highly fatal internal failure. This virus is a life-long infection in the area, undermines people's immune balance, and makes the human body become a carrier of various diseases. HIV-1 itself does not cause any disease, but when the immune system is destroyed by HIV, the human body loses the chance of replicating immune cells due to its low resistance, thereby infecting other diseases and causing various compound infections to die.
Latravavir potassium is currently the only integrase inhibitor approved for the treatment of HIV-1 infection and was used as part of a combination therapy to treat adults with HIV-1 infection who have not been treated and who have received treatment. Ratlavir Potassium inhibits HIV-1 DNA insertion into human DNA by integrase and has the ability to restrict virus replication and infect new cells, and its rapid antiviral activity has been demonstrated.
"The results of the REALMRK trial reflect the efficacy of latilavir combination therapy in different patient populations." Kathleen Squires, Director, Department of Infectious Diseases and Environmental Medicine, Thomas Jefferson School of Medicine, Thomas Jefferson University, and Chief Experimental Investigator Kathleen Squires Dr. pointed out that "in real life, the proportion of blacks and women infected with HIV is the highest."
Test plan
This Phase III clinical, multicenter, open-ended single-arm observation trial recruited a total of 209 adult patients infected with HIV-1, including adults who had not received treatment for HIV-1 (n=22), and had been infected with HIV-1. Patients who were treated but had no effect (n=98) and patients who were intolerant of current treatment (n=89). Among them, black patients accounted for 74.6% (156/209) and female patients accounted for 46.9% (98/209).
All patients received a combination of 400 mg lativavir potassium twice daily for 48 weeks. Other anti-HIV drugs in the combination therapy program are limited to approved, licensed drugs. Of the 209 patients enrolled in the trial, 3 were randomized but not treated. Patients participating in the trial came from North America, South America, the Caribbean, and South Africa.
The primary endpoint of this trial was the proportion of patients with a viral load below 50 copies/mL at week 48. The secondary end points included the proportion of patients with viral load levels below 400 copies/mL, the mean difference between CD4 cell counts and baseline, and viral load. The amount of change from baseline and the time at which the virological response was lost.
test results
According to the definition of treatment-related discontinuation that was ineffective, 11 patients who were randomized to treatment were excluded from the primary analysis because 48 weeks prior to treatment discontinued due to reasons unrelated to treatment.
The results of the study showed that after 48 weeks of combined therapy with latatevir potassium, in HIV-1-infected adult patients, 70.3% (137/195) of patients with HIV-1 viral load dropped to 50 copies/mL. Among them, 67.8% (61/90) of female patients and 72.4% (76/105) of male patients had viral load levels below 50 copies/mL, 67.6% (98/145) of black patients and 78.0% (39%). /50) The viral load level of non-black patients dropped below 50copies/mL.
The overall average CD4 cell count increase in patients was 111 cells/mm3 (95% CI) compared to baseline.
The overall rate of patients who received latilavir therapy was 14.8%. In women and men, the rates of arrest were 17.3% and 12.6%, respectively.
The trial found that 69.1% of female patients and 75.2% of male patients had clinical adverse events (AEs). In women and men, the incidence of drug-related clinical adverse events was 26.8% and 14.7%, respectively, and 3.1% of women and 0.9% of men stopped treatment due to clinical adverse events. 69.9% of black patients and 79.2% of non-black patients had clinical adverse events. The incidence of drug-related clinical adverse events was 21.6% in black patients and 17.0% in non-black patients. 2.6% of black patients stopped treatment due to clinical adverse events.
The common drug-related clinical adverse events that occurred in the trial (the proportion that occurred in all populations was greater than or equal to 2%) included abdominal stomach upset, diarrhea, nausea, vomiting, myalgia, and headache.
Extended reading
HIV refers to human immunodeficiency virus, which is divided into HIV-1 type and HIV-2 type. HIV-1 is the main HIV strain that is currently globally prevalent.
HIV-1 targets the most important T4 lymphoid tissue in the human immune system, destroys T4 lymphoid tissue in large numbers, and produces highly fatal internal failure. This virus is a life-long infection in the area, undermines people's immune balance, and makes the human body become a carrier of various diseases. HIV-1 itself does not cause any disease, but when the immune system is destroyed by HIV, the human body loses the chance of replicating immune cells due to its low resistance, thereby infecting other diseases and causing various compound infections to die.
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