Lancet made significant progress! New three-drug combination therapy COVID-19 is effective!

, June 9, 2020 /
PRNewswire/ -- According to a study conducted by six hospitals in Hong Kong, the first three-drugclinical trial involving 127 adult COVID-19 patientsA two-week antiviral therapy (interferon beta-1b-litonavir-libavirin) during a seven-day period of COVID-19 symptoms is safe and more effective than using Lopinavir-Litonove alonethe early major findings, published in the Lancet, do not include severe COVID-19 demission, and the authors stress the need for larger phase 3clinical trialstesttheefficienance of this three-drug strategy for treating PATIENTs with COVID-19the secondary results of the study showed that the use of three-drug combination therapy within 7 days of onbear symptoms showed significant clinical improvement and significantly reduced hospital stays compared to those who only used lopinavir-litonevirPhoto Source: Flu experience shows that the use of multiple antiviral drugs may be more effective than single drug treatment and minimize the risk of antiviral drug resistanceThe authors speculate that this may be a possible way to treat COVID-19, where viral loads also peak when symptoms appear"Our trials have shown that early use of a triple combination of antiviral drugs for mild to moderate COVID-19 may quickly suppress the number of viruses in patients, alleviate symptoms, and reduce the risk to health care workers, reducing the duration and number of virus transmissions (when the virus is detected and potentially contagious)In addition, this combination of treatments appears to be safe and patients are well tolerated," said Kwok-Yung Yuen, a professor at the University of Hong Kong who led the study"Despite these encouraging findings, we must demonstrate in larger Phase III trials that interferon-1b alone or in combination with other drugs is effective in patients with more severe conditions (more time for the virus to replicate),"continued"
previous studies have found that the combined use of lopinavir-litonevir (commonly used for HIV) and ribavirin , an oral hepatitis C virus drug, significantly reduced respiratory failure and death in SARS patients in 2003 Interferon beta-1b has been developed to treat multiple sclerosis (MS) and has been shown in animal studies of MerS coronavirus infection to reduce viral load and improve lung problems the open label study included 127 adults (with an average age of 52) who were laboratory-confirmed as SARS-CoV-2 infection in one of the six public hospitals between February 10 and March 20, 2020 In Hong Kong, all the people who tested positive for the new crown virus were taken to hospital Participants were randomly assigned to a 14-day three-drug group: Lopinavir-Litonavir (400 mg/100 mg) and ribavirin (400 mg) /12 hours, plus three injections of interferon beta-1b (8 million IU) (8 million IU) or every 12 hours alone using Lopina-Litonave (41, controlled cases) In the trial, all patients received standard care, including ventilation support, dialysis support, antibiotics
and corticosteroids The average number of days from the onset of symptoms to the start of the study treatment is 5 days during the study, the researchers observed the clinical process of symptoms, as well as changes in laboratory test results (such as blood tests, chest x-rays) and viral shedding, and regularly conducted molecular tests on viral loads in nasopharyngeal swabs, later mouth-swallowing saliva, throat swabs, feces, and urine At the beginning of the study, all participants' nasopharyngeal swabs were SARS-CoV-2 positive the main endpoint of is the time of the nasopharyngeal swab SARS-CoV-2 negative Secondary results include the time at which COVID-19 symptoms disappear, defined as a national early warning score (NEWS) of 0, a sequential organ failure assessment (SOFA) score of 0 indicating normal function, and a 30-day mortality rate and length of hospital stay three drug combination therapy within 7 days of the initial start of treatment effectively inhibited the viral load of nasopharyngeal swabs (no detection of the virus), significantly shorter than the control group using lopinavir-litonevir treatment alone (average 12 days) secondary results supported the study's findings, showing better clinical improvement in the combination of three drugs -- the three-drug combination halved the time it took to disappear symptoms (an average of 4 days vs 8 days), and the Time scored 0 by SOFA was also reduced (on average 3 days, 8 days) and the average length of hospital stay (9 days, 14.5 days) was also significantly reduced further secondary analysis also focuses on the timing of treatment and patient outcomes They found that 52 patients who started combination therapy (using interferon beta-1b) within 7 days of the onset of symptoms had better clinical and virological results than the control group (24 patients) who were treated at the same time However, in patients treated 7 days or more after the onset of symptoms, there was no difference between the combined treatment group and the control group (34 patients in the combined treatment group received lopinavir-litonarin and ribavirin treatment, but did not receive interferon beta-1b treatment, 17 patients in the control group) "These findings suggest that interferon beta-1b may be a key component of combination therapy and deserve further study of THE treatment of COVID-19," said Dr Jenny Lo of The University of Hong Kong Interferon is a naturally occurring protein that occurs when a virus is infected, and it is hoped that interferon beta-1b will improve the body's ability to fight SARS-CoV-2 Future phase 3 trials will soon confirm or refute the effectiveness of this candidate drug as a key treatment for COVID-19 "
picture source: No difference in adverse event rates between treatment groups (48%; 41/86 patients in joint group vs 49%; 20/41 control group), no serious adverse reactions In 1 case of the control group, patients had severe adverse liver function events and stopped treatment The most common adverse events are diarrhea, fever and nausea No patients died during the study period authors highlighted several limitations of the study, including an open-label study in which researchers and patients alike knew that participants received treatment without a placebo group They also noted that 34 patients in the combined treatment group were admitted to the hospital seven days or more after the onset of symptoms and did not receive interferon beta-1b treatment, but the findings could be confusing as part of the combined treatment group Dr Sarah Shalhoub, from the University of Western Canada, who was not involved in the study, wrote in a related commentary: "So far, most of the published studies have been retrospective or observational As a result, this forward-looking, randomized controlled design adds significant value to treatment and eliminates some of the limitations inherent in retrospective research continued: "This study points a way in finding much-needed SARS-CoV-2 therapies However, as the authors acknowledge, future studies will need to test the efficacy of interferon beta-1b alone or in combination with other drugs to diagnose the efficacy of severe or critical patients with a placebo " (BioValleyBioon.com) References: New triple antiviral drug combination early show for the treating COVID-19 in phase 2 random trial Ivan Fan-Ngai Hung et al.
Triple group of the snoison beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial.
The Lancet (2020) DOI: 10.1016/S0140-6736 (20)31042-4