There is not much differences in gut microbiota between patients with chronic 

A team, led by Pao-Yuan Huang, Division of Hepato-gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, evaluated the fecal microbiota before and after treatment with direct antiviral agents in patients with HCV infections.

Gut microbiology is linked to liver disease because of the gut-liver circulation through the gut microbial-liver axis. However, there is not much data on the effects of treatment for HCV on the gut microbiota.

In the prospective study, the investigators examined patients at the Kaohsiung Chung-Gung Memorial Hospital in Taiwan between December 2019 and November 2020. Each participant was diagnosed with chronic HCV and received DAA treatment.

The investigators collected fecal samples from each participant at baseline and 24 weeks following the end of treatment. They also collected fecal samples once from healthy control participants at baseline.

They determined the taxonomic composition of the gut microbiota using 16 S ribosomal RNA gene sequencing of stool samples.

The study included 60 patients with chronic HCV infections and 60 health control participants matched by age and gender.

Each patients achieved a sustained virologic response and alpha diversity was not significantly different between any of the groups.

The investigators found minor differences in the microbial community structure between the control group and the chronic HCV group (R = 0.0146; 

 = 0.098). They also found less significant differences between the chronic HCV group and the SVR24 group (R = -0.0139; 

There were also 3 phyla and 8 genera differentially abundant between the control group and the chronic HCV group.

“Individuals with CHC do not exhibit significant gut microbiota alterations and eradication of HCV by DAA is not associated with significant modification of the gut microbiota,” the authors wrote.

 have lower bacterial diversity in their gut microbiota, even when their liver disease is less severe.

A team of researchers in Japan wanted to know more about the gut microbiota of patients with HCV, and what effect, if any, progression of HCV had on gut bacteria.

Earlier research has shown that dysbiosis affects liver disease in a number of ways, including nonalcoholic fatty liver and nonalcoholic steatohepatitis.

To investigate the relationship, the researchers looked at fecal samples from 166 chronic HCV patients and compared those samples to samples from 23 healthy patients. Those samples were examined via analyzed using 16S ribosomal RNA gene sequencing.

Among the HCV-infected patients, researchers noted lower bacterial diversity compared to the healthy control patients. HCV patients’ gut microbiota showed a decrease in the order Clostridiales and an increase in Streptococcus and Lactobacillus. Even patients in the persistently normal serum alanine aminotransferase (PNALT) phase of the disease showed evidence of dysbiosis. Inoue said that suggests dysbiosis is a result of HCV, rather than a pre-existing factor.

Effects of direct anti-viral agents on the gut microbiota in patients with chronic hepatitis C

Journal of the Formosan Medical Association.

Articles

The investigators found minor differences in the microbial community structure between the control group and the chronic HCV group.

Chronic HCV Patients do not Have Significant Gut Microbiota Differences

Promising results from the first and largest clinical trial to date evaluating the effect of cannabinoids on sleep were 

 by Radicle Science. A majority of individuals who received one of the various cannabinoid products examined in the study experienced a significant improvement in sleep quality and duration. 

The impact of the cannabinoid products was compared to that of melatonin, which is the one of the most researched and frequently used non-prescription sleep aids. However, one of the prominent side effects of melatonin is grogginess, which was less prevalent with cannabinoid use. 

"With sleep issues impacting 50 to 70 million Americans, scientifically-validated research is needed more than ever on how to help improve rest. Sleep is among one of the most popular therapeutic usages for cannabinoids, and we're excited to have begun this groundbreaking work in researching formulations and dosages to discover those with greatest effect," Jeff Chen, MD, CEO and Co-Founder, Radicle Science said in a 

The "Radicle Discovery Sleep Study" used only products by Open Book Extracts (OBX), "an NSF- and ISO 9001-certified manufacturer and distributor known for the industry's most innovative and highest quality cannabinoid ingredients and finished wellness and self-care products," according to the 

The blinded, randomized, controlled clinical trial included 1800 individuals (56% women) in the US. After randomization, the study groups received one of the 5 cannabinoid products, and the control group received 5 mg of melatonin. All cannabinoid products contained CBD and some included cannabinol (CBN) and cannabichromene (CBC), which are rarer cannabinoids. One of the products was cannabinoids combined with 5 mg of melatonin.

Each day of the trial period, the individuals took their respective products and reported their usage, side effects, sleep quality and other health outcomes including pain and anxiety, over the coure of 4 weeks. 

Significant Improvements in Sleep Outcomes

Improvements in sleep quality, well-being, anxiety and pain were observed in each group. At onset, most individuals reported an effect within the first hour of taking the product with a similar effect shown in groups who received cannibinoids compared with those who received melatonin.

Of the individuals who took 5 mg of melatonin and those who took the melatonin combined with CBD and CBN, 71% demonstrated a significant improvement in sleep outcomes. For comparison, 69% of individuals taking a combination of CBD, CBN, and CBC, yielding significant improvements as well. 

The mean increase in sleep duration ranged from 34-76 minutes per night with no significant difference reported between products. A favorable safety profile was displayed by all products with mild adverse events and no significant differences in frequency. 

All cannabinoid groups reported a lower incidence of grogginess than the group that received only melatonin. And while a statistically significant difference wasn't indicated between the products, the statement acknowledged that the combination of CBD, CBN, and CBC was associated with the greatest proportion of individuals that reported a significant improvement in their pain and anxiety. 

"What's especially interesting is that cannabinoid formulations for sleep can also help people who also experience pain or anxiety. Instead of having to take several products to address their ailments, they may be able to take just one," Dave Neundorfer, CEO, OBX stated. 

A majority of individuals who received one of the various cannabinoid products experienced a significant improvement in sleep quality and duration. 

Cannabinoids Improve Sleep in the First and Largest Cannabinoid Clinical Trial

 conversation with Aaron Kowalski, PhD, CEO of JDRF on the introduction of the 

 Index, we discuss the actionable items surrounding the conversation on accessbility to care. 

Back in August of this year, the Inflation Reduction Act in the United States capped the prince of insulin at $35 for a month's supply for Medicare recipients. Kowalski and his organization advocated for the position with the diabetes caucus in Congress.  

However, he admitted his disappointment that the same protection did not extend to the private market and that in fact, it was egregious that members of Congress voted against this expansion. Kowalski added that they are cotniuing to push towards the private insurance market so "that people don't have to make the decision between paying rents and insulin." 

Kowalski further laid out a moving time line for US legislation to build upon the success off the Inflation reduction Act and generic insulins to make it to market, and what may need to be done regarding the current global state of affairs. 

"We have a signficant amount of work to do, because you have a number of countries out there who struggle with their populations getting acess to insulin and care," he said. 

Kowalski added that the T1D Index has provided a trustworthy numerator and denominator to better understand how many people are out there with T1D. Alongside the knowledge of the incidence, however, comes the need for greater change. 

"There's the change that's needed where we are not accepting that today is good enough," Kowalski said. "And it's not even close to good enough."

The first step would be increased access to insulin and care, because that's the contiuum needed for these patients to live, he said. Improvements in acess to glucose monitoring can make a difference for these patients. 

An effort to create policies that can bend the curve may save bad days for patients for T1D and even their lives. Kowalski added that ultimately, the goal is to walk away for the disease. 

"I believe if you can unite a global army of people with T1D, given the global problem that we're facing, we will get to cures faster," he said. "And I think that's the really interesting part of this puzzle is, can you create a virtuous cycle of driving improved care all the way through curative approaches, and make that all happen faster?" 

100 years after the discovery of insulin, the T1D Index may provide a foundational understanding of what steps need to be taken to both improve lives and reduce the incidence of T1D. 

Aaron Kowalski, PhD: Creating a Cycle of Improvement for Type 1 Diabetes 

, Aaron Kowalski, PhD, CEO of JDRF, mentioned that he loves discussing science with a type 1 connection. He was diagnosed with T1D at 13 years of age, one of six who have T1D in his family. 

Today, as the head of JDRF, he is working to leverage global data on T1D to both identify and implement interventions that may change the trajectory of T1D. 

While T1D was once considered fully fatal, the introduction of insulin over 100 years ago was able to help patients manage their disease. But, the condition still has no cure and rates of diagnoses are often misrepresented both in the United States and abroad.

 to discuss JDRF’s Type 1 Diabetes Index (T1D Index). The first-of-its-kind data simulation tool measures the human and public health impact of the T1D crisis, aiming to fill in gaps in data on its global incidence.

“100 years post advent of insulin, there are so many people still dying for lack of diabetes treatment,” he said. “To accelerate life changing breakthroughs, you've got to understand who will benefit and ultimately deliver benefits to them. We still have just incredible gaps in our understanding of who is out there with the disease, and particularly underserved populations, we know now that people aren't getting the care they deserve and need and that's unacceptable.”

The index included measures on “missing people” and “number of years lost,” each an estimate of how T1D has affected those living with the condition. The number of years lost is a measure of time lost due to ill-health, disability, or early death, while missing people is an estimate of the number of people who would still be alive today if they had not died early due to complications from T1D.

Kowalski once more discussed his own diagnosis in 1984, stating that the doctors informed him that his life would be shortened and he would deal with complications, including kidney, eye, and heart disease. The index revealed that this is still prevalent in the United States and globally, particularly in underserved parts of the world.

The data from the index on areas such as Africa suggest children are not living a decade with T1D, taking away decades of their lives. With the introduction of insulin and treatment for these underserved populations, Kowalski noted that they could restore decades of life for little amounts of money.

“If we could deliver that care to everybody, we could save many, many days of life for many, many people,” he said. “That’s what we're trying to quantify, because if you can do that, you can then measure it and demonstrate that interventions are cost effective and obviously societally incredibly impactful.” 

Those interventions may change the impact of the disease for millions of people with four key topics, including a timely diagnosis, access to insulin and blood glucose testing strips, pumps and continuous glucose monitors, and ultimately, emerging preventions and cures.

Kowalski explicitly discussed the accessibility to insulin, stating “there’s no question here, people can’t live without insulin”. He highlighted how one-quarter of T1D people ration their insulin because they cannot afford it, suggesting how higher health care costs directly translate into adverse events.

He indicated that his company is working on making generic insulin available at just above cost in the US and projects globally that are focused on providing both insulin and care.

“We see pathways to viable solutions in the US and globally that will ensure that there are pathways for people who need insulin to get it, to get it affordably, to not have to ration it, and to do much, much better,” Kowalski said.

With the launch of the T1D index, the global burden of the disease and its impact is better understood. Dr. Kowalski joins to dig deeper into its importance and his personal connection to T1D. 

Aaron Kowalski, PhD: Connecting the Dots with the Type 1 Diabetes Index 

A recent study found that treatment of moderate-to-severe 

 with tildrakizumab was effective up to 36 weeks in a real-world setting.

While several effective biological therapies have been developed to treat plaque psoriasis, few have shown to be well-tolerated. When tildrakizumab—a monoclonal antibody—was 

 in two phase 3 trials prior to this study, it was shown to be safe and effective.

This study, led by Alessio Gambardella, MD, and Gaetano Licata, MD, of the University of Campania Luigi Vanvitelli’s Department of Mental and Physical Health and Preventive Medicine, expanded upon these previous studies by allowing the treatment of patients with other comorbidities and varying other clinical characteristics.

“In this retrospective study we evaluated the efficacy of tildrakizumab in 30 patients with moderate to severe plaque [psoriasis] up to 36 weeks in a real-world setting,” Gambardella and colleagues wrote. “The majority of patients were currently employed, had little time to travel to a hospital and therefore suitable for treatment every 12 weeks.”

The investigators used a retrospective study of 30 total participants with moderate-to-severe plaque psoriasis (PsO). The study involved the participants being treated with 100 mg of tildrakizumab and then observed for 36 weeks in a real-world setting.

Most of the participants in the study were employed and, consequently, were only able to visit the hospital every 12 weeks. The primary exclusion criteria for the recruited participants was that they were required to have moderate-to-severe PsO, with body surface area involvement being ≥10%, a Physician's Global Assessment (PGA) score of ≥ 3, and a Psoriasis Area and Severity Index (PASI) score of ≥ 12.

Additionally, the participants had to have either failed to respond or have side effects or contraindications to a minimum of 2 conventional psoriasis treatments. The investigators treated the participants with 100 mg of tildrakizumab through subcutaneous injection at weeks 0, 4, and every 12 of the following weeks.

The investigators assessed the clinical efficacy of the treatment by using participants’ PASI scores at weeks 4, 12, 24, and 36. In addition, they used the PGA scores, Dermatology Life Quality Index (DLQI) scores, and Health-Related Quality of Life (HRQoL) scores.

The investigators found that participants’ PASI scores of less than 3 were reported following 12, 24, and 36 weeks in 86.7%, 100%, and 100% patients, respectively, treated with tildrakizumab. 

They also found that PASI scores substantially decreased from 17.6 ± 4.7 at baseline to 4.7 ± 4.7 and 1.1 ± 3.9 at 4 and 12 weeks, remaining less than 1 up to 36 weeks (

 < 0.001 versus baseline). Furthermore, PASI −75,–90, and −100 responses were achieved in 100%, 96.7%, and 60% of participants respectively at 36 weeks.

The research team reported that DLQI also decreased significantly from baseline (13.8 ± 2.9) to 3.6 ± 1.6 by 4 weeks, 1.4 ± 0.6 by 12 weeks, and 0 at weeks 24 and 36 (

Additionally, a multivariate regression demonstrated that tildrakizumab treatment’s effect on DLQI and PASI scores by 4 weeks was independent from the variables of gender, age, disease duration, BMI, previous biologic, or the existence of comorbidities.

“Tildrakizumab was found to be effective and safe in moderate-to-severe plaque PsO in real-life clinical practice up to 36 weeks,” they wrote. “This benefit was independent of other predictor variables, therefore allowing it to be administered to patients with a range of clinical characteristics (including previous biological treatment) and the presence of comorbidities.”

Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting

,” was published on Wiley Online Library.

Research suggests that tildrakizumab may be useful in real-life settings against moderate-to-severe plaque psoriasis.

Plaque Psoriasis Treated With Tildrakizumab Shown to be Effective in Real-World Settings

neovascular age-related macular degeneration (nAMD)

 had predominantly persistent intraretinal fluid (PP-IRF) through year 2 in the Comparison of Age-related Macular Degeneration Treatment Trials (CATT).

The data suggest PP-IRF through year 1 was associated with worse long-term visual acuity, but the relationship disappeared after adjustment for baseline predictors of visual acuity.

“Predominantly persistent intraretinal fluid through year 2 was independently associated with worse long-term visual acuity and scar development,” wrote study author Gui-shuang Ying, PhD, Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania.

The study investigators aimed to describe PP-IRF and its association with visual acuity and retinal anatomic findings at long-term follow-up in eyes treated with pro re nata (PRN) ranibizumab or bevacizumab for nAMD in the CATT trial.

The presence of intraretinal fluid on optical coherence tomography (OCT) scans were assessed at baseline and monthly follow-up visits by the Duke OCT Reading Center. The investigators further defined predominantly persistent IRF through week 12, year 1, and year 2 as the presence of IRF at the baseline and in ≥80% of follow-up visits.

For eyes with baseline IRF, a comparison was performed between the mean visual acuity scores (letters) and changes from the baseline in eyes with and without PP-IRF. The adjusted mean visual acuity scores and changes from the baseline were calculated using linear regression analysis to account for baseline patient features identified as predictors of visual acuity in previous CATT studies.

The main outcomes were identified as PP-IRF through week 12, year 1, and year 2 as well as visual acuity score and visual acuity changes, and scar development at year 2. Outcomes were adjusted for concomitant predominantly persistent subretinal fluid.

Of 363 eyes with baseline IRF included in the study, 108 (29.8%) had PP-IRF through year 1 and 95 (26.1%) had PP-IRF through year 2.

In a comparison of eyes with PP-IRF through year 1 to those without PP-IRF, the mean 1-year visual acuity score was 62.4 and 68.5, respectively (

 = .002) and 65.0 and 67.4, respectively (

Then, PP-IRF through year 2 was associated with worse adjusted 1-year mean visual acuity scores (64.8 vs. 69.2; 

 = .01) as well as worse adjusted 2-year mean VA scores (63.0 vs 68.3; 

Moreover, PP-IRF through year 2 was associated with a higher 2-year risk of scar development (adjusted hazard ratio, 1.49; 

The study, “Predominantly Persistent Intraretinal Fluid in the Comparison of Age-Related Macular Degeneration Treatments Trials,” was published in 

PP-IRF through year 2 was independently associated with worse long-term visual acuity and scar development. 

Predominantly Persistent IRF in nAMD Eyes Linked to Worse Long-Term Visual Acuity  

, diabetic macular edema (DME), and vein occlusion-related macular edema showed limited visual outcomes after anti-VEGF therapy for up to 5 years, according to a new retrospective analysis.

The findings suggest patients with nAMD were likely to lose visual acuity at both the 3- and 5-year mark.

David F. Williams, MD, MBA, Retina Consultants of Minnesota and the team of investigators assessed the clinical practice visual acuity outcomes in these patients populations using a retrospective analysis of the Vestrum Health Retina Database.

“Across all 4 disorders, the mean change in VA correlated with treatment intensity at 1, 3, and 5 years,” Williams wrote.

The population consisted of treatment-naive patients with nAMD, DME, branch retinal vein occlusion-related macular edema (BRVO-ME), or central retinal vein occlusion-related macular edema (CRVO-ME) who received anti-VEGF injections between 2014 and 2019 and had follow-up data for ≥12 months. Investigators analyzed data on age, sex, the number of anti-VEGF treatments, and visual acuity.

They identified the primary outcome measure as the mean visual acuity change up to 3 years (BRVO-ME and CRVO-ME) and 5 years (nAMD and DME).

At 1, 3, and 5 years, there were 67,666, 21,305, and 5208 eyes with nAMD, respectively. With each respective population, after a mean of 7.6, 19.5, and 32 injections, there was a mean change of +3.1, –0.2, and –2.2 letters, respectively.

At 1, 3, and 5 years, there were 40,832, 7,728, and 1192 eyes with DME, respectively. After a mean of 6.2, 15.4, and 26.0 injections for each year’s population, there was a mean change of +4.7, +3.3, and +3.1 letters, respectively.

Then, at 1 and 3 years, there were 12,451 and 3,027 eyes with BRVO-ME identified. After a mean of 7.1 and 18.2 injections, there was a mean change of +9.5 and +7.7 letters, respectively.

Moreover, at 1 and 3 years, they identified 9298 and 2264 eyes with CRVO-ME. After a mean of 7.3 and 18.8 injections, there was a mean change of +8.3 and +6.0 letters, respectively (

 <.01 for all visual acuity changes of >1 letter.

For all 4 conditions investigated, the mean visual acuity increased with the mean number of anti-VEGF injections, eyes with a baseline visual acuity of 20/40 or better tended to lose visual acuity, and eyes with progressively worse baseline visual acuity saw a progressively greater visual acuity gain at 3 years.

Better visual acuity in patients at baseline was indicated as being more vulnerable to vision loss, according to the study investigators.

The study, “Longer-Term anti-VEGF Therapy Outcomes in Neovascular Age-Related Macular Degeneration, DIabetic Macular Edema, and Vein Occlusion-Related Macular Edema: Clinical Outcomes in 130,247 Eyes,” was published in 

Patients with nAMD, DME, BRVO-ME, and CRVO-ME showed limited visual acuity outcomes in clinical practice. 

Mean Changes in Visual Acuity Linked to Anti-VEGF Treatment Intensity 

 (NAFLD) who are fatigued are at an increased risk of a number of negative outcomes, including cardiovascular disease, poor sleep, and mortality.

A team, led by Zobair M. Younossi, MD, Betty and Guy Beatty Center for Integrated Research, Inova Health System, determined the prevalence of fatigue and its association with all-cause mortality in patients with NAFLD.

Patients with NAFLD who have fatigue could have worsened health-related quality of life and higher rates of mortality.

In the study, the investigators looked at data on mortality from NHANES 2005-2010 (n = 5,429, mean age 47.1 years, 49.7% male, 69.9% white) and 2017-2018 (n = 3,830, mean age 48.3 years, 48.6% male, 62.3% white).

The investigators defined NAFLD by the fatty liver index for NHANES 2005-2010 and by transient elastography for NHANES 2017-2018. They also assessed fatigue using Patient Health Questionnaires.

In the 2005-2010 cohort, 37.6% of the patient population were diagnosed with NAFLD. In this group, fatigue was more common in the NAFLD group compared to non-NAFLD control participants (8.35% vs 6.0%; 

The numbers were similar in the later cohort.

Here, 36.9% of the patient population was diagnosed with NAFLD.

In this group, fatigue was more pronounced than the non-NAFLD control group (8.7% vs 6.2%).

NAFLD also resulted in a number of other negative outcomes, including sleep disturbance (34.0% vs 26.7%), cardiovascular disease (10.7% vs. 6.3%), significant hepatic fibrosis (liver stiffness > 8.0kPa, 17.9% vs 3.5%), and advanced hepatic fibrosis (> 13.1 kPa, 5.4% vs 0.9%) (all 

In addition and outside of a NAFLD diagnosis, the presence of depression (OR, 11.52, 95% CI, 4.45-29.80, 

<0.0001), cardiovascular disease (OR, 3.41, 95% CI, 1.02-11.34, 

= 0.0462), and sleep disturbance (OR, 2.00; 95% CI, 1.00-3.98; 

= 0.0491) were independently associated with fatigue.

On the other hand, good sleep quality (OR, 0.58; 95% CI, 0.35-0.96, 

After conducting a multivariable Cox model, the investigators found adults with NAFLD and fatigue had a 2.3-fold higher mortality rate than a cohort of patients with NAFLD without fatigue (HR, 2.31; 95% CI, 1.37-3.89; 

“Fatigue amongst those with NAFLD is associated with increased risk for mortality and is mainly driven by depression, sleep disturbance, and CVD,” the authors wrote. “These findings have important clinical implications.”

 data show the disease is increasing worldwide and remains especially high among men.

A team, led by Kiarash Riazi, MD, Division of Gastroenterology and Hepatology, Department of Medicine, Cumming School of Medicine, University of Calgary, examined the burden of NAFLD by estimating the temporal trends of worldwide prevalence and incidence.

In the systematic review and meta-analysis, the investigators searched various databases between inception and May 25, 2021 for observational cross-sectional or longitudinal studies in patient populations representative of the general adult population for which NAFLD was diagnosed using an imaging method in absence of excessive alcohol consumption and viral hepatitis.

Overall, the prevalence of NAFLD worldwide was 32.4% (95% CI, 29.9-34.9%). However, the prevalence of the disease has significantly increased over time, from 25.5% (95% CI, 20.1-31.0%) in or before 2005 to 37.8% (95% CI, 32.4-43.3%) in 2016 or later (

The prevalence of disease was also higher in men (39.7%; 95% CI, 36.6-42.8%) than it was in women (25.6%; 95% CI, 22.3-28.8) (

The Impact of Fatigue on Mortality of Patients with Non-alcoholic Fatty Liver Disease (NAFLD): Data from National Health and Nutrition Examination Survey (NHANES) 2005-2010 and 2017-2018

NAFLD resulted in a number of other negative outcomes, including sleep disturbance, cardiovascular disease, significant hepatic fibrosis, and advanced hepatic fibrosis. 

Higher Mortality Rate for NAFLD Patients With Fatigue

Data from a large randomized clinical trial that evaluated the use of high-flow oxygen as opposed to standard oxygen in patients with COVID-19 related respiratory failure demonstrated no significant difference between the 2 approaches in reducing mortality. 

Since the COVID-19 pandemic led to 6 million deaths worldwide as a result of hypoxemic respiratory failure, these findings follow a series of various studies that have evaluated supportive noninvasive oxygenation with the objective of avoiding intubation, including noninvasive ventialtion with pressure support, continous positive airway pressure, and high-flow nasal cannula oxygen, which was examined in this study. 

While several trials have indicated the use of high-flow oxygen decreased the risk of intubation, there's been no evidence demonstrating that this practice does not improve survival rates. Additionally, the conflicting evidence on the risks associated with intubation initiated a debate in the medical community regarding the benefit of utilizing high-flow oxygen for this population. 

Jean-Pierre Frat, MD, PhD, CHU de Poitiers, Médecine Intensive Réanimation, and a team of investigators performed the SOHO-COVID clinical analysis across 34 French intensive care units as an ancillary trial of the ongoing SOHO clinical study which included patients with acute hypoxemic respiratory failure regardless of the cause. Enrollment for this study occurred from January-December 2021, with March 5, 2022 serving as the final follow-up. 

All 711 participating patients included were experiencing respiratory failure due to COVID-19 with a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of 200 mm Hg or below. Randomization assigned 357 patients to receive high-flow oxygen treatment, and 354 to receive standard oxygen via a nonbreathing mask set at a 10-L/min minimun at initiation. 

In order to determine if high-flow oxygen could improve a patient's chances of survival, investigators set the primary outcome as mortality at day 28. A few of the 13 secondary outcomes included the proportion of patients requiring intubation, the number of ventilator-free days at day 28, mortality at day 90, mortality and length of stay in the ICU, as well as adverse events. 

High-Flow Oxygen Reduces Intubation, Not Mortality

In assessment of the primary endpoint, investigators reported mortality in 36/357 (10%) patients who received high-flow oxygen, and 40/354 (11%) patients who received standard oxygen, at day 28. The relationship failed to demonstrate a statistically significant benefit.

The group that received high-flow oxygen had a significantly lower intubation rate, however, the number of ventilator-free days reported at day 28 was not significant between the groups. Aside from the reduced intubation rate, none of the secondary outcomes yielded significant results, including length of stay and mortality in the ICU, and mortality throughout day 90.

Ventilator-associated pneumonia, the most common adverse event, occurred in 93/160 (58%) patients in the high-flow oxygen group and in 99/186 (53%) patients in the standard oxygen group.

"Among patients with respiratory failure due to COVID-19, high-flow nasal cannula oxygen, compared with standard oxygen therapy, did not significantly reduce 28-day mortality," investigators concluded.

Effect of High-Flow Nasal Cannula Oxygen vs Standard Oxygen Therapy on Mortality in Patients With Respiratory Failure Due to COVID-19: The SOHO-COVID Randomized Clinical Trial

Conflicting evidence on the risks associated with intubation in patients with COVID-19 initiated a debate in the medical community regarding the benefit of utilizing high-flow oxygen.

High-Flow Oxygen Fails to Reduce Mortality due to COVID-19 Respiratory Failure

, Patrick S. Walsh, MD, discussed his team’s research into the use of oseltamivir—a neuraminidase inhibitor—for pediatric patients with 

Walsh works as an assistant professor of Pediatrics at the Medical College of Wisconsin. He and David Schnadower, MD, MPH, with the Division of Emergency Medicine at Cincinnati Children’s Hospital Medical Center, led their team in a 

 in which they identified evidence of oseltamivir’s use as an antiviral drug treatment specifically for younger influenza patients.

The team’s research had determined that among their sample size, influenza patients treated early with oseltamivir were found to have lower hospital readmission rates, lower rates of in-hospital mortality, and hospital quicker lengths-of-stay (LOS).

“We developed interest in the project early on in my fellowship because we were, honestly, somewhat skeptical of the evidence behind the drug oseltamivir,” Walsh said. “We thought, given the lack of evidence, we could potentially look into it a little bit further and a few years later, here we are.”

Prior to Walsh’s research, there had not been a significant amount of data regarding the specific use of oseltamivir in pediatric patients, although it had become accepted as the primary antiviral drug treatment for influenza patients since its approval by the US Food and Drug Administration (FDA) in 1999.

“I think there’s a few different reasons,” Walsh explained. “One, there are randomized clinical trials from back when it was first becoming FDA-approved, kind of in the pre-H1N1 time. It’s not that the data doesn’t exist, but there’s maybe some debate on how strong the evidence is for treatment with the drug.”

Walsh went on to describe his beliefs on the reason for the study’s use of a larger database, as well as the lack of significant background information on pediatric patient oseltamivir-use.

“I do think there’s a lack of evidence in the pediatric, and really any inpatient population, and I think the reason is probably because it’s difficult to get enough patients with the outcomes of interest to truly compare, which is part of why we designed the study the way we did, with such a large database,” he said.

 aligned with longstanding recommendations for the antiviral treatment’s use by healthcare providers.

A discussion was held regarding research on the use of antivirals on younger influenza patients.

Patrick S. Walsh, MD: Pediatric Influenza Patients and Treatment With Oseltamivir

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