A new trial testing fecal microbiota transplantation (FMT) as a treatment for recurrent 

 infections (CDI) was stopped early because FMT was significantly more effective treating the disease than placebo.

A team, led by Simon Mark Dahl Baunwall, MD, Department of Hepatology and Gastroenterology, Aarhus University Hospital, compared the efficacy and safety of FMT compared to placebo following treatment with vancomycin for a first or second C difficile infection.

In the randomized, double-blind, placebo-controlled trial (EarlyFMT) the investigators consecutively screened 86 patients at a university hospital in Aarhus, Denmark between June 21, 2021 and April 1, 2022. Of the 86 screened patients, 42 were included in the intention-to-treat final analysis.

Each patient was at least 18 years old with a first or second C difficile infection, defined as at least 3 watery stools per day and a positive C difficile PCR test.

Each patients was randomly assigned to either the FMT group (n = 21) or placebo (n = 21) administered on day 1 and between day 3-7, after they received 125 mg oral vancomycin 4 times daily for 10 days.

The investigators sought primary endpoints of the resolution of C difficile-associated diarrhea 8 weeks after treatment.

Each patient was followed up with for 8 weeks or until recurrence.

However, the trial was stopped following the interim analysis on April 7, 2022 for ethical reasons because a significantly lower rate of resolution was found in the placebo group compared to the FMT group (Haybittle-Peto boundary limit 

<0·001). The analysis shows 90% (n = 19; 95% CI, 70-99) of the FMT group and 33% (n = 7; 95% CI, 15-57) of the placebo group had a resolution of C difficile-associated diarrhea at week 8 (

There was an absolute risk reduction of 57% (95% CI, 33-81).

For safety, 204 adverse events were identified, with 1 or more adverse events reported in 20 patients in the FMT group and all 21 patients in the placebo group. The most common adverse events were diarrhea (n = 23 in the FMT group; n = 14 in the placebo group) and abdominal pain (n = 14 in the FMT group; n = 11 in the placebo group).

The investigators also identified 3 serious adverse events potentially related to the treatment (n = 1 in the FMT group; n = 2 in the placebo group). However, no deaths or colectomies during the 8-week follow-up occurred.

 infection, first-line fecal microbiota transplantation is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from 

Fecal microbiota transplantation for first or second Clostridioides difficile infection (EarlyFMT): a randomized, double-blind, placebo-controlled trial,

Articles

A significantly lower rate of C difficile resolution was found in the placebo group compared to the FMT group.

New FMT Trial Halted Due to Effectiveness

Nonpharmacologic interventions may be effective in improving 

 hygiene with medical and surgical patients, a recent study suggests.

 settings often report sleep difficulties, with many negative side effects associated. In addition to poor cognitive functioning and mental health, sleep inadequacies can affect fall risk, delayed healing from wounds, increased resistance to insulin, and immunosuppression.

Enhancement of sleep for hospital patients, consequently, was seen as necessary and relevant as a topic of research by this study’s investigators led by Eva S. van den Ende, MD, and Prabath W. B. Nanayakkara, MD, PhD, of Amsterdam UMC’s Department of Internal Medicine Section of Acute Medicine.

“Popular pharmacologic interventions to improve sleep are use of benzodiazepines and melatonin,” van den Ende and colleagues wrote. “However, there is insufficient evidence for the success of these medications in hospitalized patients. A systematic review and meta-analysis reported that the benefits often do not outweigh the risks of medication.”

As a result of these risks and the potential for negative outcomes, nonpharmacologic intervention was seen as an important subject of interest.

The investigators recruited 374 total patients for the nonrandomized trial, each included if they had been admitted to 1 of the 3 participating hospital wards, had spent one night in the hospital, and were 18 years or older.

The research team developed a sleep folder which contained an overview of sleep hygiene tips and tricks, as well as such tools as tea without caffeine, earplugs, aromatherapy oil, and response codes for soothing music, mindfulness, and audiotape-guided imagery. The researchers also provided training sessions for nurses on the importance of sleep and  quizzes were designed to test for knowledge post-session.

They also changed medication and vital sign checks to slightly later times. Patients were given a sleep registration bracelet, detecting motion in order to measure sleep. The patients would fill out questionnaires regarding their previous nights’ sleep, questioning prior to 11 a.m. to allow for maximum recall bias minimization.

The investigators measured participants’ sleep through actigraphy as well as the Dutch-Flemish Patient-Reported Outcomes Measurement Information System. In addition, further patient outcomes that were assessed were patient-reported sleep disturbance factors and their use of the provided sleep-enhancing tools.

The intervention group was 152 patients and the control was 222, with the median age being 65 years. In total, 331 participants were included in the overall assessment. For the intervention group, total sleep time was 40 minutes longer than that of the control group due to 30-minute wake time delays. However, sleep quality was not substantially different with either group.

The final wake time delays and postponement of nursing rounds in the morning were positively received by those working in the hospital, and they were maintained even following the study’s completion. The investigators found no significant differences in the nurses’ distribution of potential sleep-enhancing or sleep-disturbing medications.They recommend this change in time, citing its benefits to inpatient sleep and general simplicity.

The investigators also found that the primary factors disturbing sleep were reported as pain, ambient light and noise, bathroom visits, and staff waking the patients. They also found that of the sleep tools given, sleep masks and earplugs were the ones implemented the most (16% and 12%, respectively). Significant decreases in nightly vital sign checks were observed (intervention: 11%; control: 54%; 

“Future research could focus on whether more comfortable sleeping masks and earplugs would increase popularity and whether there are alternatives to attenuate external stimuli at the patient level without completely shutting the patient off from the outside world (such as a dome designed to reduce exposure to sound and light),” they wrote.

Evaluation of Nonpharmacologic Interventions and Sleep Outcomes in Hospitalized Medical and Surgical Patients/ A Nonrandomized Controlled Trial

A study from the Netherlands suggests steps to address patients’ sleep health.


Postponing Morning Rounds for Nurses May Lead to Sleep Improvement for Patients

Experiencing a nightmare is a common phenomenom, particularly among the general adolescent population. Various consequences have been linked to nightmares and can have a severe impact on 

, even leading to increased risk of suicide.

The experience has been characterized as dysphoric, frightening, or disturbing dreams that can inflict intense irritability and lead to 

. As the prevalence of nightmares experienced by an individual increases, so does their vulnerability for 

, daytime sleepiness, anxiety and depressive symptoms, post-traumatic stress disorder (PTSD), behavioral problems, and impaired psychosocial function.

While previous evidence has shown that adults with major depressive disorder (MDD), bipolar disorders, or schizphrenia encounter this dysphoric dream state more frequently than the general population, there's a lack of evidence when it comes to adolescents with MDD.

Insomnia, Nightmares & Depression in Adolescents

Investigators including Shuang-Jiang Zhou; Jing-Xu Chen, Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School,  aimed to amend the gap in literature regarding nightmare prevalence among adolescents with major depressive disorder. The team conducted a large-scalem cross-sectional investigation in outpatient centers at 4 large psychiatric hospitals in China from January-October 2021. 

Participating individuals were between the ages of 12-18 years old with a diagnosis of major depressive disorder according to the DSM-IV who were not receiving any treatment at the time of their depressive episode. Those with significant physical illness, another mental illness, substance abuse or dependency, were pregnant, or had undergone treatment with electroconvulsive therapy in that last month were excluded. The healthy control group was matched by gender and age with no personal or family history of mental illness.

The analysis measures consisted of insomnia, daytime sleepiness, nightmare frequency, nightmare distress, depression severity, anxiety severity, and suicide risk. 

The Relationship Between Nightmares & Suicide Risk

Findings revealed that the group with depression had a higher proportion of insomnia and suicide risk, as well as an increased frequency of nightmares compared with the control group.

Of the adolescents with depression, 67.5% experienced nightmares within the previous month, which was compared with 28.7% among the control group. On a weekly basis, the rate for the control group was 6%, while the rate among the adolescents with depression was 28.7%. Both sets of relationships were deemed statistically significant. 

A statistically significant association was identified between suicide risk and nightmare frequency. Suicide risk was present in 38.1% of the group with depression, and of that subpopulation, 51.6% experienced frequent nightmares which was a significantly higer rate than those without risk of suicide. 

Investigators also observed that the suicide risk was higher among adolescents in a recurrent depressive episode compared to those experiencing their first. Severe nightmare distress in those at risk for suicide (54.7%) was notable compared to those without suicide risk (24.3%).

"In conclusion, the current study, which included a large clinical population, provides evidence that nightmares occur frequently among adolescent patients with MDD," investigators wrote.

"Furthermore, the results of this study demonstrate that nightmare distress is independently associated with an increased risk of suicide. These findings may have important implications for further research on night-suicide mechanisms and for identifying individuals who are at a risk of suicide by asking about nightmare distress. Since nightmares are potentially modifiable, and the clinical efficacy of psychotherapy is well documented, intervention programs aimed at addressing nightmare-related distress may play an important role in preventing suicide among adolescents with MDD."

Nightmare Distress as a Risk Factor for Suicide Among Adolescents with Major Depressive Disorder

Various consequences have been linked to nightmares and can have a severe impact on mental health, even leading to increased risk of suicide.

Higher Risk of Suicide Observed in Adolescents Suffering from Nightmare Distress

Research suggests that acupuncture may be a useful treatment for those with 

In patients with PD, anxiety is associated with consistent worry, tension in muscles, a lack of concentration, and increases in tremors. Just over 30% of Parkinson’s patients report symptoms of anxiety, leading to patients having a generally diminished wellbeing.

Symptoms of anxiety are significantly associated with accelerated progression of Parkinson’s in PD patients. The study’s investigators, led by Li-xing Zhuang, PhD, and Jing-qi Fan, PhD, of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, investigated the topic due in part to the dearth of information on acupuncture’s efficacy for PD.

“Acupuncture aimed at alleviating anxiety has clinical effects with good compliance. Nevertheless, we could not find data to confirm acupuncture’s utility for anxiety in PD.,” Zhuang and colleagues wrote. “Thus, we conducted this double-blinded, clinical trial to investigate the effect of acupuncture for anxiety in PD.”

The investigators used a randomized, double-blind clinical trial, placing study participants into either an intervention or control group setting and having them receive clinical monitoring (CM). The intervention arm received real acupuncture (RA) and the control arm received what the researchers called ‘sham acupuncture’ (SA).

In total, 70 patients—34 women and 36 men—with Parkinson’s were recruited for the study, enrolling from June 2021 to February 2022. A total of 64 were able to complete the full intervention and 8-week follow up. PD patients were given either RA or SA for 8 weeks.

The investigators used the Hamilton Anxiety Scale (HAM-A) to score participants’ anxiety levels during the process. Their secondary endpoints included scores on the Unified Parkinson Disease Rating Scale (UPDRS) as well as the Parkinson Disease Questionnaire (PDQ-39). They also included adrenocorticotropic hormone (ACTH) and cortisol (CORT) blood serum levels measured by enzyme-linked immunosorbent assay (ELISA).

The research team calculated PD patients’ PDQ-39, HAM-A, and UPDRS scores at baseline, just after treatment, and then 8 weeks following treatment.

The investigators reported that the RA study arm had a mean HAM-A score reduction of 4.38 (95% CI, –5.12 to –3.63; 

 < .001) points at baseline and that compared to the SA arm, RA group participants did not have a significant HAM-A score reduction by the treatment’s completion (0.22 [95% CI, −0.63 to 1.07]; 

 = .62). Despite this fact, they noted that after the follow-up meeting, RA group participants reported a statistically significant 7.03 point HAM-A score decrease (95% CI, 6.18 to 7.88; 

 < .001) in comparison with the other group.

The research team also reported significant changes after the 8-week post treatment follow up for the secondary endpoints of the study. At the end of treatment, there was not a statistically significant change in PDQ-39 Emotional Well-Being (EW) and UPDRS scores, but after the follow up, the RA group difference was substantially distinct from that of the SA group (UPDRS I: 3.40 [95% CI, 2.36 to 4.45]; 

 < .001; PDQ-39-EW: 2.13 [95% CI, 1.15 to 3.10]; 

“To our knowledge, this is the first randomized clinical trial of the effectiveness of an acupuncture treatment regimen targeted for anxiety in patients with PD,” they wrote. “There was no significant variance in the degree of improvement between the RA and SA groups after acupuncture. However, we found that 2 months after the treatment, the improvement… of the participants in the RA group was better than that of those in the SA group.”

The investigators added that anxiety in PD patients saw clinical improvement after the 8-week follow up, suggesting that the placebo effect would have disappeared over that time if in fact it had affected those in the RA group.

Effectiveness of Acupuncture for Anxiety Among Patients With Parkinson Disease/ A Randomized Clinical Trial

A study in China found that Parkinson’s patients treated with acupuncture saw reduced anxiety levels.

Study Finds Acupuncture May Be Effective for Anxiety in Patients With Parkinson’s Disease 

New evidence from a Mount Sinai study suggested that consistent lack of 

 has negative effects on immune stem cells and increases the risk of inflammatory disorders and 

. And while it might be thought that a period of inadequate sleep can be amended by catching up on sleep, findings indicated that the cellular effects can’t be reversed.

This study is the first to demonstrate the relationship between sleep and DNA within the immune cells–particularly, that sleep alters the structure of this DNA. Consistently cutting sleep short, even for 90 minutes a night, can lead to increased vulnerability to disease and negative impacts.

“This is important because it is yet another key observation that sleep reduces inflammation and, conversely, that sleep interruption increases inflammation,” Filip Swirski, PhD, Director of the Cardiovascular Research Institute at Icahn Mount Sinai, and lead investigator, said in a 

. “This work emphasizes the importance of adults consistently sleeping seven to eight hours a day to help prevent inflammation and disease, especially for those with underlying medical conditions.”

Does 90 Minutes of Sleep Make a Difference?

Swirski and his team conducted the investigation by evaluating the immune cells of 14 healthy adults who regularly achieved 8 hours of sleep each night and assessed their sleep for a duration of 6 weeks. Investigators continued to analyze their immune cells for the following 6 weeks while participating individuals reduced their sleep duration by 90 minutes each week.

Upon comparison, the team discovered significant changes in the samples of immune cells collected from the periods of full sleep and restricted sleep. At the conclusion of the 12th week, an increased number of immune cells were present in blood samples, due to the lack of sleep.

“This study begins to identify the biological mechanisms that link sleep and immunological health over the long-term,” Swirski stated. “It shows that in humans and mice, disrupted sleep has a profound influence on the programming of immune cells and rate of their production, causing them to lose their protective effects and actually make infections worse—and these changes are long-lasting.”

Investigators also observed an altered DNA structure was present in each participating individual, suggesting that recovering lost sleep time is not able to completely reverse the impact that inadequate sleep has.

“Our findings suggest that sleep recovery is not able to fully reverse the effects of poor-quality sleep,” Cameron McAlpine, PhD, Assistant Professor of Medicine at Icahn Mount Sinai, and co-lead investigator, stated. “We can detect a molecular imprint of insufficient sleep in immune stem cells, even after weeks of recovery sleep. This molecular imprint can cause the cells to respond in inappropriate ways leading to inflammation and disease.”

“It was surprising to find that not all clusters of stem cells responded to insufficient sleep in the same way,” he continued. “There were some stem cell clusters that proliferated and grew in number, while other clusters became smaller. This reduction in overall diversity and aging of the immune stem cell population is an important contributor to inflammatory diseases and cardiovascular disease.”

Sleep exerts lasting effects on hematopoietic stem cell function and diversity

New evidence from a Mount Sinai study suggested that consistent lack of sleep has negative effects on immune stem cells and increases the risk of inflammatory disorders and heart disease.

Poor Sleep Causes Irreversible Negative Effects to Immune Cells, New Evidence Shows

New cross-sectional findings suggest rural counties in the United States had the highest overall 

 rate in comparison with other urbanization levels.

Subnational disparities, including a higher annual diabetes mortality rate (ADMR) in men in rural counties, those aged 25 to 54-years in all urbanization levels, and the rural Southern region, were observed by study investigators.

“Taken together, the results describe subnational trends in diabetes mortality, highlight persistent rural disparities, and identify areas for investigation and intervention.,” wrote study author Sagar B. Dugani, MD, PhD, MPH, Division of Hospital Internal Medicine, Division of Health Care Delivery Research, Kern Center for the Science of Health Care Delivery, Mayo Clinic.

The prevalence of diabetes and access to care can be impacted by factors including rurality and trends in mortality. Still, rural populations often have sparse information available on these trends, limiting the development of interventions to reduce death.

From 1990 to 2007, the age-standardized incidence rate of diabetes increased and then decreased through 2017. But, longitudinal trends on diabetes-related mortality are incompletely described and national trends may not reflect subnational trends.

In order to examine diabetes rates and trends, the US Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database was examined from January 1999 to December 2018.

Study investigators grouped mortality by region (Midwest, Northeast, South, or West), county urbanization (meto, medium-small, or rural), age group (25 - 54, 53 - 74, or ≥75 years), and gender (men or women) in 2-year groups.

They used weighted multiple linear regression models and jackknife resampling with a 3-segment time component. Models included exposures with up to 3-way interactions and were age-standardized to the 2009 - 2010 population. ADMR was calculated per 100,000 people.

The analysis was based on 4,022,238,309 person-years in adults 25 years or older, with diabetes being a multiple cause of death for 4,735,849 adults (annual mean, 117.7 deaths oer 100,000 people).

Increasing rurality was linked to a lower proportion of women and a higher proportion of adults 55 years or older. The overall population saw the ADMR was highest in rural areas compared with medium-small and metro counties.

Data suggest the ADMR in 2017-2018 vs 1999-2000 were highest and unchanged in rural counties (157.2 [95% CI, 150.7 - 163.7] vs 154.1 [95% CI, 148.2 - 160.1]; 

It was significantly lower in medium small counties (123.6 [95% CI, 119.6 - 127.6] vs 133.6 [95% CI, 128.4 - 138.8]; 

 = .003) and urban counties (92.9 [95% CI, 90.5 - 95.3] vs 109.7 [95% CI, 105.2 - 114.1]; 

Mortality rates were higher in men in rural counties in 2017 - 2018 compared with 1999-2000 (+18.2’ 95% CI, 14.3 - 22.1), but were unchanged in medium-small counties and significantly lower in metro counties.

Meanwhile, in 2017 - 2018 vs 1999-2000, the ADMR was significantly lower for women at all urbanization levels, but the smallest magnitude of decrease was seen in rural counties (-14.0; 95% CI, -17.7 to -10.3; 

Age was additionally a factor, as the ADMR was significantly higher in older age groups within all urbanization levels. The 25- to 54-year age group had the largest magnitude of increase in rural counties (+9.4’ 95% CI, 8.6 - 10.2) when compared with medium-small and metro counties.

Region-specific diabetes mortality by urbanization suggested the mortality rate in 2017-2018 versus 1999-2000 was higher only in the rural South (+13.8; 95% CI, 7.6 - 20.0; 

“Regional differences in the ADMR may be linked to differences in disease burden, with a higher age-adjusted prevalence of diabetes in the South, modifiable risk factors (eg, physical activity),environmental pollution, and race or ethnicity, among other factors,” Dugani added.

Assessment of Disparities in Diabetes Mortality in Adults in US Rural vs Nonrural Counties, 1999 - 2018

Diabetes mortality rates in 2017-2018 compared with 1999-2000 were highest and unchanged in rural counties. 

Persistent Disparities in Diabetes Mortality Observed in US Rural Counties 

Treatment of type 2 diabetes (T2D) with sodium-glucose cotransporter 2 (SGLT2) inhibitors may lead to lower risk for 

, compared with glucagon-like peptide-1 receptor agonists (GLP-1 RA).

The new data from a large clinical cohort study suggest a 22% lower risk of DED with SGLT2 inhibitor use, rather than GLP-1 RA use.

“Given that DED affects about one-fifth of patients with T2D and reduces the patients’ quality of life, our findings with the small absolute risk difference (2.5 per 1000 person-years) between SGLT2 inhibitors and GLP-1 RAs may provide an important reference for clinical decisions about prescribing different antidiabetic medications to delay or prevent DED in patients with T2D,” wrote study author Jia-Horung Hung, MD, Department of Ophthalmology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University.

Some newer drugs have been approved for treatment of DED by the US Food and Drug Administration in 2016 and 2021, yet the influence of antidiabetic drugs on the incidence of DED remains unknown.

As chronic inflammation is a large part of the pathophysiologic process of DED, anti-inflammatory benefits from SGLT2 inhibitors may lower its incidence. The retrospective cohort analysis of an electronic medical record database in Taiwan was conducted to identify patients with T2D newly receiving SGLT2 inhibitors or GLP-1 RAs from 2016 to 2018.

Investigators noted that GLP-1 RAs were chosen as the active comparator as they share similar pleiotropic effects with SGLT2 inhibitors. They defined the first data of use of either agent as the index date and the year before the index date as the baseline period.

The primary outcome was identified as the incidence of DED, with follow-up from index until occurrence of DED, last clinical visit, death, or end of the database in December 2021. The analysis included propensity scores based on logistic regression that included that baseline covariate, including age, sex, comorbidities, glucemic controls, and kidney function.

Hung and colleagues included a total of 10,038 patients with T2D newly receiving SGLT2 inhibitors and 1077 patients newly receiving GLP-1 RAs in the analysis. The SGLT2 group included 5689 men (56.7%) with a mean age of 59.5 years, while the GLP-1 RA group included 587 men (54.5%) with a mean age of 58.5 years.

After a mean follow-up of 3.9 years with 391 DED outcomes, investigators observed a difference in the DED incidence between the SGLT2 inhibitor (9.0 events per 1000 patient-years) and the GLP-1 RA (11.5 events per 1000 patient-years). This yielded a hazard ratio of 0.78 (95% confidence interval [CI], 0.68 - 0.89).

They added that they did not find any significant differences between the SGLT2 inhibitor and GLP-1 RA regarding hemoglobin (HbA1c), estimated glomerular filtration rate (eGFR), and urine albumin-creatinine ratio (UACR).

Moreover, subgroup analyses indicated that the lowered DED risks associated with SGLT2 inhibitor use were similar across different age, sex, blood glucose level, and kidney function groups as the main analysis.

The study, “Comparison of Sodium-Glucose Cotransporter 2 Inhibitors vs Glucagonlike Peptide-1 Receptor Agonists and Incidence of Dry Eye Disease in Patients with Type 2 Diabetes in Taiwan,” was published in 

The analysis suggests people with T2D newly receiving SGLT2 inhibitors may have lower risk for DED in comparison to those receiving GLP-1 RAs. 

SGLT2 Inhibitor Use May Lower Risk for Dry Eye Disease in People with T2D 

This article was originally published in 

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on September 22 to recommend a Biologics License Application (BLA) for RBX2660 (Rebyota) to treat recurrent 

The treatment, developed by Ferring Pharmaceuticals, is aimed at reducing recurrent CDI after antibiotic usage by being administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.

Are the available data adequate to support the effectiveness of REBYOTA to reduce the recurrence of 

 infection (CDI) in adults 18 years of age and older following antibiotic treatment for recurrent CDI?

Are the available data adequate to support the safety of REBYOTA when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI?

VRBPAC voted 13 to 4 in favor of the first question, and 12 to 4 in favor of the second, with 1 abstention.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic. It reduces the cycle of recurrent C diff infections by restoring the gut microbiome and inhibiting antibiotic-induced dysbiosis.

There are other treatments for patients with recurrent CDI, such as fecal microbiota transplantation (FMT). However, FMT is only recommended for patients with multiple recurrences who have also failed applicable antibiotic treatments. RBX2660 is intended to treat patients suffering from debilitating CDI, but who may not qualify for FMT.

CDI has a high rate of morbidity and mortality, in addition to draining health care resources. Approximately 500,000 Americans contract C diff each year, and 30,000 die from this highly resistant bacterium. This burden becomes greater and deadlier with each CDI recurrence.

The treatment was previously granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA. The treatment will be administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.

, proton pump inhibitors, previous CDI, health care exposure, age above 65 years, and comorbid conditions such as malignancy, kidney disease, inflammatory bowel disease, and immunosuppression.

RBX2660 is a standardized, stabilized, investigational microbiota-based live biotherapeutic. 

FDA Committee Recommends Approval for Live Microbiota C Difficile Medication

The risk of myocarditis for patients with HIV is not necessarily associated with a 

 (HCV) coinfection, but this risk does increase as the patient ages.

A team, led by Raynell Lang, MD, MSc, Department of Medicine, , University of Calgary, identified whether HCV coinfections increases the risk of type 1 myocardial infarction and if the risk differs by age.

Patients with HIV are often at an elevated risk of cardiovascular disease, but the impact of HCV coinfections is not yet understood. Some studies have found a 50-75% increased risk of cardiovascular disease in patients with HIV, compared to patients without HIV.

“The risk of CVD among people with hepatitis C virus (HCV) infection alone is not as consistent, with some studies demonstrating increased risk and others showing no association,” the authors wrote. “Because of shared transmission routes, HIV/HCV coinfection is common (10%–30%) globally. Less is known about CVD risk among PWH with HCV, particularly within an aging population on contemporary antiretroviral therapy (ART).”

In the study, the investigators used data from the NA‐ACCORD (North American AIDS Cohort Collaboration on Research and Design) from 2000-2017 for patients with HIV aged between 40-79 years who had initiated antiretroviral therapy. NA‐ACCORD is a collaboration of 29 clinical and interval cohorts from the US and Canada, and the North American region of the International epidemiology Databases to Evaluate AIDS.

The investigators sought primary outcomes of an adjudicated type 1 myocarditis event. Patients who started direct-acting HCV antivirals were censored at the time of initiation.

The team then calculated crude incidence rates per 1000 person-years for type 1 myocardial by calendar time. They also estimated adjusted hazard ratios and 95% confidence intervals for type 1 myocarditis using discrete time-to-event analyses with complementary log-logm models among patients with and without HCV.

Overall, 23,361 patients with HIV, 20% (n = 4677) had HCV. There were 89 (1.9%) patients with type 1 myocarditis had HIV and HCV coinfections and 314 (1.7%) of patients with HIV without HCV coinfections had type 1 myocarditis.

The results show HCV was not linked to an increased risk type 1 myocarditis in patients with HIV (aHR, 0.98; 95% CI, 0.74-1.30).

This risk also increased with age and was amplified in patients with HCV (aHR per 10-year increase in age, 1.85; 95% CI, 1.38-2.48) compared to patients without HCV (aHR per 10-year increase in age, 1.30; 95% CI, 1.13-1.50) (

“HCV coinfection was not significantly associated with increased [type 1 myocarditis infarction] risk; however, the risk of [type 1 myocarditis infarction] with increasing age was greater in those with HCV compared with those without, and HCV status should be considered when assessing CVD risk in aging [people with HIV],” the authors wrote.

Evaluating the Cardiovascular Risk in an Aging Population of People With HIV: The Impact of Hepatitis C Virus Coinfection

Journal of the American Heart Association

This risk also increased with age and was amplified in patients with HCV compared to patients without HCV.

Hepatitis C Not Significantly Associated With Myocarditis Risk for HIV Patients

, Professor of Pediatrics and Pathology, and Director of the Hemophilia and Coagulation Disorders Program, University of Michigan, discussed the impact of efanesoctocog alfa on patients with 

"We've had some tremendous innovation in this space, particularly for hemophilia A, over the last few years, we have had some other extended half life factory products, but none of them have achieved the kind of pharmacokinetics that we're observing with efa (efanesoctocog alfa)," he explained. 

The novel recombinant factor VIII therapy just 

 priority review status from the FDA at the end of the summer with a decision expected by February 28, 2023. The phase 3 clinical trial data was submitted by developing company Sanofi along with the Biologics License Application (BLA). 

Because efanesoctocog alfa is an intravenous therapy that would only require administration once per week, compared with 3 or more times per week, this candidate has the potential to improve treatment adherence, and subsequently, the control of bleeding events and overall patient health.

"The other thing that is important for this type of therapy is the spontaneity that will come back to patients lives," Pipe said. 

Those who live with the rare condition must regularly be monitoring their factor levels, even throughout the day, which contributes to almost every decision they make, he explained. Whether an individual is invited to a friend's for dinner or planning on participating in a family hike, their factor levels need to be within healthy range. 

"This type of therapy, maintaining levels for the majority of the week in the normal range is going to return a lot of that spontaneity to patients, and they won't have to think as much about where their plasma levels are at any given time," Pipe said.

He elaborated on the breakthrough potential of efanesoctocog alfa.

"We're really striving to take patients to higher and higher levels of, what we would call, health equity. We want our patients to live lives that they choose, reach the goals that they're shooting for, and to have a level of health equity that is similar to their unaffected peers. And I think this type of innovation is taking us one step closer closer to achieving all of those goals."

Videos

Dr. Steven Pipe talks about the profound effect the novel recombinant factor VIII candidate demonstrated in patients with hemophilia A. 

Efanesoctocog Alfa: The Breakthrough Hemophilia Therapy Candidate

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