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Interim President and CEO and Director of Arbutus Biopharma.

Arbutus CEO Michael McElhaugh discussed trial results showing that a combination of imdusiran, an RNAi therapeutic, and pegylated interferon alfa-2α can achieve a functional cure in chronic hepatitis B patients.

Imdusiran for Chronic Hepatitis B Achieves Functional Cure in 50% of Patients

Along with a 1 reported case in Massachusetts, the

New Hampshire Department of Health and Human Services (DHHS) has confirmed a person infected with eastern equine encephalitis (EEE) has died. The public health agency said the person was hospitalized due to severe central nervous system disease. The last reported human EEEV infection in New Hampshire was in 2014, when DHHS identified 3 human infections, including 2 fatalities. In the same statement, DHHS mentions there has been 1 confirmed case in Vermont this summer.

On August 16, the Massachusetts Department of Public Health (MDPH) released a statement discussing the confirmation of the first human case of EEE in the state this year. The confirmed case was discovered in an 80 year old man who was exposed to the vector borne disease in Worcester County. As a result, the risk level in the local communities of Douglas, Oxford, Sutton, and Webster has been raised to critical, and in Dudley, Northbridge, and Uxbridge the risk is increased to high.

Additionally, the neighboring communities of Auburn, Charlton, Grafton, Leicester, Mendon, Millbury, Millville, Southbridge, and Upton are now considered at moderate risk according to MDPH.

“This is the first time we have seen a person infected with EEE in Massachusetts since 2020,” Public Health Commissioner Robbie Goldstein, MD, PhD, said in a statement. “EEE is a rare but serious disease and a public health concern. We want to remind residents of the need to protect themselves from mosquito bites, especially in areas of the state where we are seeing EEE activity.

Though very rare, EEE is serious and a potentially fatal disease that can affect people of all ages. EEE is generally spread to humans through the bite of an infected mosquito. There were 12 human cases of EEE in Massachusetts in 2019 with 6 deaths, and 5 human cases with 1 death in 2020. There were no human cases of EEE in Massachusetts in 2021, 2022, or 2023.

EEE has a fatality rate of 33% to 70%, with most deaths occurring 2–10 days after the onset of symptoms.

In addition to a high mortality rate, long-term physical and mental complications, including permanent neurological deficits have been identified in many people who survive EEE.

Plymouth is approximately 40 miles south of Boston along the coast, and Worcester County is in the middle of the state, so the 2 areas are not in close proximity, but due to the elevated risk locally, the town of Plymouth decided to take action in response to outdoor parks. As of last Friday, all town public parks and fields are close daily from dusk until dawn.

“As Mass DPH has now elevated Plymouth’s EEE risk status to high, it is important to take extra precautions when outdoors and follow state and local health guidelines to avoid unnecessary risk to exposure to EEE. The health and safety of our community, residents, and visitors remain our priority,” Plymouth’s Commissioner of Health and Human Services, Michelle Bratti, said in a statement.

According to the Centers for Disease Control and Prevention (CDC) most people who are infected with the virus do not develop symptoms; however, for those that do, the date from the bite to the onset of the illness is 4 to 10 days. EEE can also result in fever or neurologic disease. The type of illness will depend on the age of the person and other factors. Those who are infected can develop meningitis.

There are no FDA-approved treatments for EEE and for patients who develop severe cases, they can be hospitalized to receive supportive treatment.

Over the weekend, MDPH detailed plans of spraying for mosquitos including aerially in areas of Plymouth County, and truck-mounted spraying in parts of Worcester County. As of Saturday, 10 communities in Massachusetts were raised to high or critical risk for EEE virus.

“The risk from EEE is high in parts of Plymouth County and critical in parts of Worcester County,” State Epidemiologist Catherine M. Brown, DVM, said in a statement. “In addition to recommending that people use mosquito repellent with an EPA-registered active ingredient and clothing to reduce exposed skin, we also recommend that evening outdoor events be rescheduled to avoid the hours between dusk and dawn. The mosquitoes most likely to spread EEE are most active during the dusk to dawn hours.”

There are preventative strategies to avoid EEE, and the MDPH has listed such measures 

For those who live in Massachusetts and want more information on EEE, it can be found 

 or by calling the DPH Division of Epidemiology at 617-983-6800.

1.NH DHHS Identifies Person Infected with Eastern Equine Encephalitis Virus in New Hampshire.The New Hampshire Department of Health and Human Services. August 27, 2024. Accessed August 28, 2024.
https://www.dhhs.nh.gov/news-and-media/nh-dhhs-identifies-person-infected-eastern-equine-encephalitis-virus-new-hampshire
2. State health officials announce season’s first human case of Eastern Equine Encephalitis in Massachusetts. MDPH. August 16, 2024. Accessed August 27, 2024.
https://www.mass.gov/news/state-health-officials-announce-seasons-first-human-case-of-eastern-equine-encephalitis-in-massachusetts
3.Plymouth to Close all Public Parks and Fields from Dusk to Dawn. Town of Plymouth. August 23, 2024. Accessed August 27, 2024. PDF.
4. Eastern Equine Encephalitis: Symptoms, Diagnosis, and Treatment. CDC. May 15, 2024. Accessed August 27, 2024.
https://www.cdc.gov/eastern-equine-encephalitis/symptoms-diagnosis-treatment/index.html
5. State officials announce plans to spray for mosquitoes in sections of Worcester and Plymouth counties due to EEE. MDPH. August 24, 2024. Accessed August 27, 2024. 
https://www.mass.gov/news/state-officials-announce-plans-to-spray-for-mosquitoes-in-sections-of-worcester-and-plymouth-counties-due-to-eee



The town of Plymouth decided to prohibit people from using the parks from dusk to dawn due to concerns over eastern equine encephalitis after a man contracted the rare disease in the state.

Concerns Over Mosquito-Borne Illness Causes Massachusetts Town to Create Curfew for Parks, Spraying in Counties

Sakoulas offered his insights for when he considers discharging patients and strategies to avoid readmission.

Considerations for  Discharge

 There has been data to demonstrate cefteroline response in community acquired bacterial pneumonia can be as early as 72 hours. What is the clinical significance of this and what does that mean for hospital discharge and the potential economic impact?

 The faster a patient improves, the sooner they can be discharged, potentially transitioning to an oral agent or even completing therapy altogether, depending on their circumstances. We’re now moving toward shorter therapy durations for straightforward community-acquired pneumonia, typically five to seven days. So, if a patient has already received three or four days of antibiotics in the hospital, they may not even need an oral antibiotic upon discharge. This minimizes exposure to additional medications.

Quick response time is critical, not only for discharge but also because patients who respond more rapidly tend to have a lower risk of readmission. Slow responders—those who are still not improving significantly after four or five days—are more likely to be readmitted. This ties back to the analogy of a slippery surface: if a car is still sliding after the brakes are applied, it’s likely to encounter more problems stopping. In the same way, shortening a patient’s response time may reduce their likelihood of readmission.

We see a similar concept with endocarditis. For example, if a patient undergoes valve replacement surgery and their cultures are negative at the time, their prognosis is generally better than if they have a positive culture during surgery, which also extends their required treatment duration.

Although readmission rates are heavily influenced by comorbidities, it remains to be studied whether a more aggressive approach with patients who have comorbidities could shorten their response time and, ultimately, reduce their chances of readmission. Nonetheless, it’s logical to aim for faster recovery to facilitate earlier discharge, benefitting both patient outcomes and hospital efficiency.

 What are some of the other risk factors for readmission?

Age is definitely a major factor, especially for those over 65, as it increases risk for nearly everything. Other main risk factors include structural lung disease, diabetes, and heart disease, which can impact respiratory function. Among these, diabetes is particularly notable. A well-controlled diabetic is very different from a patient with a hemoglobin A1c in the double digits; the latter is functionally neutropenic, making bacterial infections especially challenging to manage. 

what should be the plan for discharge so you don't see readmission for these individuals?

This is always a challenge. The goal is to cover as much ground as possible with therapy while the patient is a captive audience in the hospital. By using the most potent therapy available during their hospital stay, we hope to prevent infection from spreading, which may reduce complications and follow-up needs once they leave.

Additionally, there’s value in optimizing antibiotic dosing, especially for specific populations. For instance, a recent study at our hospital found that obesity is a risk factor for outpatient parenteral antimicrobial therapy (OPAT) failure and readmissions. Unfortunately, many antibiotic dosing studies have not adequately addressed the obese population. A study published in 

 earlier this year (April) provided insights into more appropriate dosing strategies for obese patients. This is worth exploring because these patients may not be receiving enough of the drug to effectively treat the infection.

In summary, ensuring appropriate dosing—especially for obese patients—and using the most potent therapy possible, along with strong follow-up care, can help address issues early and potentially prevent a small problem from escalating into one that requires hospitalization.

The conversation was edited for grammar and clarity.

A recent systematic review and meta-analysis assessed the efficacy of an 8-week regimen of daclatasvir (DCV) plus sofosbuvir (SOF) in patients with chronic hepatitis C virus (HCV) infection. The analysis aimed to determine the sustained virologic response at 12 weeks after treatment (SVR12) for this shortened regimen, which is being considered as a potential option for low- and middle-income countries (LMICs) due to the high cost of direct-acting antivirals (DAAs).

The analysis included six studies with a total of 159 patients. The pooled SVR12 rate for the 8-week regimen ranged from 91% to 97%. The pragmatic analysis showed an SVR12 of 97% (95% confidence interval: 91%-100%), while a conservative approach, which took response-guided treatment (RGT) into account, revealed an SVR12 of 93% (95% CI: 84%-95%).
In an exclusive interview with 

, Ahmed N. Farrag, BPharm, co-author on the study said, “Our study demonstrates the promise of an 8-week DCV-SOF regimen with an estimated pooled SVR12 rate exceeding 90% across all sensitivity analysis scenarios, suggesting substantial potential for reducing treatment duration and thereby, the associated treatment costs by one third.”

He further emphasized that this reduction could make hepatitis C treatment more accessible in LMICs. Although, Farrag highlighted that while these findings are promising, a head-to-head randomized controlled trial (RCT) comparing the 8-week regimen to the standard 12-week course is essential, “Such a trial will provide definitive evidence needed to inform global health policies and ensure the regimen's efficacy in broader patient populations.”

The study's sensitivity analyses accounted for potential confounders, including comorbidities such as HIV and cirrhosis, as well as the use of the RGT approach, where only patients who achieved rapid virologic response (RVR) were assigned to the 8-week course. Farrag stated, “Statistically speaking, our confidence arises from the 95% confidence level for the predicted intervals for the pooled SVR12 rates as per our meta-analysis. Nonetheless, translating these findings into real-world settings, which encompass diverse patient populations including those with comorbidities or those who are treatment-experienced, presents additional challenges.”

Despite these adjustments, he noted that real-world effectiveness would require further evaluation, “Real-world "effectiveness" from different clinical settings would present a more comprehensive perspective on these confounders.”

In discussing the potential barriers to widespread adoption of the 8-week regimen, Farrag identified challenges, “Clinically: Identifying patients suitable for the shorter regimen is crucial. For instance, patients with cirrhosis and those with HIV co-infection who typically won't be eligible for the shortened regimen.”

He continued to explain, “Economically: While the 8-week regimen potentially reduces treatment costs, possible anticipated treatment failures and the consequent need for retreatment are essential considerations.”

Farrag also highlighted the importance of pharmacoeconomic studies in evaluating the cost-effectiveness of the regimen. “Although several studies indicated that patients who did not achieve SVR12 following standard or short courses of direct-acting antivirals achieved high cure rates when retreated, pharmacoeconomic studies including cost-effectiveness and cost-benefit analyses, specifically, from payer perspectives, are required. These studies are expected to account for the upfront savings and the downstream costs of retreatment.”

Farrag concludes, “while the high efficacy of the 8-week DCV-SOF regimen is promising, its widespread adoption will benefit from further validation through head-to-head clinical trials and a thorough pharmacoeconomic analysis, considering potential retreatments for those who experience treatment failures.”

Farrag AN, Kamel AM. Efficacy of 8-week daclatasvir-sofosbuvir regimen in chronic hepatitis C: a systematic review and meta-analysis. Virol J. 2024;21:275. November 4, 2024. Accessed November 13, 2024. 

https://doi.org/10.1186/s12985-024-02544-2

Results suggest a shorter treatment duration could reduce costs and improve access in low- and middle-income countries.

Efficacy of 8-Week Daclatasvir-Sofosbuvir Regimen for Chronic Hepatitis C

The country’s largest fecal distributor, OpenBiome, could be prevented from offering the product next year if the FDA does not approve the product 

Due to FDA Policy Change, Fecal Microbiota Transplants are in a Tenuous Position

This fall, there has been some legal limbo going on at the FDA as it pertains to deciding if the federal agency should restrict the nonprofit company, OpenBiome, from continuing to distribute its fecal products for use in fecal microbiota transplants (FMT). This procedure has been a life-saving treatment for both adult and pediatric patients suffering from fulminant 

Prior to this fall, the FDA had allowed the distribution of the company’s fecal products under enforcement discretion for many years.

 However, the FDA changed its position creating an uneasy, untenable position for the future of FMT—at least in the short term.

Without OpenBiome’s ability to distribute their product, many patients might not have immediate access to FMT, and this is not an ideal situation considering the severity of infection for patients with fulminant 

, including the possibility it could cause death.

However, OpenBiome and another stakeholder, the 

 patient advocacy organization, the Peggy Lillis Foundation (PLF), have both pointed out the FDA has been open in listening to the needs of 

 patients and the community in allowing for the fecal products to be distributed while they try to find a more permanent solution.

“We are thankful to the FDA for listening to the patient and clinician communities and prevailing evidence and making this decision to prioritize patient care. As part of this guidance, we are submitting an [investigational new drug] IND application to the FDA by November 30th,” OpenBiome wrote in a statement on their website.

Christian Lillis, the CEO of PLF, believes the FDA policy change was more about unexpected consequences, and that the federal agency did not foresee this issue arising.

"I really think that this was unintended, and I'm glad that they [the FDA] listened to us and have come up with—at least a solution in the interim—that we can hopefully work together,” said Lillis.

The FDA has extended the deadline for OpenBiome to continue distributing their product through the end of this year, while they prepare their IND application.

Beginning in September and lasting through the end of October, many were concerned that OpenBiome, the country’s largest distributor of fecal microbiota transplant (FMT) products might be forced to stop altogether.

OpenBiome noted that it was only going to continue offering the products through October 31 in light of the fact the federal government said it would need to review the IND.

To be clear, these traditional FMT differ from the newer 

 that have been FDA approved over the last 2 years. LBP have been indicated for patients with recurrent 

, and not the other aforementioned groups. These newer modalities have been shown to be efficacious and safe.

Lillis and PLF remain what he calls “treatment agnostic” to the existing modalities.

“We need to be clear from the jump that the Peggy Lillis Foundation doesn't endorse or recommend any particular treatment,” Lillis said. “That decision is best made between a patient and their doctor, but what we do want is as many options to treat this infection as possible. And that's why we also need to maintain access to traditional FMT and it's really for a particular subset of patients.”

References
1. Enforcement Discretion for Investigational FMT Extended for Severe and Fulminant CDI. Openbiome statement. Accessed November 13, 2024.
https://openbiome.org/fmt-distribution-through-december-31/

The country’s largest fecal distributor, OpenBiome, could be prevented from offering the product next year if the FDA does not approve the product used for fecal microbiota transplants  to treat fulminant C difficile.   

Due to FDA Policy Change, Fecal Microbiota Transplants Are in a Tenuous Position

Chad Costley, MD, MBA, provided an update on BlueWillow Biologics' NanoVax™ intranasal vaccine for H5N1, with Phase 1 trial data showing broad immune responses and no serious adverse events.

Rebuilding Trust in New Intranasal Vaccine for Avian Flu and Other Respiratory Diseases

At the World Vaccine Congress Europe, Chad Costley, MD, MBA, president and CEO of BlueWillow Biologics, presented an update on the company’s NanoVax intranasal adjuvant vaccine for avian flu (H5N1). In our interview, Costley discussed the vaccine's design, addressed concerns about safety and public hesitancy, and highlighted the study's potential.

The trial design simulated real-world infection and assessed how NanoVax™ primes the immune system. “With avian flu, we had a naive patient population who had not been exposed to the virus,” Costley explained. “We administered two intranasal doses of our adjuvanted recombinant protein vaccine followed by a third intramuscular dose.” He emphasized that the intramuscular dose, derived from an existing licensed H5 vaccine, was used as a “proxy for infection” to test how well the body would respond if it were exposed to the virus in the real world. “This approach helps us see whether our intranasal vaccine can prime the immune system to mount a robust, protective response upon real infection,” Costley added.

Vaccine hesitancy remains a challenge, especially in the context of COVID-19 and flu vaccines. Costley emphasized the potential for NanoVax™ to address these concerns, particularly for individuals who fear needles. “A significant portion of vaccine hesitancy is due to needle phobia,” said Costley, noting that intranasal vaccines, such as NanoVax™, can bypass this issue. “Any intranasal vaccine, including ours, can avoid the discomfort and reluctance that comes with needles.” He also noted that misinformation about vaccine safety remains a barrier.

Addressing safety concerns, Costley referenced Berna's historical issues with intranasal adjuvanted vaccines. This example of a 2000s-era flu vaccine that caused Bell’s Palsy in some recipients, led to widespread distrust of intranasal adjuvants. “We think our platform addresses those safety issues directly,” he explained. “We have a novel oil-and-water emulsion that prevents adjuvants from reaching the olfactory bulb in the nose, which could lead to neurological side effects.” BlueWillow’s clinical trials have shown no serious adverse events to date, strengthening the safety profile of NanoVax.

Costley also underscored the advantages of intranasal vaccination for respiratory diseases like influenza, pointing out that this method mimics the natural route of infection. “We don’t get infected through our arms, we get infected through our noses,” he explained. “An intranasal vaccine has the potential to prime the immune system at the site of infection, providing a more robust and natural response.”

NanoVax contrasts with most current intranasal vaccines, which rely on live attenuated viruses. While live virus vaccines like FluMist have benefits, they also carry risks. NanoVax uses a recombinant protein and adjuvant system, generating immunity without the risks associated with live viruses.

Costley emphasized that the goal of vaccination is not only to prevent illness but also to reduce viral transmission. “What we learned from COVID is that protection means more than just keeping people from getting sick. It also means reducing viral shedding and carriage, which are critical for controlling the spread of disease,” Costley said. He believes NanoVax has the potential to address both aspects, providing immunity against disease while also reducing the likelihood of contagion. “For respiratory diseases, that dual protection is absolutely critical.”

Although BlueWillow has not yet disclosed the full results of its H5N1 clinical trial, Costley shared that the Phase 1 trial exceeded expectations. “We’re very excited to report that through some additional funding, we’ve been able to expand the data set, which now includes not just mucosal antibodies but systemic responses, cellular responses, and ADCC (antibody-dependent cell-mediated cytotoxicity) responses,” he said. Costley expressed optimism that the full results will soon be made public, though additional weeks of analysis are required.

BlueWillow Biologics' NanoVax platform offers an intranasal alternative to injection-based vaccines and could reshape vaccine delivery. With trial results and a safety profile, it could play a key role in preventing disease and transmission as more data from its H5N1 trials are released.

BlueWillow Biologics to Present Significant Progress on Its Novel Intranasal Vaccine Technology at World Vaccine Congress Europe. 

October 28, 2024. Accessed November 12, 2024. https://www.biospace.com/press-releases/bluewillow-biologics-to-present-significant-progress-on-its-novel-intranasal-vaccine-technology-at-world-vaccine-congress-europe 

Chad Costley, MD, MBA, provided an update on BlueWillow Biologics' NanoVax intranasal vaccine for H5N1, with Phase 1 trial data showing broad immune responses and no serious adverse events.

Conferences

Rebuilding Trust in Intranasal Vaccines for Avian Flu and Other Respiratory Diseases

George Sakoulas, MD, provided commentary on challenging patients with comorbidities such as COPD, structural lung disease, asthma, and other health issues

Clinical Considerations for Treating Patients with Pneumonia 

As we are heading into seasonal respiratory virus season, what are you seeing in your own practice and region of the country in this regard, and how should clinicians be preparing to combat a resurgence in COVID 19 and the early onset of respiratory season?

I'm based in Southern California, working as an ID physician. What we're noticing here is a slight uptick in flu cases. In fact, as of this time of year, we're seeing about three times more flu cases than we had at the same point last year. This suggests we might be in for a heavier flu season than usual, at least based on early indicators. Typically, our flu season peaks in January. In Southern California, it's quite predictable—flu activity often surges right after the holiday season. People travel, visit family, return home, and then around January 5th, it's as if a fire is lit.

We also had a COVID bump in August, which mirrored trends across much of the country, though it was far less severe than what we saw during the pandemic years. We had some hospitalizations, but most were incidental.

For clinicians, the main preparation is staying informed and encouraging patient vaccination. We now have vaccines for influenza, COVID, and RSV. RSV vaccines are recommended for anyone over 60 or for anyone at high risk over 75. Encouraging vaccination is really the most effective tool we have since the therapeutic options for viral infections are limited. Although some treatments show statistically significant effects in studies, the clinical impact often seems minor.

In short, with viral infections, prevention through vaccination is key. We as healthcare providers are mandated to get vaccinated, and ideally, the best time to do so is now.



For pneumonia patients with lung function related comorbidities—such as COPD or structural lung disease, smokers, over age 65, asthma—who are these most challenging patients and why?

 Older patients present unique challenges, especially those with structural lung disease. Anytime there’s an infection or problem in the lungs, entering that illness with a compromised organ system makes it significantly more challenging. This is mainly because they have limited respiratory reserve. When someone with underlying health issues gets an illness, even a minor one, it can affect them much more severely than a healthier person. Additionally, these patients often receive frequent antibiotic treatments due to repeated exacerbations and ongoing care needs. Frequent antibiotic use increases the risk of antibiotic resistance, which, in turn, makes them more susceptible to infections by unusual organisms that are less common in straightforward cases of community-acquired pneumonia.

 What are the clinical considerations you are thinking about in your treatment management?

 When it comes to pneumonia—and, really, most infections—it often comes down to two main factors: comorbidities and severity of illness. Stopping an infection is a bit like stopping a car. Your level of sickness can be thought of as your speed, while your comorbidities are like the type of surface you're on. If you have multiple comorbidities, it’s like driving on an icy downhill road; if you're very sick, it’s as if you're moving at a high speed. These are the two factors I explain to patients and students when discussing how we assess infection risks and make treatment decisions.

For example, if a patient has multiple comorbidities or has been on prior antibiotics, we need to make specific treatment decisions. However, if a younger patient with no major risk factors becomes severely ill—such as requiring ICU admission or ventilation within the first 24 to 48 hours of hospitalization—I start to consider staph pneumonia, particularly during the respiratory season we discussed earlier.



The conversation was edited for grammar and clarity. 

George Sakoulas, MD, provided commentary on challenging patients with comorbidities such as COPD, structural lung disease, asthma, and other health issues.

Michael J McElhaugh

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