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McAlister is an infectious diseases pharmacist at Orlando Health Dr. P. Phillips Hospital in Orlando, FL. He serves as the PGY-1 Pharmacy Residency Program director and has clinical interests in antimicrobial stewardship, HIV, Gram-negative resistance, and precepting/teaching.

New therapeutics offer some hope in this emerging market.

STAY PrEPARED: Understanding COVID-19 Pre-Exposure Prophylaxis

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

Kenneth Lawrence, PharmD, discusses the global problem and the need for a layered, multifaceted approach to antimicrobial resistance (AMR) 

Antimicrobial Resistance: Cause for Alarm and Optimism?

World Antimicrobial Resistance Awareness Week (WAAW) is being observed this week. It is commemorated annually from November 18–24, and it is “a global campaign to raise awareness and understanding of AMR and promote best practices among One Health stakeholders to reduce the emergence and spread of drug-resistant infections,” according to the World Health Organization’s (WHO) website. This year’s theme is Educate. Advocate. Act now. 

Within this awareness campaign is the concept of One Health. According to WHO, “One Health is an integrated, unifying approach to balance and optimize the health of people, animals and the environment. It is particularly important to prevent, predict, detect, and respond to global health threats such as the COVID-19 pandemic. The approach mobilizes multiple sectors, disciplines and communities at varying levels of society to work together. This way, new and better ideas are developed that address root causes and create long-term, sustainable solutions. One Health involves the public health, veterinary, public health and environmental sectors.”

The scope of AMR globally is enormous and AMR-associated mortality is expected to increase for years to come. A study published earlier this year in 

 looked at AMR-associated mortality from this year up to 2050 and the number of deaths in that time period. This was a modeling analysis that predicted that more than 39 million people could die from AMR globally in that time period.

According to the study’s investigators, more than 1 million people died each year as a result of AMR between 1990 and 2021. The study also estimates 1.91 million people could potentially die as a direct result of AMR in 2050, an increase of almost 70% per year compared to 2022. Over the same period, the number of deaths in which AMR bacteria play a role will increase by almost 75% from 4.71 million to 8.22 million per year 

Although the medical community and public health officials are both fully aware of AMR’s impact, this is not something that is commonly discussed with the public. “This is what many people refer to as a silent pandemic,” said Kenneth Lawrence, PharmD, member of the 

board of directors. “Many people, if you were to talk to them, know somebody that may have been impacted by AMR. So I think this topic is something that really does need to come more into the forefront.”

One of the more promising developments, according to Lawrence, was that the United Nations came together this past summer during a General Assembly where all nations attended the meeting and discussed AMR. 

“At that meeting, there were not only a number of important stakeholders, most importantly for me and I think others, there were also several patients and patient advocates there who spoke directly to those members of the General Assembly,” Lawrence said. “And fortunately, what came out of that is some political declarations that there would be political will targets directed towards reducing the number of deaths due to AMR by an appreciable number by 2030.” 

The 2030 number is symbolic and significant as the WHO often uses this year as a landmark to see progress across several health initiatives.

One area Lawrence believes can make a significant impact is antimicrobial stewardship. He and stakeholders within the Peggy Lillis Foundation are trying to focus on the appropriate use of antibiotics. “We know, based on current studies, that about 30% of those antibiotics prescribed, whether they're for adults or pediatrics, are unnecessary,” Lawrence said. “And the most common infections where we see those are viral infections due to upper respiratory tract infections.”

Education is another key in employing stewardship says Lawrence.

“It really starts with education, not only of those junior physicians, but also the patients, helping them understand that antibiotics may not always be necessary.”

He says it’s about working with clinicians to ensure that patients are receiving the right medication. “It's not always the broadest spectrum antibiotic that's necessary and making sure that it's the appropriate duration of treatment.”

“We're now learning with very good studies that long courses of antibiotics may not be necessary for a number of the common infectious disease syndromes. There was some literature that came out about shorter treatment of bloodstream infections of less than 10 days." Additionally he says the utilization of newer diagnostics to get to a more accurate diagnosis in a timely manner is also part of the stewardship equation.

“We need to get patients out of the hospital to switch them to oral medication; those are all things that can help reduce the overall use of antibiotics—to tailor the antibiotic use, and over the long run, reduce the risk of of antibiotic resistance, and, more importantly, improve patient safety. I can't underscore enough that antimicrobial stewardship focuses on patient safety.”

For more news and information on AMR, check out our coverage from the 

1.World AMR Awareness Week 2024. WHO. Accessed November 22, 2024. https://www.who.int/campaigns/world-amr-awareness-week/2024

2.One Health. WHO. September 21,2017. Accessed November 22, 2024.
https://www.who.int/news-room/questions-and-answers/item/one-health

3.Naghavi, Mohsen et al. Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. 

. September 16, 2024. doi: 10.1016/S0140-6736(24

Kenneth Lawrence, PharmD, discusses the global problem and the need for a layered, multifaceted approach to antimicrobial resistance (AMR) and some of the ongoing inroads and progress being made to address the medical issue.

Antimicrobial Resistance: Cause for Concern and Optimism?

Robert H. Hopkins, Jr., MD, National Foundation for Infectious Diseases (NFID) medical director and ACIP liaison offers insights on a variety of respiratory vaccines 

Respiratory Vaccines Update 

Thus far into the respiratory virus season, COVID-19, influenza, and RSV vaccine uptakes have been low across all 3 immunizations, with the flu shot having the highest utilization. A Centers for Disease Control and Prevention’s (CDC) 

 report published yesterday offered insights on the statistics so far into the respiratory virus season 

“As of November 9, 2024, cumulative estimated coverage with 2024–2025 influenza and COVID-19 vaccines among adults aged ≥18 years was 34.7% and 17.9%, respectively. Estimated RSV vaccination coverage was 39.7% among adults aged ≥75 years and 31.6% among those aged 60–74 years at increased risk,” the authors wrote.

And in addition to the low uptake for respiratory virus vaccines, federal public health guidance and FDA approvals have been evolving. This year, federal public health officials have made changes and updated recommendations on a number of these vaccines, including RSV, COVID-19, and pneumococcal disease. Updates have been reflected in the CDC Advisory Committee on Immunization Practices (ACIP) meeting in October as well as recent FDA approval decisions. Here is some more information about a few of the changes regarding respiratory virus vaccines.



 for adults aged 18 to 59 years who are at increased risk. This is a departure from previous approvals and guidance.

“RSV vaccines, manufactured by Pfizer, GlaxoSmithKline and Moderna are all now FDA approved for use in older adults,” said Robert H. Hopkins, Jr, MD, medical director, National Foundation for Infectious Diseases (NFID) and ACIP liason. “Pfizer sought expanded approval from FDA based on a clinical trial which looked at immunogenicity, and looked at safety and tolerability of this vaccine in persons 18 to 49 with chronic medical conditions...It's important to note that ACIP also approved the GlaxoSmithKline RSV vaccine for use in adults 50 to 59 in June based on somewhat similar data in a trial.”



, the committee recommended a second COVID-19 vaccine dose for individuals aged 65 and older and younger individuals with moderate to severe immunocompromised conditions, spaced 6 months apart.

Although ACIP offered a recommendation looking at seniors and the immunocompromised, Hopkins believes vaccine coverage should extend beyond those populations.

“I would strongly recommend that everyone 6 months of age and older—who's not already done so since September—to get the 2024-2025 COVID-19 vaccine,” Hopkins said. 

As part of his reasoning, he points to racial and ethnic disparities in terms of groups being more susceptible to severe forms of COVID-19. “It's much less well known that we continue to have significant racial and ethnic disparities in the rate of COVID-19 hospitalizations,” Hopkins said. “The rate for Native American, Alaskan natives, and Black Americans are significantly higher than for white, Hispanic, and Asian Americans.

Lastly, he points to the pediatric population and hospitalization.

“The highest rate of hospitalization for COVID in children is less than 4 years and particularly in children from 6 months to 40 or 6 months and younger. Kids 6 months and younger are too young to be vaccinated on their own, obviously, and they're best protected by maternal vaccination during pregnancy, only half of the kids admitted to the hospital with COVID 19 had underlying medical conditions. Eighteen percent of those kids ended up in the ICU. Of children 6 months to 17 years admitted to the hospital, less than 5% had received the current vaccine prior to admission,” Hopkins said.

“So, this all comes down to the fact we're missing far too many opportunities to save lives, hospitalizations, and morbidity with the COVID vaccine.”

During that same round of ACIP meetings, the committee recommended the pneumococcal conjugate vaccine for PCV-naive adults aged 50 and older. Again this recommendation is a departure from previous guidance.

Hopkins says this change is from 2 newer pieces of information that includes risk-based criteria.

“A significant portion of persons 50 and older who have chronic medical conditions, which would put them into a risk-based recommendation that we previously had in place, either are unvaccinated and know they have those risk factors, or don't know they have those risk factors,” Hopkins said. “Second, there's a significant risk disparity based on race and ethnicity. For example, Black men are at increased risk for invasive pneumococcal disease in that 50 plus age group, and that's not been a risk-based group. And so, it's the hope that moving to an age-based recommendation will allow us to close some of these gaps, protect more of these people from hospitalization and other adverse outcomes, including death.”

The beginning of the holiday season is starting next week with Thanksgiving, and typically incidence rates for seasonal viruses increase during this time of year as people travel and gather together with family and friends. This is another good reason for people to protect themselves as well as loved ones, especially those who are in vulnerable populations including seniors, people with existing health conditions, and those who are immunocompromised.

1.Kriss JL, Black CL, Razzaghi H, et al. Influenza, COVID-19, and Respiratory Syncytial Virus Vaccination Coverage Among Adults — United States, Fall 2024. MMWR Morb Mortal Wkly Rep 2024;73:1044–1051. DOI: 

2. Abene S. Day 1 Recap from CDC ACIP Meeting: COVID, Pneumococcal, Influenza, and RSV Vaccine Recommendations. 

. October 24, 2024. Accessed November 22, 2024.
https://www.contagionlive.com/view/day-1-recap-from-cdc-acip-meeting-covid-pneumococcal-influenza-and-rsv

Robert H. Hopkins, Jr., MD, medical director, National Foundation for Infectious Diseases (NFID) and ACIP liaison, offers guidance and insights on a variety of respiratory vaccines. 

A large randomized controlled trial has found that 7 days of antibiotic treatment for bloodstream infections is noninferior to the standard 14-day regimen. The BALANCE trial, published in 

, involved 3,608 hospitalized patients across 74 hospitals in seven countries. By 90 days, 14.5% of patients in the 7-day group had died, compared to 16.1% in the 14-day group , a difference of 1.6 percentage points (95.7% CI, −4 to 0.8). These findings suggest that shorter antibiotic courses may be a viable option for many patients, especially those who are critically ill.

The trial included a diverse range of hospitalized patients with bloodstream infections, 75.4% of which were community-acquired, and 42.2% originated from the urinary tract. Over half (55%) of participants were critically ill and in the ICU. The trial also showed consistent results across secondary outcomes, including rates of 

 infections and antibiotic-resistant bacterial colonization. Importantly, the trial excluded severely immunosuppressed patients and those with 

 infections, which generally require longer treatment.

In an exclusive interview with Nick Daneman, MD, FRCPC, MSc, one of The BALANCE trials lead investigators, he explained the trial's exclusion criteria. “We included most immunosuppressed patients, and only excluded patients with neutropenia and transplantation.” He continued, “

has many surface molecules that enable it to bind to a range of tissues including bones, joints, and heart valves among others, and so it commonly causes metastatic infection. Therefore, it theoretically requires a longer duration of treatment. Observational studies suggest higher failure rates with shortened treatment. A randomized clinical trial is needed to evaluate Staphylococcus aureus treatment duration but the treatment arms would likely be longer than 7 days in such a trial.”

The shorter 7-day regimen offers both patient-level and public health benefits. Reducing antibiotic exposure could help curb antimicrobial resistance, while potentially lowering healthcare costs by avoiding prolonged treatment. Despite concerns about long-term resistance risks, Daneman pointed out that, “Our primary outcome (death at 90 days) is patient important and is a relatively long-term outcome from the onset of infection. We found a strong signal of non-inferiority of shorter duration treatment. In fact, the point estimate for 90-day death rate was lower in those receiving 7-day treatment. Therefore, we do not have concerns that shorter duration treatment could result in worse outcomes.”

Regarding antimicrobial resistance, Daneman stated, “There are strong theoretical reasons why shorter duration treatment should cause less ecologic harms of antimicrobial resistance than longer duration treatment. Even though we were unable to demonstrate a reduction in resistance with shorter treatment in this study, we think it is very unlikely that resistance would be higher with reduced durations.”

Despite some non-adherence in the trial, with 23.1% of patients in the 7-day group and 10.7% in the 14-day group receiving longer treatment, Daneman provided guidance on safely implementing a 7-day regimen in practice, especially for critically ill patients. He explained, “Our results clearly indicate that a strategy of planning for 7 days of treatment is non-inferior to a strategy of committing all patients to 14 days of treatment. Some patients might require prolongation of treatment beyond 7 days, and that will require clinical judgement. However, randomization to a 7-day strategy was clearly non-inferior to a 14-day strategy even in critically ill patients enrolled in intensive care units.”

These findings align with the CDC’s focus on preventing healthcare-associated infections and minimizing unnecessary antibiotic use. As highlighted in the CDC’s 2023 National and State HAI Progress Report, healthcare-associated infections, particularly those caused by resistant bacteria like MRSA and 

, continue to pose significant challenges.

 Reducing unnecessary antibiotic use, as suggested by the BALANCE trial, could help mitigate the spread of resistant infections and improve patient outcomes.

In conclusion, the BALANCE trial suggests that 7-day antibiotic courses may be a viable alternative to the standard 14-day treatment for bloodstream infections, offering benefits in patient outcomes and reducing unnecessary antibiotic use. These findings support broader efforts to reduce antimicrobial resistance and improve infection prevention practices in healthcare.

1. Antibiotic Treatment for 7 versus 14 Days in Patients with Bloodstream Infections. Published November 20, 2024. Accessed November 21, 2024. 

https://www.nejm.org/doi/full/10.1056/NEJMoa2404991

2. CDC. Current HAI Progress Report. November 7, 2024. Accessed November 21, 2024. 

https://www.cdc.gov/healthcare-associated-infections/php/data/progress-report.html

The BALANCE trial suggests that shorter treatment durations may reduce healthcare costs, antibiotic exposure, and antimicrobial resistance risk, providing an alternative for critically ill patients.

7-Day Antibiotic Regimen Found Noninferior to 14-Day Treatment for Bloodstream Infections

 Paul Feuerstadt, MD, FACG, AGAF, discusses what the data says as well as offers insights about what patients can expect and medical peer-to-peer information about the procedure. 

Two Years FDA Approved, Rebyota Continues to Show Efficacy and Safety

It has been 2 years this month since fecal microbiota, live – jslm (Rebyota) was FDA approved for the indication of recurrent 

 treatment in individuals 18 years of age and older, following antibiotic treatment for recurrent 

New data was released at this year’s ID Week showing its continued efficacy and safety 2 years after the approval. Ferring Pharmaceuticals announced results of its outpatient real-world study using Rebyota. 

In one of the analysis, investigators reviewed the medical records of 64 adult patients from 32 physician offices nationally who received Rebyota from February 2023 to March 2024. In total, 59 patients completed the 8-week follow-up period, of which 75% (n=44) had no CDI recurrence. There were no adverse events reported with treatment aside from minor leakage during administration in 4 patients (6.2%).

Participants in the analysis had a median age of 75 years and were predominantly female (65.6%). Patients had multiple comorbidities (Charlson score 4.5) and 59.4% had 2 or more rCDI risk factors, the most common being age, 65 years or older (75%), and concurrent use of gastric acid suppressants (59.4%). The median number of prior CDI episodes was 3. Fidaxomicin (57.8%) was the most utilized standard-of-care antibiotic for treatment of CDI prior to Rebyota administration.

Additionally there has been other data being released from the PUNCH CD3 trial.

“The open label study data that was published earlier in 2024, which was the largest study that looked at live biotherapeutic products, looked at 697 total patients, so a massive group expanding upon the PUNCH CD3 trial—the randomized control trial that had a placebo arm within this open label study,” said Paul Feuerstadt, MD, FACG, AGAF an associate clinical professor of medicine at the Yale School of Medicine. “Patients with IBS are going to show up in a provider's office with their current 

. Patients with ulcerative colitis and Crohn's disease are also going to show up in providers offices' with 

 so how does this work in a real world type scenario? And across those 697 patients, they found an efficacy of 73.8% further validating the randomized control trial from phase 3. And of those 73.8%, 91% remained responsive at 6 months. So in a real world, formalized study setting, we see very, very encouraging data.”

Feuerstadt also says in his conversations with patients he explains the differences from taking antibiotics and getting this treatment. 

“If we explain it appropriately, the patients will understand that the antibiotic controls the phase that causes symptoms, but that spore phase, the phase that remains in their system after the antibiotics that requires a healthy, diverse microbiota, and that regrowth of the microbiota without supplementation causes a recurrence. Therefore, if you're putting the microorganisms into the place where the infection is, you're preventing that recurrence. So patients can wrap their head around that concept and understand how you're treating the entire infection and how you're shutting down that cycle of recurrence. And that clicks in their head, where they have that aha moment,” Feuerstadt said.

For those not familiar with Rebyota, it is a live biotherapeutic product (LBP) that is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes, including 

. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in 1 visit.

. Real-World Effectiveness of Fecal Microbiota, live-jslm for the Prevention of Recurrent Clostridioides difficile Infection. Poster #220 presented at IDWeek 2024. October 16-19, 2024. Los Angeles, CA.



Paul Feuerstadt, MD, FACG, AGAF, discusses what the data says as well as offers insights about what patients can expect and medical peer-to-peer information about the procedure. 

Two Years After its FDA Approval, Rebyota Continues to Show Efficacy and Safety

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

Arbutus Biopharma Corporation has announced breakthrough data from its IM-PROVE I Phase 2a clinical trial, demonstrating that a combination of imdusiran (AB-729), an RNA interference (RNAi) therapeutic, and a short course of pegylated interferon alfa-2α (IFN) can achieve a functional cure in patients with chronic hepatitis B virus (cHBV) infection. The data, showing up to 50% of patients achieving a functional cure, will be presented at The Liver Meeting® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD) on November 18.

In our interview with Michael J McElhaugh, interim president and CEO and director of Arbutus Biopharma, he discussed the promising results from the IM-PROVE I trial. “The data from this study reveal significant long-term potential for imdusiran in combination with interferon as a pathway toward a functional cure for cHBV,” McElhaugh said. “This combination has the potential to change the treatment landscape for Hepatitis B.”

The IM-PROVE I trial included HBeAg-negative patients with suppressed HBV who received six doses of imdusiran alongside 24 weeks of interferon, in addition to ongoing nucleos(t)ide analogue (NA) therapy. Results revealed that 50% (3/6) of patients with baseline hepatitis B surface antigen (HBsAg) levels less than 1000 IU/mL achieved a functional cure, defined as sustained HBsAg loss and undetectable HBV DNA for 24 weeks after stopping all treatments. Overall, 25% (3/12) of patients across the cohort achieved a functional cure.

According to McElhaugh, the IM-PROVE I study focused on evaluating the combination of imdusiran and interferon in e-antigen-negative patients who had previously been chronically suppressed with nucleoside analogs, the current standard of care. The trial tested four different treatment regimens to evaluate how well imdusiran could reduce surface antigen levels, a key marker of the virus, in combination with interferon over periods ranging from 12 to 24 weeks.

“The primary goal of this trial was to reduce surface antigen levels with imdusiran,” McElhaugh explained. “After the interferon phase, we paused all treatments and monitored patients for 24 weeks without therapy, which is the regulatory definition of a functional cure. This means Hepatitis B DNA is undetectable, and surface antigen is lost or reduced to below the limit of quantification.”

The results from the study were groundbreaking, particularly in the group that received imdusiran continuously in combination with 24 weeks of interferon. In this cohort, 25% of patients achieved a functional cure, a result McElhaugh calls “one of the best seen in the field.” Even more notable was the response rate in patients with baseline surface antigen levels below 1,000 IU/mL, where 50% of patients achieved a functional cure.

Michael McAlister, PharmD, BCIDP

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