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Lee is associate dean, research studies and interim director, Animal Cancer Care and Research Center professor, Virginia Tech.

Margie Lee, DVM, MS, PhD, wants young researchers and providers to know that despite the current environment, this is not the first time science has had to deal with a challenges to research and funding. 

Understanding the Long Game of Resources, Funding in Research

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

VOLITION and OPERA study data presented at IAS 2025 show patient preference and real-world use of injectable CAB + RPV LA, informing the treatment strategy of ViiV CMO Jean van Wyk.     Ask ChatGPT

Nearly 90% of treatment-naïve people with HIV chose to switch to long-acting injectable therapy after achieving viral suppression, according to findings from the Phase IIIb VOLITION study presented by ViiV Healthcare at IAS 2025. The study enrolled 145 newly diagnosed individuals who began treatment with the daily oral regimen dolutegravir/lamivudine (DTG/3TC). Once they achieved viral suppression, typically in just over four weeks, participants were given a choice: remain on daily oral medication or switch to the long-acting injectable regimen, cabotegravir plus rilpivirine (CAB + RPV LA), administered every two months. An overwhelming 89% (n=129) opted for the long-acting option at their next study visit.

Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, explained, “This study was specifically designed to see how quickly we can get treatment-naive individuals to get to a point where they can potentially choose long-acting injectable therapy."

“They were started on a medication called Dovato, which is a combination of dolutegravir and lamivudine... the moment they became undetectable—which means that they have no virus replicating in their blood—they were immediately given the choice: do they want to stay on the daily oral medication, or do they want to switch to long-acting injectable therapy?”

Participants reached viral suppression with a median time of 4.14 weeks, and data showed that convenience was a key driver in their decision-making.“About 80% of them said it’s because they don’t want to worry about forgetting to take a tablet every day, and about two-thirds of them said it removed the worry about traveling with medication,” van Wyk added.

This strong preference aligns with outcomes from other studies and real-world experiences.“We’ve seen this in studies and in real-world evidence, and it’s just a testament to the power of choice—giving people the choice of a medication that might be best suited to them,” said van Wyk.

OPERA Real-World Data Reinforces Effectiveness in Treatment-Experienced Populations

While VOLITION focused on newly diagnosed individuals, real-world data from the OPERA cohort broadened the picture to include treatment-experienced people living with HIV, especially those with viremia at baseline.

Among 3,304 participants in OPERA, 11% (n=368) had viral loads above 50 copies/mL at initiation of CAB + RPV LA. Remarkably, 88% of these viremic individuals achieved suppression to <50 copies/mL, showing the potential of long-acting treatment even for those with complicated treatment histories.“This time, specifically, we looked at people who are treatment-experienced… but for whatever reason, it wasn't working for them and they became viremic again,” van Wyk explained.

“We had well over 300—nearly 400—people included in this analysis, and they had viremia… what we found was that, over time, they had really good responses—very good effectiveness rates from this OPERA analysis—with around 88% of individuals having an undetectable viral load.”

A separate sub-analysis of viremic women in the OPERA cohort demonstrated even more impressive results, with 92% achieving viral suppression after switching to long-acting therapy.“Again, we saw very similar and good treatment outcomes—just over 90%, 92% of women—having an undetectable viral load after they’d gone on to long-acting injectable therapy,” van Wyk said.

In addition to VOLITION and OPERA, ViiV is building a growing portfolio of real-world effectiveness data. Supporting studies such as CARLOS (Germany), COMBINE-2 (Europe), and BEYOND (U.S.) continue to confirm low virologic failure, strong adherence, and high patient satisfaction across diverse populations—including both virally suppressed and viremic individuals at the time of switch.

“That includes viremic and suppressed populations at the time of switch—again, showing really good effectiveness rates, low rates of virologic failure, and persistence on treatment over time,” noted van Wyk. As the HIV treatment landscape shifts toward personalization and patient-centric care, Jean van Wyk’s leadership at ViiV is shaping a strategy rooted in flexibility, access, and real-world insight.“It’s just a testament to the power of choice,” he said. “Giving people the choice of a medication that might be best suited to them.”

ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable 

 from daily pills after achieving rapid viral suppression. 

. June 14, 2025. Accessed June 14, 2-25. https://www.businesswire.com/news/home/20250714839509/en/ViiV-Healthcare-data-show-89-of-treatment-nave-people-with-HIV-choose-to-switch-to-long-acting-injectable-Vocabria-Rekambys-from-daily-pills-after-achieving-rapid-viral-suppression

At IAS 2025, the VOLITION and OPERA study data show patient preference and real-world use of injectable CAB + RPV LA, informing the treatment strategy of ViiV CMO Jean van Wyk.


Conferences

Long-Acting HIV Therapy Gains Ground in Both New and Experienced Patients

Merck (NYSE: MRK) announced today it is initiating two global Phase 3 clinical trials for MK-8527, its investigational once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP). The announcement coincides with the presentation of Phase 2 data at IAS 2025, the 13th International AIDS Society Conference on HIV Science, held in Kigali, Rwanda.

Merck has announced the launch of 2 global phase 3 clinical trials for MK-8527, its once-monthly oral HIV preexposure prophylaxis (PrEP) candidate. The announcement coincides with new phase 2 data presented at IAS 2025, the 13th International AIDS Society Conference on HIV Science. Luisa M Stamm, MD, PhD, associate vice president of infectious disease clinical research and section head for HIV at Merck, said the candidate shows promise in addressing current prevention gaps.

“MK-8527 is a novel class of antiretrovirals,” Stamm explained. “It primarily inhibits viral replication through 2 unique mechanisms of action. Firstly, it incorporates into the reverse transcriptase and blocks RT translocation, preventing further incorporation of nucleotides into the nascent viral DNA. This results in immediate chain termination. Secondly, if translocation does occur, 8527 induces a structural change in the viral DNA that results in a delayed chain termination.”

Together, these actions contribute to MK-8527’s high potency and strong resistance barrier. The drug also has a long intracellular half-life, making it suitable for extended dosing. “The intracellular triphosphate—the active form of 8527—has a half-life of 10 days,” Stamm noted. “At the selected phase 3 dose of 11 mg, we are predicted to stay above the target efficacy concentration for a month.”

New Trials Aim to Address Gaps in Global PrEP Access

Merck’s 2 newly launched phase 3 studies—EXPrESSIVE-10 and EXPrESSIVE-11—will enroll more than 9000 participants collectively. EXPrESSIVE-10, conducted in partnership with the Gates Foundation, will enroll 4580 adolescent girls and women aged 16 to 30 years in Kenya, South Africa, and Uganda. EXPrESSIVE-11 will enroll 4390 participants across 16 countries beginning in August 2025.

“Our once-monthly PrEP candidate, MK-8527, has the potential to address critical gaps in HIV prevention, particularly for communities with limited access to daily options,” said Eliav Barr, chief medical officer at Merck Research Laboratories.

Stamm added that the trials were designed to reflect real-world use and prevention challenges. “When we were thinking about the EXPrESSIVE studies, we decided that daily FTC/TDF [emtricitabine/tenofovir disoproxil fumarate] was a reasonable comparator,” she said. “Globally, FTC/TDF is the most accessible standard of care currently, and we thought it was most valuable to do a comparison of oral daily vs oral monthly—so oral vs oral.”

Both studies will use adjudicated HIV infections as the primary end point and will integrate pharmacokinetic (PK)-based adherence assessments. “We acknowledge that with these regimens, efficacy is highly linked to adherence,” Stamm said. “These PK assessments will help us better understand how adherence impacts efficacy for both the daily and monthly regimens.”

To ensure representative and equitable enrollment, participants will be randomly assigned 1:1 and stratified based on key variables. “For EXPrESSIVE-10, we will be stratifying by age,” she said. “For EXPrESSIVE-11, we’ll stratify by geography and gender/gender identity.”

At IAS 2025, Merck shared data from a phase 2 double-blind trial (NCT06045507) in 350 adults with low-risk disease. Participants received MK-8527 at doses of 3, 6, or 12 mg or placebo monthly for 6 months. Results showed no clinically significant laboratory abnormalities—including in CD4 and lymphocyte counts—and a safety profile comparable to placebo. “The data we’re presenting at IAS 2025 support advancing into phase 3 trials,” said Barr.

Global Collaboration and Community Engagement

EXPrESSIVE-10 is being funded by the Gates Foundation through the International Clinical Research Center at the University of Washington and the University of Alabama at Birmingham. Community advisory groups will play a key role in guiding culturally sensitive outreach and participant engagement at 31 sites across sub-Saharan Africa.

“Only 18% of global PrEP demand is met,” said Trevor Mundel, president of global health at the Gates Foundation. “We need long-acting, scalable solutions like MK-8527 to close the prevention gap.”

Stamm emphasized the care taken to select trial locations where PrEP could make the greatest impact. “The team has worked on selecting countries and sites with populations that would most benefit from PrEP, with the highest likelihood of exposure to HIV,” she said.

Stay tuned for part 2, where Luisa Stamm will discuss the HIV prevention pipeline and provide closing thoughts on the program.

At IAS 2025, Luisa Stamm, MD, PhD, explains the NRTTI’s mechanism, study setup, and key data on HIV prevention efforts.

Merck’s MK-8527 Advances to Phase 3 for Once-Monthly HIV Prevention

TAXIS Pharmaceuticals announced today that it has received a US Food and Drug Administration (FDA) qualified infectious disease product (QIDP) designation for TXA14007, its investigational efflux pump inhibitor (EPI), in combination with levofloxacin for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia.

The QIDP designation will allow the company to have access to the FDA's Fast Track program, allow for priority review, and make the compound eligible for a potential 5-year extension of market exclusivity upon approval. These advantages are designed to accelerate the development and review processes, ensuring that novel therapies can reach patients faster and address urgent public health needs efficiently. With the support of this designation, TAXIS Pharmaceuticals is poised to advance the development process for its EPIs.

"The QIDP designation is a critical milestone in our mission to deliver effective solutions against antimicrobial resistance," TAXIS Pharmaceuticals CEO Gregory Mario said in a statement. "Too many people are dying from infections like hospital-acquired pneumonia—infections that should be treatable. We are committed to our mission because we know that lives are on the line."

TAXIS is a clinical-stage company developing new classes of therapies to treat multidrug-resistant bacterial infections. Their investigational drug candidates include EPIs, dihydrofolate reductase inhibitors, and FtsZ inhibitors and aim to combat antimicrobial resistance.



A Group of Antimicrobial Compounds Shows Novelty Action Against Multidrug-Resistant Gonorrhea


The TXA14007 class of EPIs significantly enhanced the effectiveness of levofloxacin and other antibiotics against a wide range of drug-resistant 

strains found in clinical settings. Preclinical data on TXA14007 show no signs of inherent toxicity and find that it is effective in improving the action of levofloxacin in animal efficacy models.

This news marks the company’s second FDA QIDP designation. The first was granted for TXA709, the company's first investigational FtsZ inhibitor candidate, aimed at treating antibiotic-resistant methicillin-resistant 

(MRSA). TAXIS is seeking additional funding and partnerships with drug manufacturers to continue the development and commercialization of its investigational EPIs and its broader portfolio of investigational therapies aimed at addressing the escalating burden of antimicrobial resistance.



Reference
1. TAXIS Pharmaceuticals earns FDA QIDP designation for TXA14007, an investigational efflux pump inhibitor (EPI) to combat antibiotic-resistant pneumonia. Press release. TAXIS Pharmaceuticals. July 15, 2025. Accessed July 15, 2025. 
https://www.prweb.com/releases/taxis-pharmaceuticals-earns-fda-qidp-designation-for-txa14007-an-investigational-efflux-pump-inhibitor-epi-to-combat-antibiotic-resistant-pneumonia-302503970.html

The designation is for the company’s TXA14007, its investigational antibiotic to be studied in combination with levofloxacin. 

TAXIS Pharmaceuticals Earns FDA QIDP Designation for Its Efflux Pump Inhibitor for Pneumonia

 suggests that current communication strategies about antimicrobial use (AMU) in food-producing animals often fail to employ framing techniques that resonate with key stakeholders, particularly farmers and producers, potentially weakening support for critical 

 (AMR) measures. The study offers not only a novel framework for evaluating AMR policy language but also a call to reframe the narrative in ways that are grounded, inclusive, and actionable across disciplines and regions.

The study, led by Carly Ching, PhD, a research scientist at Boston University, analyzed policy documents issued by international organizations, including the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (WOAH). Using a combination of inductive and deductive coding, the research team examined how the risks of AMR and rationales for reducing AMU in agriculture were framed across institutional texts.

The most frequently used motivational frame overall was “human health,” making up 20.9% of all frames identified. This was followed by “animal health and welfare” at 18.2% and “food production and security” at 14.5%. Notably, frames appealing to self-interest, those that might directly motivate behavior change among farmers or agricultural workers, were rarely present.

“Pushback from industry stakeholders continues to hinder progress on antimicrobial resistance policies in livestock,” Ching said in our email interview. “Framing and language choices are critical tools to build political legitimacy and end-user support.”

When asked how self-interest framing could be responsibly applied in public health communications, Ching explained, “Public health communicators can operationalize self-interest framing by emphasizing direct benefits to the target audience that align with scientific evidence. Sharing personal stories from other producers who have successfully reduced antimicrobial use can also help build trust and relevance. As such, cocreation with farmers, producers, veterinarians, and other stakeholders is important to improve resonance and accuracy. Importantly, farmers are also part of the wider community and thus act with overlapping agency, so connecting individual benefits to broader core public health outcomes can bolster messaging.”

The analysis also uncovered notable institutional differences in framing priorities. “We analyzed documents published by the Quadripartite Joint Secretariat on AMR. In reviewing documents from the FAO and WOAH, we found each organization focused on different priorities,” Ching said. “FAO emphasized ‘food production and security,’ while WOAH focused more on ‘animal health and welfare’ and rarely used the food-related frame. This makes sense to some degree, as it aligns with their respective missions.”

However, the team noted that a dominant use of one animal-related frame often came at the expense of others. “Across all documents, we noticed that when one of these animal-specific frames was used more, the other was used less. Interestingly, both organizations also frequently used the collective ‘human health’ frame more than a second animal-specific one. This suggests a tendency to focus on one main animal-related reason for addressing antimicrobial resistance rather than balancing multiple motivations.”

Ching also discussed the importance of cultural and sector-specific messaging. “In terms of sector or culturally tailored messaging, while human and animal health are connected in a One Health approach, the expectations are often different,” she noted. “In agriculture and farming, there is a push to be voluntarily better than standard practices, while in human health care, clinical guidelines pertaining to antimicrobial use are standard. Therefore, calling normal farm practices ‘misuse’ can confuse or upset farmers, since these are common in their context. Farming norms can also vary by country. To build trust and cooperation, it’s important to use inclusive, nonblaming language that respects different practices and avoids implying one region has superior practices.”

The study concludes with practical recommendations aimed at refining AMR policy communication strategies: increasing the use of self-interest frames, making messaging more accessible, and explicitly addressing underlying assumptions that may not align with agricultural realities.

When asked how these findings could shape future AMR action plans under the One Health framework, Ching emphasized, “From our findings, we recommend creating messages that are more personally relevant to the end-user, using clear language, and choosing frames that support global interests and cooperation. Although our focus was on reducing indiscriminate antibiotic use in food-producing animals, we found that One Health messaging still leans heavily toward human health, with less attention to the other sectors, including the environment. Thus, a conscious effort still needs to be made to present and uphold an integrated perspective of all One Health domains. Finally, these recommendations should be adapted to local contexts with input from key stakeholder groups, including end-users.”

Reference
Ching C, Zaman MH, Wirtz VJ. Policy discourse on AMR in food-producing animals: examining framing and language for effective communication. 

Analysis by Carly Ching, PhD, reveals that global AMR policies overemphasize human health while neglecting farmer-focused messaging that could improve adoption and impact.

Study Results Find AMR Policy Messaging Misses the Mark With Agricultural Stakeholders

On June 17, 2025, the US Food and Drug Administration approved a new prefilled syringe presentation of recombinant zoster vaccine, adjuvanted (Shingrix) developed by GSK for the prevention of shingles (herpes zoster). The approval follows a regulatory review of data demonstrating the comparability of the prefilled syringe with the current reconstituted format.

The new format removes the need for health care providers to manually reconstitute the vaccine before administration, offering a more convenient delivery method. The vaccine’s composition, glycoprotein E antigen combined with the AS01B adjuvant system, remains unchanged.

Since its initial US approval in 2017, more than 90 million doses of zoster vaccine have been distributed across the country. It is indicated for use in adults 50 years or older as well as adults at increased risk due to immunodeficiency or immunosuppression.

Shingles, caused by the reactivation of varicella-zoster virus (VZV), affects approximately 1 million Americans annually. By age 50, most adults carry latent VZV, and age-related immune decline increases the risk of developing shingles.

Shingles is a painful rash illness caused by reactivation of the VZV—the same virus responsible for chickenpox. It typically begins with tingling, pain, or itching, followed by a blistering rash on one side of the body or face that heals in 2 to 4 weeks. Although most recover fully, the most common complication is postherpetic neuralgia, a severe, long-lasting nerve pain that affects 10% to 18% of patients with shingles, especially older adults. Other rare but serious complications include vision loss, bacterial infections, pneumonia, encephalitis, and even death. Vaccination is recommended to reduce risk and severity.

The new presentation supports broader access and ease of administration, aligning with GSK’s strategy to optimize delivery of preventive vaccines in aging and immunocompromised populations.

1. US FDA approves GSK’s SHINGRIX in a prefilled syringe presentation. News release. GSK plc. July 17, 2025. Accessed July 17, 2025. https://www.businesswire.com/news/home/20250717301201/en/US-FDA-Approves-GSKs-SHINGRIX-in-a-Prefilled-Syringe-Presentation

2. Shingles (herpes zoster). Centers for Disease Control and Prevention. Accessed July 17, 2025. https://www.cdc.gov/shingles/index.html


New format eliminates reconstitution step, offering greater convenience for providers and supporting expanded access for at-risk adults.

Margie Lee, DVM, MS, PhD

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