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Garges is the Chief Medical Officer of ViiV Healthcare. 

New data at CROI 2025 shows zero cases of HIV acquisition reported with Apretude (cabotegravir long-acting (CAB LA) for PrEP in varied clinical settings and populations in 2 implementation studies in the US and Brazil.

Apretude PrEP Shows High Efficacy, Safety in Diverse Studies

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

New pharmacokinetic data from CROI 2025, shared by Moupali Das, reveal long-lasting plasma concentrations, surpassing twice-yearly subcutaneous formulation for HIV prevention

Once-Yearly Lenacapavir Formulations Show Sustained Efficacy for HIV PrEP in Phase 1 Study

At the CROI 2025, Moupali Das, MD, MPH, vice president of HIV prevention and virology pediatrics at Gilead Sciences, discussed new findings from a Phase 1 study investigating two formulations of once-yearly intramuscular (IM) lenacapavir for HIV pre-exposure prophylaxis (PrEP). These results, published simultaneously in 

, present significant progress in the fight against HIV and could pave the way for a new class of long-acting prevention options.

Comparing Once-Yearly and Twice-Yearly Formulations of Lenacapavir

In the Phase 1 study, participants received a single dose of 5000 mg of either formulation 1 (with 5% ethanol) or formulation 2 (with 10% ethanol), administered via intramuscular injection. Both formulations demonstrated promising pharmacokinetic profiles, with concentrations of lenacapavir maintained at levels above the threshold associated with efficacy for over 56 weeks.

Das explained, “The bottom line is, the formulations compare quite well. The pharmacokinetics data show that these once-yearly formulations of lenacapavir last longer than 52 weeks—specifically, 56 weeks—and remain above the 95% effective concentration.”

Key results from the study included median trough concentrations at Week 52 of 57 ng/mL (for formulation 1) and 65.6 ng/mL (for formulation 2), both of which surpassed the median trough concentration observed in the twice-yearly subcutaneous (SC) formulation (23.4 ng/mL at Week 26 from previous PURPOSE trials). These results highlight that the once-yearly formulations not only last longer but also maintain higher plasma concentrations compared to the twice-yearly SC formulation.

The study confirmed that these high concentrations were sustained throughout the 56-week period. The median peak plasma concentration for formulation 1 was 247 ng/mL while formulation 2 had a higher peak at 336 ng/mL, which remained well above the highest concentration observed for the twice-yearly SC formulation (67.3 ng/mL).

Injection Site Reactions and Safety Profile

As with many injectables, injection site reactions are a key consideration in any clinical trial. In this study, the most common adverse event reported was injection-site pain, a result consistent with what has been seen with other long-acting injectable formulations. According to Das, “The most common side effect was injection-site pain, which is not surprising. In our study, 80% of people receiving formulation 1 and 75% with formulation 2 reported some pain at the injection site. It was mostly mild to moderate and resolved within a few days.”

Das also noted that pre-treatment with ice, a strategy proven useful in earlier studies with the twice-yearly SC formulation, helped reduce the pain associated with the injections. “Pre-treatment with ice, as we used in the PURPOSE trials, was effective in reducing injection-site pain, and we continued that in this study.”

The safety profile of the once-yearly formulations was consistent with what has been observed in prior lenacapavir studies. No severe adverse events or abnormal lab findings were reported, indicating that both formulations of lenacapavir were well tolerated.

Given the encouraging data from the Phase 1 study, Das outlined the next steps in the development of once-yearly lenacapavir for HIV PrEP. “We’re continuing to monitor plasma concentrations and safety, and we plan to initiate a Phase 3 trial later this year to determine which formulation we will pursue for further development,” Das explained. “These findings are very promising, and we are hopeful that once-yearly lenacapavir will eventually become a viable option for HIV prevention.”

Das emphasized that lenacapavir’s flexibility—offering potential formulations in daily oral, weekly oral, and long-acting injectable forms—could help address a variety of patient needs. “Lenacapavir is a unique molecule with multiple ways to be used in HIV prevention, from oral tablets to long-acting injectables,” she said. “We’re particularly excited by the potential of the once-yearly injectable, as it could address adherence challenges many individuals face with daily regimens or more frequent injectable options.”

“Many people face challenges when it comes to daily pills or even something more frequent like monthly injections,” Das said. “We’re hopeful that if the once-yearly formulation is approved, it will improve adherence, help people stay on PrEP, and ultimately reduce new HIV infections globally.”

The Phase 1, open-label study included 40 healthy adult participants aged 18-55 years. Participants were divided into two groups, with one group receiving formulation 1 (5% ethanol) and the other receiving formulation 2 (10% ethanol). The study followed participants for up to 56 weeks, measuring plasma concentrations of lenacapavir at multiple time points, from baseline to Week 56. The pharmacokinetic parameters assessed included the area under the concentration-time curve (AUC), peak plasma concentration, and trough concentration (Ctrough).

The study's results were compared to data from the PURPOSE 1 and PURPOSE 2 Phase 3 trials, which evaluated twice-yearly subcutaneous lenacapavir for HIV prevention. As noted, the once-yearly IM formulations not only sustained higher concentrations for a longer period but also demonstrated safety and tolerability profiles in line with previous findings.

Gilead Sciences, Inc. First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in 

. March 11, 2025. Accessed March 11, 2025. 

https://www.gilead.com/news/news-details/2025/first-clinical-data-for-gileads-investigational-once-yearly-lenacapavir-for-hiv-prevention-presented-at-croi-2025-and-published-in-the-lancet

Jogiraju V, Pawar P, Yager J, et al. Pharmacokinetics and safety of once-yearly lenacapavir: a phase 1, open-label study. 

. Published March 11, 2025. doi: 10.1016/S0140-6736(25)00405-2

New pharmacokinetic data, shared by Moupali Das, MD, MPH, reveal long-lasting plasma concentrations, surpassing twice-yearly subcutaneous formulation for HIV prevention

Conferences

Gilead's Once Yearly Lenacapavir Formulations Show Sustained Efficacy for HIV PrEP in Phase 1 Study

Investigators found they could reduce the once-daily (OD) dosing of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; Biktarvy; Gilead) from OD up to 3 weeks safely and effectively over a nearly a year time period.

“In virally suppressed [people with HIV] on [BIC/FTC/TAF] BETAF OD, the strategy of reducing the BETAF OD dose to 3W, 2W, or 1W for 48 weeks was safe, well tolerated, and effective as compared with continuing OD,” the investigators wrote.

 The findings were presented as a poster at 

, held March 9-12, in San Francisco, California.

BIC/FTC/TAF in the small pilot study encompassed 40 participants with well-controlled HIV. Individuals were randomized (n = 10 per arm) to: OD, 3W (Mon-Wed-Fri), 2W (Tue-Fri), or 1W (Wed) with visits at baseline and 4, 12, 24, 36, and 48 weeks.

The investigators had strict criteria for dissolution of both the arms and individual participants.

“Individuals with viral failure (confirmed VL ≥50 c/mL) underwent genotypic resistance testing and were switched to OD up to 48 weeks,” the investigators wrote. “We measured ultrasensitive VL; total, defective, and intact HIV reservoir (IPDA); CD4 and CD8 cells; hsCRP and IL-6; and plasma and intracellular trough drug levels at baseline, 12, and 48 weeks. The stopping rule was >30% viral failure in any of the dose reduction arms.”

In terms of viral rebound, 3 participants experienced the phenomenon, with 2 of them coming from the 1-week cohort and 1 coming from the 3-week cohort. The investigators reported no resistance mutations developed, and viral suppression was restored after they went back to OD dosing.

"There were no significant differences in ultrasensitive VL, HIV reservoir, CD4 or CD8 cells, and hsCRP or IL-6 among arms. Although trough plasma and intracellular drug levels significantly decreased in 3W, 2W, and 1W relative to OD at 12 and 48 weeks, mean trough levels at 12 and 48 weeks in 3W and 2W, but not in 1W, were generally above the known inhibitory concentrations," the investigators wrote.

FDA approved the Gilead ART back in February 2018. At the time of the approval, the company said the following in its press release: “Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy (FTC/TAF) dual nucleoside reverse transcriptase inhibitor backbone, and is the smallest INSTI-based triple-therapy STR available.”

1. Chivite I, et al. Safety, Tolerability, and Efficacy of a BIC/FTC/TAF Dose Reduction Strategy. Poster #659 presented at CROI 2025. March 9-12, 2025, San Francisco, California.
2. Rosa K.FDA Approves Bictegravir for HIV-1. 

February 7, 2018. https://www.contagionlive.com/view/fda-approves-bictegravir-for-hiv



In a small study, investigators found they could reduce the antiretroviral therapy (ART) dosing to longer durations and the treatment remained safe and efficacious.

Exploring Novel Dosing Strategies by Reducing Once Daily Biktarvy

Annie Antar, MD, PhD, offers some insights as to why some individuals develop this condition.  

Does Slow Viral Clearance and Viral Rebound During Infection Contribute to Long COVID?

The pathogenesis in how Long COVID developing remains a mystery and truly undefined as to why some people become afflicted by this condition and why others do not. However, investigators are gathering clues towards increasing evidence of how it takes hold.

Annie Antar, MD, PhD, assistant professor of medicine, Johns Hopkins University School of Medicine believes there are 2 ways in which Long COVID might develop and they might be related. She has been examining how delayed viral clearance and viral rebound during acute COVID contribute to the development of Long COVID.

“I think what might be happening is there might be a two-hit hypothesis, where you have one hit, which is like you're in the minority of people who happen to have virus persist, but then something else happens, and then that's triggering you to develop the syndrome of Long COVID, while other people who have virus persisting don't feel the same way,” Antar said.

Antar and coinvestigators studied the relationship between severe COVID-19 viral dynamics during infection. Their findings were published in 

“We observed that slower viral clearance rates during acute COVID-19 were associated with increased risk and more symptoms of Long COVID. Early viral-host dynamics appear to be mechanistically linked to the development of Long COVID,” Antar and her coauthors wrote.

In terms of biomarkers to help predict Long COVID risk, Antar believes IgA autobody response could be one that is involved, but she acknowledges it could be multifactorial.

“I do think that probably IgA antibody response is a big part of that. There are other parts of your immune system that are involved in clearing virus and viral antigen, things like macrophages, can clear viral antigen from the tissue and destroy it, and also help prompt more of an immune response. So it could be antibody responses, it could be weakened T cell responses, it could be weakened kind of innate responses, things like macrophages that it should be patrolling. So I think all those things are probably involved. And, in terms of biomarkers, the virus itself is a great biomarker," Antar said.

Ultimately, the understanding of the pathogenesis is still undetermined, but they are getting closer to understanding it. Antar will presenting data from her published paper at 

1.Herbert C, Antar AAR, Broach J, et al. Relationship Between Acute SARS-CoV-2 Viral Clearance and Long COVID-19 (Long COVID) Symptoms: A Cohort Study. 

. 2025;80(1):82-90. doi:10.1093/cid/ciae539

Annie Antar, MD, PhD, offers insights around her research on her findings on this subject.

Nilu Goonetilleke, LLBHons, BScHons, presents findings from the Phase I study, showing a 50% reduction in T cell response with age, while 85% of participants demonstrated strong immune responses.

The M&M Study: Age-Related T Cell Response in People with HIV on ART in MVA.HIVconsvX Vaccine Trial

, held March 9-12, in San Francisco, California, Nilu Goonetilleke, LLBHons, BScHons, PhD, associate professor at UNC School of Medicine, discussed The M&M Study, a Phase I trial investigating the MVA.HIVconsvX vaccine. The vaccine uses a Modified Vaccinia Ankara (MVA) vector to express HIVconsvX immunogens and aims to induce HIV-specific T-cell responses. The study examined the impact of age on immune responses to the vaccine in people with HIV (PWH) on ART, which suppresses but does not cure the infection. The results showed that while age was associated with a reduced T-cell response, the vaccine was safe and induced T-cell responses across all age groups.

The study found that vaccination increased HIV-specific T-cell responses in PWH on ART, with 11% of participants showing new responses. The magnitude of the T cell response decreased with age, showing a 50% reduction over a 20-year period. Longer ART duration was positively associated with stronger T-cell responses, suggesting ART may help mitigate age-related immune decline. Virological assessments showed no significant changes in low-level viremia or total integrated DNA, though a modest increase in intact integrated DNA was observed.

This was a double-blind, randomized trial. There were 21 participants on ART for at least 24 months with CD4 counts above 350 cells/mm³ were vaccinated with MVA-based vaccines expressing Mosaic-1 (M3), Mosaic-2 (M4), or both (M3+M4), or a placebo. T-cell responses were assessed using IFN-γ ELISpot assays, and virological endpoints, including low-level viremia and integrated DNA, were evaluated. Linear regression was used to analyze the impact of age and ART duration on vaccine-induced T-cell responses.

The MVA.HIVconsvX vaccine demonstrated a strong safety profile, with all adverse events being mild and resolving within 24 hours. Goonetilleke explained, “These are what we describe as viral-vectored vaccines, and the MVA used in this study is an attenuated virus that cannot replicate. It’s been tested in elderly individuals and newborns and has always been shown to be safe.”

The study revealed that older individuals had a lower T-cell response to the vaccine. Goonetilleke discussed this finding, “It is well documented that as we age, our immune response generally weakens. For T-cell vaccines like the MVA.HIVconsvX, our bodies become less capable of producing a broad and diverse range of T-cells, which is vital for the success of vaccination.”

Goonetilleke also pointed out that longer durations on ART were linked to better immune responses. She said, “What was particularly interesting about this study was that people who had been on ART for a longer period had better immune responses, which suggests that ART may help mitigate the effects of aging on immune function.”

Goonetilleke remains optimistic about the potential for future HIV vaccines. She highlighted that the MVA.HIVconsvX vaccine induced a robust immune response in nearly 85% of participants, regardless of their age, which suggests strong potential for widespread vaccine applicability. “This is a vaccine designed to target the conserved regions of HIV, which is promising because it can work across a diverse population of PWH,” she said.

Looking ahead, Goonetilleke noted that strategies such as booster doses or modified vaccination regimens could enhance the immune response, particularly for older individuals. “For people who are older, we’re looking at doing boosting vaccinations or modifying the vaccine to better focus the immune response against HIV.”

Goonetilleke N, et al. Age inversely correlates with T-cell response to MVA.HIVconsvX vaccination in PWH on ART. Poster #425 presented at CROI 2025. March 9-12, 2025, San Francisco, California.

Nilu Goonetilleke, LLBHons, BScHons, presents findings from the phase 1 study, showing a 50% reduction in T cell response with age, while 85% of participants demonstrated strong immune responses.

At CROI 2025, Nilu Goonetilleke, LLBHons, BScHons, PhD, presents findings showing the bivalent HIVconsvX vaccine targets both Mosaic-1 and Mosaic-2, resulting in broader immune responses.

The CM Study: Bivalent HIV Vaccine Induces Stronger T Cell Responses in People with HIV on ART

, held March 9-12, in San Francisco, California, Nilu Goonetilleke, LLBHons, BScHons, PhD, associate professor at UNC School of Medicine, discussed The CM Study, a phase 1 trial investigating the ChAdOx1 and MVA-based HIVconsvX vaccine. The vaccine uses viral vectors to express the HIVconsvX immunogens, Mosaic-1 and Mosaic-2, and aims to induce HIV-specific T-cell responses in people with HIV (PWH) on ART. The study hypothesized that the bivalent regimen, including both immunogens, would elicit a stronger and broader T-cell response than the monovalent regimen. The findings showed that the bivalent vaccine induced a significantly greater T-cell response targeting both immunogens, supporting the hypothesis that a broader immune response could be achieved.

The study found that the monovalent (C62-M4) and bivalent (C1C62-M3M4) vaccine regimens were safe, with mild adverse events that resolved within 24 hours. The bivalent vaccine, which targets Mosaic-1 and Mosaic-2, induced higher T-cell responses, especially to Mosaic-1, at days 140 and 196, indicating a more sustained and broader immune response. The placebo group showed no significant changes in T-cell frequency.

This was a double-blind, randomized trial with participants on ART for at least 24 months and CD4 counts above 350 cells/mm³. The participants were divided into three groups: 

Group 1 received the monovalent vaccine (C62-M4)

Group 2 received the bivalent vaccine (C1C62-M3M4)

T-cell responses were measured using IFN-γ ELISpot assays, and virological endpoints, including low-level viremia and integrated DNA, were assessed. Linear regression was used to analyze the effect of ART duration on vaccine-induced T-cell responses.

Goonetilleke emphasized the safety profile of the vaccines, saying, “Both the MVA and ChAdOx1 vectors are attenuated viruses, meaning they cannot replicate. These viral vectors have been used safely in a variety of populations, including in smallpox vaccination and more recently in COVID-19 vaccines.”

Regarding the bivalent vaccine's effectiveness, Goonetilleke explained, “The bivalent regimen induced broader immune responses because it targets two different conserved regions of HIV. This could be crucial, as HIV is highly diverse and using multiple immunogens may help cover the variety of viral strains circulating within individuals.”

The study also revealed that participants in the bivalent group showed a stronger and more sustained immune response, particularly to Mosaic-1. Goonetilleke noted, “The bivalent vaccine produced responses to both Mosaic-1 and Mosaic-2, which suggests it could be more effective at targeting the diversity within the HIV reservoir.”

Looking ahead, Goonetilleke is optimistic about the implications for ART-free remission strategies. She added, “The fact that the bivalent vaccine induced a strong T-cell response in a small group of participants suggests that this approach could contribute to HIV cure strategies, especially in combination with other treatments.”

Future steps for this research include evaluating the vaccine’s effect on the HIV reservoir, with plans for post-hoc analyses to explore how age and ART duration impact T-cell responses. Goonetilleke concluded, “We are excited about further studies to refine these vaccines, especially in exploring how they can support ART-free remission for individuals living with HIV.”

Goonetilleke N, et al. ChAdOx1.HIVconsvX and MVA.HIVconsvX vaccination is safe and immunogenic in PWH on ART: The CM Study. Poster #428 presented at CROI 2025. March 9-12, 2025, San Francisco, California.

Nilu Goonetilleke, LLBHons, BScHons, PhD, presents findings showing the bivalent HIVconsvX vaccine targets both Mosaic-1 and Mosaic-2, resulting in broader immune responses.

Harmony Garges, MD, MPH

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