In an update in the ongoing, national listeria outbreak associated with deli meat, the US Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today that deli food manufacturer, Boar’s Head, is recalling all liverwurst product that is currently available in commerce because it may be adulterated with listeria. In addition, the company is also recalling deli meat products that were produced on the same line and on the same day as the liverwurst and, therefore, may be contaminated. Overall Boar’s Head, is recalling approximately 207,528 pounds of products.¹

FSIS is working with the Centers for Disease Control and Prevention (CDC) and state public health partners to investigate the multistate outbreak of listeria infections linked to meats sliced at delis. As of July 25, 34 sick people have been identified in 13 states, including 33 hospitalizations and 2 deaths.¹

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS).²

WGS showed that bacteria from sick people’s samples are closely related genetically. This suggests that people in this outbreak may have gotten sick from eating this food.²

The products subject to recall were distributed to retail deli locations nationwide. The products shipped to deli retailers bear establishment number “EST. 12612” inside the USDA mark of inspection on the product labels.¹

The problem was discovered when FSIS was notified that a sample collected by the Maryland Department of Health tested positive for listeria. The Maryland Department of Health, in collaboration with the Baltimore City Health Department, collected an unopened liverwurst product from a retail store for testing as part of an outbreak investigation of listeria infections. Further testing is ongoing to determine if the product sample is related to the outbreak. Anyone concerned about illness should contact a healthcare provider. ¹

The Products affected include:

• 3.5-lb. loaves in plastic casing, or various weight packages sliced in retail delis, containing “Boar’s Head Strassburger Brand Liverwurst MADE IN VIRGINIA.” The products shipped to retailers bear sell by dates ranging July 25, 2024, to Aug. 30, 2024, printed on the side of the packaging.
• 9.5-lb. and 4.5-lb. full product, or various weight packages sliced in retail delis, containing “Boar’s Head VIRGINIA HAM OLD FASHIONED HAM” with sell by date “AUG 10” on the product packaging.
• 4-lb., or various weight packages sliced in retail delis, containing “Boar’s Head ITALIAN CAPPY STYLE HAM” with sell by date “AUG 10” on the product packaging.
• 6-lb., or various weight packages sliced in retail delis, containing “Boar’s Head EXTRA HOT ITALIAN CAPPY STYLE HAM” with sell by date “AUG 10” on the product packaging.
• 4-lb., or various weight packages sliced in retail delis, containing “Boar’s Head BOLOGNA” with sell by date “AUG 10” on the product packaging.
• 2.5-lb., or various weight packages sliced in retail delis, containing “Boar’s Head BEEF SALAMI” with sell by date “AUG 10” on the product packaging.
• 5.5-lb., or various weight packages sliced in retail delis, containing “Boar’s Head STEAKHOUSE ROASTED BACON HEAT & EAT” with sell by date “AUG 15” on the product packaging.
• 3-lb., or various weight packages sliced in retail delis, containing “Boar’s Head GARLIC BOLOGNA” with sell by date “AUG 10” on the product packaging.
• 3-lb., or various weight packages sliced in retail delis, containing “Boar’s Head BEEF BOLOGNA” with sell by date “AUG 10” on the product packaging.¹

Symptoms and Treatment

Listeria in healthy people may have short-term symptoms such as a fever, headache, stiffness, and gastrointestinal discomfort, including diarrhea. However, in children, seniors, and people with weakened immune systems, this foodborne infection can be more severe and could be fatal in some cases. The infection can also cause miscarriages and stillbirths in pregnant women. For anyone who is suffering these symptoms after eating these products, they are recommended to contact a healthcare provider right away.³

In terms of treatment, for those with mild symptoms, no treatment is required, but severe or serious infections can be treated with antibiotics, according to the Mayo Clinic. Additionally, during pregnancy, prompt antibiotic treatment might help keep the infection from affecting the baby Mayo writes on its site.³

For consumers with questions regarding the recall can contact Boar’s Head Provisions Co., Inc., Customer Service at 1-800-352-6277. Media with questions can contact Elizabeth Ward, vice president of communications, Boar’s Head Provisions Co., Inc., at media@boarshead.com.

For any anyone who purchased these products they are recommended to either return them to the place of purchase or discard.

References

1. Boar’s Head Provisions Co. Recalls Ready-To-Eat Liverwurst And Other Deli Meat Products Due to Possible Listeria Contamination. July 26, 2024. Accessed July 26, 2024.
https://www.fsis.usda.gov/recalls-alerts/boars-head-provisions-co–recalls-ready-eat-liverwurst-and-other-deli-meat-products
2. Investigation Details. CDC July 19, 2024. Accessed July 20,2024.
https://www.cdc.gov/listeria/outbreaks/delimeats-7-24/details.html
3. Parkinson J. Chicken Recall Due to Possible Listeria Contamination. Contagion. July 9, 2024. Accessed July 20, 2024.
https://www.contagionlive.com/view/chicken-recall-due-to-possible-listeria-contamination

High Rates of HCV Reinfection in NYC

Over nearly two decades, a study conducted in New York City has revealed high rates of Hepatitis C virus reinfection among men who have sex with men and have HIV. Published in Clinical Infectious Diseases, research by Daniel S Fierer, MD, Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai underscores that sexual transmission of HCV is far from uncommon or inefficient in this population. Despite the availability of direct-acting antiviral treatments, the study found these alone are insufficient to eliminate HCV among MSM in NYC.

SHEA Advocates for CDC Funding Amid Antimicrobial Resistance Concerns

The CDC published new data concerning the prevalence of seven key antimicrobial-resistant pathogens in healthcare settings. The report highlights a notable increase in infections linked to the COVID-19 pandemic, which strained healthcare systems and led to longer hospital stays, disrupted infection control practices, and increased inappropriate antibiotic usage. This resulted in a peak in antimicrobial resistance (AR) during 2021, followed by a decline due to aggressive public health interventions. Comparative data indicate a 20% rise in hospital-onset infections from six bacterial pathogens during the pandemic, with rates remaining elevated into 2022. In response to the CDC’s new findings, Thomas R Talbot, III, MD, MPH, FSHEA, president of the SHEA Board of Trustees, discussed with Contagion SHEA’s proactive efforts to ensure ongoing funding for CDC programs aimed at combating AR.

Can Daily Doxycycline Prevent STIs?

In recent years, doxycycline post-exposure prophylaxis (Doxy-PEP) has emerged as a significant intervention in the prevention of sexually transmitted infections, particularly among high-risk populations like men who have sex with men, transgender women, and others vulnerable to antibacterial STIs. The CDC now recommends offering a prescription for Doxy-PEP to be self-administered within 72 hours following oral, vaginal, or anal sex, with a suggested dose of 200mg and a maximum of 200mg every 24 hours. Additionally, ongoing research, including a pilot study presented by Troy Grennan, MD, MSc, FRCPC at the International AIDS Society 2024 conference, explores the feasibility and efficacy of daily doxycycline or doxy-PrEP as a preventive measure against STIs.

Efficacy of the Antibiotic Omadacycline in Treating Pneumonia

Paratek Pharmaceuticals, Inc. has released findings from a phase 3 clinical trial assessing the efficacy of omadacycline (Nuzyra), an oral and intravenous antibiotic taken once daily, for treating moderate to severe community-acquired bacterial pneumonia (CABP). The study, which enrolled 670 high-risk patients, compared omadacycline with moxifloxacin, a standard treatment, demonstrating its potential as a significant therapeutic option for managing this critical respiratory illness. Randy Brenner, Paratek’s chief development and regulatory officer, underscored the importance of these results.

The Evolution of Lenacapavir

Gilead released a statement yesterday afternoon to clarify some of the ongoing events at the conference and the calls to make lenacapavir widely available at a discounted price. In the statement the company started by saying lenacapavir is not available anywhere in the world. However, they did say in the statement that, the regulatory filing for lenacapavir for HIV prevention will include the results of both PURPOSE 1 and PURPOSE 2, if positive, to ensure lenacapavir for HIV prevention can be approved for multiple populations and communities most in need of additional HIV prevention options. Gilead expects results from PURPOSE 2 in late 2024/early 2025.

We want to welcome you to the third episode from our complicated UTI roundtable series, which is a collaborative effort that includes Contemporary Pediatrics, Contagion, and Contemporary OB/GYN. This series looks to discuss several topics around these infections including diagnosis, treatment, challenges in managing UTIs in patients with dementia and neurogenic bladders, antibiotic resistance, and considerations for patients and caregiver engagement.

Our panel of clinicians includes:

• Barbara Trautner, MD, PhD, professor, Infectious Diseases, Section of Health Services Research, Baylor College of Medicine
• Kimberly Claeys, PharmD, PhD, associate professor of Practice, Sciences, and Health Outcomes Research, University of Maryland Baltimore
• Laila Woc-Colburn, MD, associate professor, Division of Infectious Diseases, Emory University School of Medicine

This is a 3-part series, and in today’s episode, the clinicians discuss new therapeutic agents, either in late stage development or recently approved, as well as consideration for patients and caregiver engagement in terms of diagnosis or treatment.

“As we talk about complicated UTIs vs uncomplicated [UTIs] and vs asymptomatic bacteriuria, the question becomes, are the FDA guidance documents with a composite endpoint appropriate for the actual approval of these drugs, or should we be looking at more clinically based?”

— Kimberly Claeys, PharmD, PhD

Click here for episode 1

Click here for episode 2

This roundtable is part of ongoing educational and informational multimedia series we are producing and for any feedback or suggestions, please feel free to email John Parkinson at jparkinson@mjhlifesciences.com.

Effective responses to the COVID-19 pandemic and its aftermath necessitate ongoing challenges and adaptations.

Image credits: Unsplash

On July 23, 2024, the most recent edition of the Annals of Family Medicine includes three significant studies addressing different facets of COVID-19. These studies explore topics from potential treatments and the prevalence of post-COVID conditions to the pandemic’s impact on primary care and the use of telehealth. They provide valuable insights for healthcare professionals and policymakers grappling with the enduring challenges of the pandemic.¹

Study 1: Post-COVID Conditions in US Primary Care

This first study aimed to quantify the burden of post-COVID conditions (PCC) among adult patients diagnosed with COVID-19 across the US since COVID-19 is known to potentially lead to other chronic conditions, highlighting issues such as breathing difficulties, fatigue, and sleep disturbances. According to clinical registry data, the prevalence of these conditions among primary care patients appears to be lower compared to what has been reported in subspecialty and hospital settings.²

The study analyzed 28,215 COVID-19 patients and 235,953 with influenza-like illness (ILI), higher rates of conditions were observed in COVID-19 patients: breathing difficulties (4.2% vs 1.9%), type 2 diabetes (12% vs 10.2%), fatigue (3.9% vs 2.2%), and sleep disturbances (3.5% vs 2.4%).²

“Our findings suggest that in the primary care setting, PCC occurred slightly more often than similar conditions that occurred after ILI or wellness visits, although these differences were modest,” according to the investigators. “PCC symptoms were captured for only 12% of patients after COVID-19 infection. Our findings also suggest that the prevalence of PCC in this health care setting is less than 12% for the 17 assessed diagnostic categories at 6 months of follow-up.”²

The study, utilizing the American Family Cohort, matched patients using propensity scores, examining 17 condition categories across 2020-2021 COVID-19 patients compared to 2018 influenza-like illness and 2020-2021 wellness visit control groups.²

Study 2: Nirmatrelvir/Ritonavir Treatment for COVID-19

The effectiveness and safety of the approved nirmatrelvir/ritonavir (N/R) regimen for treating mild to moderately severe COVID-19 remain uncertain. Initial findings suggest N/R may reduce COVID-19 hospitalizations.³

“These findings should be interpreted with caution given the limited evidence, particularly for RCTs, and the heterogeneous evidence, particularly for RWS. In addition, the findings might not be generalizable,” according to the investigators.³

The review analyzed 4 randomized controlled trials (RCTs) with 4,070 participants and 16 real-world studies (RWS) involving 1,925,047 adults. RCTs showed mixed results on hospitalizations with N/R compared to placebo or no treatment (RR = .17; 95% CI, .10-.31), while real-world studies indicated lower hospitalizations (RR = .48; 95% CI, .37-.60) and all-cause mortality (RR = .24; 95% CI, .14-.34) with N/R versus no treatment. A random-effects model pooled data from RCTs and RWS, highlighting variability (I2 statistic) and the need for further studies to determine N/R’s efficacy and safety for COVID-19 treatment.³

Study 3: Primary Care Disruption and Telehealth Usage During COVID-19

The pandemic worsened existing healthcare disparities and access to primary care. The study aimed to quantify the nationwide decline in primary care visits and increase in telehealth use during this period, examining if certain patient groups were disproportionately affected. Primary care visits decreased significantly, while telehealth use rose across all patient groups, with varying degrees of change based on patient characteristics.⁴

A study aimed to quantify the nationwide decline in primary care visits and the rise in telehealth during the pandemic, focusing on how specific patient groups were affected. Findings revealed a 7% decrease in total visit volume and a 17% decrease in in-person visits, offset by a 10% increase in telehealth utilization across patient groups. Significant drops in visit volume were noted among pediatric patients (−24%), Asian patients (−11%), and those with multiple comorbidities (−9%). Telehealth use was highest among Hispanic or Latino patients (17%) and urban residents (12%).⁴

According to the investigators, “Decreases in well-child visits have been linked to lower vaccination rates and increases in mental health crises, though it is unclear whether well-child visits were affected as much as other types of pediatric care. Decreases in well-child visits have been linked to lower vaccination rates and increases in mental health crises. Though it is unclear whether well-child visits were affected as much as other types of pediatric care.”⁴

Researchers used electronic health records from 1,652,871 patients in 408 practices to analyze changes in visit volume and telehealth adoption. They explored correlations with patient characteristics such as age, gender, race, ethnicity, comorbidities, rural or urban residence, and area-based social deprivation levels.⁴

In conclusion, the Annals of Family Medicine studies offer insights into COVID-19’s impact on healthcare. They are exploring long-term health effects post-infection, treatment efficacy, and changes in healthcare delivery. Healthcare professionals and policymakers should use these insights to strengthen healthcare systems, ensuring fair access and prepared responses for future health crises. These studies are important for informed decision-making and proactive healthcare planning during ongoing COVID-19 uncertainties.

References

1. Annals of Family Medicine: New COVID-19 Research Studies Provide Latest Insights into Post-COVID Conditions, Potential Treatment, and Impact on Primary Care and Telehealth Utilization. PRNewswire. Published July 23, 2024. Accessed July 24, 2024. https://prnmedia.prnewswire.com/news-releases/annals-of-family-medicine-new-covid-19-research-studies-provide-latest-insights-into-post-covid-conditions-potential-treatment-and-impact-on-primary-care-and-telehealth-utilization-302204402.html

2. Velásquez E, Kamdar N, Rehkopf D, et, al. Post-COVID Conditions in US Primary Care: A PRIME Registry Comparison of Patients With COVID-19, Influenza-Like Illness, and Wellness Visits. The Annals of Family Medicine. Published July 22, 2024. Accessed July 24, 2024.DOI: https://doi.org/10.1370/afm.3131

3. Okoli G, Askin N, Rabbani R. Nirmatrelvir/Ritonavir Regimen for Mild/Moderately Severe COVID-19: A Rapid Review With Meta-Analysis and Trial Sequential Analysis. The Annals of Family Medicine. Published July 22, 2024. Accessed July 24, 2024. DOI: https://doi.org/10.1370/afm.3120

4. Morgan Z, Bazemore A, Peterson L, et, al. The Disproportionate Impact of Primary Care Disruption and Telehealth Utilization During COVID-19. The Annals of Family Medicine. Published July 22, 2024. Accessed July 24, 2024. DOI: https://doi.org/10.1370/afm.3134

HIV-1 Virus Particles Transmission electron micrograph of HIV-1 virus particles (colorized red) replicating from an HIV-infected H9 T-cell (blue).

Image credit: NIDID

In the last few years, Gilead’s lenacapavir (Sunlenca) has seen a lot of movement that include a CRL, FDA approval, potentially a new indication looking at HIV prevention, and even a call for it to become an HIV vaccine. Recent data coming from a trial in South Africa demonstrated its possible utility as an HIV prevention tool. And to add more intrigue to lenacapavir, during this week’s International AIDS Society 2024 conference, there has been a call to consider it as a potential HIV vaccine.

Multidrug Resistant Therapy

Lenacapavir was initially developed as therapy for adult patients living with HIV, whose infections could not be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. Multidrug resistance is an ongoing clinical management challenge, and in this space, there is limited options.

In March of 2022, Gilead received a complete response letter (CRL) from the FDA. The letter cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action.

The CRL was not reflective of the therapy itself.

“Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type. We look forward to discussing this further with FDA over the coming months so that we can make this investigational new therapy available to people living with multidrug-resistant HIV as soon as possible,” Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a statement at the time.¹

Gilead worked with the FDA to provide the federal agency with the information and compliance that was needed, and when it was FDA approved in December 2022, it was a welcome addition for patients and clinicians.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement when it was approved.¹

Lenacapavir is the first of a new class of therapies called capsid inhibitors to be FDA-approved for treating HIV. This antiretroviral works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle. The approval was based from the data of the CAPELLA study, which was a double-blinded, placebo-controlled global multicenter trial designed to evaluate lenacapavir when administered every 6 months as a subcutaneous injection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV infection.¹

Overall, 72 participants were enrolled with 36 in each of the 2 cohorts. In terms of the makeup of the participants, 25% were female, 38% Black, the median age 52 years, 19% had VL > 100k c/mL, 64% had CD4 <200 cells/μL, 46% had HIV-1 resistant to all 4 major classes (NRTI, NNRTI, PI, INSTI), and 17% did not have any fully active agents in the optimized background regimen (OBR).¹

In cohort 1 (randomized group), participants were assigned (2:1) to add oral lenacapavir or placebo to their failing regimen (600 mg on Day 1[D] and 2 and 300 mg on D8). At Day 15, those on oral lenacapavir received subcutaneous (SC) lenacapavir 927 mg every 6 months; those on placebo started the 2 week oral lead-in, followed by SC Q6M. All randomized participants initiated an investigator-selected, OBR at D15 the investigators explained.¹

In cohort 2 (non-randomized group), the participants started OBR concurrent with lenacapavir (oral lead-in → SC). The investigators reported the secondary endpoint of W52 efficacy by FDA-snapshot algorithm in the randomized cohort and additional available efficacy and safety from both cohorts.¹

Earlier this year, new data was presented at the CROI meeting that demonstrated treatment benefits over a 2-year period from the phase 2/3 CAPELLA trial evaluating the lenacapavir.²

“We found even as far out as two years or the so called 104 [week] data, that about 82% of individuals—when we excluded those who are missing— were virologically suppressed…that’s unheard of numbers for this kind of patient population,” Onyema Ogbuagu, MBBCh, FACP, FIDSA, director of HIV Clinical Trials program at Yale School of Medicine, and principal investigator on the trial said in an earlier interview with Contagion. “We have other studies with other agents that have shown lower rates of treatment success with these kinds of patients.”²

Read more: Examining a Newer Therapy for Heavily Treated HIV Patients

HIV Prevention

One of the bigger developments around the antiviral has been the recent data related to lenacapavir as a potential HIV prevention tool.

Last month, the company announced significant findings from its phase 3 PURPOSE 1 trial, that showed a 100% efficacy in preventing HIV infection among cisgender women. The trial included more than 5300 participants from both South Africa and Uganda.³

The second phase of the study will span from 1 to 3 years, with participant visits occurring every 4-13 weeks, totaling between 4 and 8 visits annually. Each participant in this phase will receive both a daily pill and a semiannual injection, with one containing the active drug and the other serving as a placebo.³

Read more: Lenacapavir’s 100% Efficacy: Gilead’s Step Towards HIV Prevention

A Possible Vaccine?

At the ongoing IAS HIV conference, a poster presented by Fortunak et al and coinvestigators offered some analysis looking at utilizing lenacapavir as a vaccine. Specifically, they wrote it could be mass-produced under a voluntary license for approximately $40 per person year at scale. They said lenacapavir is currently charging $40,000 per person-year for it in high-income countries.⁴

They put forth 2 hypothesis: could the lenacapavir injectable be priced at $100 person-year at a committed demand of 1 million people per year; or could the Cost of Goods (COS) eventually be competitive with oral PrEP?⁴

Lenacapavir has both oral and injectable modalities currently in usage.

It remains to be seen how Gilead views these hypotheses; however, from today’s press statement, it appears the company is planning to move forward with a strategy to utilize lenacapavir as PrEP. “Gilead is building an access strategy that prioritizes speed and enables the most efficient path for the regulatory approval of twice-yearly lenacapavir for PrEP in countries that account for most of the global disease burden.”⁵

References
1.Sunlenca (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV. Gilead news statement. December 22, 2022. Accessed July 24, 2024.
https://www.contagionlive.com/view/fda-approves-lenacapavir-for-hiv-treatment

2.Parkinson J. Examining a Newer Therapy for Heavily Treated HIV Patients. Contagion. March 7, 2024. Accessed July 24, 2024.

3. Gilead’s Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention. GILEAD Press Release. Published June 20, 2024. Accessed July 24, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/6/gileads-twiceyearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention

4. Fortunak K, et al. Generic production of lenacapavir targeting under $100 PPPY[1]: Analysis of the Active Pharmaceutical Ingredient. Presented at International AIDS Conference 2024. July 22-26, 2024. Munich, Germany. LB40.

5. Full Efficacy and Safety Results for Gilead Investigational Twice-Yearly Lenacapavir for HIV Prevention Presented at AIDS 2024. Gilead press release. July 24, 2024. Accessed July 24, 2024.
https://www.gilead.com/news-and-press/press-room/press-releases/2024/7/full-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024