Jun 15, 2026 | By Brenda Sposato HTN Correspondent

VERO BEACH — When parents choose a pediatric provider, they’re doing more than selecting a doctor’s office. They’re choosing a trusted partner to help guide their child’s health and development from infancy through adolescence.

At Whole Family Pediatrics, that relationship is at the center of everything they do.

Serving families throughout Indian River and St. Lucie counties, the organization’s pediatric team focuses on providing comprehensive care while building lasting relationships with children and their families.

For Tiffany Poisson, Director of Clinical Services & Quality and a pediatric provider at Whole Family Pediatrics, the philosophy is simple.

“I want parents to know they can trust Whole Family Pediatrics to care for their children the same way we would care for our own family and feel confident in the services we provide,” Poisson said.

That approach extends beyond treating childhood illnesses, focusing on a child’s growth, development and overall well-being.

Dr. Lori Bowers said families who choose Whole Family Pediatrics are choosing more than a healthcare provider.

“When families choose us, they’re choosing a medical home where children are cared for in a collaborative environment and treated like family,” Bowers said.

A major focus of pediatric care is prevention. Providers say busy schedules and competing priorities can sometimes make it difficult for families to keep up with routine checkups and follow-up care. Through appointment reminders, flexible scheduling and a commitment to accessibility, the team works to make preventive care easier for parents.

Well-child visits, developmental screenings and routine assessments help identify concerns early while providing parents with guidance and support through every stage of their child’s development.

Whole Family Pediatrics also recognizes that caring for a child often means supporting parents and caregivers as well. In addition to pediatric services, the organization offers behavioral health services, nutritional counseling, transportation assistance, pharmacy services and support from a social services team.

Parents who may have felt rushed or overlooked in previous healthcare experiences often express appreciation for the time, attention and personalized care they receive at Whole Family Pediatrics.

The practice’s “Whole Family” approach allows providers to connect parents and caregivers with additional resources when needs arise, recognizing that healthy, supported adults are better equipped to raise healthy, thriving children. For families facing financial challenges, the organization also offers a sliding fee scale and assistance programs to help ensure children receive the care they need.

“We want every parent and child to feel heard, understood and valued,” Poisson said. “My hope is that every child leaves knowing they are cared for and every parent leaves feeling supported and confident in the guidance they’ve received.”

It’s a simple mission: helping children feel cared for and giving parents confidence that someone is walking alongside them every step of the way.

With locations at 840 37th Place in Vero Beach and 725 N. U.S. 1 in Fort Pierce, Whole Family Pediatrics is dedicated to providing accessible, compassionate care for Treasure Coast families.

An extension of Whole Family Health Center, Whole Family Pediatrics offers comprehensive healthcare for children from birth through adolescence, with a focus on preventive care, wellness and developmental support.

For more information, visit wholefamilypediatrics.org or call 772-918-9300.

Full Article at: Hometown News – Whole Family Pediatrics treats children like ‘our own family’

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It has been 30 years since Dr. Gerald Pierone Jr. opened the doors of Whole Family Health as a nonprofit medical facility dedicated to caring for people with HIV/AIDS on the Treasure Coast – patients who, at the time, had few options and even fewer advocates.

What began as a focused HIV/AIDS mission has since grown into a comprehensive community health center, now providing primary care, women’s health, pediatrics, behavioral health, and onsite pharmacy services, continually evolving to meet the changing needs of the community.

The extent of that growth recently made it clear that Whole Family Health needed more space. To accommodate expanding services, the organization launched its first-ever capital campaign to purchase and renovate a building on 37th Place, transforming it into a state-of-the-art medical facility for its newly opened Women’s Health and Pediatrics practices.

With renovations now complete and offices fully staffed, donors were invited to tour the space and see firsthand how their contributions are shaping the future of care on the Treasure Coast.

The newly renovated, 15,000-square-foot building allows Whole Family Health to significantly expand pediatric services, add adult exam rooms, enhance pharmacy operations, and launch its new Complete Women’s Health initiative.

The $5 million capital campaign supporting the facility represents a major milestone for the organization. To date, more than $1.5 million has been raised, with naming opportunities still available for future donors.

Because many supporters of Whole Family Health are not patients themselves, the private tours offered an important window into the impact of their generosity. Donors were struck by the pristine, modern clinical environment, the advanced equipment, and the welcoming atmosphere they are helping bring to the community.

Whole Family Health’s approach to expansion differs from many healthcare providers, according to CEO Marie Andress.

“We seek to own all of our facilities,” Andress said. “As a nonprofit exempt from real estate taxes, ownership becomes more cost-effective than leasing, which is a significant advantage in a low-margin field like primary care.

“Medical office space is expensive and highly specialized. Exam rooms require plumbing, electrical work, cabinetry, equipment and technology – and none of that is easily transferable. We prefer to invest in facilities we own rather than build out leased space we may eventually have to vacate.”

Equally important, she added, is the role environment plays in healing.

“We believe patients’ experience is influenced by their surroundings, so we designed these offices to be attractive, welcoming and uplifting,” Andress said. “While they are fully functional medical spaces, they look and feel different from most traditional clinics.”

The new Complete Women’s Health practice delivers integrated women’s primary and gynecological care under one roof. Services include preventive and wellness visits, chronic disease management, vaccinations and flu shots.

Gynecological care addresses contraception, abnormal bleeding, menopause and menstrual disorders. The practice also offers full-service aesthetic treatments, helping patients look and feel their best as part of a holistic approach to care.

Whole Family Pediatrics was designed with both children and families in mind. The new facility employs three full-time and two part-time pediatricians who provide wellness and preventive care, sick visits, chronic disease management, immunizations and physicals. To help limit the spread of illness, sick children have a separate waiting area from those attending wellness visits – a small but meaningful detail that reflects the organization’s patient-centered philosophy.

Whole Family Health operates as a fee-for-service organization without direct federal or state funding. A significant portion of its patients live below 200 percent of the federal poverty level, including seniors and working families with limited incomes. Critical support for uninsured residents comes from the Indian River County Hospital District, supplemented by generous donors and grantors who share the belief that access to quality healthcare should not depend on financial circumstances.

“When I began Whole Family Health Center in 1995, my mission was to care for patients living with HIV who had no other options,” Dr. Pierone said. “Today, our 200 dedicated staff provide comprehensive medical, behavioral health and preventive care for more than 20,000 patients, regardless of their insurance status or ability to pay. The demand for our services continues to grow.”

The numbers tell a compelling story. Last year alone, Whole Family Health handled more than 70,000 patient visits, filled 135,000 prescriptions, processed 45,000 referrals, and responded to 235,000 appointment-related calls. The organization also operates mobile outreach services, community wellness events and assistance programs aimed at reaching vulnerable populations.

Whole Family Health gained national recognition during the COVID-19 pandemic for its leadership in research and patient care. Through its research partner, the Pierone Research Institute, the organization collaborated with the National Institute of Allergy and Infectious Diseases on clinical trials for COVID-19 treatments, including monoclonal antibodies and antiviral therapies.

“I believe that’s when Whole Family Health truly differentiated itself,” said donor Allen Jones while touring the new facility. “They treated patients empathetically and efficiently, provided vaccines to the community, and were the only clinic offering monoclonal antibody treatments at the time.

“Dr. Pierone is an expert in infectious diseases and has mentored his staff exceptionally well.

When he sees a need in the community, he steps up to meet it.”

For Dr. Pierone, the mission that began three decades ago remains unchanged.

“Quality healthcare shouldn’t depend on your ability to pay,” he said. “At Whole Family Health Center, we care for those who might otherwise be left behind. Because of our generous donors, we can continue to expand our services and ensure that compassionate, high-quality care remains within reach for everyone in our community.”

For more information about Complete Women’s Health, visit completewomenshealth.org or call 772-918-9500. For more information about Whole Family Pediatrics, visit wfhcfl.org or call 772-918-9300. Both practices are located at 840 37th Place in Vero Beach.

The post Whole Family: Expanded new Vero facility caters to women’s health, pediatrics appeared first on Whole Family Health Center.

By Brianne Tracy | Published on September 30, 2025 03:27PM EDT

Olivia Munn is being recognized for her work as a breast cancer advocate.

On Sept. 10, the Your Friends & Neighbors actress, 45, was honored with the Excellence in Cancer Awareness Award at the 32nd Annual Action for Cancer Awareness Awards luncheon on Capitol Hill in Washington, D.C. The luncheon was hosted by Prevent Cancer Foundation’s Congressional Families Program.

The theme of this year’s event was “Shining a Light on Prevention.” Along with Munn, Florida’s Whole Family Health Center and congressional spouses Wayne Kye (married to New York Representative Grace Meng) and Marcia S. Latta (married to Ohio Representative Bob Latta) were honored.

Munn shared photos from the luncheon in an Instagram post on Sept. 29, writing in the caption that she was “incredibly humbled” to have received the honor.

“I’m grateful that there are many people who understand the importance of early detection as well as the crucial research that’s needed to help find a cure for so many people battling cancer,” she wrote.

Munn wrote that her breast cancer — which she was diagnosed with in 2023 after her ob-gyn calculated she was high-risk using the free online Tyrer-Cuzick risk assessment tool — is “aggressive and fast-moving.”

She added that her mom Kim’s breast cancer “is HER2-positive which was considered a ‘death sentence’ until the development of targeted therapies like Herceptin in the late 1990s which was discovered solely because of dedicated researchers.”

Munn first revealed her mom’s breast cancer diagnosis in July. At the time, Munn wrote on her Instagram that her mom had received a score of 26.2% from the Tyrer­-Cuzick breast cancer risk assessment, which says that if a person scores 20% or higher they are high risk.

Munn’s mom was diagnosed after an MRI confirmed her breast cancer, and she went through 12 rounds of chemo and Herceptin treatments. Hercaptin treatments work by blocking the body’s signals that tell cancer cells to grow and multiply.

“We now need every gynecologist to incorporate the lifetime risk rest into their care plan,” Munn wrote at the time. “All of these things matter, you can’t leave one off. My mom wanted me to tell you that she hopes by sharing her story it will help save someone’s life.”

Munn concluded her Sept. 29 Instagram post shouting out her fellow honorees. She also thanked Dr. Janine Bera, who presented her with the award, Prevent Cancer Foundation’s Lisa McGovern and “everyone who came out to show their support.”

For Full Article please visit: https://people.com/olivia-munn-honored-capitol-hill-breast-cancer-advocacy-11821652

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By Web Desk | September 30, 2025

Olivia Munn was diagnosed with breast cancer in April 2023.

Olivia Munn is opening up about her cancer journey while receiving a special honor for raising awareness.

On September 29, the New Girl alum awarded with the Excellence in Cancer Awareness Award by the Prevent Cancer Foundation Congressional Families Program.

Taking to her Instagram account on Monday , she wrote, “I’m incredibly humbled to have received the Excellence in Cancer Awareness Award from Prevent Cancer Foundation Congressional Families Program. I’m grateful that there are many people who understand the importance of early detection as well as the crucial research that’s needed to help find a cure for so many people battling cancer.”

Munn explained that her own breast cancer is “aggressive and fast-moving.”

The mom of two also reflected on her mother’s battle with HER2-positive breast cancer, which she said “was considered a ‘death sentence’ until the development of targeted therapies like Herceptin in the late 1990s which was discovered solely because of dedicated researchers.”

She congratulated other award recipients, including “Wayne Kye, DDS, M.S. and Marcia S. Latta, Ed.D.” as well as “Tiffany Possion who accepted the Community Impact Award for the Whole Family Health Center in Florida.”

Munn concluded her post by expressing gratitude “who came out to show their support.”

“Thank you to Dr. Janine Bera for presenting me the award. And a special thank you to Lisa McGovern for all of the work, time and love she’s put into the Congressional Families Program,” she added.

https://www.geo.tv/latest/626243-olivia-munn-reflects-on-cancer-battle-after-receiving-major-award

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TOPLINE:

In routine care clinics across the US, the fixed-dose, three-drug combination regimen bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and the two-drug regimen dolutegravir/lamivudine (DTG/3TC) effectively maintained virologic suppression in people with HIV infection, although discontinuations were more common with the DTG/3TC regimen.

METHODOLOGY:

• Researchers conducted an observational study in the US comparing the virologic efficacy and discontinuation rates of the three-drug B/F/TAF regimen and the two-drug DTG/3TC regimen in people with HIV infection who were virologically suppressed (viral load < 200 copies per mL).
• The study included 3713 people who switched to B/F/TAF (median follow-up duration, 16 months) and 2327 who switched to DTG/3TC (median follow-up duration, 15 months) between August 2020 and June 2022.
• Participants were followed up until regimen discontinuation, defined as any modification in the regimen components or an antiretroviral therapy gap of over 45 days, loss to follow-up (12 months after last contact), death, or study end.
• Confirmed virologic failure was defined as two consecutive viral loads of ≥ 200 copies per mL or discontinuation after a viral load of ≥ 200 copies per mL.

TAKEAWAY:

• Incidence rates of virologic failure were 1.7 and 2.1 per 100 person-years among participants who received B/F/TAF and DTG/3TC, respectively. Participants on B/F/TAF were 16% less likely to experience virologic failure compared with those on DTG/3TC (adjusted hazard ratio [aHR], 0.84; 95% CI, 0.59-1.18).
• Incidence rates of discontinuation were 12.4 and 14.8 per 100 person-years for participants treated with B/F/TAF and DTG/3TC, respectively. Treatment with B/F/TAF was associated with a 17% lower likelihood of discontinuation than treatment with DTG/3TC (aHR, 0.83; 95% CI, 0.73-0.94).
• Treatment-related discontinuations accounted for 6% vs 9% of B/F/TAF vs DTG/3TC discontinuations, with the higher proportion of virologic non-suppression largely attributable to the DTG/3TC group.

IN PRACTICE:

“In conclusion, this large study of real-world data in the US confirms that while the likelihood of discontinuation was statistically higher with DTG/3TC than B/F/TAF, both regimens are well tolerated and effective treatment options for virologically suppressed individuals in routine clinical care,” the authors of the study wrote.

SOURCE:

The study was led by Gerald Pierone, Jr, Whole Family Health Center in Vero Beach, Florida. It was published online on August 30, 2025, in HIV Medicine.

https://www.medscape.com/viewarticle/higher-discontinuation-dolutegravir-lamivudine-than-2025a1000p9f

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Q: Where did you go to college/graduate school?

I completed a bachelor’s in biomedical sciences with a minor in public health from the University of South Florida and a Doctor of Pharmacy degree from the University of Florida.

Q: Where do you live?

I live in the Treasure Coast of Florida.

Q: If a friend came to visit you in your hometown, where would you take them? Where would you take them in your state?

Hometown: Start with a walk at Indian RiverSide Park, featuring a scenic waterfront trail, splash pad for kids, pet-friendly areas, and picnic spots. For lunch or dinner, downtown Stuart is my go-to spot, with a variety of dining options, a large playground, waterfront views, shopping, and a basketball court—fun for the whole family.

State: I grew up in Hollywood, Florida. While I prefer a quieter, less populated area to raise my children, I often find myself heading south to Miami and Fort Lauderdale for staycations. The diversity and waterfront hotels offer endless activities in South Florida.

Q: Tell us about your health care facility.

WFHC’s vision is to provide integrated, compassionate, affordable, quality health care for the communities we serve. Originally an HIV health care provider, WFHC has evolved into a nonprofit community health center offering primary medical care for children and adults, behavioral health, lab, and pharmacy services. Serving the Treasure Coast for more than 25 years, WFHC operates four state-of-the-art clinical offices—three in Vero Beach and one in Fort Pierce. In 2017, WFHC became a federally qualified health center look-alike (FQHC-LA). Of patients with known incomes, 80.4% are at or below 200% of the federal poverty level (FPL). In 2023, WFHC served approximately 15,000 patients, with a mission to provide high-quality, caring, accessible health care services—adult and child, medical, mental and oral health—to everyone. Providing integrated compassionate, affordable, quality health care by targeting the medically underserved, vulnerable, and uninsured whose barriers include low income, low educational success, lack of health insurance, and lack of reliable transportation is our goal.

Q: What are some concrete examples of how your facility has benefitted from the 340B program?

The 340B Program has been crucial, allowing us to extend scarce federal resources to those in need. Savings from this program have enabled WFHC to recruit several providers to meet the increasing demand for services.

WFHC continues to expand its footprint by renovating and expanding the primary Vero Beach Clinical Office, purchasing the previously rented plaza in Fort Pierce, and opening a 3,000-sq-ft medical office for a second adult primary care office in Vero Beach. The need for behavioral health (BH) services has significantly increased. The closure of the UF Health Center for Psychiatry and Addiction Medicine left approximately 2,600 patients without essential psychiatric, therapy, and substance use services. We expanded our BH Department to meet the growing demand and recently opened a stand-alone 3,100-sq-ft BH office.

Q: Tell us what makes you most proud of your work and your organization.

From our founder and CMO, Dr. Gerald Pierone, to our CEO, Marie Andress, and the entire senior leadership team, we are united in our mission to increase access to affordable, quality health care. We take pride in fostering a compassionate organization, maintaining a clean space, creating a welcoming environment, and hiring quality professionals to deliver excellent care. We prioritize diversity and inclusion so that all patients feel welcome, regardless of their background.

Having worked in retail pharmacy, I have seen patients ration their health care due to unaffordable medications. It is a privilege to work with the most needy, ensuring that all patients have access to quality medical care and the prescription medications necessary to treat their chronic conditions.

Q: How has your facility benefitted from the services of your 340B vendors/contractors?

Our TPAs have been crucial to our program and navigating evolving contract pharmacy restrictions. I rely on 340B Report for the latest news and legislative updates. Additionally, outside consulting agencies have been invaluable for independent audits, sharing best practices to ensure 340B compliance and optimization from their unique perspectives.

Q: What advice do you have for 340B covered entities or staff that are new to the program?

Get connected with your state’s PCA (FACHC in Florida), NACHC, and network with other leaders and health centers. Noddlepod is also a great resource to connect with health centers across the US. I have found a strong sense of community with health centers. By networking, you will find many resourceful leaders who are willing to share information and collaborate, as we all share a similar mission to increase access to care for all patients, especially those in need.

For questions, Edline can be reached at evictor@wfhcfl.org.

To learn more about Whole Family Health Center, Inc., click here.

For Full Article Visit: https://340breport.com/edline-victor-pharmd-aahivp-director-of-pharmacy-whole-family-health-center-apexus-sponcon-spotlight/

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Free-spirited baby boomers challenged social norms and launched the sexual revolution of the 1960s and ’70s. Now that lifestyle is playing a part in the rise of sexually transmitted diseases (STDs) among older people that challenges traditional perceptions of seniors’ sexual health.

While STDs are commonly associated with younger individuals, recent data shows a significant increase in infection rates among those aged 55 or older.

“The rates of STDs for people in their 60s is still just a fraction of those for people in their 20s who are at the peak of their sexual activity, but they are rising faster percentage-wise,” said Dr. Gerald Pierone, a board-certified infectious disease doctor who practices at Whole Family Health in Vero Beach and Fort Pierce.

Historically, older people have been considered at low risk for STDs because they weren’t very sexually active, but with the advent of drugs like Viagra and other social factors, this assumption falters.

According to the Centers for Disease Control and Prevention (CDC), cases of gonorrhea have grown roughly sevenfold since 2010 among American adults older than 55. Data also shows that cases of chlamydia have more than quadrupled since 2010 and cases of syphilis were nearly eight times higher among the same age group.

“One reason is that people are entering into new relationships later in life due to divorce or death of their spouse,” Dr. Pierone said. “They may have been in a relationship for 20 or 30 years and they aren’t necessarily thinking about condoms or about the risk of sexually transmitted diseases. It’s not uncommon for someone who enters into a relationship later in life and becomes intimate to find out that they have HPV or the herpes simplex virus.

“We call it the condom gap because younger people who are sexually active are more likely to use condoms. Older people didn’t grow up in an era of wearing a condom because they didn’t grow up with HIV.”

Another contributing factor is the lack of awareness and education regarding STDs among older adults. Many seniors grew up in a time when discussing sexual health was taboo, and as a result, they may not be well informed about the risks of STDs or the importance of using protection. Older adults may also mistakenly believe that they are not at risk for STDs, especially if they are past childbearing age.

“Sexual activity has definitely been extended because people are living better,” Dr. Pierone continued. “There are a lot of robust, very active people in their 60s, 70s and 80s. And there are also medications like sildenafil (Viagra) for men that are able to preserve sexual function.”

The stigma associated with sexual activity in older age also plays a role. It can prevent older adults from seeking information, testing or treatment for STDs because they feel it is somehow inappropriate for them to have sexual partners. Additionally, healthcare providers may not prioritize sexual health discussions with their older patients, further exacerbating the issue.

Diagnosing STDs in older adults presents unique challenges because symptoms of STDs can often mimic other age-related health issues, such as urinary tract infections or skin conditions. This can lead to delays in diagnosis and treatment, increasing the risk of complications. Untreated syphilis, for example, can lead to serious long-term health problems including cardiovascular and neurological damage.

“The good news is that most of these sexually transmitted infections are pretty easy to treat,” Dr. Pierone assured. “Gonorrhea is an easy injection and often a pill that goes with it, as are so many others. Syphilis is an injection. Those are curable with a very short treatment. Now hepatitis C, HIV and even HPV are different. They tend to become chronic infections and may require longer term, more complicated treatment plans.”

Treatment of STDs in older adults also requires special consideration as they may have comorbid conditions or may be taking multiple medications that can complicate treatment regiments. Additionally, the social and psychological impact of an STD diagnosis can be significant in older adults, leading to feelings of shame, guilt or depression.

Fortunately, while this trend is taking hold nationwide, Vero Beach has not been heavily affected to date.

“We really don’t see that many STD cases among the elderly here in Indian River County,” said Dr. Pierone. “We’ve only seen two or three cases in the last year of people over the age of 55 compared to 30 to 50 cases of younger people. National and state numbers are often disproportionate for some areas versus others. It has a lot to do with culture. We don’t live in an area where we are out partying a lot, and our community is a more conservative community than you might find in a larger city or more metropolitan area.”

Addressing the rise in STD rates among the elderly requires a multifaceted approach. First is increasing awareness and education for that population through public health campaigns with messages about the importance of STD prevention, testing and treatment.

Healthcare providers should be more proactive in discussing sexual health with older patients and encouraging them to routinely screen for STDs. And efforts should be made to reduce the stigma associated with sexual activity in older age. This could be achieved through community-based programs that promote healthy aging and normalize discussions about sexual health at all stages of life.

Anyone entering into a new relationship should talk to their partner about STDs prior to having sex so they can take any needed precautionary measures. It’s possible to reverse this troubling trend so that adults can enjoy healthy, satisfying sex lives without the risk of infection.

Dr. Gerald Pierone received his medical degree from the University of Florida and completed his internal medicine residency training at the University of Medicine and Dentistry in New Jersey. He trained in infectious diseases at the Mount Sinai School of Medicine in New York.

He is board certified in Internal Medicine and Infectious Diseases and a member of the Infectious Diseases Society of America. He can be reached at Whole Family Health in Vero Beach at 772-257-5785 or in Fort Pierce at 772-468-9900.

For Full Article Visit: https://veronews.com/2024/09/19/old-and-restless-why-std-rates-are-on-the-rise-among-seniors

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The final lecture, graciously hosted at Northern Trust, illuminated health’s pivotal role in individual well-being and community resilience. Central to the discussion was the imperative of ensuring equal access to healthcare services, with speakers showcasing concerted efforts to reduce disparities and promote health equity across all segments of society.

The event featured a distinguished lineup of healthcare leaders, each bringing invaluable expertise and insights. Marie Andress, CEO of Whole Family, is a beacon with 25 years of dedication to serving underserved communities. Dr. David Peter, Hospital CEO and VP CMO of Cleveland Clinic Indian River exemplifies a commitment to patient-centered care and community health. Meanwhile, Vicki Soule, CEO of Treasure Coast Community Health (TCCH), embodies over three decades of unwavering dedication to providing essential healthcare services to marginalized populations.

Marie Andress’s presentation shed light on Whole Family’s mission to deliver essential healthcare services to underserved populations, emphasizing that 64% of their patients fall below 200% of the poverty level, with services reaching over 15,050 individuals across four locations. Dr. David Peter underscored Cleveland Clinic’s patient-centric approach, noting its substantial healthcare service volume, with 227,000 outpatient visits and 22,000 admissions annually. Vicki Soule of TCCH highlighted the organization’s extensive outreach, providing vital care to more than 28,000 patients across numerous locations while addressing prevalent challenges such as workforce shortages and inflation impacting affordability within the community.

Despite acknowledging the challenges facing the healthcare landscape, including the availability of specialists, financial constraints, and workforce shortages, there was an overarching optimism about the potential for innovation and collaboration to overcome these hurdles and improve health outcomes for all residents.

The lecture also underscored the indispensable role of philanthropy in driving collaborative efforts to address healthcare disparities. Partnerships with local funders, including Northern Trust, have been instrumental in supporting initiatives to advance health equity and build a healthier community.

“As stewards of community well-being, United Way of Indian River County is honored to have hosted the final lecture in the ‘Powered by Purpose’ series,” said Meredith Egan, United Way CEO. “Through the generous support of sponsors like Northern Trust, we are empowered to drive meaningful change and foster a healthier, more equitable future for all residents.”

About United Way of Indian River County

United Way of Indian River County (UWIRC) is a 501(c)(3) non-profit organization that fights for the health, education, and financial stability of every community member. United Way works with local programs to provide resources to individuals and families in crisis today, while working year-round to improve community conditions and create lasting solutions. We are effectively building a strong foundation and improving lives by mobilizing the caring power of our community. For more information about your local United Way, please call (772) 567-8900 or visit our website, UnitedWayIRC.org.

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Gerald Pierone Jr,¹ Laurence Brunet,² Jennifer S Fusco,² Cassidy E Henegar,³ Supriya Sarkar,³ Jean Van Wyk,⁴ Vani Vannappagari,³ Michael B Wohlfeiler,⁵ Gregory P Fusco<sup>2

1</sup>Department of Adult Primary Care, Whole Family Health Center, Vero Beach, FL, USA; ²Department of Epidemiology, Epividian, Raleigh, NC, USA; ³Epidemiology and Real World Evidence, ViiV Healthcare, Research Triangle Park, NC, USA; ⁴Global Medical, ViiV Healthcare, Brentford, UK; ⁵Department of Medicine, AIDS Healthcare Foundation, Miami, FL, USA

Correspondence: Laurence Brunet, Epividian, 150 Fayetteville Street, Suite 2300, Raleigh, NC, 27601, USA, Tel +1-919-827-0010, Email laurence.brunet@epividian.com

Purpose: Two-drug regimens (2DR) may address drug–drug interactions and toxicity concerns. Dolutegravir/lamivudine (DTG/3TC) 2DR was approved in the US for both treatment-naïve and treatment-experienced individuals with a viral load < 50 copies/mL. This study describes real-world DTG/3TC 2DR treatment outcomes among treatment-experienced individuals, stratified by age, sex, and race.
Methods: From the OPERA^® cohort, people with HIV with a viral load < 50 copies/mL who switched from a commonly used three-drug regimen to DTG/3TC 2DR as per the label between April 8, 2019 and April 30, 2021 were included. Incidence rates (Poisson regression) for loss of virologic control (first viral load ≥ 50 copies/mL), confirmed virologic failure (2 viral loads ≥ 200 copies/mL or discontinuation after 1 viral load ≥ 200 copies/mL), and DTG/3TC 2DR discontinuation were estimated overall and stratified by age, sex, and race.
Results: The 787 individuals included were followed for a median of 13.6 months (IQR: 8.2, 22.3). Confirmed virologic failure occurred in ≤ 5 individuals. Loss of virologic control occurred at a rate of 14.0 per 100 person-years (95% CI: 11.7, 16.8). DTG/3TC 2DR discontinuation occurred at a rate of 17.5 per 100 person-years (95% CI: 15.0, 20.3); 4% discontinued for treatment-related reasons (viremia, adverse diagnosis, side effect, lab abnormality). For all outcomes, incidence rates were comparable across strata of age, sex, and race.
Conclusion: This descriptive study demonstrates that DTG/3TC 2DR is an effective and well-tolerated treatment option for people with HIV with a viral load < 50 copies/mL at switch, regardless of their age, sex, or race.

Keywords: antiretroviral therapy, cohort, electronic health records, suppressed, viral load

Introduction

Two-drug regimens (2DR) may be a valuable antiretroviral therapy (ART) option to alleviate concerns of drug–drug interactions and antiretroviral toxicity.^1–4 Dolutegravir/lamivudine (DTG/3TC) 2DR was approved in the US for ART-naïve (April 2019)⁵ and ART-experienced individuals on a stable ART regimen with a viral load (VL) <50 copies/mL, no treatment failure history, and no resistance to DTG or 3TC (August 2020).⁶ Its safety, tolerability, non-inferiority to three-drug regimens (3DR), and real-world effectiveness has been established among ART-experienced individuals in clinical trials and real-world observational studies.^7–24 However, very few studies have assessed the effectiveness of DTG/3TC 2DR based on age, sex, or race.^25,26

We aimed to describe the real-world experience of ART-experienced individuals with a VL <50 copies/mL switching to DTG/3TC 2DR from a commonly prescribed three-drug regimen in the US, including the impact of age, sex, and race on treatment outcomes.

Methods

This study utilized data from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA^®) cohort, which consists of prospectively captured routine clinical data from electronic health records from 84 clinics in 18 US states and territories. This study included all HIV-1 positive individuals aged 13 years or older who switched to DTG/3TC 2DR between April 8, 2019 and April 30, 2021 from either bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC), DTG/abacavir (ABC)/3TC or DTG+TAF/FTC. All had a VL<50 copies/mL at switch and no known history of virologic failure or resistance. All were followed from switch to the first of (a) any antiretroviral change, (b) loss to follow up (ie, 18 months after the last clinical contact), (c) death, or (d) study end (October 31, 2021).

Virologic outcomes were assessed in the subset with ≥1 follow-up VL. Loss of virologic control was defined as the first VL ≥50 copies/mL during follow-up. Confirmed virologic failure was defined as two consecutive VL ≥200 copies/mL, or regimen discontinuation after 1 VL ≥ 200 copies/mL.

Regimen discontinuation was defined as either a switch from DTG/3TC 2DR to any other regimen (stop DTG or 3TC and/or add any other antiretroviral) or ART interruption (>45 days without ART). Treatment gaps of >45 days were classified as discontinuations to account for possible delays between prescription receipt and pharmacy pick-up, as well as potential stockpiling of pills if adherence was incomplete. Reasons for discontinuation were inferred from electronic health records and based on provider notes, diagnoses, and laboratory results. Treatment-related reasons included a VL ≥200 copies/mL within 30 days before discontinuation, an adverse diagnosis or side effect, or a laboratory abnormality (ie, value 3 times the upper limit of normal). Treatment-unrelated reasons for discontinuation included a treatment gap >45 days, switch to a long-acting regimen or a note regarding either access issues, non-adherence, patient preference, provider preference or any other reasons. If both treatment-related and treatment-unrelated reasons were identified, the discontinuation was classified as treatment-related. If neither was identified, the reason for discontinuation remained unknown.

For all outcomes, incidence rates were estimated with univariate Poisson regression to account for differential durations of follow-up. Results were presented overall and stratified by age (<50 vs ≥50 years old), sex (male vs female), and race (Black vs non-Black race). Incidence rate ratios were estimated with univariate Poisson regression to compare the rate of each outcome across strata of age, sex, and race.

Results

A total of 787 individuals with a VL <50 copies/mL switched to DTG/3TC 2DR from DTG/ABC/3TC (n = 421), BIC/TAF/FTC (n = 240), or DTG+TAF/FTC (n = 126). Demographic and clinical characteristics at switch are presented in Table 1.

 

Table 1 Study Population Characteristics at the Time of Switch to DTG/3TC 2DR in the OPERA Cohort (N = 787)

 

During follow-up, a median of 3 VL measurements were available per person (IQR: 2, 5). Overall, 118 individuals (17%) had a VL ≥50 copies/mL documented (median: 80 copies/mL; IQR: 60, 147), for an incidence rate of 14.0 per 100 person-years (95% CI: 11.7, 16.8). Of the 84 individuals with additional VL available after a first VL ≥50 copies/mL, 70 (83%) immediately re-suppressed (ie, blip; single elevated VL followed by a VL <50 copies/mL); similar proportions of blips were observed across strata, ranging from 82 to 86%). Across age, sex, and race strata, incidence rates ranged from 13.0 to 17.7 per 100 person-years, without meaningful variation. No statistically significant difference was observed between groups, with confidence intervals for incidence rate ratios crossing the null for all comparisons (Table 2). Only 30 individuals (4%) had ≥1 VL ≥200 copies/mL during follow-up (median copies/mL: 842; IQR: 260, 3600), for an overall rate of 3.3 per 100 person-years (95% CI: 2.3, 4.7; not shown). Confirmed virologic failure was rare, occurring in ≤5 individuals over follow-up; no statistically significant differences were observed across strata (Table 2).

 

Table 2 Incidence of Virologic Outcomes Among Individuals Who Switched to DTG/3TC 2DR and Have ≥1 Follow-Up Viral Load, Compared Across Strata of Age, Sex, and Race

 

Over a median follow-up of 13.6 months (IQR: 8.2, 22.3), 170 individuals (22%) discontinued DTG/3TC 2DR. Only six (4%) discontinued for treatment-related reasons: viremia (n ≤ 5), adverse diagnosis or side effect (n ≤ 5). For 37% of discontinuations, treatment-unrelated reasons were identified: provider preference (n = 48), switch to a long-acting regimen (n = 13), therapeutic gap (n = 10), access issues (n = 6), patient preference (n ≤ 5). No reason could be identified for the remaining 59% of discontinuations. Overall, discontinuation occurred at a rate of 17.5 per 100 person-years (95% CI: 15.0, 20.3). Incidence rates were comparable across strata of age, sex, and race, ranging from 15.3 to 18.2 discontinuations per 100 person-years and all incidence rate ratio confidence intervals crossing the null (Table 3).

 

Table 3 Duration of Follow-Up and Incidence of Regimen Discontinuation Among Individuals Who Switched to DTG/3TC 2DR, Compared Across Strata of Age, Sex, and Race

 

Discussion

In this study of adults with a VL <50 copies/mL in routine clinical care in the US, switching to DTG/3TC 2DR was virologically effective. The consistency of results across strata of age, sex, and race suggests that all groups were able to take DTG/3TC 2DR with comparable success.

Low rates of loss of virologic control (first VL ≥50 copies/mL) and rare virologic failure were observed in this population. This is consistent with results from a meta-analysis of six observational studies, where only 1% of virologically suppressed individuals switching to DTG/3TC 2DR had virologic failure (two consecutive VL ≥50 copies/mL or a single VL >1000 copies/mL) at weeks 48 and 96.¹³ In other observational studies of virologically suppressed switch to DTG/3TC 2DR, the incidence rate of virologic failure ranged from 0.9 to 1.2 per 100 person-years or from 0.1% to 3% by 48 weeks,^19–22 with loss of undetectability in only 1–4% of individuals at week 48, 1–5% at week 96, and 7% over five years.^{14–18,20,23} The presence of M184V resistance mutations at DTG/3TC 2DR may be associated with earlier time to, though not with an increased likelihood of, virologic failure.^20,22 Emergence of resistance appears to be rare among individuals experiencing failure on DTG/3TC 2DR.^21,22

Other studies have reported 2% to 20% of DTG/3TC 2DR discontinuation among ART-naïve and ART-experienced individuals, compared to 22% in OPERA.^12,13,21 However, DTG/3TC 2DR was well tolerated in this study: only 4% of discontinuations were deemed to be treatment-related. Similarly, discontinuation due to adverse events, intolerance, or toxicity were reported in 1% to 8% in trials and observational studies.^{11,12,14,21,24} The most common reason for discontinuation was provider preference, which does not provide much context, but has been noted as a common reason for switch in other studies.^27–29 Notably, in a recent survey of 27 US healthcare providers, 89% reported provider-initiated regimen switches, while all reported switch discussions initiated by their patient, driven among other things by their community or commercials.²⁹ Switch to a long-acting regimen was another documented reason for discontinuation in this study. A large survey of 553 people with HIV and 450 physicians in the US and Canada showed that 59% of people with HIV and 55–66% of physicians would prefer/recommend a long-acting injectable to overcome treatment challenges such as daily pill burden and adherence.³⁰

The real-world effectiveness of DTG/3TC 2DR in individuals aged ≥65 years old has been assessed in two recent observational studies. Among 112 individuals ≥65 years of age starting DTG/3TC 2DR in Northern Italy (6 ART-naïve, 106 ART-experienced), 93% had an undetectable viral load at end of follow-up.²⁵ In another Italian cohort, 72 ART-experienced individuals aged ≥65 years who switched to DTG/3TC 2DR with a viral load <20 copies/mL, 89% had maintained a viral load <20 copies/mL after 12 months.²⁶ In OPERA, age was stratified at 50 years instead of 65 because only 5% of the population were aged 65 years or older. However, the proportion who maintained virologic control was slightly lower in OPERA (83%) than in the Italian cohort, although no difference by age was observed in OPERA. While loss of virologic control was numerically higher in women than men in OPERA, no statistically significant difference was observed in the incidence rates. A study comparing virologic outcomes of DTG-based regimens (2DR and 3DR combined) between women and men in the ICONA cohort has shown a higher likelihood of treatment failure, but not virologic failure in women compared to men. Treatment failures in women appeared to be driven by discontinuations due to toxicity.³¹

Of note, this study included 19 individuals with HIV-HBV co-infection. The DTG/3TC 2DR label includes a boxed warning stating that additional treatment or alternative regimens should be considered for chronic HBV due to risks of emergent 3TC-resistant HBV variants.³² This study population was restricted to individuals on a DTG/3TC single-tablet 2DR. Therefore, there was no concurrent prescriptions for any other ARV agents active against both HIV and HBV (tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine), although the use of entecavir was not assessed.

A limitation of this study was that the experience of individuals switching to DTG/3TC 2DR from regimens other than DTG/ABC/3TC, BIC/TAF/FTC or DTG+TAF/FTC was not represented. Due to the absence of a comparison group, while we can conclude that DTG/3TC 2DR was associated with favorable outcomes among people with undetectable VL, no inference can be drawn in terms of its effectiveness compared to other regimens. In addition, this is a purely descriptive study, and no statistical adjustments were performed to control potential confounding. The duration of follow-up was relatively short, with close to half of individuals followed for a year or less, thus preventing the assessment of long-term treatment outcomes. Assessment of virologic outcomes were restricted to individuals with at least one follow-up VL. However, confirmed virologic failure required two consecutive VL unless the regimen was discontinued, and all did not have the opportunity for this event to be observed over the study period. The presence of ART resistance following virologic failure could not be assessed: such tests are not done systematically in routine clinical care, and results may be incomplete in the EHR. Adherence information was also unavailable. Since OPERA clinical data are collected for the medical management of patients and reasons for discontinuation are often poorly documented in electronic health records, 59% of discontinuers did not have an identifiable reason for discontinuation despite using diagnoses, laboratory results, and provider notes to determine likely reasons. Moreover, 28% of DTG/3TC 2DR discontinuations were justified as a provider preference, although the reason for such preference was not documented in the EHR. Finally, this study spanned from April 8, 2019 (~11 months COVID-19 pre-pandemic) to October 31, 2021 (~20 months since pandemic onset). The COVID-19 pandemic has disrupted healthcare services, including HIV care.³³ In OPERA, lower rates of clinical visits, VL measurements, and regimen discontinuations were observed between March and October 2020, compared to the prior eight months.³⁴ The impact of the pandemic on HIV care and treatment outcomes may have varied over this long study period.

This study also has several strengths. The study population was derived from the OPERA cohort, which includes a diverse population and is representative of routine HIV clinical care in the US. Indeed, the 140,817 people with HIV in the OPERA cohort at the time of this study represented approximately 13% of people with HIV in the US.³⁵ The 787 individuals who switched to DTG/3TC 2DR within the first 24 months of commercial use were followed for a median of 13.6 months (max 30.7 months) after switch, allowing time to observe the clinical outcomes of interest. Clinical diagnoses, prescriptions, and laboratory results were captured prospectively from electronic health records for all individuals receiving healthcare at participating sites, thus providing complete and accurate clinical information reflecting real-world clinical practices.

Conclusion

In conclusion, this descriptive study demonstrated that a 2DR consisting of DTG/3TC is an effective and well-tolerated treatment option for virologically suppressed people with HIV, regardless of their age, sex, or race.

Ethical Considerations

The OPERA^® observational database complies with all HIPAA and HITECH requirements and has received annual institutional review board (IRB) approval by Advarra IRB (Pro00023648), including a waiver of informed consent and authorization for use of protected health information. All data are anonymized to ensure confidentiality of all participants.

Acknowledgments

This research would not be possible without the generosity of people living with HIV and their OPERA^® caregivers. Additionally, we are grateful for the following individuals: Lito Torres (SAS programming), Robin Beckerman (QA), Bernie Stooks and Lisa Lutzi (IT/data management), and Judy Johnson (medical terminology classification). The abstract of this paper was presented at the 24^th International AIDS Conference as an ePoster presentation with interim findings (EPB164), available at: https://aids2022.org/wp-content/uploads/2022/08/AIDS2022_abstract_book.pdf. This work was supported by ViiV Healthcare.

Disclosure

GP Jr is a member of the Epidemiology and Clinical Advisory Board for Epividian. LB, JSF, and GPF are employed by Epividian, Inc.; Epividian has had research funded by the AIDS Healthcare Foundation, EMD Serono, Gilead Sciences, Janssen Scientific Affairs, LLC, Merck & Co., Theratechnologies Inc., and ViiV Healthcare. MBW has participated in post-conference advisory boards for the Conference on Retroviruses and Opportunistic Infections (CROI) and International AIDS Conference (IAC) and also serves as a principal investigator on ViiV Healthcare clinical trials but does not receive personal compensation for this work, which goes directly to the AIDS Healthcare Foundation. MBW is also a member of the Epidemiology and Clinical Advisory Board for Epividian. CH, SS, JvW, and VV are employed by ViiV Healthcare and hold stocks and shares in GSK as part of their employment. The authors report no other conflicts of interest in this work.

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The post Switching to Dolutegravir/Lamivudine Two-Drug Regimen: Durability and Virologic Outcomes by Age, Sex, and Race in Routine US Clinical Care appeared first on Whole Family Health Center.

The ladies of Indian River Impact 100 gathered at the United Against Poverty UP Center, enjoying wine and assorted hors d’oeuvres before hearing from the five 2023 $100,000 grant recipients, each expressing gratitude before relating how the money they received has been utilized to date.

After welcoming everyone, Suzi McCoy Shriner, current president, reminded that Impact membership dues must be received by Feb. 29 in order to vote in April to determine which nonprofits will receive 2024 grants.

“I just love what these nonprofits are doing in the community,” said past president Mary Ellen McCarthy, who introduced each speaker.

Rev. Dr. Crystal Bujol, founder and artistic director of the Gifford Youth Orchestra, spoke of their project to build a Music Center with an Audio, Recording and Communications Studio in the heart of the Gifford community. To date, renderings have been made of the facility, and they have purchased two portable Bose speaker systems with microphones.

With a recording studio, she explained, they can capture performances that will last forever, adding, “It will spread as far as airwaves will take it. And that’s what your investment is going to do for not only our children, but for their children, and their children’s children.”

Debbi Arseneaux, learning and arts integration manager at the Learning Alliance, spoke about their Moonshot Lab School and Hub for Teacher Training initiative, which was launched in partnership with the school district. The focus is teachers’ professional development and building a culture of literacy and learning through creative and engaging K-2 classroom instruction.

“Children are engaging in literacy by using art and drama to build comprehension, knowledge, creativity skills and learning,” said Arseneaux, adding that as students progress, each level becomes a steppingstone to further learning.

Liz Bruner, vice president of philanthropy, said the Senior Resource Association grant enabled them to greatly reduce the number of seniors on the Meals on Wheels wait list.

MOW provides meals and a human connection to eligible seniors via trained volunteers, who deliver hot meals each weekday and frozen meals on Friday for the weekend.

“We also purchased two institutional appliances,” said Bruner, explaining that the additional heating and cooling units were needed to keep food temperature safe.

Charlene Morris, a licensed mental health counselor at the Source, spoke about their new Dignity Wellness program. Over the past six months, they have taught 23 employees and 17 volunteers to recognize the signs, symptoms and risk factors associated with mental health disorders.

“And the feedback has been really great,” said Morris, adding that mental health is just as important as physical health.

While people become homeless due to a wide variety of reasons, she said the single greatest reason is a profound catastrophic loss of family, so the Source provides what they yearn for: a sense of belonging, of community.

Marie Andress, CEO of the Whole Family Health Center founded by Dr. Gerald Pierone, said they were able to purchase and begin using a Mobile Medical Office, which is removing barriers to care, especially for those with limited mobility or transportation access.

“Essentially, our mission is to provide accessible, caring, healthcare services to everyone.

But of course, we want to get to the most vulnerable people,” said Andress. She said they can now take the MMO to areas with vulnerable populations, such as the homeless individuals assisted by the Salvation Army and agencies such as the Hope for Families Center.

Impact 100 members donate $1,100 ($100 for administrative costs) and collectively vote to provide high-impact $100,000 grants to local charities. For more information, visit Impact100ir.com. For full story visit https://veronews.com/2024/02/22/impact-day-feasting-on-grant-recipients-positive-feedback/

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