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

The post Olivia Munn Says She’s ‘Incredibly Humbled’ as She’s Honored on Capitol Hill for Her Breast Cancer Advocacy appeared first on Whole Family Health Center.

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

The post Olivia Munn recalls ‘aggressive’ cancer fight while receiving award appeared first on Whole Family Health Center.

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

The post Higher Discontinuation of Dolutegravir/Lamivudine Than Bictegravir/Emtricitabine/Tenofovir Alafenamide in the US appeared first on Whole Family Health Center.

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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VeroNews.com

Four new vaccines designed to protect against Respiratory Syncytial Virus are on the Centers for Disease Control and Prevention’s agenda this week, with two vaccines expected to be available this fall to help older adults fend off the potentially dangerous virus.

Respiratory Syncytial Virus, or RSV – discovered in the late 1950s – is a highly contagious, lower-respiratory infection that nearly went dormant during COVID-19 lockdowns, but the threat from RSV is now on the rise again here.

Up north, RSV tends to be seasonal, ramping up in fall and peaking in the winter. But locally, RSV season runs 12 months of the year, and according to the Florida Department of Health’s weekly RSV report, the percentage of patients testing positive for RSV is increasing in Indian River and St. Lucie counties.

The likelihood that a safe and effective RSV vaccine will be available for the first time this fall is an exciting development, since there is no specific, widely recommended treatment for RSV once a patient is infected – only supportive care of the lungs with oxygen and bronchodilators. More than 14,000 Americans die from RSV each year.

“I think that all individuals above age 60 should strongly consider getting this RSV vaccine.

This is especially important for those with chronic health conditions,” said Vero Beach infectious disease expert Dr. Gerald Pierone of Whole Family Health. “I am looking forward to the roll out of these RSV vaccines because I think they will lessen the risk of hospitalization and death from this infection.”

Dr. Kenneth Alexander, Chief of Infectious Diseases at Nemours Children’s Hospital, Florida, sees RSV mostly from the pediatric medicine side, which has over the years developed some tools to prevent RSV while waiting for a vaccine.

“Respiratory syncytial virus (RSV) has long been recognized as the leading cause of pneumonia affecting babies in the first year of life. RSV pneumonia can be especially severe in babies that were born prematurely, and in babies with congenital heart or lung disease,” Alexander said. “Unfortunately, we lack specific treatments for respiratory syncytial virus.”

While doctors use expensive antibody drugs in at-risk pediatric patients in an effort to keep them out of the hospital, Alexander said that “right now, none of the active vaccines is approved for use in babies. Instead, they are approved for use in adults age 60 and over.”

Over the past two months, the FDA vaccine panel has moved four different RSV vaccine formulas through the approval process – two for older adults, one for infants and one for pregnant women. Now the CDC will weigh the need for these vaccines and their efficacy in clinical trials.

Local seniors with grandchildren, or friends and family who work in childcare or in the school system need to think about the risks of RSV.

“We have learned in recent years that RSV is not just a disease of babies. It turns out that RSV is a particularly bad actor in the elderly and is a common cause of both hospitalization and mortality,” Alexander said. “Children get RSV and then share it with their grandparents. Hopefully, we will begin to see people over 60 get RSV vaccination to prevent pneumonia in adults.”

Outbreaks of RSV must be reported to local health departments, but RSV can go undiagnosed because its initial symptoms – runny and/or stuffy nose, sore throat, cough, fever, chills headache and fatigue – resemble other common infections. Two out of three babies will contract RSV by the time they reach the one-year-old mark.

When a patient shows up to an urgent care or doctor’s office in the post-pandemic new normal era, if a rapid Covid test is negative, an Influenza rapid test may be performed, and possibly a test for Strep, but the testing typically stops there unless the doctor suspects RSV.

Most cases of RSV resolve in 10 to 12 days, but in a person at risk for complications, RSV can cause inflammation of the small airways of the lung (bronchiolitis) and pneumonia.

Until the new single-shot vaccines – GlaxoSmithKline’s Arexvy and Pfizer’s Abrysvo – are available, Dr. Pierone reminds patients about the common-sense things they can do to avoid getting any type of viral infection this summer.

“I think that because of COVID, there is much more attention being paid to avoiding contact with people who have an upper respiratory infection. In the past it was very common for people to go to work or school even though they were sick with a cold,” Pierone said. “So the right thing to do if someone is coming down with an infection is to avoid going to cocktail parties, dinner parties, and areas of common congregation to avoid transmitting different viral infections to others. There is also ample evidence that wearing a mask can lessen the risk of acquiring viral infections.”

For full story visit https://veronews.com/2023/06/22/two-vaccines-for-rsv-likely-available-in-fall/

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Treasure Coast Newspapers

INDIAN RIVER COUNTY – Gifford Youth Orchestra, The Learning Alliance, Senior Resource Association, The Source, and the Whole Family Health Center are the five winners of $100,000 grants from Impact 100 for 2023.

Ballet Vero Beach, Bike Walk Indian River County, Indian River County Healthy Start, Junior Achievement of Palm Beach and Treasure Coast, McKee Botanical Gardens and the Vero Beach Theatre Guild each were recognized with $11,800 merit grants by the organization.

Awardees were selected during the annual membership meeting on April 12.

“After hearing presenting sponsor, Tracy Sorzano of PNC Private Bank and the passionate presentations by the 11 grant finalists, the members voted for the five finalists whose projects they believed will have the most lasting impact on the community,” said Mary Ellen McCarthy, president of Impact 100. “We collectively believe the five local nonprofits selected will make transformational changes in our community.” https://4ab311212d005bf26ac70c718182077a.safeframe.googlesyndication.com/safeframe/1-0-40/html/container.html Those five nonprofits proposed diverse projects ranging from an audio, recording and communications studio for the Gifford Youth Orchestra; The Moonshot Lab School and Hub for Teacher Training by the Learning Alliance; Meals on Wheels Waitlist Relief by the Senior Resource Association; The Dignity Wellness Program at The Source; and a mobile medical office by the Whole Family Health Center.

Marie Andress, CEO of the Whole Family Health Center said they were pleased and honored to receive the grant to establish Whole Family’s latest service for the community. https://cm.tcpalm.com/article-body/inline-desktop-anon_042023_AprilEvergreen  “This initiative is transformational as it will provide and promote better healthcare for vulnerable members of our community,” said Andress. “The mobile medical office will remove barriers to care especially for those with limited mobility or no access to reliable transportation.”

Karen Deigl, president and CEO of the Senior Resource Association, said the grant will allow many members of the community waiting for Meals on Wheels to receive services.

“On any given day, the Meals on Wheels waitlist numbers (include) 300 needy Indian River County seniors,” said Deigl. “This generous grant allows our volunteer team to deliver more than 14,000 meals to older adults who need nutritional support. This is true impact!”

The Source Executive Director Anthony Zorbaugh said the gift from Impact 100 is life transformational for the organization.

“Providing mental health for our members to move out of homelessness will have a major impact in our community,” Zorbaugh said.

Barbara Hammond, CEO of The Learning Alliance said the organization is very excited to be the recipient of an Impact 100 grant that will bring an arts integration specialist into the organization’s moonshot school.“This is really going to bring language comprehension to life in meaningful and engaging ways for our children and our teachers,” Hammond said. Crystal Bujol from the Gifford Youth Orchestra said building an audio recording and communications studio has been a dream of hers for a long time.  “The GYO believes that energy can be captured and redirected to music, drama, and vocal arts.,” said Bujol.  “The women from Impact 100 have given us a grant to help make that happen in a very powerful and meaning way.  We will be able to help the children not only learn the etiquette of recording their voices and performances but also develop the skills it takes to turn their demand to be heard into a work of art.”

About Impact 100

Impact 100 was founded in 2008 with the idea 100 women each donating $1,000 could make a transformational difference in the community. The group now includes more than 550 members. Since its inception more than decade ago, Impact 100 has distributed more than $6 million to nonprofit organizations.

The grant selection process is a complex one, beginning in November when a grant committee begins vetting the applications they have received from county nonprofits. Over the next few months, committee members meet with the various organizations before selecting finalists in March. https://4ab311212d005bf26ac70c718182077a.safeframe.googlesyndication.com/safeframe/1-0-40/html/container.html Members of Impact 100 could vote by mail, online or at the annual meeting. Leslie Rossway Swan, IRC Supervisor of Elections, and her staff assisted with the voting process, including providing official ballots and voting machines. The votes were certified by Nuttall, Donini & Associates, CPA’s.

Overall, the annual meeting is the culmination of a comprehensive process that involves outreach to local nonprofits with visioning, grant writing and application support, thorough vetting of applications, and informed voting by Impact 100 members to identify projects that can make a meaningful difference in the community.

“Our process ensures the most deserving projects are selected to receive funding and support from Impact 100 Indian River,” McCarthy said. 

2023-2024 Impact grants

The members of Impact 100 Indian River have already started work on their next grant season. The visioning committee is working with nonprofit leaders to cultivate ideas and develop collaborations for potential Impact 100 grant proposals. Nonprofits can request a visioning session and find more information at: https://impact100ir.com/grants/ https://4ab311212d005bf26ac70c718182077a.safeframe.googlesyndication.com/safeframe/1-0-40/html/container.html Two nonprofit workshops are scheduled to support those nonprofits interested in applying for a grant—a grant writing workshop at 9 a.m. on Tuesday, May 16, and a nonprofit information session at 9 a.m. on Sept. 6. Both workshops will be held at Northern Trust, 755 Beachland Blvd.

Grant applications for 2023-2024 will be accepted from June 1 to Nov. 3.

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