HOUSTON, Aug. 9, 2022 /PRNewswire/ — Boldly breaking new ground in a sought-after genre, Ro Smith takes lesbian lit erotica to the next level with a tasteful take on ménage à trois.
A Taste for Three will be released on Amazon on August 31st, 2022, with the kindle version already available to pre-order.
The author is known for her lusty lesbian micro reads, often with a black female lead.
Previous publications includes The Little Book of Quickies Series – a three-part series of sensual short stories, with each new release attracting an array of rhapsodic reviews.
A Taste for Three follows on from Pandora’s Box, a quickie from Part 1 of the series, featuring lesbian couple Eve and Chloe and their unexpected new lover, Renae.
Raunchy romance novels are nothing new, but most feature a tired take on heteronormativity that fails to arouse interest among even the straightest of readers.
Evocative novelist Ro Smith is ready to revolutionize the romance literary landscape with her latest triumph, A Taste for Three. Alluring and avant-garde, this story serves to satisfy those innermost desires, exploring the uncharted intricacies of a three-woman relationship.
Eve and Chloe are the couple that becomes a triad when curvaceous beauty, Renae, brings a much-needed dose of desire, with unexpected consequences. Expertly written to underscore themes of exclusion, Ro Smith’s take on this typically taboo lifestyle is absorbing no matter your orientation.
It allows for heightened awareness and understanding by drawing on realistic dialogue and themes that resonate with all who have ever felt desire. Most importantly, Ro Smith paves the way for other black female authors by featuring a strong black female lead, bringing much-needed representation to an international readership.
As she told us; “Black women…especially black, curvy women who happen to be lesbian, are rarely ever written as the main character or love interest in books. I want to change that. Being black is beautiful. Being curvy is beautiful. Being lesbian is beautiful. We, too, deserve to be placed on pedestals.”
And when it comes to diversity in romance novels, Ro’s not wrong. According to The State of Radical Diversity in Publishing, only 11.9% of all romance novels in 2021 were penned by BIPOC (black, indigenous, and/or people of color) authors. In 2017, that number was as low as 6.2%. The report is carried out annually by Bea and Leah Koch, who proudly run a queer-owned romance bookstore named The Ripped Bodice.
These statistics show that A Taste for Three is sure to provide a much-needed dose of diversity in a systemically stagnant romance literary genre.
About the Author
Ro Smith is a risqué erotica and fiction writer with a penchant for providing refreshing character roles in a contemporary literary market. Previous titles include the Little Book of Quickies Series. All three are currently available on Amazon in Kindle and paperback format.
Her debut standalone story puts polyamorous romance books on the map with a realistic portrayal of diverse romantic relationships.
Car brands have been targeting the LGBT consumer (especially the L and G) very early on – as buying a car involves quite a bit of money. Some brands focus on gay men, others typically on lesbians – but in recent years it’s mostly been ‘loading the brand’ with diversity, via lifestyle campaigns.
It is not only about convincing the LGBT to buy that car, but also to remain loyal to the brand (repeat purchases), and above all to recommend it to ‘relatives’ in the LGBT community (NPS, member get member). See also my articles A pink Cadillac?, Subaru – the ladies love it and Toyota, ally since 1992. Saturn was there early, and 20 years ago Mercedes also contributed. Their compatriot BMW started Marketing the Rainbow a little later, but has since shown a few nice campaigns. ‘Ride with Pride’, ‘Driven by Diversity’: the slogans write themselves.
BMW is a German multinational company (est. 1916), which produces luxury automobiles and motorcycles in Germany, Brazil, China, India, South Africa, the UK, and the US. They also own Mini and Rolls-Royce. The company has significant motorsport history, especially in Formula 1, sports cars and the Isle of Man TT: it’s all very masculine.
BMW’s corporate home page includes a section on Diversity, where they say: “For us, diversity means living a culture that is based on appreciation and respect, so that people of all origins can contribute and develop with their personality and identity. BMW Group PRIDE stands for exactly that. The network acts as the mouthpiece of the LGBT+ community where diversity, equality, trust, respect and inclusion come first. Together, we ensure a positive, tolerant and open work environment in which everyone is welcome regardless of their sexual identity.”
The beginning: a paradox
It started in 2006 with a paradox: BMW of North America came under fire from Gaywheels.com – for advertising in gay and lesbian magazines. They called BMW hypocritical by targeting “the deep pockets” of gays and lesbians in publications like OUT and The Advocate, but didn’t offer domestic-partner benefits to employees. Their sister brands Mini and Rolls-Royce were already steps ahead. This changed in 2008, when BMW followed the colleagues, after which Gaywheels endorsed them as gay-friendly.
A year before, a local dealer in Texas, Classic BMW, had started to look at the gay drivers. One ad stated “Being Out Has Never Been So In”. Another aimed at lesbians with the slogan “Freedom to Go Where You Want and Be Who You Are”. A third ad was more neutral and stated: “It’s about respect”.
In 2007, they ran a teasing campaign which included billboards: the visual showed a convertible with the text “Hard Top. Firm Bottom. It’s so L.A.”, playing with words commonly known in the gay world. Another read: “When the top’s away, the car will play”. They were the work of David Morris Parson, who was rewarded with the Commercial Closet Award, for respecting diversity. However, the use of stereotypes was not appreciated by everyone. A market survey in Texas revealed that the target group found the ad, in particular the tagline, both offensive and insulting (sic.), because they used negative stereotypes, in this case the promiscuous gay.
BMW of North America was a top sponsor of the 2012 Lavender Law® Conference and Career Fair of the National LGBT Bar Association.
In California, Berkeley Motor Works listed itself in the GayPinkSpots directory as gay-friendly BMW auto repair shop.
In Palm Springs, the BMW Performance Driving School considered itself to be a Palm Springs Area Destination, possibly of the gay kind, by being included on the visitgaypalmsprings.com website.
In 2015, the BMW 2 Series received the Pink Brand of the Year Award in Belgium. They commented: “The LGBT community really likes our BMW 2 Series. This week, we received the Pink Brand of the Year Award and we are proud of it. Because sheer driving pleasure is for everyone.”
A report conducted in China in 2016 showed that “if you were to stereotype members of the LGBT community in China, you’d come to find that China’s gay men have deemed BMW, Mercedes-Benz, and Audi to be their top three auto brands. Meanwhile, lesbians picked Land Rover, Lamborghini, and Mini Cooper.”
In New York, BMW and Bleu Magazine organized an “ultimate brunch”, celebrating the vibrant culture of the LGBT community, similar to a Chicago event.
And now… “Thought Leadership”
In 2017, Hildegard Wortmann, Senior VP BMW, said: “To stay relevant to digital natives, who are more interested in smartphones than cars, automakers must be prepared to take more risks when positioning their brands and not shy away from edgy subject matter“. Since advertising no longer has the same reach, marketing executives need to be more willing to stretch the limits and be prepared to go directly to the customers and take a stance on key social issues such as gay and lesbian rights. She referred to it as providing “thought leadership.” Her team placed a specially designed BMW i8 at the Coachella Valley Music and Arts Festival in California, making a connection with “sex, drugs and rock ‘n’ roll”. Taking the risk brought rewards as the social media impact was immediate with people posting pictures of themselves in front of the BMW i8. “We’re using their community in order to boost our message,” Wortmann said.
The story behind the British vanity licence plate “YES I GAY” is a bit vague and might be a hoax, as it appeared on two different silver BMW’s. The plate was not issued by BMW though, and just happened to be attached to one. Or two?
In the 2018 campaign “Unexplainable”, a 30-second beautiful lifestyle video features a series of kisses at the end: one kiss is shared between two men. Blink and you’ll miss it.
Prides around the world
Over the years, they were present at – or supported – pride festivals around the world.
During the 2019 WorldPride in New York, there was an extensive program. BMW launched the #GoWithPride campaign: the programming included the creation of a custom wrapped BMW 8 Series, together with Jonathan Adler, who shared his journey to the WorldPride NYC Parade in the BMW 8 Series Convertible on BMWUSA’s Instagram page.
Also, there was a partnership with CNN, the “QUEER CITY: A CNN Experience”, a multimedia museum experience, which explored the real stories of people behind landmark moment in New York City’s queer history. At the location, BMW set up a photo booth, where visitors could take a picture expressing what Pride meant to them. These then became part of an exhibit wall thus including attendees into the festivities.
A fleet of #GoWithPride wrapped BMW 8 Series Convertibles carried the WorldPride Parade’s grand marshals. BMW partnered with GLAAD, outside of their NYC headquarters leading up to the weekend’s events. The company made a donation to GLAAD and provided food, beverages and giveaways, while a fleet of BMW X7 Sports Activity Vehicles delivered t-shirts to over 200 GLAAD volunteers.
2020 Driven By Pride
In 2020, while corona prevented Pride festivals to be celebrated “as usual”, BMW of North America launched a new campaign in celebration of Pride Month, entitled “Driven By Pride.” It featured various activations, including BMW’s support of The Trevor Project’s “Pride Everywhere” campaign, and communications across BMW’s digital channels.
NYC Pride hosted a special broadcast event featuring five custom-wrapped BMW 8 Series Convertibles. The vehicles featured blended rainbow colors that represent the entire Pride flag and LGBT+ community, as well as a special “PRIDE” BMW roundel design on the hood of each vehicle, replacing the BMW letters with PRIDE.
Along with the car show, the event included live musical performances from Janelle Monae, Billy Porter, Deborah Cox and Luisa Sonza. In addition, the broadcast features grand marshals from the LGBT+ community, including Dan Levy of Schitt’s Creek.
“While many of this year’s live Pride activities were cancelled out of necessity, BMW continues to stand with the LGBT+ community in this celebration of Pride and unity,” said Uwe Dreher, vice president of marketing, BMW of North America. “As the world continues to demonstrate for racial equality and justice amidst the ongoing COVID-19 pandemic, there has never been a more urgent time to celebrate togetherness and unity.”
Through their employee platform, attention was given to the International Day Against Homophobia, Transphobia and Biphobia.
2021 Driven By Pride
For the third year the Driven By Pride campaign was run. It featured designer LaQuan Smith rejoining forces with BMW to design original Pride vehicle wraps for the BMW 4 Series Coupe, following Smith’s role in BMW’s New York Fashion Week partnership.
The wrap was to be featured on five BMW 4 Series vehicles in the annual New York City Pride parade, which in the end only took place virtually.
For the same event, performer, activist and world-renowned drag queen, Shangela, joined BMW for digital content as part of the Pride campaign. She also joined GLAAD’s head of talent, Anthony Ramos, for an Instagram Live interview, sponsored by BMW.
Gay Games Munich
On Facebook the BMW Group PRIDE, together with “The Proud Wiesn”, one of the big LGBT+ Oktoberfest events – sponsored by BMW – rooted for their hometown Munich to be the host for the Gay Games 2026. Messages of support were also posted on Instagram. The honor went to Valencia.
A little later than other car brands, BMW joined the rainbow train. This was selective and always befitting their luxurious character. Often cars were decorated in Pride colors, activities around Pride were sponsored or even organized. Outside of these events, the brand doesn’t do much, although the casual kiss in a TV commercial does earn points. There were also collaborations with various charities. They therefore score a 7.5/10.
Employee Resource Group leads participation in Phoenix community event
PHOENIX–(BUSINESS WIRE)–University of Phoenix employees support the Phoenix Pride Parade, held November 6, the annual celebration of the LGBTQ+ community held in Phoenix, Arizona. University of Phoenix Employee Resource Group (ERG), Allies of Pride, with over 500 members, promotes the event to staff, students and faculty and provides volunteer support.
During the pandemic, many similar celebrations and in-person community events and support opportunities were cancelled or delayed.
“It’s important to remember that Pride is not just a parade or a specific month in which we celebrate. Pride is what we do every day. It’s what’s inside us, how we live our lives open and honestly and how we support each other. Pride is never cancelled,” shares Julie Fink, vice president of Human Resources at University of Phoenix. “However, we are excited to have a visual and in-person celebration of our community and support for each other, which is so critical as we emerge from a very difficult year and a half. This parade is an opportunity to celebrate, be together, and to support our loved ones, family members, and each other.”
The purpose of Allies of Pride employee resource group is to promote awareness within the University and community of LGBTQ understanding and acceptance. Additionally, the goal is to attract “allies” who support LGBTQ causes and rights to create a stronger support network both internally and externally of the organization.
“The University of Phoenix is dedicated to the work of advancing inclusion as part of its focus on Diversity, Equity, Inclusion and Belonging (DEIB),” Fink states. “It has received perfect successive scores on the HRC Corporate Equality Index. This highlights the University’s willingness to review practices to make changes or adapt to evolving nondiscrimination views.”
The HRC Corporate Equality Index is a self-reported system that evaluates workplace equality in regard to specific criteria, including workforce protections, inclusive benefits, supporting an inclusive culture and corporate social responsibility, and responsible citizenship. University of Phoenix has received a perfect Equality Index score consecutively over the past four years.
University of Phoenix is continually innovating to help working adults enhance their careers in a rapidly changing world. Flexible schedules, relevant courses, interactive learning, and Career Services for Life® help students more effectively pursue career and personal aspirations while balancing their busy lives. For more information, visit phoenix.edu.
Elton John’s iconic style and famed music career comes to life through an exclusive new eyewear collection
Eyewear line gives fans access to high-quality, stylish products while benefiting the Elton John AIDS Foundation
BENTONVILLE, Ark.–(BUSINESS WIRE)–Elton John Eyewear, a new line of stylish, accessible eyewear, is launching at Sam’s Club today and at Walmart later this week.
Elton John collaborated closely with the retailers on the development of the brand, with each pair inspired by his iconic style and famed music career. Each frame was given a name by Elton himself, like “Rocketman,” a nod to his chart-topping hit and most recent Academy Award Nominated film of the same name, “A-List” reflecting moments when he was at the peak of his career, and “Prodigy,” representing his rise from a shy piano prodigy in the UK to international celebrity. From their shapes and colors to their lenses, the goal of the collection was to ensure that there is a frame for every fan.
“Elton John Eyewear celebrates confidence, self-expression, and authenticity,” said Elton. “The line is designed to have something for everyone, so no matter who you are, you can always Look Yourself. It’s not just about glasses, it’s about changing the way people see themselves.”
The launch of Elton John Eyewear also furthers Walmart’s support of the Elton John AIDS Foundation’s mission. Walmart Inc. will donate a minimum of $1 million annually from the Elton John Eyewear collection to support the Elton John AIDS Foundation to increase HIV education and awareness and encourage individuals to take the first steps toward a healthier future.
“Our customers and members are going to love this collection. We’re thrilled to celebrate Elton John’s creativity and iconic style by launching a fun, on-trend eyewear collection that will help customers feel their best, all at an every day low price,” said Janey Whiteside, executive vice president and chief customer officer, Walmart US. “On top of that, we’re proud to shine a light on the work of the Elton John AIDS Foundation and donate a portion of the sales to their important mission.”
“We know Sam’s Club members and Walmart customers look to us for quality, on-trend brands at an amazing price, and the Elton John Eyewear Collection delivers just that,” said Megan Crozier, Chief Merchant, Sam’s Club. “We’ve created an eyewear line using materials, elements and contours across expressive silhouettes, making the brand feel like luxury at an affordable price, while also telling Elton John’s phenomenal story.”
The Foundations Collection
The exclusive, evergreen collection – The Foundations Collection – will be available for purchase nationwide in Sam’s Club Vision Centers and on samsclub.com today and at Walmart later this week.
The Foundations Collection includes 60 frames in total: 36 frames that are unique to Sam’s Club and 24 frames that are unique to Walmart. The frames will retail between $95-$100 and are available in prescription, non-prescription, sun and reader categories.
Each frame is embolized with a signature temple tip silhouette with “E” Star mark and Elton John iconic star brand detailing. All details were carefully planned and crafted, with frames featuring vibrant color attributes, elevated metals, and stones.
Elton John Eyewear Found Only at Sam’s Club
Sam’s Club will also offer its members two additional collections that celebrate Elton John’s confidence and self-expression. The Capsule Collection, designed for collectability, showcases Elton John’s musical journey. “The Formative Years” (Capsule I), represents Elton’s childhood and time as a student in music, so the eyewear reflects its most classic and conventional looks. “The Working Musician” (Capsule II) continues the story, showcasing the time when Elton John discovers Rock and Roll is his true calling. As such, the Capsule II offers next generation styles. Currently, five Capsule Collections are planned.
Finally, just in time for the holidays, Sam’s Club will launch The Master Collection. Drawn from Elton’s personal collection, Elton John Eyewear will recreate and reissue his most iconic looks with “collector” frames that are only available at samsclub.com. Each frame will be signed, numbered and sold in limited quantities, with retails starting at $350.
Next year, Elton John Eyewear is expected to offer additional frames, as well as expand its reach to additional locations across Walmart Inc. retail stores globally.
Walmart and Sam’s Club are committed to providing quality, affordable and accessible healthcare in the communities they serve. That includes offering affordable fresh foods and other grocery items, household essentials, and reduced-price prescriptions, along with a broad assortment of high-quality items at a great value, like Elton John Eyewear.
In addition to Elton John Eyewear, Walmart customers can also purchase the latest album by Elton John, The Lockdown Sessions, with an exclusive bonus track called Cold Heart (PS1 Remix) by Elton John & Dua Lipa. The CD is available for $13.97 in stores and Walmart.com.
About Elton John
Elton John’s career achievements to date are unsurpassed in their breadth and longevity. He is one of the top-selling solo artists of all time, with 1 diamond, 40 platinum or multi-platinum, and 26 gold albums, over 50 Top 40 hits, and he has sold more than 300 million records worldwide. He holds the record for the biggest-selling single of all time, “Candle in the Wind 1997”, which sold over 33 million copies. ‘Diamonds’ the Ultimate Greatest Hits album, reached the Top 5 of the UK album charts on its release in November 2017, becoming Elton’s 40th UK Top 40 album in the process. This release celebrated 50 years of his songwriting partnership with Bernie Taupin. August 2018 saw Elton named as the most successful male solo artist in Billboard Hot 100 chart history, having logged 67 entries, including nine No. 1s and 27 Top 10s. In August 2021, Elton achieved his 68th Hot 100 hit with single “Cold Heart (Pnau Remix),” featuring Dua Lipa. The wildly popular track marked his record return to the Billboard Hot 100’s Top 40, extending his run to 50 years. He now holds the longest span of Hot 100’s Top 40 appearances in history. In May 2021, he was honored with the iHeartRadio Icon Award in recognition of his incredible influence on music and pop culture.
In January 2018, Elton announced the “Farwell Yellow Brick Road” Tour at New York’s Gotham Hall. Encompassing five continents, and over 350 dates, the tour kicked off September 2018 and marks his retirement from touring after more than 50 years on the road. In 2019 it was named Billboard’s “Top Rock Tour” and Pollstar’s “Major Tour Of The Year.” To date, Elton has delivered more than 4,000 performances in more than 80 countries since launching his first tour in 1970. 2019 also saw the release of Rocketman and global bestselling autobiography, ME. An epic fantasy musical motion picture of Elton’s life, Rocketman has been a commercial and critical hit, taking close to $200m at the box office. The film has won an Oscar, two Golden Globe Awards and a Critics’ Choice Award and garnered BAFTA nominations. Its soundtrack was also nominated for a GRAMMY Award.
In 1992, Elton established the Elton John AIDS Foundation, which today is one of the leading non-profit HIV/AIDS organizations and has raised over $515 million to date in the global fight against HIV/AIDS. In June 2019, President Emmanuel Macron presented Elton the Légion d’Honneur, France’s highest award, for his lifetime contribution to the arts and the fight against HIV/AIDS.
Walmart Inc. (NYSE: WMT) helps people around the world save money and live better – anytime and anywhere – in retail stores, online, and through their mobile devices. Each week, approximately 220 million customers and members visit approximately 10,500 stores and clubs under 48 banners in 24 countries and eCommerce websites. With fiscal year 2021 revenue of $559 billion, Walmart employs 2.2 million associates worldwide. Walmart continues to be a leader in sustainability, corporate philanthropy and employment opportunity. Additional information about Walmart can be found by visiting corporate.walmart.com, on Facebook at facebook.com/walmart and on Twitter at twitter.com/walmart.
About Sam’s Club
Sam’s Club®, a division of Walmart Inc. (NYSE: WMT), is a leading membership warehouse club offering superior products, savings and services to millions of members in nearly 600 clubs in the U.S. and Puerto Rico. Now in its 39th year, Sam’s Club continues to redefine warehouse shopping with its highly curated assortment of high-quality fresh food and Member’s Mark items, in addition to market leading technologies and services like Scan & Go, Curbside Pickup and home delivery service in select markets. To learn more about Sam’s Club, visit the Sam’s Club Newsroom, shop at samsclub.com, and interact with Sam’s Club on Twitter and Facebook.
About Elton John AIDS Foundation
The Elton John AIDS Foundation was established in 1992 and is one of the leading independent AIDS organisations in the world. The Foundation’s mission is simple: an end to the AIDS epidemic. The Elton John AIDS Foundation is committed to overcome the stigma, discrimination and neglect that keeps us from ending AIDS. With the mobilisation of our network of generous supporters and partners, we fund local experts across four continents to challenge discrimination, prevent infections and provide treatment as well as influencing governments to end AIDS. www.eltonjohnaidsfoundation.org
9th Circuit Court of Appeals ruled earlier that HIV patients may make a discrimination claim under the Affordable Care Act against CVS for requiring HIV patients to use mail-order pharmacies or to go to a few of CVS’s selected specialty pharmacies, where patients say they are not getting full service
In 2018, AHF warned the U.S. Department of Justice that the then-proposed CVS merger with Aetna would create a monopoly-like behemoth that would harm patients, which appears to be the case here with pharmacy choice
WASHINGTON–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF), the largest global AIDS organization, filed a brief of amicus curiae with the Supreme Court of the United States earlier today in CVS Pharmacy, Inc. vs. Doe, a case set to be heard and decided by summer 2022.
In December 2020, the U.S. 9th Circuit Court of Appeals ruled in Doe vs. CVS Pharmacy, Inc. that people living with HIV can state a discrimination claim under the Affordable Care Act against CVS Pharmacy, Inc., for requiring them to use mail-order pharmacies to obtain HIV/AIDS medications or to go to one of a few designated “specialty” pharmacies that are little more than pick-up stations, as part of in-network pharmacy services for private insurance plans. CVS appealed the ruling and the Supreme Court agreed to hear the case. In its brief, AHF asks the Supreme Court to affirm the earlier judgement of the Ninth Circuit.
“For people living with HIV/AIDS, real specialty pharmacies and pharmacists that focus on HIV/AIDS and in-person treatment provide demonstrably superior care than do mail-order pharmacies and retail pharmacies. We believe that CVS’s denial of choice in pharmacy services for HIV/AIDS patients is both wrong and discriminatory,” said Jonathan M. Eisenberg, Deputy General Counsel — Litigation for AHF.
AHF’s amicus curiae brief focuses on three primary arguments:
That U.S. Statutory Law Requires Courts to Protect People Living with HIV/AIDS from Disability Discrimination by Healthcare Providers,
That Coerced Use of Mail-Order Pharmacies Is Highly Detrimental to People Living with HIV/AIDS, and
That Coercing People Living with HIV/AIDS to Use Mail-Order Pharmacies Is a Disability-Rights Violation, by Both Intent and Impact.
“CVS said to people living with HIV that they can only go to a few of its selected pharmacies and/or be compelled to utilize its PBM’s mail order pharmacies. Patients asserted they weren’t getting full service there, which discriminated against them. They wanted to keep their current pharmacies which provide more comprehensive and specialty services,” said Tom Myers, Chief of Public Affairs and General Counsel for AHF. “We filed this amicus brief to support HIV/AIDS patients’ legal arguments in the case before the Supreme Court and to defend patients’ rights and choice in their pharmacy services.”
The December 2020 9th Circuit Court ruling validated AHF’s earlier warning of the CVS threat to the HIV response back in 2018. See AHF press statement (Nov. 28, 2018) “CVS-Aetna Merger is Bad for HIV Patients.”
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million individuals in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us @aidshealthcare.
– Clinical Data Across a Diverse Range of People Living With HIV on Biktarvy Treatment in the International BICSTaR Study Showed High Effectiveness and High Levels of Adherence –
– Long-Term Switch Data Presented at EACS 2021 Further Establish the Robust and Durable Efficacy Profile of Biktarvy –
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from the ongoing, multinational, observational single-arm, non-comparative real-world cohort BICSTaR study, which is designed to evaluate the antiviral effectiveness and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 1,135 people living with HIV. The BICSTaR study also collected patient-reported outcomes in routine clinical practice to better understand the impact of treatment on health-related quality of life in people living with HIV. These data were presented at the 18th European AIDS Conference (EACS 2021).
Gilead presented an analysis of patient-reported outcomes after 12 months of treatment with Biktarvy from the BICSTaR study. During the study, conducted at sites in Europe, Canada and Israel, people living with HIV who initiated treatment with Biktarvy between June 2018 and September 2020 completed questionnaires at baseline and 12 months. The questionnaires assessed patient-reported outcomes covering a range of measures. The results underline the importance of collecting patient-reported outcomes in order to understand the impact on mental health status, health-related quality of life and treatment satisfaction of people living with HIV.
“Despite advances in antiretroviral therapy, people living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centered care,” said Fernando Bognar, MD, Vice President, Medical Affairs, HIV at Gilead Sciences. “The patient-reported outcomes observed in the BICSTaR study provide a first-hand assessment of the impact of HIV treatment and care on the quality of life that people living with HIV experience. As physicians and people living with HIV look to understand what long-term treatment means to them individually, these data presented at EACS also reinforce that Biktarvy can meet the specific treatment needs of diverse groups of people, including men and women aging with HIV and those with existing comorbid conditions.”
In a second analysis of the BICSTaR study, 97% (n=149/154) of treatment-naïve adults and 96% (n=771/800) of treatment-experienced adults achieved and maintained virologic suppression (HIV-1 RNA <50 copies/mL) after one year of treatment. Participants included adults 50 years of age or older, cisgender women, and late presenters (CD4 <200 cells/μl and/or ≥1 AIDS-defining event at baseline). Both treatment-naïve and treatment-experienced participants had high persistence with Biktarvy (91%, n=1032/1135) across both groups, Biktarvy was generally well-tolerated and no resistance to the components of Biktarvy emerged. 148 (13%) participants had any adverse event and 2 (<1%) had a serious adverse event. The most common drug-related adverse events observed to date in the BICSTaR study were weight increase (3%), nausea (1%), depression (1%), headache (1%), fatigue (1%), diarrhoea (1%) and sleep disorder (1%). These large cohort findings continue to reinforce the real-world effectiveness of Biktarvy across populations and are consistent with evidence from randomized clinical trials.
Additional Biktarvy data presented at EACS 2021 include a Phase 3 trial (Study 1878) that demonstrated the durable efficacy of Biktarvy. In the study, 99% of people living with HIV who switched to Biktarvy from a boosted protease inhibitor-based regimen maintained and achieved long-term viral suppression through a median of 101 weeks (n=525/532), including 98% of participants with pre-existing resistance (n=212/217; median of 108 weeks) and 98% of participants with viral blips (n=39/40; median of 109 weeks), with no treatment-emergent resistance to Biktarvy. A pooled analysis of five Phase 3 studies (1844, 1878, 4030, 4449, 4580) also found that regardless of pre-existing TAMS (thymidine analog-associated mutations M41L, D67N, K70R, L210W, T215Y/F, and K219Q/E), a high proportion of those on Biktarvy were able to maintain virologic suppression and had an absence of treatment-emergent resistance. These data support the continued evaluation of Biktarvy as a potential option for virologically suppressed people living with HIV with known resistance. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational, and the safety and efficacy of Biktarvy for this use have not been established.
Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.
There is currently no cure for HIV or AIDS.
The Bictegravir Single Tablet Regimen (BICSTaR) Study is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people living with HIV. Among the people living with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.
Biktarvy is a complete HIV-1 treatment that combines three powerful medicines to form the smallest integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete single-tablet regimen and should not be taken with other HIV-1 medicines.
In February 2018, the U.S. Food and Drug Administration (FDA) approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg. In October 2021, the FDA approved a new low-dose tablet formulation of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg. For all patient populations, Biktarvy is only indicated for the treatment of HIV-1 infection in people who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
U.S. Important Safety Information for Biktarvy
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted.
Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
Warnings and precautions
Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.
Dosage and administration
Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
Hepatic impairment: Not recommended in patients with severe hepatic impairment.
Prior to or when initiating: Test patients for HBV infection.
Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
Pregnancy and lactation
Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
U.S. Indication for Biktarvy
Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Biktarvy; the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy; Gilead’s ability to receive FDA and other regulatory approvals for additional indications for Biktarvy, and the risk that any such approvals, if granted, may have significant limitations on its use; the risk that physicians may not see the benefits of prescribing Biktarvy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.
U.S. full Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS,are available at www.gilead.com.
Biktarvy, Descovy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
WASHINGTON, Oct. 25, 2021 /PRNewswire/ — Supplier diversity is the cornerstone to a new era of diversity, equity, and inclusion in today’s evolving business ecosystem. EverGlade Consulting is excited to announce that it has been approved as a Certified LGBT Business Enterprise® with the National LGBT Chamber of Commerce (NGLCC) Supplier Diversity Initiative.
Visibility and representation have been shown to be marked characteristics that foster more inclusivity and advance equitable agendas within businesses, organizations, and even governmental entities. As part of this effort, EverGlade Consulting became part of this certification program in the hopes to promote more transparency and visibility within the professional services industry.
“EverGlade Consulting is excited to add this NGLCC certification to its credentials and looks forward to being a proud example of economic opportunity and advancement for other LGBT+ owned businesses,” explained Chairman and President Jerry Jia-Sobota.
“When I started my career in government contracting two decades ago, being out was much more difficult,” explained Eric Jia-Sobota, National Leader of EverGlade’s Consulting Practice. “It was important then and even more important now to be visible as business leader and owner, especially in a field that is not especially known for LGBT businesses,” he concluded.
About EverGlade Consulting
EverGlade Consulting is a Washington, DC based consulting firm that helps clients navigate the federal landscape. We are inspired by technology-driven companies whose focus is to secure non-dilutive funding through the federal government. We offer services ranging from proposal support through the implementation of systems to comply with federal regulations at agencies including BARDA, the DOD, HHS, NIAID, and DTRA.
For additional information about EverGlade Consulting, visit:
The National LGBT Chamber of Commerce is the business voice of the LGBT community and the largest global not-for-profit advocacy organization specifically dedicated to expanding economic opportunities and advancements for LGBT people. NGLCC is the exclusive certification body for LGBT-owned businesses. www.nglcc.org
LOS ANGELES–(BUSINESS WIRE)–#BehaviorialScience–UCLA Extension, a national leader in comprehensive continuing and professional education programs, today announced a $1.5 million grant from the U.S. Health Resources and Services Administration (HRSA) to support the creation of a Behavioral Health Support Specialist Training Certificate (BHSS). The program provides training to upskill paraprofessionals to address the needs of the LGBTQIA+ population of greater Los Angeles.
“UCLA Extension’s mission and 100-year history support the advancement and empowerment of individuals,” said Eric A. Bullard, Dean of Continuing Education and UCLA Extension. “This grant removes financial barriers to access training in the Behavioral Health Support Specialist Program and allows us to serve the needs of the greater LGBTQIA+ community in greater Los Angeles.”
Evidence indicates the LGBTQIA+ population is underserved in the areas of behavioral disorders, violence, and homelessness. The certificate addresses gaps with evidence-based training for healthcare support workers (and non-clinical staff) by developing knowledge, skills, and practice to meet the needs to mitigate and help prevent behavioral health concerns.
The Behavioral Health Support Specialist Training Certificate totals 33.5 academic credit units and consists of nine (9) courses: Fundamentals of the U.S. Health and Behavioral Healthcare Systems; Health Care Law, Legal Issues, and Ethics in Behavioral Health; Fundamentals of Human Sexuality; Working with Diverse Populations in Behavioral Health; Behavioral Health Support Practice; Communication Strategies in Behavioral Health Care; Navigating High-Stakes Conversations and Motivating Patients; Supervised Field Work (Internship); Capstone Project in Behavioral Health Support.
With an anticipated cohort of 26 students per year, the program enables trainees to obtain a California Consortium of Addiction Programs and Professionals Education Institute (CCAPP-EI) credential for behavioral health workers, with credits and training hours eligible for different types of credentials offered by CCAPP-EI, depending on their desired career path. The goal is to put health support workers on a path of career advancement. The certificate training is at no cost for tuition and students receive a stipend of $5,000 per trainee to complete the program.
“Working with community-based organizations as well as health care experts has allowed us to develop a unique program,” said Denis Couturier, Program Director, Custom Programs and Corporate Education. “Our community partners are very supportive of professional development.”
UCLA Extension instructor Benjamin O. Toubia, PsyD, contributed subject matter guidance on the Behavioral Health Support Specialist grant proposal. He is a marriage and family therapist, community health expert and LGBTQIA+ affirmative treatment specialist with experience in providing services for and teaching students about LGBTQ-affirmative treatment. Toubia’s research background and clinical practice stresses the importance of research on LGBTQ-specific issues as foundational for sustainable addiction recovery in the LGBTQ community.
Health Resources and Services Administration (HRSA)
This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $1,574,294. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
UCLA Extension’s Custom Programs and Corporate Education unit (CPCE) exists to serve organizations with training and development needs for the current and future workforce. With collaborations across industries in entertainment, healthcare, and finance, as well as governmental agencies and community-based organizations and nonprofits, CPCE is a leading educational provider for domestic and international groups, offering in-person and online programs.
Founded in 1917 as the continuing education division of the University of California at Los Angeles, UCLA Extension has delivered the most advanced courses and certificates that annually enhance the careers of thousands of individuals across the United States and the world. UCLA Extension offers online and in-person courses for professionals in the arts, business, management, education, engineering and digital technology, entertainment studies, public policy, health care, humanities and sciences, and many other fields. Find out more at uclaextension.edu