Natreve Announces Partnership with The Trevor Project on World Mental Health Day OutBuro lgbt professional entreprenuer networking online community gay lesbian transgender queer bisexual nonbinary

Mission-Driven Wellness Company, Natreve, Announces Partnership with The Trevor Project on World Mental Health Day

VANCOUVER, BC, Oct. 7, 2021 /PRNewswire/ — Natreve, the mission-driven and ocean-forward premium wellness company dedicated to providing the most innovative, highest quality products, announced today its partnership with The Trevor Project, the world’s largest suicide prevention and crisis intervention organization for lesbian, gay, bisexual, transgender, queer & questioning (LGBTQ) young people. The brand will become an official corporate partner of the renowned organization on World Mental Health Day (October 10).

“Support from brands like Natreve is so essential to our life-saving work,” said Sofi Goode, Corporate Development Manager at The Trevor Project. “We’re so thankful for not only their generous donation – which will allow us to keep operating and scaling our free, 24/7 crisis services, but for the message of love and acceptance that they’re sending to LGBTQ young people everywhere by backing our organization.”

“At Natreve we’re just as focused on creating premium wellness products as we are on cultivating a community that believes in diversity, equality, and acceptance,” said Roland Radu, Founder of Natreve. “We are honored to team up with The Trevor Project to support LGBTQ young people. While our partnership officially kicks off on this important day, World Mental Health Day, we look forward to continuing our support throughout 2021 and 2022.”

While this year has been difficult for everyone, it has been especially challenging for  LGBTQ youth, who often face more rejection, bullying  and discrimination than their straight or cisgender peers. As a corporate partner, Natreve will work with The Trevor Project to help end suicide among LGBTQ young people through a donation of $25,000.

For more information visit Natreve.com or TheTrevorProject.org.

About The Trevor Project
The Trevor Project is the world’s largest suicide prevention and crisis intervention organization for lesbian, gay, bisexual, transgender, queer & questioning (LGBTQ) young people. The Trevor Project offers a suite of 24/7 crisis intervention and suicide prevention programs, including TrevorLifeline, TrevorText, and TrevorChat as well as the world’s largest safe space social networking site for LGBTQ youth, TrevorSpace. Trevor also operates an education program with resources for youth-serving adults and organizations, an advocacy department fighting for pro-LGBTQ legislation and against anti-LGBTQ rhetoric/policy positions, and a research team to discover the most effective means to help young LGBTQ people in crisis and end suicide. If you or someone you know is feeling hopeless or suicidal, our trained crisis counselors are available 24/7 at 1-866-488-7386 via chat www.TheTrevorProject.org/Help, or by texting START to 678-678.

About Natreve
Launched in 2019, Natreve is a mission-driven and ocean-forward premium wellness company dedicated to providing the most innovative, highest quality products, to help you Eat Right and Do Good. Natreve is proud to be the world’s first plastic and carbon-neutral wellness company, with a vision to become the world’s most sustainable wellness brand. Protein powders include WheyVegan, and Keto options available in unique and decadent flavors such as French Vanilla Wafer Sundae, Fudge Brownie, and more. The Wellness Series offers science-backed drink mixes including Stress LessImmune Strength, and Sleep Peaceful. Natreve products are Non-GMO Project verified, Informed Sport certified, and free from gluten, hormones, artificial sweeteners, flavors, and colors. For more information visit www.natreve.com.

MEDIA CONTACTS
Lauren Newhouse
Konnect Agency
[email protected] 
407-342-2833

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SOURCE Natreve

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AHF Praises President Biden’s Pick for New PEPFAR Chief

LOS ANGELES–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS care provider operating in 45 countries, praised today President Biden’s decision to nominate John Nkengasong to lead the US President’s Emergency Plan for AIDS Relief (PEPFAR).

Nkengasong currently serves as the Director of the Africa Centres for Disease Control and Prevention (ACDC). Before joining ACDC as its inaugural director, he served as an acting deputy director at the US CDC Center for Global Health. Nkengasong is a virologist by training and holds a dual US and Cameroonian citizenship.

“We believe Dr. Nkengasong is well suited to lead PEPFAR because his tireless efforts in fighting COVID-19 as the head of ACDC are widely praised across Africa. As a virologist, he understands both the HIV and the COVID-19 pandemics, and has the requisite managerial and scientific credentials to successfully lead PEPFAR,” said AHF Africa Bureau Chief Dr. Penninah Iutung. “We hope the US Senate will fully support Dr. Nkengasong’s nomination and move quickly to confirm his appointment. To-date PEPFAR has saved millions of lives, most of them across Africa, and during the ongoing pandemic it is also providing indispensable COVID-19 relief. With Dr. Nkengasong at the helm, PEPFAR will continue its legacy of lifesaving humanitarian work funded by the generosity of the American people.”

Congress will soon consider whether to reauthorize PEPFAR for another five years. AHF has always been a strong supporter of PEPFAR and has repeatedly advocated for its reauthorization in previous rounds.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million clients in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare

Contacts

US MEDIA CONTACT:

Ged Kenslea, Senior Director, Communications, AHF

+1.323.308.1833 work +1.323.791.5526 mobile

[email protected]

Denys Nazarov, Director of Global Policy &

Communications, AHF

+1 323.308.1829

[email protected]

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FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV

Final FDA decision anticipated by 24 January 2022; if approved, cabotegravir would be the first long-acting therapy for HIV PrEP

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for a New Drug Application (NDA) for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis, or PrEP. The Priority Review designation of cabotegravir long-acting for PrEP builds upon its prior identification as a Breakthrough Therapy by the FDA.

If approved, cabotegravir would be the first, long-acting therapy for the prevention of HIV for individuals at risk of sexually acquired HIV-1 infection, who have a negative HIV-1 test prior to initiation. The FDA has set a target approval date of 24 January 2022.

The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women.1,2 The blinded, randomised portions of both studies were stopped early by independent Data Safety Monitoring Boards after cabotegravir was shown to be superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets in preventing the acquisition of HIV.1,2

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: The FDA’s Priority Review designation of cabotegravir long-acting for PrEP underscores the importance of this medicine, supported by the results of the HPTN studies, which demonstrated cabotegravir’s superior efficacy over daily oral FTC/TDF tablets. In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options. We believe new options like investigational cabotegravir long-acting for PrEP will help play a significant role in our collective efforts to end the HIV epidemic.”

ViiV Healthcare will initiate submissions of cabotegravir long-acting for PrEP to other regulatory authorities by the end of 2021. Cabotegravir long-acting for PrEP has not been approved or licensed anywhere in the world for use in HIV prevention.

About HPTN 083 (NCT02720094)

The HPTN 083 study is a phase IIb/III double blind study designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 083 was conducted in 4,566 men who have sex with men and transgender women who have sex with men. The study opened to enrolment in November 2016 at research centres in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam.1

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the study population. The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long-acting cabotegravir were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain. For further information on HPTN 083 please see https://clinicaltrials.gov/ct2/show/NCT02720094.

About HPTN 084 (NCT03164564)

The HPTN 084 study is a phase IIb/III double blind study designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,223 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe.2

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in preventing HIV acquisition in the study population. The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long-acting cabotegravir were injection site reactions, diarrhea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash. For further information please see https://clinicaltrials.gov/ct2/show/NCT03164564.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined as a shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us/.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020, GSK’s Q2 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

GSK PLC

ViiV Healthcare Limited

No. 3888792

No. 06876960

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

References

1 Marzinke M, Grinsztejn B, Fogel J, Piwowar-Manning EM et al, Laboratory Analysis of HIV Infections in HPTN 083: Injectable CAB for PrEP. Conference on Retroviruses and Opportunistic Infections Abstract 153

2 Delany-Moretlwe S, Hughes JP et al. Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women. HIV Research for Prevention Virtual Conference (HIVR4P 2021) abstract HY01.02, 2021.

3 DC statement on FDA approval of drug for HIV prevention. News release CDC NCHHSTP Newsroom. July 16, 2012. Accessed September 7, 2021. https://www.cdc.gov/nchhstp/newsroom/2012/fda-approvesdrugstatement.html
4 Centers for Disease Control and Prevention. Prevent new HIV transmissions by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs). Accessed September 7, 2021. https://www.cdc.gov/endhiv/prevent.html

Contacts

ViiV Healthcare
Media enquiries:

Melinda Stubbee +1 919 491 0831 (North Carolina)

Audrey Abernathy +1 919 605 4521 (North Carolina)

Catherine Hartley +44 7909 002 403 (London)

GSK enquiries:
Media enquiries:

Tim Foley +44 (0) 20 8047 5502 (London)

Kristen Neese +1 804 217 8147 (Philadelphia)

Kathleen Quinn +1 202 603 5003 (Washington DC)

Analyst/Investor enquiries:

James Dodwell +44 (0) 20 8047 2406 (London)

Mick Readey +44 (0) 7990 339653 (London)

Jeff McLaughlin +1 215 751 7002 (Philadelphia)

Frannie DeFranco +1 215 751 4855 (Philadelphia)

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City of Hope and Griffith University Researchers Use Novel Method to Block HIV in Mice

Scientists developed an anti-HIV protein called ZPAMt that can be delivered to affected areas using exosomes, nanosized parts of cells able to reach difficult-to-access areas of the body, such as the brain.

DUARTE, Calif.–(BUSINESS WIRE)–Researchers at City of Hope, a world-renowned research and treatment organization for cancer and diabetes, and Menzies Health Institute Queensland at Griffith University have developed a novel anti-HIV protein that suppressed HIV levels in the bone marrow, spleen, and brain of mice and prevented the virus from replicating in those regions, according to a new study published in Nature Communications today.


Their research demonstrates that scientists could engineer nanosized parts of cells called exosomes to carry therapeutic cargo to hard-to-reach places, including the nearly impenetrable blood-brain barrier. This innovative delivery system paves the way for a future where it’s conceivable that engineered exosomes could carry cargo that either suppress infectious diseases or restructure genetic material so that pathogens are rendered harmless.

“This innovative technology could become a viable way to deliver therapies not only for HIV but also for other diseases, including ones that affect the brain, such as Alzheimer’s and Parkinson’s,” said Professor Kevin Morris, Ph.D. from City of Hope’s Center for Gene Therapy and Griffith University’s School of Pharmacy and Medical Sciences. Morris is senior author of the new study.

Human immunodeficiency virus attacks cells that help the body fight infection, making an individual more vulnerable to other infections and diseases. Many researchers believe one way to cure HIV is to “block and lock” the disease in a process that obstructs the ability of the virus to replicate and locks it in a dormant state.

“The ZPAMt HIV protein repressor we developed is packaged into exosome nanoparticles and can enter cells where it epigenetically silences HIV,” Morris said. “We show that these nanoparticles can systemically ‘block and lock’ HIV expression. This is the first time that block and lock has been successfully delivered to treat HIV in vivo in the brain.”

HIV can enter the human body in a dormant-like state; it is able to hide from the body’s immune system and evade treatments. Then, it can reactivate later. HIV hiding in the brain is especially difficult to treat because of the blood-brain barrier, which prevents both toxins and therapies from entering the brain.

Currently, there is no cure for HIV, so once someone contracts it, he or she will have it for life. An estimated 1.19 million people in the United States had HIV at the end of 2019, according to the Centers for Disease Control and Prevention.

The research was supported by the National Institutes of Health’s National Institute of Mental Health (R01 113407-01).

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHopeTM, a subsidiary launched in 2019, serves employers and their health care partners by providing access to NCI-designated cancer center expertise. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Griffith University

Griffith University is a comprehensive research-intensive university ranked in the top 2% of universities globally with 50,000 students spanning six campuses in South East Queensland, Australia. Its research excellence, innovative teaching and learning practices, and strong industry ties makes it one of the leading providers of higher education in the Asia–Pacific.

Contacts

Zen Vuong

626-409-9367

[email protected]

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OptumHealth Education Launches LGBTQ+ Education Program for Providers

Developed in partnership with OutCare Health, the no-cost, on-demand accredited series and related resource guide teaches health care professionals about the unique needs and health disparities facing the LGBTQ+ community

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–OptumHealth Education, in partnership with OutCare Health, has launched an accredited, no-cost, and publicly available education program to teach health care professionals about the unique health care needs and disparities experienced by the LGBTQ+ community. The series is designed to promote a more equitable, affirming and supportive health care environment for LGBTQ+ people through increased provider education and understanding.

According to the U.S. Department of Health and Human Services, LGBTQ+ people experience health disparities linked to social stigma and discrimination1. Studies have found that an estimated 8% of lesbian, gay and bisexual patients, and almost 27% of transgender patients, have reported being denied health care services2.

The program is an on-demand, publicly available webcast on OptumHealthEducation.com at no cost, and is eligible for continuing education credits. The series identifies the negative effects that implicit bias, stigma and discrimination can have on the mental and physical health of those in the LGBTQ+ community; discusses the appropriate pronouns and terminology to use in respectful communication with members of the LGBTQ+ community; covers the specific and unique health-related risks and disparities that are experienced by the LGBTQ+ community; and identifies how to create a health care environment in which members of the LGBTQ+ community can feel validated, welcome and safe to discuss health issues.

Future modules starting in fall 2021 will offer more in-depth provider-focused education around the unique health care needs of specific populations within the LGBTQ+ community, such as caring for transgender patients.

In conjunction with the education, Optum created PRIDE365+, a website that provides resources to educate and support LGBTQ+ community members and allies in creating open, safe and respectful working and living environments. PRIDE365+ includes a resource guide, an LGBTQ+ terminology and pronoun guide, a transgender support guide, and a “How to be an Ally” guide, along with informational content from Optum partner Trans Lifeline, a grassroots nonprofit 501(c)(3) offering emotional and financial support to trans people in crisis.

“LGBTQ+ people face a number of unique challenges and barriers when it comes to their health and well-being. Many of these barriers are rooted in discrimination, stigma and a simple lack of awareness and knowledge,” said Dr. Amy Nguyen Howell, Optum senior national medical director, Office for Provider Advancement. “We launched this educational series as part of our commitment to advancing health equity and improving the health care experience for everyone we serve.”

Caring for the LGBTQ+ Community: An Introduction, was developed in partnership with OutCare Health, a national nonprofit 501(c)(3) LGBTQ+ health equity organization, which offers directories of providers and public resources, mentorship, webinars, blogs, research and cultural competency trainings.

“We’re proud to launch this educational series with OptumHealth Education and Optum, and to address these disparities head-on,” said OutCare Health Founder and President Dr. Dustin Nowaskie. “Working with one of the leading health care services companies in the United States to design this training means we can reach more providers and make a meaningful impact on the barriers LGBTQ+ people experience within the health care system.”

Caring for the LGBTQ+ Community: An Introduction, is offered by OptumHealth Education, an organization dedicated to providing interprofessional continuing education that improves patient outcomes and positively affects the delivery of health care. OptumHealth Education is jointly accredited by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nurses Credentialing Center.

For more information or to sign up for the educational series, please visit OptumHealthEducation.com.

About OptumHealth Education

OptumHealth Education is dedicated to providing interprofessional continuing education that improves patient outcomes and positively impacts the delivery of health care. It works diligently to foster the professional development of engaged, lifelong learners who seek to advance the skills, strategy and/or performance relevant to their clinical practice and/or their role within the health care team. For more information, visit www.optumhealtheducation.com.


1 https://www.healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health

2 https://www.lambdalegal.org/publications/when-health-care-isnt-caring

Contacts

Brad Lotterman

[email protected]
714-445-0453

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Magellan Rx Management’s AIDS Drug Assistance Program Center of Excellence Expands Program That Significantly Improves Medication Adherence and Quality of Care for Patients with HIV

PHOENIX–(BUSINESS WIRE)–Magellan Rx Management, the full-service pharmacy benefits management division of Magellan Health, Inc. (NASDAQ: MGLN) has expanded Navigate Whole Health to include the AIDS Drug Assistance Program (ADAP) that applies an innovative and comprehensive approach to managing the quality of care for persons receiving treatment for HIV. Through the program, clinical pharmacists partner with providers to manage complex cases by promoting best-practices for HIV treatment and closing care gaps. The Navigate Whole Health ADAP program also supports participating ADAPs in meeting Health Resources & Services Administration (HRSA) performance measures.

“Navigate Whole Health ADAP offers a unique opportunity to support participating ADAP customers, providers and their members by concentrating on HIV/AIDS treatments, comorbid chronic diseases, behavioral health conditions, and social determinants that interfere with outcomes,” said Caroline Carney, MD, chief medical officer, Magellan Health. “We are using data science to tailor interventions to deliver the right supports to prevent interruptions in therapy and address behavioral healthcare, including depression and substance abuse.”

Adherence to antiretroviral therapy (ART) is critical to reducing viral load, transmission, and resistance. For most patients, nearly perfect (>95 percent) adherence is necessary to achieve optimal viral suppression and clinical success. However, the national average rate of adherence to ART is around 70 percent, and the total annual unadjusted costs per patient for non-adherence to HIV ART therapy ranged from $16,957 to $30,068.1,2

The Navigate Whole Health ADAP pilot program was conducted for nine months. An analysis of the first three months of intervention shows a 26.7 percent increase in HIV/ART medication adherence in six months post intervention. This program also addresses behavioral concerns, like depression, and achieved a 60 percent increase in members being adherent to their antidepressant medication adherence. “It is particularly encouraging to note that 100% of the recommendations made by Magellan clinical team were accepted by prescribers,” says Astha Chopra, vice president, clinical effectiveness, Magellan Health.

ADAP Center of Excellence

Magellan Rx established a national ADAP Center of Excellence (COE) with a dedicated call center to provide timely service and continuity of care. The dedicated ADAP team provides a multi-faceted approach to State ADAP programs across the country with a best-in class operating paradigm to help improve patient outcomes and prevent HIV. Navigate ADAP is one of the ways the Magellan Rx ADAP COE helps improve clinical quality for ADAP members.

“With over three decades of experience in serving some of the largest state ADAP programs, our Magellan team is deeply invested in the national effort to combat AIDS and the HIV epidemic through education, awareness, research and access to medications for those living with the disease. We invested in the Center of Excellence to leverage significant expertise on behalf of all our ADAP customers and their members. This program is one of many examples of our commitment to this work.” Meredith Delk, general manager and senior vice president, government markets, Magellan Rx Management.

About Magellan Rx Management: Magellan Rx Management, a division of Magellan Health, Inc., is shaping the future of pharmacy. As a next-generation pharmacy organization, we deliver meaningful solutions to the people we serve. As pioneers in specialty drug management, industry leaders in Medicaid pharmacy programs and disruptors in pharmacy benefit management, we partner with our customers and members to deliver a best-in-class healthcare experience.

About Magellan Health: Magellan Health, Inc., is a leader in managing the fastest growing, most complex areas of health, including special populations, complete pharmacy benefits and other specialty areas of healthcare. Magellan supports innovative ways of accessing better health through technology, while remaining focused on the critical personal relationships that are necessary to achieve a healthy, vibrant life. Magellan’s customers include health plans and other managed care organizations, employers, labor unions, various military and governmental agencies and third-party administrators. For more information, visit MagellanHealth.com.

1.

Machtinger EL, Bangsberg DR. Adherence to HIV Antiretroviral Therapy. HIV in Site Knowledge Base Chapter; May. 2005. [Accessed on 2021 Mar 16]. Content Reviewed; January 2006. http://hivinsite.ucsf.edu/InSite?page=kb-03-02-09.

2.

Cutler RL, Fernandez-Llimos F, Frommer M, Benrimoj C, Garcia-Cardenas V. Economic impact of medication non-adherence by disease groups: a systematic review. BMJ Open. 2018;8(1):e016982. Published 2018 Jan 21. doi:10.1136/bmjopen-2017-016982

(MGLN-GEN)

Contacts

Media: Lilly Ackley, [email protected], (860) 507-1923

Investor: Darren Lehrich, [email protected], (860) 507-1814

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AHF Dumbfounded by Gilead’s Claim of No AIDS Stigma Today

In recent legal filing in lawsuits over one of its HIV/AIDS medications that causes permanent and potentially deadly damage to the kidneys and bones, Gilead’s white shoe law firm, Sidley Austin, stumbles as it claims “…there is no shame or stigma …” associated with the disease today

At the same time its lawyers deny AIDS stigma, NBC News reported that Gilead itself funded a newly released study that found half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.”

LOS ANGELES–(BUSINESS WIRE)–Today, AIDS Healthcare Foundation announced that in a recent legal filing in personal injury lawsuits against Gilead Sciences Inc. seeking to hold the Bay Area drug maker accountable over one of its HIV/AIDS medications that allegedly causes permanent damage to the kidneys and bones, lawyers for Gilead claimed that “no shame or stigma” remains associated with HIV/AIDS today as they sought to reverse a judicial order denying Gilead access to AHF’s patient and client mailing lists.

In an August 9, 2021 filing in the Superior Court of California County of San Francisco (Case No. CJC-19-005043) seeking reconsideration of the Court’s Recommended Order No. 19 (Motions to Quash, and to Modify, Deposition Subpoena For Production of Business Records to AIDS Healthcare Foundation), lawyers for Sidley Austin, Gilead’s law firm, twice asserted there is no longer stigma associated with HIV or AIDS today, writing:

  • “Support for the HIV/AIDS community is not even stigmatized in today’s society,” (pleading, P #5, lines 19 & 20), and
  • “Further, there is no shame or stigma associated with supporting those affected by HIV/AIDS…” (pleading, P #9, lines 17 & 18).

At nearly the same time Gilead’s lawyers dubiously claimed that no HIV/AIDS stigma remains today, a new study undertaken by the LGBTQ advocacy group GLAAD and the Southern AIDS Coalition found that half of Americans “… said they’d feel uncomfortable with a HIV-positive medical professional, 42 percent were uncomfortable with a hair stylist or a barber living with the virus, and a third (34 percent) said they were uncomfortable with an HIV-positive teacher.” According to NBC News, the study, “The State of HIV Stigma 2021”, was published and widely reported on August 26, 2021.

NBC News also reported that Gilead funded the study.

Gilead’s assertions denying the existence of stigma surrounding HIV/AIDS today came about in its response to multiple personal injury lawsuits by patients taking Gilead medications. The lawsuits focus on Gilead’s failure to rectify a known defect in its tenofovir disoproxil fumarate (TDF) drug formulation, knowing that a safer alternate, tenofovir alafenamide (TAF) existed—in Gilead’s own laboratories—and for its failure to warn patients of the damaging side effects of TDF as well as Gilead’s active misrepresentation of TDF’s efficacy and risks. AHF supported many of the plaintiffs’ lawsuits, which likely led to Gilead’s discovery requests for its mailing lists.

Gilead’s zeal to maintain and maximize its corporate profits came at the expense of the health and wellbeing of its customers who were prescribed and taking TDF. According to earlier pleadings in the cases, the company knew as far back as 2001 from its own studies and other research that TDF was, ‘…highly toxic in the doses prescribed and risked permanent and possibly fatal damage to the kidneys and bones.’

“It’s official, according to Gilead: there is no longer any stigma around AIDS today,” said Michael Weinstein, president of AHF. “I suppose that means Gilead wasted a lot of money on its recent—and disheartening—GLAAD/Southern AIDS Coalition study documenting the ongoing and severe stigma around HIV and AIDS. Perhaps Gilead should instead spend its energy developing a drug to treat the willful blindness associated with its overwhelming greed. They make billions of dollars harming HIV/AIDS patients when they knew they had a better, less toxic drug sitting on the shelf. Now, they declare AIDS stigma no longer exists. Gilead, what astounding arrogance—and greed!”

About AHF

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 on Twitter: @aidshealthcare

Contacts

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 mobile

[email protected]

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DKT International and The Pleasure Project Launch 12 Global Fellows to Advocate for Sexual and Reproductive Health and Rights

WASHINGTON–(BUSINESS WIRE)–The Pleasure Project is pleased to announce the launch of the ‘Pleasure Fellow Scheme.’ Chosen from countries around the world, the 12 Pleasure Fellows will advocate for sexual and reproductive health and rights (SRHR) and provide expert and diverse outlooks on pleasure which account for different cultures, societies, and geographies. The Fellows hone their skills as pleasure advocates during a series of pleasure training seminars. Once completed, each Fellow receives funding sponsored by The Case for Her, Misscheifs and DKT International to carry out their pleasure-positive missions as newly mentored pleasure champions.

“Did your sex education mention the real reason people have sex? Did it get you ready for your sex/relationship life? The most common answer to these questions globally is no. For too long sex education has focused on all the terrible things that might happen to you after sex, like death, danger and disease. However, people are more likely to trust important sexual health information if we also acknowledge the truth: sex can feel good,” says Anne Philpott, founder and CEO of The Pleasure Project. “In 2004, I noticed a complete absence of pleasure in conversations around sexual and reproductive health, so out of frustration I started The Pleasure Project, advocating for a pleasure-positive approach. We’re confident our 12 Pleasure Fellows will make desire and wellbeing central to sex and sexual & reproductive health conversations by creatively spreading the message that pleasure is key throughout the ten countries they hail from – including Chile, the Philippines, and Kenya, to name a few. At the Pleasure Project, we are committed to putting the sexy back into safer sex.”

Given DKT International’s history with controversial, pleasure-positive mass media campaigns, like the 2013 DKT Pakistan Josh Condom advertisement, the global organization welcomed the opportunity to support the ‘Pleasure Fellow Program’ and hosted a session with the Fellows on how to overcome controversy. Both DKT and The Pleasure Project share the belief that pleasurable sex is a human right vs. fear and over-medicalization of sexual health and wellness. In addition, evidence proves that talking about pleasure also allows people to make safer choices in their sex lives and choose what to say yes or no to. In keeping with the World Association for Sexual Health’s recent 2021 declaration, sexual pleasure is a central part of the human experience and personal well-being and should exist free from discrimination, coercion, and violence.

“DKT is proud to partner with The Pleasure Project in this exciting and important work,” says Chris Purdy, CEO of DKT International. “To have effective conversations around contraception and safe sex, we must talk with consumers about why they have sex in the first place. No one ever called their partner on Sunday morning to ask about ‘how their reproductive health life was last night.’ The Pleasure Fellows will help remind the reproductive health community about this truth.”

Ultimately, the Pleasure Fellows will bring 12 new global voices and perspectives to a pleasure-positive approach, building upon the growing pleasure wave. For more information, watch the 12 Fellows in action on The Pleasure Project website here: https://thepleasureproject.org/pleasure-fellows/

About DKT International:

Since 1989, DKT International’s core mission has been to provide safe and affordable options for family planning and HIV prevention through social marketing in underserved countries throughout Latin America, Africa, and Asia.

About The Pleasure Project:

The Pleasure Project is the leading global voice on pleasure based sexual health. Since 2004, The Pleasure Project ‘puts the sexy into safer sex, because sex education is rarely sexy and erotica rarely safe’, with the aim of getting sex educators comfortable talking about all aspects of sexual health and to embrace desire, joy, happiness, and pleasure when it comes to sex education.

The Pleasure Project has just been awarded the World Association for Sexual Health Award for Excellence and Innovation in Sexuality Education 2021.

Pleasure Based Sexual Health Definition

A pleasure-based approach is one that celebrates sex, sexuality and the joy and wellbeing that can be derived from these, and creates a vision of good sex built on sexual rights. It focuses on sensory, mental, physical and sensual pleasure to enable individuals to understand, consent to, and gain control over their own bodies and multi-faceted desires. Well-being, safety, pleasure, desire and joy are the objectives of a programme with a pleasure-based approach. This approach measures empowerment, agency, and self-efficacy by whether or not an individual has been enabled to know what they want, and can ask for it, and request this of others, in relation to their sexuality, desires and pleasure.

Contacts

Jaimie Weiner

[email protected]
646-964-4446

Johnson and Johnson HIV Vaccine Trials - OutBuro LGBTQ professional entrepreneur online networking community gay lesbian bisexual transgender queer nonbinary supplier diversity

Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa

Investigational vaccine candidate did not provide sufficient protection against HIV infection

No vaccine-related safety signals identified

J&J HIV vaccine program continues with global Phase 3 Mosaico HIV study evaluating a different composition of the vaccine regimen in different populations

NEW BRUNSWICK, N.J., Aug. 31, 2021 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ), together with a consortium of global partners, today announced results from the primary analysis of a Phase 2b HIV vaccine clinical trial known as the Imbokodo study (also known as HVTN 705/HPX2008). Data showed the investigational HIV vaccine regimen did not provide sufficient protection against HIV infection in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. The investigational vaccine was found to have a favorable safety profile with no serious adverse events.

(PRNewsfoto/Johnson & Johnson)

Based on these results, the Imbokodo study will not continue. Study participants will be notified of the results, unblinded and informed whether they were in the study group who received the vaccine or the group who received placebo. Further analysis of the Imbokodo study is ongoing, and the study has provided enough data to progress with key immunological correlates research.

In parallel to the Phase 2b Imbokodo HIV vaccine trial, Janssen is sponsoring the ongoing Phase 3 Mosaico study (HVTN 706/HPX3002) which is testing the safety and efficacy of a different composition of the HIV vaccine regimen among men who have sex with men (MSM) and transgender individuals. This study is being conducted in the Americas and Europe where different strains of HIV are circulating. Given these differentiating factors and following consultations with the Mosaico study independent Data and Safety Monitoring Board (DSMB), it was decided that the Mosaico study will continue at this time.

“We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. “HIV is a unique and complex virus that has long posed unprecedented challenges for vaccine development because of its ability to attack, hijack and evade the human immune system. While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV. We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus.”

What the Imbokodo Data Tell Us
The Imbokodo vaccine regimen was administered to participants through four vaccination visits over one year. The primary analysis was conducted 24 months after participants received their first vaccinations. The study’s primary endpoint was based on the difference in number of new HIV infections between the placebo and vaccine groups from month seven (one month after the third vaccination timepoint) through month 24. These data found that through 24 months of follow up, 63 of 1,109 participants who received placebo compared to 51 of 1,079 participants who received active vaccine acquired HIV. This analysis demonstrated a vaccine efficacy point estimate of 25.2% (95% confidence interval of -10.5% to 49.3%). The vaccine regimen did not cause harm and was generally well-tolerated.

“The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region,” said Professor Glenda Gray, President and Chief Executive Officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol Chair. “This underscores the need to apply the knowledge that will be gained from this trial to continue to advance the pursuit of a global HIV vaccine.”

The Imbokodo study tested an investigational HIV regimen with an adenovirus vector containing four mosaic immunogens (Ad26.Mos4.HIV) at four vaccination visits over one year. The Imbokodo regimen contains a soluble protein component (Clade C gp140, adjuvanted with aluminum phosphate) which is administered at vaccination visits three and four. The ongoing Phase 3 Mosaico study is testing a different investigational vaccine regimen that involves the administration of a mosaic-based mixture of soluble proteins (Clade C/Mosaic gp140) at vaccination visits three and four.

About the Phase 2b Imbokodo Study
Imbokodo, a Phase 2b proof-of-concept efficacy study of Janssen’s investigational HIV vaccine regimen, began in 2017, reached full enrollment in 2019 and completed vaccinations on June 30, 2020. The study enrolled approximately 2,600 young women across five countries in sub-Saharan Africa, a region where women and girls accounted for 63 percent of all new HIV infections in 2020.1 The study took place at 23 trial sites in Malawi, Mozambique, South Africa, Zambia and Zimbabwe. Study investigators ensured that any HIV-infected participants in Imbokodo were referred to high-quality HIV treatment and care services. 

Imbokodo was supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health; the Bill & Melinda Gates Foundation; and the HIV Vaccine Trials Network (HVTN). Additional partners providing support included the U.S. Army Medical Research and Development Command (USAMRDC) and the Ragon Institute of MGH, MIT and Harvard. The study was conducted at clinical sites coordinated by HVTN, and the South African Medical Research Council (SAMRC) helped to implement Imbokodo in South Africa.

Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch).

Johnson & Johnson’s Commitment to HIV
Johnson & Johnson has been committed to the fight against HIV for 25 years, playing a central role in bringing nine therapeutics to people living with HIV, and continues to drive innovation in HIV prevention and care.

In December 2020, the European Commission authorized the first complete, long-acting injectable treatment for HIV, which combines Janssen’s rilpivirine with ViiV Healthcare’s cabotegravir, offering people with HIV living in Europe the potential of replacing daily oral treatments with six injections per year (every-other-month). In January 2021, the U.S. Food and Drug Administration approved the treatment for an every-month dosing schedule (12 injections per year), and is considering a supplement New Drug Application (sNDA) that would extend this approval to include the every-other-month dosing schedule (6 injections per year). Also in January, the dapivirine ring, a discreet long-acting HIV prevention method specifically for women developed by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches.

Johnson & Johnson also supports communities affected by HIV through initiatives such as the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition and the New Horizons program. To learn more, visit jnj.com/hiv.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at http://www.jnj.com/. Follow us at @jnjglobalhealth.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal.

*Dr. Glenda Gray, President and Chief Executive Officer, South African Medical Research Council (SAMRC), is Protocol Chair of the Imbokodo study. Janssen Vaccines & Prevention B.V. partnered with the South African Medical Research Council (SAMRC) to help implement Imbokodo in South Africa.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Janssen’s investigational, mosaic-based HIV vaccine regimen. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention B.V , any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1UNAIDS. GLOBAL HIV STATISTICS – Fact Sheet 2021. June 2021. https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf. Last accessed July 2021.

SOURCE Johnson & Johnson

CONTACT: Media Contacts: Jake Sargent, +1 732-524-1090 [email protected]; Seema Kumar, +1 908-405-1144, [email protected]; Caitlin Wheeler, +31 61547 6410, [email protected]; Investor Relations: Jennifer McIntyre, +1 732-524-3922

http://www.jnj.com

Health News - Massive Bio, Inc. to Partner With Veterans Prostate Cancer Awareness and Self-Care Catalysts - OutBuro LGBTQ professional entrepreneur online networking community gay lesbian bisexual transgender

Massive Bio, Inc. to Partner With Veterans Prostate Cancer Awareness and Self-Care Catalysts to Accelerate Clinical Trial Enrollment and Digital Health Solutions

NEW YORK–(BUSINESS WIRE)–$cancer #ChildhoodCancerAwarenessMassive Bio today announced it has entered a partnership with Veterans Prostate Cancer Awareness (VPCa), and Self-Care Catalysts to increase clinical trial and real-world evidence research participation in prostate cancer. This will help put Massive Bio in a position to attract new patients and will provide Veterans Prostate Cancer Awareness and Self-Care Catalysts with new ways to help their members fight cancer. “Today there are over 500,000 Veterans with prostate cancer in the VHA system, over 16,000 of those are fighting a metastatic form of the disease where clinical trials can help. The partnership between Massive Bio, VPCa, and Self-Care Catalysts provide the patient search and navigation tool to effectively guide thousands of Veterans to new treatments and clinical trials,” stated Mike “Bing” Crosby, Founder & CEO of VPCa.

Massive Bio is known in the healthcare industry for its SYNERGY-Artificial Intelligence (AI) clinical trial matching program, as well as its Virtual Tumor Board. Massive Bio is a leader in AI-enabled patient-centric clinical trial enrollment whose mission is to provide cancer patients access to clinical trials regardless of their location or financial situation. “We are very excited for our partnership with VPCa, and Self-Care Catalysts,” stated Selin Kurnaz, Co-Founder and CEO of Massive Bio. “Teaming up with both parties to provide prostate cancer patients with more access to clinical trials is an exciting development for our companies.” “Our partnership with Veterans Prostate Cancer Awareness and Massive Bio brings together an unprecedented platform to drive real-world evidence research and outcome,” said Grace Castillo-Soyao, Founder and CEO of Self Care Catalysts.

About Massive Bio

Massive Bio’s mission is to provide access to clinical trials for every cancer patient regardless of his/her location and/or financial ability. Massive Bio’s AI-driven platform connects cancer patients and their oncologists to bio-pharmaceutical clinical trials yielding profound improvement in access and match rates, thus leading to faster drug development timelines, and creating a novel oncology data ecosystem for improved protocol design and real-world insights. Massive Bio controls the patient enrollment value chain starting with patient identification, followed by AI-based virtual pre-screening outside the site and resolving any registration or recruitment issues for clinical trial enrollment. While improving cancer patients lives, Massive Bio serves nearly two dozen pharmaceutical companies, contract research organizations (CROs) and providers. Oncology dedicated patient recruitment, site selection, real-world data services and AI-based scaled trial pre-screening services are provided to its enterprise customers. Massive Bio was founded in 2015, is headquartered in NYC, and is privately funded by strategic and financial investors. For more information, visit https://massivebio.com or contact [email protected].

Massive Bio has also been awarded a Small Business Innovation Research (SBIR) contract by the National Cancer Institute (NCI) to develop and characterize its Deep Learning Clinical Trial Matching System (DLCTMS) Federal under SBIR Contract No. 75N91020C00016.

About Veterans Prostate Cancer Awareness

VPCa is a non-profit organization dedicated to saving lives by promoting prostate cancer awareness, education, and solutions among the veteran population and active-duty military members. Veterans Prostate Cancer Awareness (VPCa) is a 501(c)3 nonprofit organization formed in December 2016 by the founder’s personal journey with prostate cancer and his experience with the Phoenix VA Medical Center in 2014 and 2015.

About Self-Care Catalysts

Self-Care Catalysts puts patients at the center and intersection of human networks, technology and science with a platform called Health Storylines; a disease-agnostic and customizable platform that connects healthcare stakeholders to engaged patients, generating real world data that they require to make informed decisions. The Health Storylines platform enables delivery of holistic care, research and behavior intervention by always putting the patient first, allowing patients to take control of their journey, connecting them with the often-siloed healthcare ecosystem, building and earning their trust and honoring healthcare neutrality.

The partnership is announced in conjunction with the Prostate Cancer Awareness Month in September, which aligns with all three companies’ goals of raising awareness, increasing educational resources, and providing access to treatment and clinical trials. A partnership between the three companies will result in the ability to reach more patients, and to give them the best experience and treatment options for their cancer care.

Contacts

Selin Kurnaz, PhD

Co-founder and CEO of Massive Bio

[email protected]
844-627-7246

Mike Crosby, CDR USN ret.

Founder and CEO of Veterans Prostate Cancer Awareness Inc.

[email protected]
888-889-VPCa (8722)

Grace Castillo-Soyao

Founder & Chief Executive Officer, Self Care Catalysts

[email protected]
647.795.8210