AHF Files Brief Against CVS at the US Supreme Court OutBuro lgbt professional entreprenuer networking online community gay lesbian transgender queer bisexual nonbinary

AHF Files Brief Against CVS at the U.S. Supreme Court

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:

  1. That U.S. Statutory Law Requires Courts to Protect People Living with HIV/AIDS from Disability Discrimination by Healthcare Providers,
  2. That Coerced Use of Mail-Order Pharmacies Is Highly Detrimental to People Living with HIV/AIDS, and
  3. 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.

Contacts

MEDIA CONTACTS:

Jonathan M. Eisenberg, Deputy General Counsel–Litigation for AHF +1.323.860.5361 w Jonathan.esienberg@ahf.org
Ged Kenslea, Senior Director, Communications, AHF +1.323.791.5526 [cell] +.323.308.1833 [work] gedk@aidshealth.org
John Hassell, National Director of Advocacy, AHF +1.202.774.4854 [cell] John.hassell@aidshealth.org

Out of the Closet Designer Wins HBO Max Craftopia Episode OutBuro lgbt professional entreprenuer networking online community gay lesbian transgender queer bisexual nonbinary

‘Out of the Closet’ Designer Wins HBO Max ‘Craftopia’ Episode

Edgar Eiotown, a respected artist and the longtime and award-winning visual display coordinator for AIDS Healthcare Foundation’s ‘Out of the Closet’ thrift store chain, lands first place on HBO Max’s ‘Craftopia’ program, Season 2, Episode 2 (“Bow-Wow Ween”)

LOS ANGELES–(BUSINESS WIRE)–#OTC–The longtime and award-winning visual display coordinator for AIDS Healthcare Foundation’s (AHF) Out of the Closet thrift store chain, has won first place in a crafting and design competition in a special episode of HBO Max’s innovative reality program, “Craftopia.”


Edgar Eiotown, a respected artist who has designed windows and other visual displays for AHF’s 21 ‘Out of the Closet’ stores for over 20 years, triumphed over two other “Craftopia” contestants in a special Halloween-themed design competition that was the focus of Episode 2, Season 2 of the HBO Max program titled “Bow-Wow Ween.” Eiotown learned of his victory just prior to HBO Max’s streaming of the episode, which began streaming last week (October 7).

“For over twenty years, Edgar has worked his special magic with our Out of the Closet windows and visual displays harnessing his keen artistic sensibility and real-world practical design skills in his work helping to raise funds and awareness about AHF and our mission delivering HIV/AIDS prevention, care and services,” said Jonathan Kreuyer, General Manager of AHF’s Out of the Closet Store chain. “I am thrilled to learn of his win here, a well-deserved recognition of his unique talent and vision.”

In the “Bow-Wow Ween” episode of “Craftopia,” Eiotown went up against two other artists, all of whom were given two crafting assignments. The first was to create a Halloween costume for a dog (which another contestant prevailed at), and second, to create a piece of wearable art representing the concept of ‘split personality.’ Eiotown handily won this portion of the competition, creating an elaborate black, red, yellow and white costume featuring a Venetian- or Kabuki-style face mask designed with two intricately painted and distinct halves. To underscore the concept of split personality and heighten the impact of his artistic vision in his presentation to the judges, Eiotown’s mask also opened at one point right down the middle, top-to-bottom across the nose line, to reveal that he had made his face up and painted it identically as the mask—however, each half of his painted face was now the reverse of the beautifully handcrafted mask.

“Edgar: on behalf of all your Out of the Closet and AHF colleagues, we offer our congratulations and are so proud of you for your spectacular work on HBO Max’s Craftopia,” said AHF President Michael Weinstein. “Out of the Closet remains a powerhouse brand and not-so-secret weapon for AHF. Your visual artistry over the years on our behalf has been equally remarkable, adding fun to the shopping experience while helping us honor our mission of service. It is particularly amazing that you could do that much beautiful and intricate work under that kind of time pressure on your Craftopia episode. You are much more than a craftsman you are an artist. Bravo!”

In addition to his work for Out of the Closet, Eiotown is indeed also an artist whose work can be viewed at his eponymous website: www.eiotown.com. Eiotown marked his 20th year working for Out of the Closet this past April. AHF’s Out of the Closet thrift store chain celebrated its 30th anniversary last October. The OTC stores—all of which Eiotown oversees for visual display—consists of 21 stores in seven states (with another outlet set to open in San Diego at the end of October).

Over the years Eiotown’s design work for Out of the Closet has been officially honored with awards and recognitions in Los Angeles, Chicago and Dallas.

Out of the Closet Thrift stores provide people a fun, cause-worthy place to shop and donate gently used goods in support of the fight against HIV/AIDS. Many Out of the Closet Thrift Stores make HIV testing easy with fixed-site testing in stores. Many Out of the Closet sites are also connected to an AHF Pharmacy, providing a convenient one-stop experience for clients to shop and pick up their medications.

HBO Max

Instagram: @HBOMax

Twitter: @HBOMax

Facebook: facebook.com/HBOMax
www.hbomax.com
#Craftopia

#CraftopiaOnMax

Edgar Eiotown

Instagram: @eiotown

www.eiotown.com
#eiotown

Out of the Closet Thrift Stores

Instagram: @outofthecloset

Twitter: @outofthecloset

Facebook: facebook.com/OutoftheClosetThriftStores
www.outofthecloset.org
#outofthecloset

#OTC

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.

Contacts

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 [cell] gedk@aidshealth.org

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Illinois HIV Care Connect Launches HIV Innovation Campaign

SPRINGFIELD, Ill.–(BUSINESS WIRE)–#GTZIL–Illinois HIV Care Connect today launched its HIV Innovation web and social media campaign, showcasing several Illinois HIV initiatives that are helping to prevent or treat HIV more effectively.

Articles about five initiatives so far are located on the HIV Innovation page of hivcareconnect.com. The page features the Getting to Zero Illinois HIV Dashboard, the Central Illinois Friends organization, the Transgender Women Involved in Strategies for Transformation (TWIST) intervention being implemented by the Community Wellness Project in E. St. Louis, RuralHarmony‘s outreach and research effort, and Cicero’s Corazón Community Services. More articles will be added in the coming months.

The #HIVInnovation campaign will be visible on Illinois HIV Care Connect’s Twitter, Facebook and Instagram social media platforms. A quiz relating to the five initiatives offers an easy way to understand how innovative programs are improving the lives of persons living with HIV in Illinois.

The HIV Innovation campaign is Illinois HIV Care Connect’s eighth annual quality improvement initiative, following programs on HIV stigma, HIV and youth, social determinants of health, HIV treatment as prevention, viral suppression, staying in HIV care, and HIV and mental health.

“We chose HIV Innovation to celebrate the important role Illinois continues to play in the HIV arena,” said Jeffery Erdman, the associate executive director of the Illinois Public Health Association, which administers the Illinois HIV Care Connect program. “Illinois is a hub for leading HIV research, legislation, outreach and communication. Throughout the state, we continue to see remarkable innovations in virtually all aspects of HIV prevention and treatment.” Illinois HIV Care Connect is funded by the Illinois Department of Public Health.

About Illinois HIV Care Connect

Illinois HIV Care Connect is a statewide network providing medical case management, health care and support services to people living with HIV. Illinois HIV Care Connect’s eight lead agency offices serve people living with HIV in all of Illinois’ 102 counties. https://hivcareconnect.com

Contacts

Ray Valek, ray@valekco.com, 708-352-8695

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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

gedk@aidshealth.org

Denys Nazarov, Director of Global Policy &

Communications, AHF

+1 323.308.1829

denys.nazarov@ahf.org

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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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Statement from the Board of Directors: The Black AIDS Institute Announces Interim CEO

Interim CEO will serve alongside new Managing Director and Expert Consultants

NEW YORK, Sept. 23, 2021 /PRNewswire/ — The Board of Directors of the Black AIDS Institute (BAI) is pleased to announce the appointment of Toni Newman as its Interim Chief Executive Officer and Dr. Kemal M. Atkins as Managing Director to help fortify BAI’s infrastructure and round out the organization’s stellar leadership team.

In addition, BAI has engaged Ms. Pat Bass and Mr. Chris Bates – two internationally recognized experts who pioneered HIV/AIDS prevention, education, and treatment programs – to assess BAI’s current capabilities and mission.

Ms. Newman is currently the Interim Executive Director at LYRIC – a non-profit in San Francisco, California that focuses on advancing the community and creating social change for lesbian, gay, bisexual, transgender, queer, and questioning (LGBTQQ) youth through education, career training, and health advocacy. She oversees the budget, programs, and community outreach for LYRIC. Ms. Newman is a distinguished Faculty Member at the Transgender Strategy Center in Los Angeles, where she advises non-profit organizations on engagement with transgender and non-conforming communities. In addition, she is the Chair of the Board of Directors for TransCanWork based in Los Angeles. Ms. Newman has a wealth of knowledge in non-profit management, budget and finance, and human resources and operations. We’re excited that she has agreed to serve as our Interim CEO as we continue implementing our transition plan to find a permanent, innovative executive staff leader.

Dr. Atkins has been engaged to help further build infrastructure and management processes at BAI. Dr. Atkins, who will serve as a consultant on a temporary basis, has an extensive background in higher education and non-profit leadership where his expertise in crisis management, such as leading institutional responses to the COVID-19 pandemic, and expertise in building national wellness health models will provide much-needed program direction for BAI.

Ms. Bass’s work in the field of HIV/AIDS prevention truly extraordinary. As one of the architects of the Ryan White CARES Act – the largest federally funded program for people living with HIV/AIDS, she helped pave the way for modern treatments to prevent the spread and contraction of the virus. Mr. Bates also has a distinguished career in HIV prevention policy – having served as the Executive Director on the Presidential Advisory Council on AIDS and Director of the Office of AIDS Policy under President Barack Obama. Together they will oversee a comprehensive review of BAI’s program efficacy, contributions, and impact in the field of HIV/AIDS prevention and provide data that informs BAI’s mission as the organization continues to refine.

Ms. Newman, Dr. Atkins, Ms. Bass and Mr. Bates will work alongside Jami Cox and Wendell Miller as we continue to deploy our substantial resources, forward-looking vision, and human capital in the fight to end the HIV epidemic in Black communities and improve the health and quality of life for Black people living with and vulnerable to acquiring HIV/AIDS across the country.

The work of BAI is as important today as it ever has been, and we’re so proud of our incredibly talented and dedicated team that understands what is at stake for the Black community impacted by HIV and committed to ending this epidemic. Please join us in welcoming these accomplished leaders to our team. And thank you for continuing to support BAI and our entire staff across our networks.

Contact:
Tori Campbell
(332) 207-1473
319716@email4pr.com

SOURCE Black AIDS Institute

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 JSargen3@its.jnj.com; Seema Kumar, +1 908-405-1144, SKumar10@its.jnj.com; Caitlin Wheeler, +31 61547 6410, Cwheele7@its.jnj.com; Investor Relations: Jennifer McIntyre, +1 732-524-3922

http://www.jnj.com

Merck Presents New Data from Ongoing Phase 2a Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Investigational, Once-Monthly, Oral Islatravir for HIV-1 Prevention at IAS 2021

Results from this study support the safety profile of oral islatravir PrEP regimen through 24 weeks versus placebo

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 2a clinical trial evaluating the safety, tolerability and pharmacokinetics (PK) of six monthly oral doses, over 24 weeks, of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of HIV-1 infection in adults at low-risk of contracting HIV-1. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose. These data were shared as a late-breaking oral presentation during the virtual 11th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

“The 24-week analysis of investigational, once-monthly oral islatravir not only builds upon the PK data we have already seen, but also provides encouraging support for the safety and tolerability profile of this HIV-1 PrEP regimen,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”

Islatravir is currently being evaluated across a variety of dosing regimens, for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. An overview of the islatravir treatment and prevention development program is available here, which includes our two Phase 3 IMPOWER trials evaluating islatravir as once-monthly oral PrEP across diverse populations of people who may benefit from additional HIV-1 prevention options.

Phase 2a Oral Study Results for Investigational Islatravir

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo. Participants received once monthly oral doses of islatravir or placebo over a 24-week blinded therapy period, followed by a 12-week blinded follow-up in all groups and a 32-week unblinded follow-up in the islatravir groups to characterize the terminal elimination phase. Outcome measures for safety, tolerability and PK will be analyzed through week 68.

Of the 242 randomized participants at this 24-week analysis, which concludes the dosing portion of the study, 92% (n=222/242) completed dosing and 8% (n=20/242) discontinued the study intervention before week 24. Less than 1% (n=2) of participants discontinued due to an AE. Of the total participants, 67.4% (n=163/242) were female, 52.9% (n=128/242) were white, 41.7% (n=101/242) were Black or African American and 14.9% (n=36/242) were Hispanic or Latino. Unblinded safety data showed that both doses of islatravir were generally well tolerated versus placebo over 24 weeks and most AEs were mild (73.5%). The most common AEs (occurring in >5% of participants) in the islatravir 60 mg, islatravir 120 mg and placebo groups respectively were headache (10.3% [n=10/97], 9.3% [n=9/97] and 4.2% [n=2/48]), diarrhea (5.2% [n=5/97], 5.2% [n=5/97] and 8.3% [n=4/48]) and nausea (5.2% [n=5/97]), 7.2% [n=7/97] and 4.2% [n=2/48]). There were no serious drug-related AEs in people who received islatravir. The study enrolled a population at low-risk for HIV infection as evidenced by no confirmed HIV infections occurring during the treatment period.

The PK analysis showed that trough concentrations (the lowest level between doses) of islatravir triphosphate in PBMCs following either 60 mg or 120 mg monthly doses continue to remain above the pre-specified PK threshold for HIV-1 prophylaxis of 0.05 pmol/106 PBMCs and were sustained through eight weeks after the last dose of islatravir.

About Islatravir (MK-8591)

Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, including the ILLUMINATE clinical trials program for once-daily treatment. Islatravir is also being studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single agent across a variety of formulations, including the IMPOWER clinical trials evaluating an oral once-monthly regimen.

Our Commitment to HIV

For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Melissa Moody

(215) 407-3536

Sienna Choi

(908) 873-4311

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Raychel Kruper

(908) 740-2107

Gilead to Present New Data at IAS 2021 Demonstrating the Company’s Commitment to Advancing Innovation in HIV Research

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company’s upcoming contributions to the 11th International AIDS Society (IAS) Conference on HIV Science, taking place virtually from July 18-21. Thirty-one abstracts reflect Gilead’s ongoing commitment to scientific innovation, a key pillar to addressing unmet needs in HIV treatment and prevention. Beyond presenting new scientific data from the company’s HIV research and development programs, Gilead will convene a symposium featuring a diverse, global panel of leading HIV researchers and people living with HIV, to discuss potential clinical pathways to achieve a functional cure and community perspectives on the process.

“Continued scientific innovation is essential to helping end the global HIV epidemic and we are committed to advancing the next generation of therapies to improve the care of people and communities impacted by this disease,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Our data at this year’s meeting demonstrate the important scientific advancements we are making to help address critical unmet needs for people with HIV and those who could benefit from PrEP medicines.”

Presentations from Gilead’s HIV research program will include:

  • A pooled analysis of 192-week data from open-label extension periods of two Phase 3 trials evaluating the once-daily, single tablet regimen, Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in treatment-naïve adults living with HIV
  • 72-week data from the BRAAVE trial evaluating the safety and efficacy of switching to Biktarvy in Black or African American adults who are virologically supressed
  • Data from the Phase 2/3 CAPELLA trial evaluating the company’s investigational, long-acting subcutaneously administered HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people living with multidrug resistant HIV
  • Interim Phase 2 data from the open-label CALIBRATE trial evaluating the safety and efficacy of lenacapavir as an investigational, long-acting HIV capsid inhibitor in combination with other antiretroviral agents in treatment-naïve people living with HIV
  • Data from a Phase 1b trial examining the impact from the investigational TLR7 agonist, vesatolimod, between certain immune responses in people living with HIV on antiretroviral therapy
  • Prevention research, including data exploring adherence to PrEP medicines among new PrEP users initiating Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for PrEP®, real-world utilization of PrEP medicines during the COVID-19 pandemic and the safety and efficacy profile of Descovy for PrEP, as well as the use of novel study designs for HIV prevention trials

Select accepted abstracts are as follows:

HIV Treatment Research

Week 72 Outcomes and COVID-19 Impact From the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults Living With HIV

Long-Term Efficacy Among Participants Switched to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) With Pre-Existing Resistance and Viral Blips

Long-Term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-Up

Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naïve Clinical Trials

Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged 65 Years or Older: Week 96 Results From an International, Phase 3b, Open-Label Trial

Investigational Long-Acting HIV Treatment Research (Lenacapavir)

Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as Part of a Combination Regimen in Treatment-Naïve People With HIV: Interim 16-Week Results of a Randomized, Open-Label, Phase 2 Induction-Maintenance Study (CALIBRATE)

Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Phase 2/3 in Heavily Treatment-Experienced People With HIV: Week 26 Results (CAPELLA)

HIV Cure Research

Proteomic Evidence of Vesatolimod-Induced Enhancement of “Cross-talk” Between Innate and Adaptive Immune Cells in HIV Controllers on ART

HIV Prevention Research

Outcomes of Participants Switching from F/TDF to F/TAF for PrEP: Week 48 Results From the DISCOVER Open Label Phase

Comparing Adherence to HIV Pre-Exposure Prophylaxis (PrEP) Among New, Male PrEP Users Initiating F/TAF vs. F/TDF

Real-World Utilization of F/TDF and F/TAF for HIV Pre-Exposure Prophylaxis During the COVID-19 Pandemic in the U.S., December 2019 – June 2020

HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEP Trials

For more information, including a complete list of abstracts, please visit: https://www.ias2021.org/the-programme.

Please see below for U.S. Indications and Important Safety Information, including Boxed Warnings, for Biktarvy® and Descovy for PrEP®.

Lenacapavir and vesatolimod are investigational compounds and are not approved by the U.S. Food & Drug Administration or any regulatory authority for any use. Their safety and efficacy have not been established. In May 2019, FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug 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.

There is currently no cure for HIV or AIDS.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component 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.

Contraindications

  • 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.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through Week 144 were diarrhea (6%), nausea (6%), and headache (5%).

Drug interactions

  • 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: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
  • Renal impairment: 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.
  • 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 Descovy for PrEP

Descovy for PrEP is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use:

  • Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

U.S. Important Safety Information and Indication for Descovy for PrEP

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP IN UNDIAGNOSED EARLY HIV-1 INFECTION and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Descovy for PrEP must be prescribed only to patients confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate
  • (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed.
  • Severe acute exacerbations of hepatitis B have been reported in patients infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of Descovy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HBV who discontinue Descovy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindication:

  • Descovy for PrEP is contraindicated in patients with unknown or positive HIV status.

Comprehensive management to reduce risks:

  • Use Descovy for PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs).
  • HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are not limited to: condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network.
  • Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs).
  • Reduce potential for drug resistance: Only prescribe Descovy for PrEP to patients confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking Descovy, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in patients with undetected HIV-1 infection who are taking only Descovy because Descovy alone is not a complete regimen for treating HIV-1.

    • Some HIV tests may not detect acute HIV infection. Prior to initiating Descovy for PrEP, ask patients about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection.
    • If HIV-1 infection is suspected or if symptoms of acute infection are present while taking Descovy for PrEP, convert the Descovy for PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection.
  • Counsel on adherence: Counsel patients to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some patients, such as adolescents, may benefit from more frequent visits and counseling.

Warnings and precautions:

  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients (see Dosage and Administration section).
  • Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions:

  • Most common adverse reactions (≥2%) in the Descovy for PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain.

Drug interactions:

  • Prescribing information: Consult the full Prescribing Information for Descovy for more information, warnings, and potentially significant drug interactions, including clinical comments.
  • Metabolism: Drugs that inhibit P-gp can increase the concentrations of tenofovir alafenamide (TAF), a component of Descovy. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy.
  • Drugs affecting renal function: Coadministration of Descovy 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: One tablet taken once daily with or without food.
  • HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section).
  • HBV screening: Test for HBV infection prior to or when initiating Descovy.
  • Renal impairment and monitoring: Not recommended in patients with creatinine clearance (CrCl) <30 mL/min. Prior to or when initiating Descovy, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

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.

Forward-Looking Statements

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 or studies within currently anticipated timelines or at all, including those involving Biktarvy, Descovy for PrEP, lenacapavir and vesatolimod; the possibility of unfavorable results from such ongoing and additional clinical trials; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and vesatolimod and as a result, these compounds may never be successfully commercialized; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including marketing approvals of lenacapavir and vesatolimod, and the risk that any such approvals, if granted, may have significant limitations on its use; 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 March 31, 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 for PrEP, including BOXED WARNINGS, are available at www.gilead.com.

Biktarvy, Descovy for PrEP, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

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.

Contacts

Jacquie Ross, Investors

+1 (650) 358-1054

Brian Plummer, Media

+1 (202) 309-5207

Black AIDS Institute Releases Juneteenth Conversation with Billy Porter on Black Freedom, HIV, and Stigma

LOS ANGELES, June 24, 2021 /PRNewswire/ — Black AIDS Institute (BAI), the nation’s only Black HIV organization focused on ending HIV and stigma in Black communities, released a Juneteenth conversation with celebrity Billy Porter about how his recent HIV disclosure has freed him from shame. This personal story highlights how the intersecting stigmas of being Black, gay, and living with HIV fuel the epidemic among Black Americans and present a tangible barrier to accessing lifesaving HIV prevention and treatment options. Featured as a part of BAI’s Black Voices Matter campaign, which amplifies celebrities who are using their platforms to support the Black HIV movement, this conversation was released on Juneteenth to honor individual Black freedom and inspire healing. Watch on Facebook or YouTube.

Billy Porter Talks With Black AIDS Institute About HIV, Stigma, and Black Freedom
Billy Porter Talks With Black AIDS Institute About HIV, Stigma, and Black Freedom
Billy Porter Speaks To Black AIDS Institute
Billy Porter Speaks To Black AIDS Institute
Black AIDS Institute logo

“This Black Voices Matter conversation with Billy Porter is critical because 40 years into the epidemic, we know that stigma is a key driver of HIV into Black communities. While Billy’s fearless public disclosure is unique, his traumatizing life experience is not. This conversation underscores the importance of talking about HIV and defeating systemic anti-Blackness. It is the only way we can access proven HIV prevention and treatment options to end the cycle of HIV in Black communities in the next 10 years under the President’s “Ending the HIV Epidemic” national initiative,” said Raniyah Copeland, President and CEO, Black AIDS Institute.

ABOUT BLACK AIDS INSTITUTE
Founded in 1999, Black AIDS Institute (BAI) is the only uniquely and unapologetically Black think and do tank in America. Our mission is to stop the AIDS epidemic in Black communities by engaging and mobilizing Black institutions and individuals to confront HIV. Black Empowerment is our central theme and we are led by people who represent the issues we serve. We source our capacity building, mobilization, and advocacy efforts from Black leaders and communities across the country, and provide culturally respectful, high-quality, HIV prevention and care services for Black people in Los Angeles. Learn more at https://blackaids.org

PRESS CONTACT
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SOURCE Black AIDS Institute