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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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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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Gilead warns that counterfeit versions of its HIV meds are being found in US

U.S. pharmacies are selling counterfeit versions of HIV medication, according to the biopharmaceutical company Gilead Sciences. Specifically, Gilead warned that knock-off versions of its Biktarvy and Descovy medications have circulated through pharmacies due to unauthorized distributors. Both medications are used to treat people living with HIV. Descovy is also used as pre-exposure prophylaxis (PrEP) to prevent HIV-negative people from contracting the virus. The company is working with the U.S. Food and Drug Administration, pharmacies and other legal authorities to track down the culprits and remove the counterfeit meds from the market. Gilead said the counterfeit and tampered medicines can “bring serious and sometimes life-threatening health risks to individuals.”

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Moderna starts human trials for its revolutionary HIV vaccine this week

This week the pharmaceutical company Moderna will start its human trials for this HIV vaccine. Its HIV vaccine will be the first of its kind to use Messenger RNA (MRNA) an approach Moderna used in its effective COVID-19 vaccination. The clinical trials will start Aug 19, 2021, and end sometime around Spring 2023 according to the National Institute of Health Trial Registry. It will involve 56 HIV-negative participants age 18-56. Participants will be given one of two forms of MRNA to cause the body to form defenses against HIV infection. In the past HIV vaccines used inactivated forms of the virus. Previous trials have shown that those forms of vaccines didn’t produce any immune responses. In fact on trial in Thailand canceled one trial during the 2000s after the inactive forms of the virus actually increased people’s chances of catching HIV rather than prevent HIV infection.

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Queer News Tonight Health Q&A

“Welcome to Queer News Tonight’s Q&A on LGBTQ+ Health & Pandemic. Since February 2020  this segment has been unique in America answering you LGBTQ+ community questions about our unique health needs. We are proud to have Queer News Tonight Health Anchor Dr. Howard Grossman. He is an American pioneer in HIV/AIDS medical treatment and was the Executive Director of the American Academy of HIV Medicine. He is a nationally recognized medical expert and proud member of our LGBTQ+ community. Good evening Dr. Grossman. Before we move into questions, what are your thoughts on this week’s health news for our community? Let’s jump right into tonight’s questions.

Question 1: More people have now died in Florida than DeSantis won the election by. Do you think there will be political change because of the pandemic?

Question 2: The “LAMBDA” Variant has now been seen in the US. How much should we worry?

Question 3: Forecasts indicate the new COVID surge in Florida may not peak until September. Do you think Pride celebrations for this year should be postponed?

That is tonight’s Queer News Tonight Q&A on LGBTQ+ Health & Pandemic. We are here every Tuesday with Dr. Howard Grossman to answer your questions. Need medical assistance? We encourage you to contact Dr. Howard Grossman here in Wilton Manors and all across South Florida.”

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AIDS Walk Atlanta & Music Fest Returns Featuring Ludacris and Sevyn Streeter

AIDS Walk Atlanta & Music Fest returns to Piedmont Park Saturday, September 25, 2021 

Canceled in 2020 due to COVID-19 restrictions, this 30th annual event—which raises thousands of dollars to support 10 local AIDS service organizations—culminates with a free concert featuring Atlanta’s own Chris “Ludacris” Bridges and Sevyn Streeter

ATLANTA–(BUSINESS WIRE)–The annual AIDS Walk Atlanta and Music Fest presented by AHF Pharmacy, will return to Piedmont Park, on Saturday, September 25, 2021, after having been canceled last year due to COVID-19 restrictions prohibiting large-scale public gatherings. The event, which attracts thousands of attendees from across the metro Atlanta community, will begin at 10:00 a.m. (EDT) starting with a 5K run and walk and culminating with a free concert event.

Now in its 30th year, AIDS Walk Atlanta has become one of the most anticipated outdoor fundraising events in the metro area. Previous artists, including Monica, Erica Campbell, Amara La Negra, Raheem DeVaughn, Mumu Fresh and Grace Gibson, have performed at the AIDS Walk. This year’s event will feature Atlanta’s own award-winning hip-hop artist and actor, Chris “Ludacris” Bridges, as the headliner as well as R & B vocalist, Sevyn Streeter. With a goal of raising $1 million, this year’s event will provide unrestricted funds to support the following ten non-profit organizations:

  1. AID Atlanta
  2. A Vision for Hope
  3. Center for Black Women’s Wellness
  4. Center for Pan Asian Community Services
  5. Jerusalem House
  6. National AIDS Education & Services for Minorities
  7. Open Hand
  8. Positive Impact Health Centers
  9. Someone Cares
  10. Thrive SS

AIDS Healthcare Foundation (AHF), the producer of the annual walk and music fest since 2019, enhances the impact of the fundraising, by contributing a dollar-for-dollar match for all monies raised by each of the benefiting organizations.

“This annual event offers a time to create a greater awareness of the impact of HIV and AIDS on the local Atlanta community, as well as an opportunity to bring together thousands of individuals from across the region to raise critical funds for these 10 worthy organizations,” stated Dawn Averill, AHF Atlanta regional director. “AHF is proud to present this event as one of the many ways that we educate and empower the local community to join the fight against HIV and AIDS.”

To learn more about registering for the walk or run, create a team or join a team, go to aidswalkatlanta.com.

According to Georgia Department of Public Health:

  1. 70% of individuals living with HIV resided in the City of Atlanta;
  2. Across the state, Fulton and DeKalb have the highest numbers and rates of persons diagnosed with, and living with HIV;
  3. 79% of those diagnosed with HIV were male, 19% female, 2% transgender, with Black Americans accounting for the racial group most impacted by HIV

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

AHF East Coast:

Imara Canady

National Director, Communications and Community Engagement, AHF

work: +1.470.639.6591

mobile: +1.770.940.6555

[email protected]

AHF HQ:

Lauren Hogan

Communications Manager, AHF

mobile: +1.310.940.0802

[email protected]