GlaxoSmithKline Pipeline Update

GSK has officially updated its clinical research pipeline to include a vaccine for HSV-2! Their therapeutic vaccine for HSV-2 isn’t mRNA (or what they called SAM technology) but an adjuvanted therapeutic vaccine.

The trial (currently recruiting) is a Phase 1/2 combined trial that ends in 2024. GSK will test 9 different formulations as a prophylactic, the one that has the highest efficacy will then be tested in Part 2 as a therapeutic. Ultimately, advocates assume, that GSK will make one vaccine as both a prophylactic/therapeutic.

GSK Formulation: GSK3943104A: Therapeutic HSV (Immunomodulator): Active Immunization to suppress recurrence of genital herpes in adults aged 18 years and older.

GSK is the manufacturer of Shingrix (shingles vaccine released in 2017) and is perfectly positioned to leverage their knowledge from this very effective vaccine for another herpes virus for a new formulation to treat Herpes Simplex. Shingrix is also a recombinant protein adjuvanted vaccine with 90-97% efficacy over 7 years with one 2-dose regimen.

GSK has a proven platform for developing a highly effective recombinant protein – adjuvanted herpes vaccine. They are now simply tweaking it slightly for a new target in HSV-2. HSV and VZV (VZV = Varicella-zoster virus the virus that causes chickenpox and shingles) are both alpha herpes viruses. They are genetically very closely related, are latent viruses that live in the body for life, and when reactivated exhibit symptoms in the body similarly. Both herpes simplex and zoster are viruses that hide in the nerve ganglia and reactivate on the skin in the same manner with blisters, prodrome, etc.

Advocates are excited that GSK is taking this approach and hopeful that as one of the largest pharma companies globally, and entering clinical studies for herpes simplex for the second time, they’re confident about the safety and efficacy of this formulation. The new formulation is estimated to reduce viral shedding to the extent that the infection would be non-transmissible to partners or what is known as a functional cure.

For other projects in the Herpes Cure Pipeline, see here.

For more details on the new GSK clinical trial for Herpes and to apply to participate please visit here.

Herpes Cure Advocacy is excited to announce we are pursuing filing as a non-profit organization with 501c3 status.

Herpes Cure Advocacy is launching a small capital campaign to raise $25,000 – these funds will allow us to further our work to advance the treatment and prevention of Herpes Simplex Virus types 1 and 2 in the United States.

Resources will allow the expansion of HCA grassroots advocacy work to broaden, be more effective, and to leverage professional tools and strategies that can effectively create change in the complex public health landscape. Resources will be used to support the following efforts:

Funds can support:

• Legal and accounting fees
• Marketing, communications, operations to support organizational goals
• Admin and operational support staff
• Conference fees and travel

We’re fundraising to support Herpes cure advocacy, including stakeholder engagement and lobbying congress for clinical research for a herpes cure, vaccine and treatments.

Hi, my name is Nicole and I have always thought of myself as a good person. However, sometimes, life can throw you into a dark corner that you never even dreamed imaginable. My experience with HSV2 has been devastating. I am ashamed that I allowed this to happen to me and I turned around and infected someone who absolutely adores me, who is innocent and didn’t deserve this curse. Living with HSV2 is extremely taxing, mentally, physically, emotionally and spiritually – it unfortunately impacts every part of my life. I know what it feels like to feel good, confident and clean, no pain, no itching, because prior to being infected with HSV2, I felt this way. I believe a cure must be an option because I cannot imagine living like this for the rest of my life-I just cannot. I struggle at times with severe depression and anxiety. Antivirals only help in a small way, for me to manage outbreaks 50% of the time, if that. I have to take the antivirals daily, without fail, and especially around my menstrual cycle, which triggers outbreaks.

Years ago, when I first started having symptoms, I sought out clinics – two different medical clinics as I knew something was wrong with my body – down there. Both times, I was either given a prescription for a UTI or for a yeast infection. Even the medical professional didn’t think it was herpes or maybe they didn’t know that when there is viral shedding it can mimic the appearance of a yeast infection…I didn’t know that then, but now I sure do after 13 years of living with HSV-2.

Living with herpes is like having the joy & happiness taken away from the most precious & sacred moments; My husband and I are tentatively planning a wedding vow renewal and I am afraid to plan it as I don’t know ( I cannot say with confidence that I won’t have an outbreak at that time, how horrible would that be!) I have the beautiful dress, but I long for the security of knowing that I will be able to wear it confidently…also, it is extremely hard to see myself with pride as a woman, when I feel as though I wear a scarlet letter on my chest. It’s hard, very hard. I long for the days when I felt clean. 

HSV-2 is more than a virus, it steals your joy. It feels like a dark cloud of impending doom lurking, always lurking. How can anyone live a good life with this looming anxiety? The outbreaks are so painful – ulcers, pain, shame, guilt – the cycle does not end. I pray for a cure, for with a cure, there is hope.

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Hi there Herpes Advocates, we’re happy you’re here.

Advocacy Alert: Request a Patient Listening Session at the FDA

The landscape for prevention of HSV in America is inadequate. There is a critical loophole without an accurate test to diagnose asymptomatic infection. Currently available FDA-approved tests for HSV are inaccurate 50% of the time with confirmatory testing. As a result clinical care, and public health outcomes are suffering.

With only these sub-optimal diagnostic tools in our diagnostic toolkit, Americans are lead to believe they are HSV+ when they are not, or that they are HSV- when they have the infection.

We need your help to tell the FDA: We want a patient listening session to discuss the sub-optimal diagnostic serology tests that they have approved.

Step 1: Fill out this form to request a patient listening session.

Answers to Form fields:

• Patient Group: Herpes Cure Advocacy
• Question or Meeting: Meeting
• What is your request about? A Medical Device
• Is your request about a specific FDA Program: Yes, Patient Listening Session
• Name or condition: Herpes Simplex Virus
• Question: Diagnostic Tests have sub-optimal results, and are wrong 50% of the time. This is leading to many false +/- results and is impacting public health outcomes dramatically. Please schedule a patient listening session so that the impacts of the sub-optimal tests, both on patients health and wellbeing, and impacts to prevention of HSV from a public health perspective can be discussed.

Step 2: Email the FDA HSV Diagnostics Team

Please email all of the following people, and copy info@herpescureadvocacy.com:

CDRH_PatientEngagement@fda.hhs.gov, patientaffairs@fda.hhs.gov, Maria.Garcia@fda.hhs.gov, Kathleen.Whitaker@fda.hhs.gov, Eva.Rorer@fda.hhs.gov, Laura.Ulitzky@fda.hhs.gov, Ryan.Karsner@fda.hhs.gov, Himani.Bisht@fda.hhs.gov
Kathryn.Capanna@fda.hhs.gov , tracy.gray@fda.hhs.gov, Michelle.Tarver@fda.hhs.gov

SUBJECT LINE: Please Schedule a Patient Listening Session to Discuss Health Outcomes w/Sub-Optimal FDA-Approved HSV Diagnostic Tests

SUGGESTED EMAIL CONTENT:

Dear Dr. Maria Garcia Ines and team, I have today submitted this form to request a patient listening session to discuss patients experiences with the sub-optimal results from FDA-approved tests for Herpes Simplex Virus. Currently available tests are proven wrong 50% of the time with confirmatory testing. This is a critical problem in our public health interventions for HSV that needs to be addressed urgently – we should have better standards for our public health interventions and diagnostic tools!

Many reports of inaccurate tests have been filed with the FDA already and studies have been shared documenting the sub-optimal results. Also, please review this study. and please review this study.

Please prioritize the health of American people, by taking the time to schedule a listening session so that you can hear and understand the severe impacts to patients lives first hand.

Feel free to add any of your own personal story with HSV testing that is relevant.

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My diagnosis with HSV-1 was traumatic. It was a result of a date where the other party did not disclose their positive status. They had the virus for 10+ years and knew about it, yet did not tell me. When she revealed this to me, after I had already been exposed several times, it was too late. I tested as soon as I could, and it came back positive. When I heard the news, I was at work and shaking. I could barely function and was disassociated for weeks. I had suicidal ideation and almost made an attempt on my life. 

Since having been diagnosed, dating has been near impossible. This virus has impacted my life immensely. In public social engagements, I am paranoid of inadvertently giving it to someone else through a shared glass or utensil. On my health (mental and emotional), I struggle to function when an outbreak occurs. I want to break down, cry, and still I often think about self harm. It doesn’t matter how common the virus is, there’s trauma, health risks, and for many, considering taking their own life from the suffering and pain.

There needs to be action. There needs to be funding for a vaccine and a cure. To save lives and begin repairing the damage to millions of people on their health and their future, and to end the suffering for so many.

I don’t want to be by myself forever and I have teetered on the edge of taking my own life several times because of this virus. There is new technology out there for treating illnesses and new research showing this virus has more detrimental health ramifications than just a few bumps. A vaccine to COVID was developed in record time. No more excuses. There needs to be action. There needs to be funding for a vaccine and a cure. To save lives and begin repairing the damage to millions of people on their health and their future, and to end the suffering for so many. No. More. Excuses. Just like how the polio vaccine was sold for $1, because the inventors knew that the public health was more important profit. It’s time to make a new vaccine and treatment for HSV in the same spirit of Polio and be rid of this virus.

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“There has not been any kind of herpes advocacy in the 30 years that I’ve been involved in STI prevention and research. It was something that was just never addressed,” said Jeff Klausner, an infectious disease physician at UCLA and the former director of STD prevention and control at San Francisco’s public health department. “There’s just been no one who’s tried. Except now…”

This full feature article is available on Endpoints news. If needed, read more for free here.

Herpes Cure Advocacy is pleased to report that with the passing of FY 2022 budget that the Dept. of Health and Human Services National Strategy and Strategic Plan for the treatment and prevention of Herpes Simplex Virus has a budget of $250,000.

This small investment in strategic planning is an important step forward in the field that has been stagnant for many years.

Please view the budget report here, page 110, which reads:  “In addition, the agreement includes $250,000 for OASH to develop a national strategic plan or amend the STIs National Strategic Plan for the treatment and prevention of HSV types 1 and 2.”

Herpes Cure Advocacy will continue to advocate for federal investment in the treatment and prevention of herpes simplex, for funding for the implementation of this OASH FY 2022 plan, clinical research for treatment, impacts and risk of neurological complications, and a working group led by the CDC to develop a serology test to accurately diagnose asymptomatic infection.

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