Herpes Advocates: Nicole’s Story

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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Request a Patient Listening Session at the FDA

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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Koda’s Patient Story

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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After Covid-19 success, patients with the world’s ‘most stigmatized’ infection push for their own Operation Warp Speed

“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.

FY 2022 Budget Includes National Strategy and Strategic Plan for HSV

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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Herpes Scientists Give Impacted Communities a Voice

The University of Washington Virology Division and the Vaccine and Infectious Disease Division at Fred Hutch Cancer Center have announced a new initiative for members of the communities affected by herpes simplex virus infection to join a new Community Advisory Board that will potentially inform future scientific research and/or clinical trials.

Led by renowned herpes simplex virus experts, Drs. Anna Wald and Keith Jerome, this initiative will inform, support and strengthen future research efforts into HSV prevention, treatment and cure. Outputs from this board may also include socio-behavioral research to reduce mental health struggles such as depression, trauma, substance use, or other socio-behavioral impacts that may impact HSV impacted communities.

Dr. Anna Wald is Professor in the Department of Medicine, Epidemiology and Laboratory Medicine & Pathology at the University of Washington and in the Vaccine and Infectious Diseases Division at Fred Hutch. Currently, she is the Head of the Division of Allergy and Infectious Diseases at the University of Washington. Dr. Wald directs the University of Washington Virology Research Clinic, a clinic dedicated to the study of epidemiology, natural history and therapeutics for viral infections. Her research has focused on genital herpes infections, including infections in pregnant women and immunocompromised hosts. Dr. Wald has been an investigator in many clinical trials for novel antiviral agents and prophylactic and therapeutic vaccines for HSV infection.


Keith Jerome, M.D., Ph.D. is a renowned virologist whose research focuses on viruses such as herpes simplex, HIV and hepatitis B that persist in their hosts. He studies the ways in which these viruses evade the immune system and potential therapies for these infections. His team studies the uses of precision gene-editing tools like CRISPR/Cas9 to remove damaging viral genes that have tucked themselves into a person’s genetic code or to insert genes that can protect cells from invading viruses.


Applications for membership are due by April 30, 2022. Further details below.

Advisory board members may provide input regarding areas of HSV research that are important to the community. Specifically:

  • Advocate for and assist in the planning and development of new HSV research projects.
  • Ensure community concerns inform the rollout of HSV clinical research studies and
  • related community engagement activities.

Community Advisory Board members will include diverse community members willing to share their lived experiences as people living with or affected by HSV or as research participants. Membership may be appropriate for community activists and advocates, representatives of local agencies or professionals associated with infectious disease prevention and services delivery, religious or community leaders, and other professionals with relevant research and/or scientific experience.

TO APPLY PLEASE CONTACT:

Mr. Michael Louella

mlouella@uw.edu

IgM test removal at QUEST Diagnostics is a win for Herpes clinical care

Herpes Cure Advocacy celebrates and thanks Quest Diagnostics for removing the HSV 1/2 IgM test from their product offerings. Quest Diagnostic joins Mayo Clinic in the removal of this test from their product offerings. This is a win for herpes advocacy and a small step forward to better clinical care for Herpes Simplex Virus in the US.

On March 17th 2022 QUEST leadership confirmed:

“Thank you for reaching out regarding Quest Diagnostics offering of Herpes Simplex Virus (HSV) 1/2 IgM antibody testing. We are in the process of discontinuing this test code as a standalone test as well as HSV 1/2 IgM that is within some testing panels.”

The IgM test is a serology test for HSV 1/2 antibodies indicated to diagnose very recent infection within 7-10 days. This test has historically proven to be highly inaccurate, with false positive/negative results nearly 50% of the time. Resulting in many patients being told they are HSV positive or negative erroneously. The CDC has been recommending against this for decades doctors have been using this test. Per 2021 CDC STI Treatment Guidelines:

Immunoglobulin M (IgM) testing for HSV-1 or HSV-2 is not useful because IgM tests are not type specific and might be positive during recurrent genital or oral episodes of herpes (460). Therefore, HSV IgM testing is not recommended.

Please see the test to be removed here.

Accurate diagnostic tools are the foundation of prevention strategy to reduce prevalence and understand spread of any infectious disease. Learn more about why more accurate diagnostic tests for HSV are critically needed.



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Herpes Cure Pipeline 2.0

Pipeline for a Herpes Cure

Herpes Cure Advocacy announces and celebrates the launch of the highly anticipated Herpes Cure Pipeline 2.0.

We track the timelines for preclinical and clinical study, formulation updates, and go-to market strategies with research teams globally.

The pipeline only includes teams with published data, and those with expressed interest of bringing a product to market. There is no other organization globally except Herpes Cure Advocacy, who are advocating, tracking, or keeping HSV advocates informed on the pipeline for a Herpes treatment or cure.

The original 1.0 edition of our pipeline was published on November 25, 2021 and continues to provide a critical service for advocates, industry, and research teams globally. Hundreds of visitors globally view the pipeline daily and it continues to be the most visited page on www.herpescureadvocacy.com.

Herpes Cure Pipeline 2.0

Pipeline projects include HSV cure or treatment research teams who have expressed intent of bringing a product to market.

Have a project to add? Email our team.



Changes of note:

  • The tracker has been divided into sections to group research items by vaccine or treatment types
  • Timing update to Harvey Friedman UPenn/BioNTech clinical trials to begin September 2022
  • Timing update and reformulation for Xvax Vaccines to begin clinical trials 2024
  • Shanghai Bdgene has been updated to reflect early success of Phase I/II trials in China (pending formal report) and that they are now seeking IND approval to begin trials in the U.S.
  • SL Vaxigen’s “SL-V20” HSV-2 therapeutic vaccine has been added and reflects completion of recruiting for Phase I trial in Korea
  • Blue Willow is now targeting 2022 or 2023 to start human clinical trials for their “NE HSV-2” therapeutic and prophylactic vaccine candidate
  • Thyreos “R2” HSV 1&2 vaccine candidate has been added, but there are little details on timing of clinical trials
  • AiCuris’ Pritelivir has been updated to indicate they are currently recruiting for Phase III clinical trials in the U.S. (they may be recruiting worldwide – we are trying to confirm)
  • Heidelberg completed Phase II trial on their “HDIT 101” HSV 2 monoclonal antibody treatment
  • BioPharma‘s “UB-621” now reflects three different candidates for their HSV-2 monoclonal antibody treatment
  • Nanoviricide’s HerpeCide Program, which is antiviral treatment, now reflects multiple programs in process for HSV 1 & 2 and including HSV-1 keratitis   

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Advocacy Preparations for FY 2023

The Herpes Cure Advocacy team is getting ready for another busy appropriations season and we need your help. Appropriations is the government process of creating a budget and deciding how public funds are spent. Every year – advocates of all kinds hold “appropriations request” meetings to ask for funds. We have a goal of meeting with elected representatives in all 50 states this year.

Can you help us reach elected in reps where you live?


Use your voice

Contacting your elected representative

We are creating a database (our HSV Advocate Army) for coordinated advocacy meetings with patient and provider advocates in all 50 states. Please let us know what state you live in by clicking here.

Contact your elected representatives: Here’s what to say:

  1. Please increase public funds in the FY 2023 budget for Herpes cure, treatment and prevention.
  2. Please ask to schedule a meeting (virtual is fine) with your reps health policy staff. HCA team members can join you for a live meeting with your elected representatives to help speak to the issues.
  3. Please ALWAYS copy info@herpescureadvocacy.com so we’re aware of when advocacy emails are sent. It also adds legitimacy to your request and helps us not duplicate HCA advocacy efforts with other advocates in your jurisdiction.
  4. Always introduce yourself as an advocate with Herpes Cure Advocacy. A sample letter/email is here. A few tips:
  • Be polite – but firm! Say thank you!
  • Email.
  • Call.
  • Ask for a virtual or in person meeting to discuss further.
  • Do all of the above!

If your elected rep is on any of the committees below – please let us know ASAP! We most critically need to reach these committee members and can be more effective with the help of their constituents.

United States SenateUnited States House of Representatives
Senate Appropriations Committee
Senate LHHS Subcommittee
Senate HELP Committee
House Appropriations Committee
House LHHS Subcommittee


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Moderna Adds Herpes Vaccine Candidate to Pipeline

Moderna is entering the global race for a Herpes vaccine. Moderna is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.  They are best known for recent success with their mRNA-based COVID-19 vaccine.

From Moderna website: Moderna’s herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is a vaccine candidate against HSV-2 disease. Moderna expects that an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, the Company aims to induce strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. There is no vaccine approved against HSV.

More details on the Moderna website here.


Get in Touch


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