Harvey Friedman provides hope for an HSV Vaccine at the University of Pennsylvania

Researchers, led by Dr. Harvey Friedman, from the Perelman School of Medicine at the University of Pennsylvania are close to clinical trials testing a vaccine protecting against genital herpes. Phase I trials for this HSV vaccine candidate, that will test prevention of genital herpes in humans, are expected to begin in September 2022.

In 2019, UPenn first published news that a novel mRNA-based genital herpes vaccine had been developed that protected almost all animal subjects exposed to the virus in preclinical studies in Dr. Harvey Friedman’s lab.

This work is in partnership with BioNtech and Dr. Drew Weissman, creators of Pfizers Covid vaccine. Latest studies in mice by Dr Friedman have shown his vaccine candidate is effective at preventing genital infection caused by HSV-1. Additional studies from July 2020 and in October 2021 have also shown the same efficacy for HSV-2.

Dr. Friedman’s lab has indicated they are also doing preclinical testing on a therapeutic. Depending on results from the prophylactic vaccine, work on a therapeutic treatment to HSV-1 or HSV-2 may not be far behind. See recent video updates from Dr. Friedman provided from February 2021, and November 2021. Learn more on Dr. Friedman’s lab website here.

Want to help? Donate today to help advance Dr. Friedman’s work for the study of a therapeutic HSV treatment! Fundraising is underway, led by a Reddit group dedicated to dialogue on Herpes Cure Research.


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“Moving Beyond a 45 year old antiviral” Article in BioCentury Magazine

Herpes Cure Advocacy win! Our team worked with editors at Biocentury magazine on this article. Enjoy!

After a decades long lull in innovation, a wave of candidates is advancing through the HSV pipeline that could combat drug resistance, suppress viral deactivation, or even clear the virus completely.”

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Hope for Herpes Keratitis Cure in China: Study results expected in 2022

In the global race for a Herpes cure, China is taking the lead. For the first time, transient gene-editing of the herpes simplex virus type 1 (HSV-1) using mRNA-based CRISPR was shown to cure herpes keratitis in mice. Chinese researchers reported in a paper published January 11, 2021 of Nature Biotechnology.

In a paper published May 2021, the team from Shanghai showed therapeutic efficacy in three different Herpes Simplex Keratitis (HSK) mouse models and human-derived corneas. The approach, an HSV-1-erasing lentiviral particle (referred to as HELP), was shown in these pre-clinical studies to significantly block HSV-1 replication and HSK occurrence in three different infection models, and eliminated the viral reservoir in the ganglia.

Shanghai BD Gene is now currently in a phase 1/2 clinical study studying the HELP approach in humans with final study results expected May 2022. This study, CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy Assisted Corneal Transplantation in the Treatment of Refractory Viral Keratitis, may facilitate the development of therapeutics targeting other viruses, including HSV-2, (HPV) and Hepatitis B (HBV). This is the first clinical study of CRISPR in the antiviral field and is Chinas first completely self-developed original gene therapy vector.

Patients worldwide are highly anticipating “first time in humans” clinical study results. Early results show that study subjects are effectively cured of the virus within 4-10 months and company representatives are expecting final results to show HELP is the worlds first proven treatment to cure for Herpes Keratitis. HELP is giving much hope to HSV carriers worldwide.

Dr. Cai Yujia, the corresponding author of the study, said: “Realizing the instantaneous delivery of gene editing enzymes in the body is the dream of our gene therapy scientists. With such a vector, we can maximize the safety of gene editing therapy, which also means The in vivo treatment of gene editing is infinitely close to clinical application.”

In August 2021, Shanghai BD Gene signed R&D cooperation agreements to explore the application of BDGene core delivery technology PVP-mrna in other major diseases such as nervous system diseases. They have also added HSV-2 to their pipeline although company reps indicate the approach is different than HSK. HSK is easier to administer treatment via intrastromal injection to the eye. For HSV-2, administering the treatment is more challenging, but something Shanghai BD Gene is considering. Alternatively this team is considering a viral-like approach for HSV-2 using mRNA.

Patient Advocates are hopeful that China, without the lengthy red tape and regulatory processes of the FDA that can take decades, bringing this treatment to market can happen quickly. Estimates indicate once results are published and peer reviewed in May 2022 that this treatment could be in the clinic, and available on the market for patients treatment, within 5 years.

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Herpes Cure Pipeline

Where are we with a Herpes Cure? Our team is tracking HSV research worldwide. (Updated 11/24/21)

These are research projects for Herpes Simplex Virus cure, vaccine, or treatment improvements globally with expressed intent of bringing a product to market.

View the Herpes research pipeline here.

Have a project to add to this list? Contact us at info@herpescureadvocacy.com.



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How to Advocate the FDA for Accurate Herpes Testing

Why do we need advocacy at the FDA? Because any Herpes Simplex Virus prevention strategy in the US is incomplete without an accurate diagnostic test. There is currently NO FDA-approved accurate diagnostic serology test (what we need to diagnose asymptomatic infection) on the market. With a virus that is primarily spread asymptomatically, 85% of new infections are spread by people who are asymptomatic and unaware of their status, the lack of accurate testing is a large and dangerous loophole.

People can currently be tested for HSV one of two ways:

Swab Test: A test of skin lesions (oral or genital) with either PCR or culture from an active outbreak.

Serology (blood) Test: A test of patient blood sample for the presence of HSV antibodies. The presence of antibodies can be measured to indicate the infection in the body. This type of test is used for routine STI screenings and/or for asymptomatic patients to diagnose infection.

The FDA approved serology tests (Herpeselect for example) have been proven to have low performance (see studies here, here and here). For this reason, the 2021 CDC STI treatment guidelines recommend confirmatory testing with the Western Blot, which is not FDA approved or covered by insurance.

There are a number of ways Herpes Advocates can ask the FDA to improve the landscape for HSV diagnostics. (Want to join the advocate army? Sign up for emails here.)


How can we advocate the FDA for better Herpes testing?

1. Contact the FDA directly: Email the following individuals to say that we need accurate FDA approved serology tests for HSV. Include the studies linked above.

PatientAffairs@fda.gov

CDRH_PatientEngagement@fda.hhs.gov

CBERAdvisoryCommittees@fda.hhs.gov

Maria.Garcia@fda.hhs.gov

ryan.karsner@fda.hhs.gov

Himani.Bisht@fda.hhs.gov

kathleen.whitaker@fda.hhs.gov

laura.ulitzky@fda.hhs.gov


2. File a report of misconduct against Focus Diagnostics Herpeselect® 1 and 2 Immunoblot IgG with the FDA.

Name of the company for which you are submitting an allegation: 
Focus Diagnostics

Telephone number: 
800.838.4548

Address:
DIASORIN MOLECULAR LLC
11331 Valley View Street
Cypress, California, 90630-4717 USA

Name and model (if applicable) of the Medical Device(s) / Electronic Products in question:
Herpeselect® 1 and 2 Immunoblot IgG

Lot numbers / serial numbers / part numbers:
IB0900G

Under detailed description, please include:

This Herpeselect test has been proven to be inaccurate in a screening population in numerous studies. Additionally, the Product Insert is misleading, as the sensitivity/specificity study is in a pre-screened population that has already tested positive for HSV with a PCR/culture test. The studies enclosed show that when the same test is used to SCREEN people whose status is not known, the results are very different and accuracy is suboptimal.

In summary, the Product Information is misleading as the intended use for general HSV screening and the study design are not consistent which should be more clearly indicated.

See studies proving inaccuracy of this test in population that was not pre-screened here, here and here. Herpeselect, when used in combination with the confirmatory test Western Blot, does not confirm 50% of the time.

3. Follow up to the misconduct report with an email: CDRHDeviceAllegations@fda.hhs.gov

Include the detailed description above in your email.


4. Report it. Have a test that was false positive/negative? File a report.

Provider Advocate? File a report of tests in your clinical practice that confirm as false positive/negative to the FDA. Providers can do this as often as you are able – each report takes 5 minutes.

Patient advocates can also report their inaccurate tests to the FDA – and send the provider report to your healthcare provider!


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Want to contact us? You can do so here. Or send us an email at info@herpescureadvocacy.com

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New HSV Advocates: A Starters Guide to Activism

Hello Herpes Advocates, We’re happy you’re here. We believe part of the reason there have been no advances in treatment or prevention in 40 years is due to stigma and lack of activism. There has never been a centralized advocacy effort for HSV until now.

Getting started with Herpes Advocacy

Step 1: Know the facts so you can speak to them in your advocacy.

Step 2: Sign up for Herpes Cure Advocacy Monthly Meeting

Step 3: Stay informed on the latest research news and advocacy updates. Sign up for Herpes Cure Advocacy news! You can view and participate in archived advocacy alerts by clicking here.

Step 4: Want to do more? Apply to be a volunteer. Have ideas? Email us.

Contact your elected representatives

Next, most important: Contact your elected representatives to ask them to prioritize Herpes cure, treatment and prevention. Especially important targets for HSV Advocacy are listed below.

A sample letter/email is here.

US SenateUS House of Representatives
Senate Appropriations Committee
Senate LHHS Subcommittee
Senate HELP Committee
House Appropriations Committee
House LHHS Subcommittee

Contact Other Stakeholders:

United States Preventative Services Task Force (USPTSF)

Why advocacy at USPSF? USPSTF establishes guidelines for medical screening in the United States. They currently recommend against screening for HSV. Learn more about them here.

Dr. Karina W. Davidson USPSTF Committee Chairchair@uspstf.net
kdavidson2@northwell.edu
General Info info@uspstf.net
Dr. Amanda Borsky
Dissemination and Implementation Advisor
Agency for Healthcare and Research Quality
Amanda.borsky@ahrq.hhs.gov

CDC: Department for Prevention of Sexually Transmitted Diseases

Why advocacy at CDC? The Center for Disease Control and prevention is responsible for prevention, surveillance, and establishes guidelines for testing and treatment for HSV in the United States. They currently recommend against screening for HSV. New STI treatment guidelines for HSV were published in 2021. Learn more about the CDC and their work here.

  • Increase prevention efforts, outline a clear strategy to reduce transmission for HSV in the United States
  • Increase training for new STI Treatment guidelines so that more people get tested (mild symptoms qualify someone for testing!)
  • There is a critical public health need for a functional, accurate, diagnostic test to diagnose asymptomatic infection
Dr. Jono Mermin
Director of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
jhm7@cdc.gov
Dr.  Leandro Mena, MD, MPH                                              
Director, Division of STD Prevention (DSTDP)
boe2@cdc.gov
Dr. Demetre Daskalakisyzq5@cdc.gov
Raul Romaguera
Acting Deputy Director (DSTDP)
rar2@cdc.gov
Dr. Laura Bachmann
Chief Medical Officer, DSTDP
frg6@cdc.gov
Jennifer Ludovic
Lead Public Health Policy Analyst , CDC
bmp8@cdc.gov
STI Treatment Guidelines Commentsstdtxguidelines@cdc.gov

FDA Contacts and Committees

Why advocacy at FDA? The FDA reviews and approves new foods and medical products and provides regulatory oversight for businesses with products on market. The currently FDA-approved serologic antibody tests for diagnosing asymptomatic infection are wrong 50% of the time. Tell the FDA that we need higher standards for diagnostic tests! More background on the need for advocacy at the FDA is here.

More steps you can take on advocacy at the FDA!

Patient Affairs Mailbox Patientaffairs@fda.hhs.gov
Center for Biologics Evaluation and Research (CBER) CommitteeCBERAdvisoryCommittees@fda.hhs.gov
Dr. Himani Bisht
Assistant Director, Division of Microbiology and Devices
Himani.Bisht@fda.hhs.gov

NIH: National Institute for Health: NIAID

Why advocacy at NIH? National Institutes of Health is responsible for research and development to bring new medical innovations to market in the United States. They fund both intra-curricular and extracurricular research through a robust grant program.

Dr. Emily Erbelding
Director of the NIAID Division of Microbiology and Infectious Diseases (DMID)
emily.erbelding@nih.gov
Dr. Barbara Mulach
Director, Office of Scientific Coordination and Program Operations, DMID
bmulach@niaid.nih.gov
Dr. Carolyn Deal
STIs Section Chief
cdeal@niaid.nih.gov
Thomas Hiltke
STIs Section Chief, STI Vaccines and Therapeutics Program Officer
thiltke@niaid.nih.gov
Dr. Jeffrey Cohen
Chief, Laboratory of Infectious Diseases
Chief, Medical Virology Section
jcohen@niaid.nih.gov

Other interest groups
Lynn Barclay
ASHA, Chief Executive Officer
lynnbarclay@ashasexualhealth.org
Fred Wyand
ASHA, Communications
FreWya@ashasexualhealth.org
Asa Radix
ASHA, Board President
aer2130@columbia.cumc.edu
Adolescents 2030info@adolescents2030.org
Beaumont Foundationcastrucci@debeaumont.org
Black Maternal Health Caucus (US Congress)BlackMaternalHealthCaucus@mail.house.gov

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Pritelivir: Clinical Trial Recruiting for resistant Herpes Simplex Virus Infection in immune compromised Patients

AiCuris AG, a German biotech company, is currently recruiting for their clinical trial on Pritelivir. Pritelivir is a highly anticipated new treatment for resistant Herpes Simplex Virus infections that cannot be managed with the available anti-virals. It is currently being tested for immune compromised patients only and, if proven safe and effective, could become a new treatment option for this population.

Link here with more details on criteria and how to apply.

Patients they are recruiting for:

Group C: For patients that are immune compromised and Acyclovir resistant

Group D: For patients that are immune compromised and present (or develop through the course of trials) foscarnet resistance/intolerance

Group E: For patients that are immune compromised but are responsive to Acyclovir

There are additional inclusion and exclusion criteria so please check the trial page on ClinicalTrials.gov on the link above.

Not all centers are already open and recruiting so if the one in your area is not recruiting yet you may want to contact them to be added to a waitlist.

Testing locations:

  • Los Angeles, California
  • New Haven, Connecticut
  • DeLand, Florida
  • For Pierce, Florida
  • Atlanta, Georgia
  • Chicago, Illinois
  • Baton Rouge, Louisiana
  • Baltimore, Maryland
  • Boston, Massachusetts
  • Detroit, Michigan
  • Pittsburgh, Pennsylvania
  • Houston, Texas
  • Seattle, Washington

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Stay informed of the latest research news and advocacy updates. Sign up for Herpes Cure Advocacy news!

Questions? Email us: info@herpescureadvocacy.com

Call for Herpes Advocates: Rally for a cure with us!

Want to rally for a cure with us? Why isn’t there a herpes cure or even a diagnostic test that works? Why have there been no treatment improvements in 40 years?

Where there is a will, there is a way. When we organize, we make change happen. Join for our monthly advocacy status meeting and see how you can help!

OCTOBER HSV ADVOCACY MEETING
October 14th 7pm EST
Register here today.

Stay informed of the latest advocacy updates. Sign up for HSV advocacy emails!

Have ideas? Are you a partner or provider who wants to collaborate? We want to hear from you.

Email us: info@herpescureadvocacy.com

Advocates Call on FDA to Remove Faulty Tests for Herpes

It is widely recognized among providers of STI screening that serology tests for Herpes Simplex Virus types 1 & 2 are highly inaccurate and often lead to false positives. So much so, that HSV is often not included in standard STI screening, despite it being the largest STI in America with no effective treatment or cure.

Advocates are asking, “If these tests don’t work, why are they on the market?” And are calling for providers and patients to report faulty test results to the FDA immediately. “Testing is the first step on the path to prevention. Americans need to be protected from this virus, and we need tests that work to do that,” says Jason Goldstein, a patient advocate with Herpes Cure Advocacy.

New CDC STI treatment guidelines, released July 2021, recognize the faulty nature of serology tests for HSV and recommend two-step confirmatory testing. Guidelines recommend confirmatory testing using the Western Blot, a test that is only available via mail order from one laboratory at the Univ. of Washington, is not automated, covered by insurance or FDA-approved.

The most commonly used test, HerpeSelect HSV-2 enzyme immunoassay (EIA), often is falsely positive at low index values (1.1–3.0) (457457). One study reported an overall specificity of 57.4%, with a specificity of 39.8% for index values of 1.1–2.9 (458). Because of the poor specificity of commercially available type-specific EIAs, particularly with low index values (<3.0), a confirmatory test (Biokit or Western blot) with a second method should be performed before test interpretation.

2021 CDC STI Treatment Guidelines for Genital Herpes Infections

Many provider advocates have already committed to reporting every test they find with inaccuracies – up to 10 a week in some practices. “It is time we start holding the FDA and manufacturers accountable. We are desperate for better tests and it’s not fair to patients to make them go through multiple, expensive tests to get an accurate answer,” says Terri Warren, RN, ANP, of Westover Research Group.

Advocates are asking providers and patients start reporting faulty tests to the FDA immediately so that manufacturers can be held accountable to either improve the test performance or develop a different test that works according to guidelines.

PROVIDERS: To report a faulty test, see the link for submission here. Each test report takes about 3-4 minutes.

PATIENTS: To report inaccurate test results submit a report here. Each test report takes about 3-4 minutes.

About Herpes Cure Advocacy: Herpes Cure Advocacy is a grassroots, membership-based international advocacy organization of 7,000+ members with a goal of cure and prevention for Herpes Simplex Virus types 1 and 2. Adequate treatment and prevention are needed for the 6 billion globally living with HSV urgently, because Herpes is not benign and because patients are waiting.

Press Inquiries:

info@herpescureadvocacy.com