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 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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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 14th 7pm EST
Register here today.

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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:

National Strategy for Herpes: A DHHS Strategic Plan in House FY 2022 Budget

Herpes Cure Advocacy confirms a national strategy and strategic plan for Herpes Simplex Virus Types 1 and 2 in the approved House FY 2022 budget.

On page 245, the House FY budget report reads:

National Strategy for Herpes Simplex Virus (HSV), Types 1 and 2.—The Committee recognizes that an estimated 1 in 3 Americans has Herpes, and that most Americans with HSV do not have symptoms and do not realize they have it. In light of the national prioritization of ending the HIV/AIDS epidemic, maternal health, neonatal health, and the all-time high of STIs, the Committee urges the Assistant Secretary for Health to develop a national strategy and strategic plan for the treatment and prevention of HSV types 1 and 2.

Herpes Cure Advocacy thanks the following people for their support in this effort: Dr. Phil Chan, Dr. Larry Corey, Dr. Robert Golden, Mr. Agustin Fernandez, Dr. Harvey Friedman, Dr. Jeffrey Klausner, Dr. Keith Jerome, Dr. Ina Park, Dr. Hilary Reno, Dr. Gary Richwald, Dr. Sten Vermund, and Ms. Terry Warren.

The national strategy is intended to outline strategic imperatives for the treatment and prevention of HSV in America. A strategic plan will consequently outline actionable objectives and tasks in order to accomplish these strategic goals.

While there is no budget assignment on the house side, HCA advocates and stakeholders continue to advocate the senate LHHS subcommittee for a fiscal budget for this project. Advocates say, “We are confident that the broad support for this public health imperative will ensure a fiscal budget assignment as the appropriations process is ongoing on the senate side. A project with no budget is too low priority – we want to guarantee this work gets done in 2022.”

About Herpes Cure Advocacy

Herpes Cure Advocacy (HCA) 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.

HCA works with patient advocates , HSV and clinical experts, and organizational stakeholders to help chart the path towards HSV treatment and prevention.

Want to join our advocate army? We need help. We’re looking to build our network of advocates, including patients and HSV field experts internationally. If you want to join the fight for Herpes treatment and prevention, please contact us.

Get in touch

The Minimization of Herpes

Can we advocate for a Herpes cure and reduce its stigma at the same time? It’s a strange dichotomy for many HSV carriers desperate for a cure. Advocacy by its nature needs to elevate the critical elements of an issue which are misunderstood, under appreciated or viewed differently by those in power. The late John Lewis called this making “good trouble.”

For example, most people won’t know Herpes has mounting evidence of serious health complications including Alzheimer’s, or is a driver of the HIV epidemic. To create urgency, as if genital lesions in 40-80 million symptomatic genital herpes carriers isn’t enough, us advocates need to elevate the burden of this disease. But by creating urgency for a cure, do we make the stigma worse?

There is another school of thought around Herpes, a camp whose main objective is stigma reduction. This group pushes acceptance that the virus is a reality, it’s not going away, it’s common, and let’s learn to live with it. Ella Dawson, a writer and sex critic well known in Herpes positive communities, is in this camp. Janelle Pierce of The STI Project also participates in the “let’s live with it, accept it and move on,” camp.

Often, even those on the front lines of women’s and sexual health, the same folks who deal out positive diagnosis and Valtrex every day, subscribe to this narrative. Herpes is really no big deal. It’s ubiquitous in the population. Take this Valtrex for the rest of your life, you’ll be fine, it’s manageable. The worst part of the condition is the stigma. Any questions?

We do have questions. Why isn’t there a cure for Herpes Simplex already? Valtrex, Aciclovir, etc. were invented 40 years ago. It is the largest major STI with no effective treatment, vaccine or cure, it causes painful recurrent lesions on your mouth and/or genitals and has mounting evidence of other serious health conditions. So what gives? Why the minimization of Herpes?

While one school of thought fights stigma only, many in the HSV research have been quietly looking for a cure for 30 years. World-renowned field experts Drs. Larry Corey and Anna Wald (among others) agree Herpes needs to be prioritized urgently and that it’s burden of disease is under appreciated. The NIH acknowledges it is a difficult and frustrating problem where we need new ideas.

In a recent dialogue among Herpes advocates, a medical assistant from Planned Parenthood insisted that “Herpes is just not a big deal.” This MA opined that Herpes Simplex Virus is not an urgent public health problem, it’s common and “most people are asymptomatic”. It’s a response that minimizes the impacts, in an effort to reduce anxiety for newly diagnosed patients or to calm down Herpes carriers asking too many questions.

Let’s apply this “it’s no biggie” rationale to drunk driving. Most people who drive cars don’t get into car accidents. That doesn’t change the fact that a small subset do, may be seriously injured or killed, and this risk is sufficient enough to make drunk driving illegal.

Those who pose a risk, drunk drivers, hopefully, take precautions to keep the rest of the population safe. Or they can go to jail. Makes sense. We don’t say, “well, most people who drive cars get home safely,” and conclude that drunk driving is not a problem.

Saying most people will never have an outbreak is gaslighting. 85% of the 6 billion people globally with HSV are asymptomatic and unaware of their status. That still leaves 40-80 million globally who have symptomatic genital herpes meaning regular, recurrent genital lesions. Imagine this is your brother or best friend. Herpes is common, yes, and still an urgent public health issue, even when only considering the millions of symptomatic individuals.

If one has oral or genital lesions, or any number of other associated health conditions, it’s really irrelevant whether other carriers are asymptomatic or not.

What is relevant is that, similar to Covid-19, Herpes spreads primarily asymptomatically. 85% of spread is from asymptomatic people unaware of their status. Shouldn’t these asymptomatic carriers have a responsibility to protect the virus’ spread to the rest of the population? In regards to Covid-19, we implemented safety protocols for the entire community to protect the most vulnerable. Why is this rationale not applied to Herpes Simplex Virus? Because people aren’t dying?

Genital herpes is a substantial health concern worldwide – beyond the potential pain and discomfort suffered by people living with the infection, the associated social consequences can have a profound effect on sexual and reproductive health.

Dr Ian Askew
Director of the Department of Sexual and Reproductive Health and Research at WHO

Current antiviral medications do not cure the virus, they only reduce symptoms by about half, and for some carriers, don’t work at all. So while symptoms are manageable for most, the infection still lives in the body, within the nerves and central nervous system. So, this may be news to some, but Herpes is not benign. The presence of the chronic infection, beyond the acute symptoms of oral and/or genital lesions, is increasingly proving to have a number of serious health complications worthy of further study.

The “acceptance” camp tries to reassure HSV carriers, its no big deal, it’s so common. Since when did high prevalence equal ambivalence? Unless you are so disillusioned to think Herpes is too big a problem to solve, or that it is just a minor skin condition not worth solving?

Many in this camp say the stigma is the worst part of the infection. Perhaps it is minimized because they don’t have the answer for, “why isn’t there a cure for this?” Perhaps clinicians don’t have time or energy to dole out tissues for the tearful newly diagnosed, those struggling with symptoms, and it is easier to encourage patients to go ahead and move on than to rail against? How many of us are asking the hard questions? How many on the front lines would be brave enough to attempt to unravel what is a massive, complex public health issue at the intersection of biotechnology, systemic racism, a broken healthcare system, capitalism, and misogyny?

Not many. Although we’re hoping to find a few brave souls.

Yes, the stigma is crippling. Herpes is the most heavily stigmatized STI, or possibly any medical condition, period. But the impacts of infection itself can also be damaging and are indeed reason enough to prioritize a cure.

Is it possible to advocate for a cure, and to stop the stigma at the same time? Of course. These ideas aren’t mutually exclusive. Ultimately, a cure would help reduce stigma and suffering. And to advocate for both we can simply say, “this virus requires a cure urgently, let’s stop minimizing the burden of disease, and also, I’m a human being worthy of curing.”

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Herpes Cure Advocacy News

Advocacy for Herpes has never truly existed, we believe, because of stigma. Herpes is the most heavily stigmatized STI, by far. It could also be the most heavily stigmatized medical condition, period. It’s hard to demand fair treatment and prevention, when you’re in the closet about your condition.

We’ve been hard at work to ask for Herpes treatment, cure and prevention. Here’s a glance into what we’ve been up to:

Legislative Affairs: In the FY 2022 appropriations cycle HCA met for the first time with members of the Senate Appropriations LHHS subcommittee to ask for a Dept of Health & Human Services national strategy and strategic plan for treatment and prevention of Herpes Simplex Virus.

This work is ongoing, as the senate budget report has not been released. We’re looking to build our network of advocates, including patients and HSV field experts in all 50 states. If you can help please contact us.

Partnerships: Without the support of field experts, our ask for Herpes treatment and prevention won’t go far. To make our advocacy more meaningful, we need Herpes Simplex Virus experts (virologists, epidemiologists, infectious disease specialists, pathologists, neurologists, STI experts, women’s health, etc.) who agree that better treatment and prevention is urgently needed. We’re working with a panel of field experts to guide our work and are always looking for more partners. Contact us if this is you.

Organizational Partnerships: Alignment with organizational partners is critical and we meet regularly with our colleagues who support our work at NCSD, Beyond AIDS, IDSA, ASHA, NASTAD and more.

Public and Media Relations: Nothing puts pressure on like a powerful story. We’re working on making inroads with the press and have some important stories in the works.

Community Building: We’re constantly growing our membership and build our army of patient advocates.

Fundraising: Skipping all the incremental work above, one of the most fastest and direct ways to advance a cure for Herpes Simplex Virus is to fund cure research. Two active campaigns we’re fundraising for, are Keith Jerome’s gene editing research at Fred Hutch Cancer Research Center and Dr Harvey Friedman’s research at UPenn. Both provide much hope to the 6 billion living with HSV globally.

Want to join our advocate army? We need patients, HSV field experts of every discipline, and organizational partners to help us chart the path forward. Email us, and let’s get to work!

Get in touch

Herpes is not Benign: Nine health complications linked to HSV

This post is for anyone supporting the narrative about Herpes Simplex Virus that “it’s not a big deal”. This is to encourage NIH for more urgency for treatment research, cure, and serology testing. This is to urge the CDC to develop a real prevention strategy including testing and tracking. Herpes Simplex Virus requires treatment and prevention now for the “massive portion of the worlds population” who are living with the virus. It is time to stop minimizing its impacts, because Herpes is certainly not benign.

Neonatal Herpes

The global incidence of neonatal herpes has been estimated to be around 10 cases per 100,000 live births which is equivalent to about 14,000 cases per year.

Neonatal infection with herpes simplex virus (HSV) is a devastating complication of genital herpes during pregnancy. It is associated with considerable morbidity and mortality: untreated, the case-fatality rate is estimated to be 60%. Even with antiviral treatment, mortality rates and lasting neurological impairment remain substantial, especially for neonates with CNS disease (about 30% of cases) and disseminated disease (25% of cases) compared with those with skin, eyes, and mucosa disease (around 45% of cases).

Bell’s Palsy

There has been increasing acceptance of HSV-1 and varicella zoster virus as the cause of Bell’s Palsy. Bell’s Palsy may result when HSV ruptures from the nerve axon, infects the Schwann sheath, and progresses centripetally. When the swelling caused by the herpetic endoneuritis reaches the enclosed space of the bony fallopian canal, compression of the facial nerve results in paralysis.

Other infectious diseases have been implicated as well.

Increased Risk of HIV

Herpes is a widely recognized driver of the HIV/AIDS epidemic. 40% of new HIV cases are HSV-related, meaning 420,000 new cases of HIV every year could be prevented with a Herpes cure. Infection with HSV-2 increases the risk of HIV acquisition 2-4 fold compared with patients without HSV-2 infection.

Even without lesions present, studies show HSV-2 creates an immune-cell environment conducive to HIV infection that persists at the location of HSV-2 genital skin lesions long after they have been treated with oral doses of the drug acyclovir and have healed and the skin appears normal.

A vaccine against HSV infection would not only help to promote and protect the health and well-being of millions of people, particularly women, worldwide – it could also potentially have an impact on slowing the spread of HIV, if developed and provided alongside other HIV prevention strategies

Dr Meg Doherty,
Director of the WHO Department of Global HIV, Hepatitis, and STI Programmes.


Aseptic meningitis occurs in 36% of women with primary HSV-2 genital infection and 13% of men5; it results in hospitalization for 6.4% of infected women and 1.6% of infected men.

Recurrent aseptic meningitis due to HSV-2 may occur with or without symptomatic herpetic mucocutaneous disorder. The manifestations of this disorder are identical to that observed with primary genital herpes. 8 in 1 series, recurrent meningitis has been observed in 19% 8 to 42% 9 of patients who experience meningitis with their first episode of genital herpes.

Neurological complications

It is widely recognized that chronic infection of the central nervous system causes neurological complications. With the virus chronically present in the body, there is an immune response that is chronically activated, causing inflammation and complications in the nervous system including the brain.

HSV encephalitis (HSE), is the most common fatal sporadic encephalitis in humans. About 90% of all HSE cases in adults and children are due to HSV-1. While the exact incidence of HSE is not known, it has been estimated at about one case per million per year. This figure is probably an underestimate since about 2000 cases occur annually in the United States.

Though rare, encephalitis can be a complication of HSV-1, while HSV-2 is more generally a suspected factor in the development of meningitis. However, the meninges are not the only component of the CNS involved in HSV-2 infection.

Virtually any part of the neuraxis may be affected by this virus, including the retina, brain, brainstem, cranial nerves, spinal cord, nerve pain and nerve roots.

Autoimmune Disorders

In the recent years, several reports have provided important information linking HHV-6A/B to autoimmune diseases (AD) including multiple sclerosis, autoimmune connective tissue diseases, and Hashimoto’s thyroiditis. In addition, it has been suggested that HHV-6A/B infection might be related to the onset of autoimmune disorders, including Sjögren’s syndrome, purpura fulminans, severe autoimmune acquired protein S deficiency severe and acute autoimmune hepatitis and autoimmune hemolytic anemia/neutropenia.

Alzheimer’s and Dementia

There is mounting evidence of a link between Herpes with Alzheimer’s and dementia. Herpes may account for 50% of Alzheimer’s cases. Infection increases likelihood by 2-3%.

Recent research, published in Science Advances, is the first to directly show in a lab model (rather than through circumstantial evidence from human studies) that the herpes simplex virus HSV-1 might cause Alzheimer’s: Human brain-like tissue infected with the virus became riddled with amyloid plaque-like formations — the hallmark of Alzheimer’s. It also developed neuroinflammation and became less effective at conducting electrical signals, all of which happen in Alzheimer’s disease.

Depression, Anxiety, Stress

Psychosocial impacts from Herpes can be severe including depression, low self-esteem and anger. HSV is a known cause of emotional trauma and stress due to the both the burden of disease (oral and/or genital lesions), it’s impacts on quality of life and relationships. Research shows a link between depressed individuals and the herpes simplex virus. The STI project estimates that 10% of Herpes carriers consider suicide.

Genital herpes is a substantial health concern worldwide – beyond the potential pain and discomfort suffered by people living with the infection, the associated social consequences can have a profound effect on sexual and reproductive health.

Dr Ian Askew
Director of the Department of Sexual and Reproductive Health and Research at WHO


Research has suggested that the herpes virus spread from the genitals to nerves in the spinal chord, and then on to neurons in the colon, killing them. In this study, the damage to the colonic neurons prevented the movement of food along the digestive tract, leading to an enlarged colon and disease.

Women’s Health

Research has indicated that Herpes is a risk factor for women for other infections of the genitalia or vagina including Bacterial Vaginosis. This study implies that HSV-2 infection is an important BV risk factor. Pharmacologic HSV-2 suppression may reduce BV incidence and BV-associated adverse events. BV can increase risk of HIV transmission, induce spontaneous abortion, or early labor in pregnancy.

Want to help us rally for a Herpes cure?

Get in touch. We need allies.

A Herpes and Alzheimer’s link?

There is mounting evidence that has increasingly pointed to HSV-1 as being possibly involved in Alzheimer’s disease.

Dr. Itzhaki, who has worked extensively to investigate the link, published a paper in 1991 which was the very first experimental study to link HSV1 and AD. In the paper, she noted that she discovered the viral DNA in a very high proportion of elderly people. Dr. Itzhaki also published this paper establishing a potential link between Alzheimer’s and Herpes.

Her study in 1997 showed that in AD patients, the virus, when in the brain, was associated with a genetic factor – the type 4 allele of the APOE gene, and significantly, it was found also that the same genetic factor is a risk for cold sores caused by HSV1. She published this more recent paper where she argues that the evidence is “overwhelming”. Recent studies by other researchers, include this one about a 3D human brain–like tissue model of herpes-induced Alzheimer’s disease. And this this one.

The association between Herpes and Alzheimer’s is also now a frequent topic of discussion on Alzheimer communities like this one.

This theory used to be considered fringe, but information about possible links has started to pile up in recent years. So far, it has not been proven that HSV-1 causes Alzheimer’s, but the various studies have demonstrated a “strong link”.

Because of such recent research results demonstrating a “strong link”, the National Institute of Aging at NIH in 2019 announced that studying the link has become a “high priority” area of research and has requested researchers to submit research proposal for possible funding.

This high priority call for research is for proposals investigating the pathogen theory of Alzheimer’s, with a focus on the role of HSV-1. It’s an area of current intense research.

In fact, Dr. Jerome at Fred Hutch Cancer Center, whose lab is working on a gene editing approach to cure Herpes Simplex Virus, has noted that they had also received an NIH grant to investigate this link. “Now, we have a grant from the NIH to work on a herpes cure—and more recently, we received a grant to actually look at the possible link between herpes infection and Alzheimer’s disease.”

There is in fact a Phase-2 study currently ongoing to try to treat early Alzheimers dementia with Valtrex at Columbia University. Results out next year.

What does a link between Herpes and Alzheimer’s mean for a cure?

This is a good news and bad news story. If Herpes is linked to Alzheimers, either as a cause in some people or as something which accelerates Alzheimers, that would be a negative for people with HSV. But if such link exists, it would be important to know that so that’s why this research is important. That is what this research will be about and we can expect to read various research results focused on this in the coming few years.

A silver lining to this is that, if the research continues to show a link with Herpes and Alzheimers, it may result in more funding for herpes research–treatment, prevention and cure research.

Herpes research has been increasingly funded in recent years. But the budget for Alzheimer’s research is many times more massive. If some of that funding is directed towards researching HSV, that would be a good thing for the 6 billion globally living with Herpes.

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Herpes Cure Research at Sanofi

Sanofi is the largest company devoted entirely to vaccines and is currently running a Phase I/II clinical trial on 6 different formulations of HSV529, G103, and an adjuvant.

HSV529 is a replication-defective vaccine while G103 is a subunit vaccine. In a Phase I trial completed in 2018, HSV529 induced a statistically significant increase in antibody titers for participants who were both positive and negative for HSV.

In a preclinical trial in guinea pigs in 2016, G103 was able to effectively reduce both symptoms and shedding by 50%.

The current Phase I/II clinical trial is looking at different combinations and formulations of HSV529, G103, and an adjuvant in order to find the optimal dose in eliminating outbreaks and shedding.

Phase I completed in May 2021 and Sanofi has a estimated completion date for Phase II in May 2024. This suggests Phase I has shown safety/potential efficacy and recruitment for Phase II is estimated to start end of 2022.

Current Herpes Cure Research at Excision BioTherapeutics

Excision Bio has illustrated the possibility in developing a curative gene therapy using CRISPR in treating both active and latent HSV infection in the body. The company has stated that they plan to begin clinical trials in Q1 2023.

Excision’s cutting edge CRISPR gene therapy platform is built on technology licensed from the Doudna Lab at UC Berkeley and the Khalili Lab at Temple University. They are the first company to remove HIV genomes from animals and generate functional cures for HIV.

The company’s primary focus at this point in time being curing HIV with CRISPR. The company is in the middle of filing their IND with the FDA for HIV clinical trials, which they plan to begin in 2021.

In February 2021 Excision announced $60 million raised in funding to focus on their research streams including HSV.

Updates on IND filing status can be found here.