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Thursday, 22 June 2017

Relationships and Sex: The major breakthrough that completely stopped this woman's painful genital herpes outbreaks

herpes

Here's what you need to know.

In the span of seven days, Mel Smith left her verbally abusive boyfriend, moved out of their house with her 13-year-old son, and found out that she had contracted genital herpes.

“I didn’t know what it was. I didn’t know what to do,” she says, remembering the time five years ago when her vagina itched so badly she couldn’t wear underwear.

Her diagnosis? Herpes simplex virus.

The World Health Organization estimates that more than 420 billion people worldwide have herpes simplex virus, commonly referred to as “herpes.”

The highly contagious virus is passed through human contact, be it orally or sexually.

There are two types: HSV-1, which mainly causes oral herpes, and HSV-2, which infects 417 million people and mainly causes genital herpes.

Women are infected with HSV-2 more than men because sexual transmission is more efficient from men to women than from women to men.

Most herpes infections don’t cause symptoms. But for some people, like Mel, painful, itchy, sore-causing genital outbreaks become the new reality.

Today, there is no known cure—just antiviral medications that can help ease the pain of outbreaks for some people.

“He told me that ‘it’s like buying a condo in Florida, you can never get rid of it,’” she says of her doctor, who prescribed her the antiviral and sent her away.

Her ex-boyfriend, who she thinks may have cheated and passed along the virus, offered no support either. He accused her of cheating on him.

So she started taking the medication to lessen the intensity of her severe outbreaks, which caused tingling on her genitals, and intense itching that often resulted in scabs or open wounds when scratched.

Still, every month when she got her period, an outbreak came with it, a common phenomenon for women with genital herpes.

Online, she found a community of people with herpes, and she also found William Halford, Ph.D., who had been studying the virus for more than 20 years.

Five years ago, Halford met filmmaker Agustin Fernandez, who was interested in investing a half-million dollars in a herpes vaccine, inspired by an ex-girlfriend who had the virus.

The doctor and filmmaker started Rational Vaccines in 2015 with the hopes that a vaccine for herpes could one day be on the market.

After writing to him about her life with severe monthly outbreaks, Mel became one of the 17 people chosen for a clinical trial run by Halford in the Caribbean.

The trial group, based in Saint Kitts and Nevis, was composed of men and women from the U.S. and U.K. of different ages and races.

Each participant had tested positive for herpes and experienced severe genital outbreaks 12 to 24 times per year.

Beginning in April 1, 2016, they were each injected with three doses, one month apart, of the vaccine.

Halford first tested the vaccine on mice, guinea pigs, himself, and co-founder Fernandez.

Though neither of them were infected with herpes, they injected themselves to prove their belief that the vaccine was safe.

Next came the trial, which not only offered further proof of the vaccine's safety in humans but its ability to help tame symptoms.

The clinical trial Mel participated in was the first live-attenuated herpes vaccine tested on humans.

Translation: Halford injected a “slow, stupid version” of the herpes virus into participants, so their immune systems could find it, fight it, and do the same thing when the real virus flared up again.

Halford and his team are still analyzing the data from the trial, and they expect to have a paper published in a medical journal by the end of 2017.

However, Fernandez said 100 percent of the patients reported improvements in the frequency of their outbreaks.

“It worked on every person in varying degrees,” he said. About 65 percent of participants said they have not had a genital herpes outbreak since the trial has ended—Mel included.

About 25 percent now have many fewer outbreaks than before, he says. Everyone in these two categories tested positive for one of two types of herpes simplex virus before the trial began.

The remaining 10 percent, all of whom were women who tested positive for both types of herpes simplex virus (HSV-1 and HSV-2), saw the least amount of improvement.

But these women still reported that their outbreaks had subsided, whether it was the intensity or the frequency.

Fernandez said that, like Mel, each of these women experienced outbreaks during their menstrual cycles.

Live viral vaccines are nothing new—the shingles and chickenpox vaccines employ the same strategy to fight the viruses. Still, Fernandez said the words “live” and “virus” in the same sentence made the FDA hesitant to approve trials in the U.S.

That’s why the company had to conduct the trial overseas. While that may sound suspect, it's similar to what happened with the chickenpox vaccine, which is now required to attend public school in all 50 states.

When scientists behind that vaccine were conducting trials in Japan in 1972, the FDA delayed bringing it to the U.S.

The regulatory agency was concerned that there could be unwanted side effects, according to the New York Times. It wasn’t approved until 1995.

Now, chickenpox is largely a thing of the past. Fernandez hopes that one day soon, herpes will be, too.

Edward Gershburg, Ph.D., who worked on the development of the vaccine with Halford at Southern Illinois University School of Medicine, confirms that this trial was the first time a live-attenuated herpes vaccine was tested on humans.

That may be because although the risk of contracting or worsening the virus from this type of vaccine is extremely small, it’s there, he says.

"We are at the point where (U.S. regulators) can’t afford even the slightest risk, even if it’s one out of several million,” he says. “Those vaccines will be somewhat considered risky.”

Fernandez says he is confident in the safety in the vaccine, but he wants to run more tests.

Within three to five years, he hopes to have a Phase 1 FDA-approved clinical trial in the U.S.

He doesn’t want to wait for the sometimes years-long approval process when he could be helping more people, he says, so he’ll organize more trials in Mexico and the Caribbean in the meantime.

With desperate emails from people with herpes pouring into his inbox every day, Fernandez says he asks himself, “What’s the bigger risk? I think it’s a little more risky to let this continue.”

“We can’t wait,” he says. “There are literally too many people suffering.”

When Harvey Friedman, M.D., professor of infectious diseases at University of Pennsylvania’s Perelman School of Medicine, read about the trial, he says it was encouraging to hear that it had positive effects on every participant.

Still, he says, it’s too early to celebrate.

“The first step is to have a control group, which he didn’t have,” he says. “He was looking at safety.”

To really prove the efficacy of the vaccine to alleviate outbreaks, patients would have to be split into two groups.

One group would get the vaccine and one would get a placebo, Friedman says. After recording the results, Rational Vaccines will have a better idea of how to proceed.

Fernandez knows it will be a long road with several phases of testing before this vaccine could possibly be available to the public, but he is prepared to do whatever it takes.

His friend and co-founder Halford has been diagnosed with terminal cancer, and the filmmaker wants to continue his legacy.

“There is nothing else more important I could do than this,” he says.

Mel has thrown out the antiviral medications that she used to hide shamefully in her medicine cabinet.

She has more time to spend with friends, her son, her boyfriend, and working on her business now that she doesn’t have painful monthly outbreaks. "I feel like a more whole person," she says.



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