Roundups Sexual Health

Sexual Health Roundup: Research Adds Credibility to HIV ‘Cure,’ Warnings About Waxing, and ‘Sexcereal’

Martha Kempner

Sexcereal: It's what's for breakfast. Plus more sexual health news from the past week.

Sexual Health Roundup is a weekly summary of news and research related to sexual behavior, sexuality education, contraception, STIs, and more.

New Research Suggests Early Drug Intervention May Be a “Functional Cure” for HIV

A few weeks ago, I wrote about a Mississippi toddler born to an HIV-positive mother who was apparently cleared of the virus through a triple cocktail of drugs delivered within hours of her birth. The child returned to the hospital after more than five months had passed without treatment; tests revealed no active virus in her system. If HIV was indeed eradicated from her body, the toddler represents only the second documented case in which this has happened. Some experts questioned whether she was ever truly infected, or if the positive test results were merely indicative of her mother’s status. However, her doctors said they believe that the drug therapy was able to “thread the needle” between when the virus entered her blood stream and when it would have taken up residence in T-cell reservoirs. Though the virus was still detectable in her body, it was reduced to such low levels that it could be controlled by the body without additional drug therapies. Experts refer to this as a functional cure.

Many experts questioned whether this kind of approach would be of any value to adults who may be infected through sexual contact and not know the exact moment when they contracted HIV. New research from France, however, suggests that there may have been similar results among a number of adults in the country. The scientists presented case studies on 14 patients who were treated with combination anti-retroviral therapy very early (during primary infection) but then stopped treatment for various reasons. The researchers found that “the number of infected cells circulating in the blood of these patients, known as post-treatment controller, kept falling,” despite the fact that they had not had treatment for as long as seven years. The researchers believe that this suggests early treatment may represent a “functional cure,” as it appears to have in the Mississippi case. 

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Christine Rouzioux, who was a member of the French team that initially identified HIV in the 1980s, agreed that this seemed to meet the definition of a functional cure. She explained, “Early treatment in these patients may have limited the establishment of viral reservoirs, the extent of viral mutations, and preserved immune responses. A combination of those may contribute to control infection in post-treatment controllers.” 

Though I still question whether using the word “cure” in cases like these is more harmful than helpful to the general public, I am interested in what the authors of the French study said in their article. They began the abstract by saying that “[g]iven the difficulty of eradicating HIV-1, a functional cure for HIV-infected patients appears to be a more reachable short-term goal.”

Later they noted that “[t]here is a renewed scientific interest in developing strategies allowing long-term remission in HIV-1-infected individuals.”

While long-term remissions may not be the cure we all dreamed of, they certainly represent progress in treating HIV infections. More importantly, renewed scientific interest in HIV and AIDS is a positive phenomenon no matter what we call the results.

Could Your Brazilian Wax Put You at Risk for Molluscum Contagious?

In our special Valentine’s Day edition of the Sexual Health Roundup, I warned that man- and woman-scaping in preparation for the big night could land you in a crowded emergency room instead of a fancy hotel room. I cited research showing that there’s been an increase in the rate of accidents among individuals who shave, trim, wax, and pluck down there. Now, a new study suggests that all that pubic hair maintenance may leave you open for at least one type of sexually transmitted infection: molluscum contagiosum

According to the Centers for Disease Control and Prevention, molluscum contagiosum is a mild skin disease caused by a virus. The virus causes small white, pink, or flesh-colored raised bumps or growths with a dimple or pit in the center. The bumps are usually smooth and firm. In most people, the growths range from about the size of a pinhead to as large as a pencil eraser. These spots are usually painless but may become itchy, red, swollen, or sore. The virus only affects the skin and does not circulate in the blood of healthy individuals.

This condition is most often found in children and can be spread by touching infected skin, which also means it can be spread during sexual activity. (It has been suggested that the virus might also be spread by sharing warm wet environments like swimming pools, hot tubs, or towels, but this has not been proven.) 

Researchers in France had noticed an increase in sexually transmitted cases of mollescum contagiosum and began to wonder whether that increase had anything to do with the trend of removing most or all of one’s pubic hair. 

Before I report on their findings, it is important to note that this is a very small study, and these results show only association, not causation. The researchers looked at the records of patients in their clinic who had been diagnosed with sexually transmitted molluscum contagiosum between 2011 and 2012—30 patients in all (six women and 24 men). Of those patients, 93 percent had removed their pubic hair, either through shaving (70 percent), clipping (13 percent), or waxing (10 percent). Ten of the 30 patients had at least one other skin condition, such as warts or a bacterial infection.

Again, the findings, which were published in the journal Sexually Transmitted Infections, are merely preliminary. Moreover, molluscum contagiousum appears to be a nuisance at worst; without treatment, it is likely to clear up within six to 12 months on its own. So why the warning about waxing? Because some experts agree that there is logic in the findings and that the same logic could be applied to the spread of other, more serious diseases like herpes. 

Healthy skin and even pubic hair can protect the body from infection. In contrast, the little cuts or nicks that are common with any kind of hair removal can make the body more vulnerable. Dr. Robert Brodell, chief of the University of Mississippi Medical Center’s Division of Dermatology, explained recently that “[t]he body has a number of defense mechanisms to prevent infection. One of those mechanisms is normal, healthy skin.”   

Dr. Jonathan Zenilman, chief of the Infectious Diseases Division at Johns Hopkins Bayview Medical Center, cautioned about reading too much into the study, but said that the findings make sense. He pointed out that herpes is known to be more transmissible if small trauma occurs to the skin during sex.

So consider this just another reason to take care of the skin in your most sensitive regions, whether you decide to go hairless or leave it au naturel.

Sexcereal: It’s What’s for Breakfast

Two things that don’t sound particularly sexy? Canada and breakfast cereal. Apparently, though, when you put them together you get a new product that’s supposed to ignite our sex drives, one bowl at a time. Sexcereal is the brainchild of Canadian businessman Peter Ehrlich, who believes it could be a vehicle for improving sexual health. After coming up with the idea, Ehrlich turned to nutritionists to develop separate formulas for men and women and to a well-known marketing firm to create packaging that would convey the cereal’s message without making it seem like a gag gift. The resulting packages have 1940s-style pin-ups on them: a man seductively holding a banana and a woman presenting a sexy bowl of berries. 

The male cereal is said to be “blended with ingredients shown to support testosterone and then some.” The ingredients include rolled oats, wheat germ, water, chia seeds, black sesame seeds, pumpkin seeds, blueberries (sweetened with apple juice), cacao nibs, goji berries, bee pollen, maca powder, camu camu, and coconut sugar.

 

The female cereal package promises “balanced hormones and then some.” It contains rolled oats, oat bran, sunflower seeds, water, flax seeds, chia seeds, soy protein, cranberries (sweetened with apple juice), goji berries, cacao nibs, almonds, ginger ground, maca powder, and coconut sugar.

 

Though much of this is just standard health store fare, maca powder is often sold as a libido booster.

 

So far, Sexcereal is only sold in some stores in Canada (though you can buy it online), so it may be a while before we can see for ourselves how it tastes and whether it works.

 

One commentator on the Toronto Sun’s website seems to have summed up the product: “At 12 dollars for a small bag, you’re definitely getting screwed.”

 

News Health Systems

HIV Drug Price Increase Brings ‘Price Gouging’ to the Forefront

Martha Kempner

Reports that a drug that treats toxoplasmosis went from $13.50 to $750 per pill caused outrage among medical experts, politicians, and the public.

Pharmaceutical company Turing came under fire last week after the New York Times reported Turing had raised by about 5,000 percent the price of an old drug used to treat an infection that can be life-threatening in those with HIV or AIDS or with otherwise compromised immune systems.

The founder and CEO of the company, Martin Shkreli, initially defended its decision by saying Turing needed to make the drug profitable and planned to use the profits to make a newer, better drug. After being vilified in the press, however, Shkreli said on September 23 that Turing would lower the cost of Daraprim, though he did not say by how much. The controversy gave both medical professionals and politicians an opportunity to discuss the rising prices for drugs that treat myriad conditions.

Daraprim was approved by the Food and Drug Administration (FDA) in 1953 to treat toxoplasmosis, a parasitic infection that can come from eating undercooked meat or unwashed fruits and vegetables. It can also be contracted from cat feces when cleaning litter boxes. The parasite is common and most people never get symptoms, but it can be very dangerous to pregnant women and those with compromised immune systems, such as the elderly, infants, certain cancer patients, and people with HIV or AIDS.

The Centers for Disease Control and Prevention (CDC) estimates that about 4,400 people are hospitalized with the infection and more than 300 die each year. Most people who get sick from toxoplasmosis can be cured with a six-week dose of Daraprim. Those who are immunosuppressed, however, may have to take the drug continually.

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Not long ago, Daraprim cost about $1 per pill. But after GlaxoSmithKline sold the drug in 2010, its price has steadily increased. That year there were about 12,700 outpatient prescriptions for total sales of $667,000. In 2014, however, the number of outpatient prescriptions for the drug dropped to 8,821, but sales of the drug totaled $9.9 million.

There is some disagreement over the exact price of the drug in August when it was sold to Turing. Most reports say it cost about $13.50 per pill, but Shkreli told the Washington Post that each pill was $18 at the time. Either way, the price hike was alarming as Turing began to sell the drug for $750 per pill; an increase of at least 4,000 percent.

This meant that the standard six-week, two-pill-a-day course of treatment went from $1,130 to $63,000. For patients over 132 pounds who have to stay on Daraprim, the drug could cost as much as $634,500 every year.

The medical community called this move unconscionable and pointed out that making the drug so expensive might mean hospitals could not keep it in stock, which would, at the very least, delay treatment for some patients. The Infectious Diseases Society of America and the HIV Medicine Association sent a joint letter to Turing calling the move “unjustifiable for a medically vulnerable patient population” and “unsustainable for the health care system.”

Shkreli defended his company’s price hike saying that the previous manufacturer was practically giving the drug away and that his company couldn’t afford to do that. He argued that the drug is so rarely used that the new price would not impact the health-care system and promised that Turing would put a lot of its profits into researching newer and better drugs to treat toxoplasmosis. He told the Los Angeles Times: “We’re not going to take this money and put it in our pocket or pay ourselves a dividend. We’re not going to stop until we’ve eliminated toxoplasmosis.”

But this rationale was not satisfactory, as research into toxoplasmosis does not appear necessary. Dr. Carlos del Rio, an HIV and AIDS specialist at Emory University, told NBC News: “This is a drug that has no major side effects … it’s usually very well tolerated. It’s not a patient population that is clamoring for a better drug.”

Politicians got in on the outrage. Democratic Presidential candidate Hillary Clinton called the move “price gouging” and “outrageous” and used the story as a hook for releasing her drug pricing plan. Sen. Bernie Sanders (I-VT), who is also vying to be the Democratic candidate for president, and Rep. Elijah Cummings (D-MD) announced that they were requesting information from Turning on the “astronomical price increase.”

The two have spearheaded congressional investigations into drug prices. “The enormous, overnight price increase for Daraprim is just the latest in a long list of skyrocketing price increases for certain critical medications,” Sanders and Cummings said in a statement. “Americans should not have to live in fear that they will die or go bankrupt because they cannot afford to take the life-saving medication they need.”

There are many other examples of companies raising drug prices for no apparent reason other than bolstering the profit margin.

Doxycycline, a common antibiotic used to treat everything from urinary tract infections and chlamydia to Lyme disease and anthrax exposure, went from $20 a bottle in 2013 to $1,849 in 2014. When Rodelis Therapeutics acquired the rights to manufacture Cycloserine, which treats multidrug-resistant tuberculosis, the cost went from $500 a bottle to $10,800. When Valeant Pharmaceuticals bought two heart medications from Marathon Pharmaceuticals, it raised the price of one by 212 percent and the other by 525 percent. This was particularly startling because Marathon had already quintupled the price of the drugs when it acquired them.

Those price hikes are part of the congressional investigations. Those increases did not, however, capture the public’s attention as much the story of Daraprim. Much of the anger seemed to be directed as Shkreli, a 32-year-old former hedge fund manager, who initially said he would not consider lowering the price and called a journalist who questioned his decision “a moron” on Twitter.

Journalists pointed out that this was not the first time Shkreli drastically raised prices on a medication. His former company, Retrophin, bought the rights to a drug called Thiola, which can prevent or reduce the frequency of kidney stones in some patients who are prone to them. When Retrophin acquired the drug, it raised the price from $1.50 per pill to more than $30, meaning that annual treatment for patients who have to stay on the drug went from $2,700 to $54,750.

Urologist Benjamin Davies of the University of Pittsburgh accused Shkreli of having “grabbed an old drug, made no changes to it at all, and hiked the price exorbitantly.”

Shkreli was ousted from and is currently being sued by Retrophin for unrelated issues.

The public pressure seems to have forced Shkreli to reconsider.

“Yes it is absolutely a reaction—there were mistakes made with respect to helping people understand why we took this action, I think that it makes sense to lower the price in response to the anger that was felt by people,” he told NBC News.

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Study: Antibody Therapy Shows Promise for HIV Treatment

Martha Kempner

A small human study has found that infusing a person's blood with HIV antibodies can cut the amount of virus in their body even if they are not taking antiretroviral drugs.

Researchers in the United States and Germany have found that infusing a person’s blood with HIV antibodies can cut the amount of virus in their body even if they are not taking antiretroviral drugs.

The findings were published in a recent issue of the journal Nature.

Certain antibodies can prevent HIV from binding to CD4 cells, which serve as host cells for the virus. Between 10 and 30 percent of individuals living with HIV are able to produce these antibodies naturally, but it often takes a few years after infection. That gives HIV time to mutate in ways that allow it to evade the antibodies once they form.

Researchers hope that by introducing synthetic antibodies sooner, they can prevent the virus both from invading CD4 cells and from mutating. This approach, which has been called passive immunization, has been successful in trials on monkeys and mice but, until this study, had not been found effective in humans.

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For this study, researchers worked with 29 people, 17 of whom were HIV-positive. Among those, 15 were not on antiretroviral drugs during the study. Participants received an antibody called 3BNC117, which has been shown to be active against 195 of the 237 known strains of HIV.

Researchers tested four doses of the antibody. They found that one infusion of the highest dose of the antibody (given to eight participants) cut the amount of virus in their blood by between eight and 250 times for 28 days. But the antibodies became 80 percent less effective at neutralizing the virus after the 28-day mark.

The researchers theorized that the virus was able to change shape during that time to evade the antibodies.

Despite the short-lived success, researchers believe their findings are important and that antibody therapy may be the future of HIV treatment and prevention.

Michel Nussenzweig, the study’s lead other, explained to Nature.com, “The goal is a once-a-year shot for prevention and a combination approach for cure”

“In contrast to conventional antiretroviral therapy, antibody-mediated therapy can also engage the patient’s immune cells, which can help to better neutralize the virus,” said Florien Klein, one of the study’s co-authors.

Others in the field, however, are questioning this method, and wondering if can ever be affordable and accessible to the majority of people living with HIV, many of whom live in developing countries.

“The practicality, utility and efficacy of this approach are hugely open questions,” Mitchell Warren, executive director of AVAC, an HIV-prevention agency, told Nature.com.

Warren, however, was optimistic that the cost of the treatment would eventually come down if it is widely accepted. “Some people would have said 10-to-15 years ago that ARVs [antiretroviral drugs] were not going to be affordable, either.”