The diarrhea just would not stop.
So says San Francisco’s Tez Anderson, 60, who is well known to many HIV longtimers as the founder of the online and in-person support network Let’s Kick ASS (AIDS Survivor Syndrome). Diagnosed with HIV in 1986 but believing that he seroconverted in 1983, Anderson was on all the side-effect-heavy HIV meds of the “bad old days”—including an early trial for AZT—before surviving into our current age of effective and relatively easy-to-manage HIV treatment.
But until only a few years ago, he had chronic diarrhea, despite the fact that tests showed he apparently had no apparent stomach bug like Giardia. “It was very unpredictable,” he recalls. “It caused me a lot of anxiety about going out and really interfered with my quality of life. I worried if I saw there was a line for the bathroom. I lived that way for years.”
Then—and, yes, we know this sounds like a drug ad, although that’s not what it is—he read online about Mytesi (crofelemer), a diarrhea treatment derived from a plant in South American rainforests and approved in 2012 by the U.S. Food and Drug Administration (FDA) to treat HIV-related diarrhea like his. (At the time the drug was originally approved, it was under the brand name Fulyzaq.) Since then, he says, “I’ve taken it for two years, and it’s worked remarkably. It doesn’t clog you up like Imodium, which has an opioid in it. It took eight weeks to really get into my system, but it stopped my diarrhea completely.”
Anderson was so happy with Mytesi that he became a spokesperson for it. Only then, he says, did he learn about HIV enteropathy, chronic diarrhea in HIV-positive folks in the absence of a bug like Giardia, believed to be caused by damage that HIV does to the gut, even on folks who are on HIV meds and undetectable.
Along the way, he says, he became friends with Mytesi’s creator, Lisa Conte, the founder and CEO of Napo Pharmaceuticals, who, years ago, began pairing Western-trained doctors and ethnobotanists with South American rainforest shamans to learn what plants they used for an array of common symptoms. [Editor's note: TheBody has no sponsorship or advertising relationship with Napo Pharmaceuticals.]
“This plant called dragon’s blood, whose scientific name is Croton lechleri, kept coming up as something used for diarrhea,” she says. When several plants were brought back to the lab for analysis, “this one kept landing on the top of the stack for its activity, safety, non-interaction with other drugs, and its ability to be harvested sustainably.”
Conte and colleagues began developing the plant for general diarrhea, but then the FDA, noting their research, asked them to develop a trial showing that the treatment worked in people with HIV with chronic diarrhea. Among those who enrolled, 20 bouts of diarrhea a week was the average, says Conte, but by the end of the trial, she says, more than 83% of participants had a 50% reduction in diarrhea, and more than 50% had a total reduction. The FDA approved the drug for HIV in 2012, but it only came to market in 2017, after Conte resolved legal wrangles with her commercial partner.
Among Mytesi’s benefits, she says, is that it is not absorbed into the systemic bloodstream but goes straight into the intestine, eliminating side effects and merely preventing the last step in the diarrhea process, which is the excessive flow of water from the body. “This is the holy grail in drug development, when you correct the last step of a problem despite its cause,” she says. “It’s almost like putting a plug in the bottom of the tub. You significantly mitigate dehydration but don’t interfere with anything else.”
According to Conte, the drug, which is now also in studies for diarrhea related to inflammatory bowel disease and cancer, has a sticker price of $2,206.52 for a month’s supply of 60 pills, but is covered by most public and private insurance plans, including 98% of state AIDS Drug Assistance Programs. “We’ve never heard of it not being covered,” she says, but doctors often have to get through prior authorization, showing that their patients have not had results with over-the-counter treatments such as Imodium.
Her company also has a co-pay and high-deductible assistance program, which will soon apply to individuals making up to $87,000 a year (more for those with more than one household member). Their goal, she said, is to make sure that nobody pays more than $25 out of pocket per prescription.
According to Conte, that promise remains despite the fact that, claiming fears of financial insolvency, her company tripled Mytesi’s price in April (and also unsuccessfully asked the FDA to approve Mytesi for COVID-related diarrhea). Their “entire program associated with patient access … was designed so that not one patient is denied product because of cost,” she said in an email.
Yet despite all this, plus her estimates that between 3,000 and 4,000 people living with HIV (especially long-term survivors like Anderson) have chronic, non-bug-related diarrhea, “fewer HIV providers than I’d like” know about Mytesi, she admits. “Maybe we all grew up with the idea that if you have diarrhea, you just pick up an over-the-counter med and it goes away. But some people have been suffering in silence for years, having to plan their days around where the bathrooms are, using over-the-counters that are intended for short-term use for months or years at a time and then ending up in a constant diarrhea/constipation cycle.”
And, indeed, based on an informal survey of a handful of HIV doctors around the country, it did seem that Mytesi was only dimly known of. That may be partly because incidence of chronic diarrhea has shrunk so dramatically in our current era of highly effective and side-effect-light HIV meds, according to longtime HIV provider Judith Feinberg, M.D., chair of the board of directors for the HIV Medicine Association.
“We saw a lot of enteropathy in the ’80s and ’90s, when people would be in the hospital for weeks, pouring out liters of liquid stool a day and on an IV to prevent complete dehydration,” she says, “but it hasn’t been a significant problem in recent years, mostly because organs that were once directly affected by HIV” are now protected due to current HIV meds. “But it may still be a problem in a subset of patients.”
In Florida, one longtime HIV doc, Gerald Pierone, M.D., said that he “almost never” saw enteropathy anymore and had not heard of Mytesi, while, in the same state, Howard Grossman, M.D., another longtime provider, said that it seemed to have helped a few of his patients.
Another longtime doc in another city, who asked not to be named, said that a handful of his patients had derived some diarrhea reduction from Mytesi, if not total eradication, which reflects what was found in Conte’s clinical trial. He also noted that options for chronic diarrhea beyond Imodium also include several irritable-bowel medications that have come out in recent years, such as Lotronex (alosetron) and Xifaxan (rifaximin).
When Anderson posted about Mytesi early last year on Facebook, he got comments from dozens of other HIV longtime survivors about their Contenuing struggles with diarrhea. A few said they’d had luck with Mytesi; others said they hadn’t heard of it but would bring it up with their doctors. Others touted a variety of non-prescription solutions, such as peppermint oil (rubbed on the belly or dropped into water), glutamine, and even yogurt and cold rice.
Then again, enteropathy’s relative rarity these days among people with HIV may be precisely the reason why those who suffer from it (and presumably have not found relief, or struggled, with Imodium) have not heard about Mytesi from their providers.
Conte, at least, is hoping that Mytesi use grows, saying that, for now, her publicly held company had gross sales of about $8 million last year, with about a 15% to 20% increase per quarter in the number of patients using the product. “It’s been a big educational campaign in the HIV community with both providers and patients,” she says, “because traditionally, patients have been told that chronic diarrhea is just something they have to live with.”