First Antidiarrheal Medication for HIV Patients Hits the Shelves

Mytesi is the only FDA approved treatment for noninfectious diarrhea in HIV positive patients.

The FDA-approved drug crofelemer (Mytesi) which treats noninfectious diarrhea in HIV patients, has officially been launched, along with a copay savings and patient assistance program to provide affordable access to the drug.

Napo Pharmaceuticals’ Mytesi, formerly marketed as Fulyzaq, is a prescription treatment for diarrhea designed to normalize the flow of water in the GI tract.

“One of the major reasons diarrhea among HIV patients remains under recognized is due to a disconnect between physicians and their patients: patients often do not report the true extent of their diarrhea, and physicians are not always fully aware of the negative impact of diarrhea on their patients’ lifestyles,” said researcher Rodger D. MacArthur, MD, investigator and author of the ADVENT trial. “In addition, both groups may not be aware that a specific treatment is available. Some health care providers believe that diarrhea is only associated with ART and that newer antiretroviral medications cause less diarrhea. However, HIV enteropathy, which is chronic diarrhea due to the direct or indirect effects of HIV on the GI tract, is a problem for many HIV patients, independent of their ART regimen.”

Subgroup analyses in the pivotal ADVENT clinical trial, which led to the regulatory approval of Mytesi, demonstrated a more pronounced effect in HIV patients who had longstanding infection, or who tried antidiarrheal medications, according to a press release.

A large proportion of HIV patients are only aware of the antidiarrheal treatments, Imodium and Lomotil. However, these treatments have not been studied on patients who are HIV-positive, and the effect of the drugs on antiretroviral medications remains unknown.

Additionally, these drugs are opioids that slowly move through the GI tract, which can cause constipation.

“Chronic, symptomatic diarrhea remains a significant, underreported consequence of HIV, whether due to the side effects of antiretroviral therapy (ART) or the direct effect of HIV on the gastrointestinal (GI) tract,” said Lisa Conte, CEO and founder of Napo. “This problem is only going to increase at the HIV-positive population gets older; more than 40% of people currently living with HIV/AIDS in the United States are over the age of 50.

“By launching Mytesi, not only are we making this important drug widely available, we are including 2 important patient assistance programs to ensure that patients can gain access to our drug, regardless of economic status. The launch of Mytesi also highlights Napo’s dedication to both superior patient care and corporate responsibility.”

The 2 patient assistance programs are the Mytesi Copay Savings Program and the NapoCares Patient Assistance Program.

The Copay Savings Program is designed to provide copay assistance to eligible patients who have private health insurance, with the intent to have patients pay no more than $25 for a Mytesi prescription. The Patient Assistance Program provides Mytesi for free to eligible patients who are not insured and may not be able to afford the medication.