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Mytesi improves chronic diarrhea in HIV patients long-term
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Mytesi, the only anti-diarrheal approved by the FDA for treating noninfectious diarrhea in adults with HIV/AIDS, generated significant long-term improvement in patients with chronic HIV-related diarrhea, according to data presented at the International AIDS Society Conference on HIV Science.
Mytesi (crofelemer, Napo Pharmaceuticals, Jaguar Health; formerly marketed as Fulyzaq) is extracted and purified from the bark sap of the Croton lechleri tree, and acts locally in the GI tract to normalize the flow of water, according to the company’s website. It is taken twice daily as a 125-mg tablet.
The randomized, double-blind ADVENT trial previously demonstrated the drug’s safety and efficacy for reducing HIV-related diarrhea, but investigators performed a supplemental analysis to evaluate its long-term efficacy.
This retrospective analysis evaluated 274 patients with HIV-related noninfectious diarrhea who were on stable antiretroviral therapy, and continued the 20-week extension phase after receiving crofelemer or placebo twice daily for 4 weeks. All patients received the study drug during the extension phase.
On average, the patients had diarrhea for 6 years with 20 watery stools per week, and 59% had previously tried at least one antidiarrheal drug.
The investigators found the drug reduced the number of diarrhea episodes by an average of 70%, and more than half of patients had complete resolution of their diarrhea.
“Mytesi achieves much greater reductions in HIV-related diarrhea than was apparent in the ADVENT primary responder analysis,” Rodger D. MacArthur, MD, of the Medical College of Georgia in Augusta, said in a press release. “Most patients saw meaningful reductions in diarrhea, with more than 75% experiencing at least a 50% reduction and more than half of patients experiencing complete resolution of diarrhea at week 24. I think it is important to note that results were consistent regardless of use of a protease inhibitor or the cause of the diarrhea.”
The drug was also well tolerated, and no serious drug-related adverse events occurred. The most common adverse events included upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%) and increased bilirubin (3.1%).
“With an estimated 20% of the more than 36 million people currently living with HIV suffering from diarrhea, there are more than seven million patients worldwide who may benefit from the reduction in diarrhea that can be achieved with Mytesi therapy,” Lisa Conte, Jaguar’s president and CEO and Napo’s interim CEO, said in the press release. – by Adam Leitenberger
Reference:
MacArthur RD, et al. Abstract #WEPEB0537. Presented at: 9th International AIDS Society Conference on HIV Science; July 23-26, 2017; Paris.
Disclosures: Conte is employed by Jaguar and Napo. Healio Gastroenterology was unable to confirm MacArthur’s relevant financial disclosures at the time of publication.