Efficacy of Crofelemer in Chronic HIV-Related Diarrhea Evaluated

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The authors found no significant difference between patients receiving a protease inhibitor vs not receiving a protease inhibitor or based on the cause of diarrhea.
The authors found no significant difference between patients receiving a protease inhibitor vs not receiving a protease inhibitor or based on the cause of diarrhea.

Napo and Jaguar announced new findings from a supplemental analysis of Mytesi (crofelemer) in patients with HIV-related diarrhea at the 9th IAS Conference on HIV Science, in Paris, France.1,2

The analysis was performed to better understand the long-term efficacy of Mytesi in patients with chronic HIV-related diarrhea; the primary safety and efficacy of Mytesi was previously established in the ADVENT trial. The trial had enrolled patients averaging 20 watery stools/week. 

Data from the analysis showed a 73% mean reduction in diarrhea episodes from baseline after treatment with Mytesi for 24 weeks. Over 75% of patients experienced clinically meaningful reduction in diarrhea, defined by ≥ 50% decrease in the number of episodes. Also, more than half of patients reported complete resolution of their diarrhea by Week 24 of treatment. 

The authors found no significant difference between patients receiving a protease inhibitor vs not receiving a protease inhibitor or based on the cause of diarrhea.

Mytesi contains a botanical drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree. Currently, Mytesi is the only antidiarrheal agent approved by the Food and Drug Administration (FDA) for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. It works locally in the gastrointestinal (GI) tract to normalize the flow of water. 

Mytesi is available as 125 mg strength delayed-release tablets in 60-count bottles. 

References

  1. Long-term crofelemer provides clinically relevant reductions in HIV-related reductions in HIV-related diarrhea [press release]. San Francisco, California: Napo Pharmaceuticals. Published July 2017. Accessed August 9, 2017.
  2. MacArthur RD, Clay P, Blick G, Waltzman R, Bell M. Long-term crofelemer use gives clinically relevant reductions in HIV-related diarrhea. Presented at: IAS 2017; July 23-26, 2017; Paris, France; Poster WEPEB0537.
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