Results from the Phase 3 Antidiarrhea Therapy in HIV Disease−Emerging Treatment Concepts (ADVENT) trial, which supports the efficacy and safety of Fulyzaq (crofelemer; Salix) for the treatment of noninfectious diarrhea caused by antiretroviral (ART) therapy in adults with HIV, were published in HIV Clinical Trials.

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Fulyzaq is an antisecretory, antidiarrheal agent that was approved in December 2012. Fulyzaq works locally in the gastrointestinal tract and has minimal systemic absorption. It normalizes gastrointestinal water flow and relieves diarrhea caused by ART.

ADVENT, a randomized, double-blind, placebo-controlled trial, enrolled 374 adult HIV positive patients currently taking ART. Patients were randomized to receive either placebo or Fulyzaq 125mg delayed-release tablets. 

The primary endpoint of clinical response was achieved by 17.6% of patients receiving Fulyzaq compared to 8.0% of patients receiving placebo (P=0.01). Fulyzaq also demonstrated a safety profile comparable to placebo and did not negatively impact ART efficacy.

This study appears in the November/December issue of HIV Clinical Trials.

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