The U.S. Food and Drug Administration (FDA) has approved Fulyzaq (crofelemer), the first drug to relieve symptoms of the diarrhea that is a side effect of antiretrovirals (ARVs). Meant for people with HIV who are on ARVs and whose diarrhea is not caused by a virus, bacteria or parasite, the medication treats watery diarrhea resulting from electrolyte secretion and water in the gastrointestinal tract. The clinical trial that proved the safety and efficacy of Fulyzaq involved 374 HIV-positive participants on stable ARVs who had a history of diarrhea and experienced a median of 2.5 watery bowel movements each day. Among those who took the drug twice a day, 17.6 percent experienced two or fewer watery bowel movements each week while 8 percent of those taking a placebo reached this clinical benchmark. Common side effects included upper respiratory tract infection, bronchitis, cough, flatulence and increased levels of the liver enzyme bilirubin (which can cause jaundice).
Treatment: Fulyzaq Approved for Diarrhea Relief
March 21, 2013 • By Benjamin Ryan