Long-term usage of crofelemer, a drug that relieves noninfectious diarrhea symptoms in patients with HIV, was well-tolerated and produced few adverse events in a recent study.
Long-term usage of Crofelemer, a drug that relieves noninfectious diarrhea symptoms in patients with HIV, was well-tolerated and produced few adverse events in a recent study.
These findings were presented by Trevor Hawkins, MD, from the Southwest CARE Center in Santa Fe, NM, and colleagues on October 5, 2013, at IDWeek 2013, a joint meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS), in San Francisco, CA.
According to the authors, noninfectious diarrhea is experienced by up to 28% of patients undergoing antiretroviral therapy (ART). The condition is caused by the dysregulation of electrolytes and water in the gastrointestinal lumen. Crofelemer is minimally absorbed, as a previous study showed it was undetectable in the bloodstream in more than 99% of HIV patients who took an oral dose. According to co-author Patrick Clay, PharmD, from the University of North Texas College of Pharmacy, the lack of crofelemer absorption means that it does not interfere with ART drug absorption or alter liver metabolism.
A previous 24-week double-blind placebo-controlled trial showed that two 125 mg doses per day of crofelemer significantly reduced diarrhea in HIV patients receiving ART compared to placebo and had a similar rate of adverse events as placebo. The present open-label study investigated whether these same trends were maintained with 48 weeks of treatment.
Two-hundred fifty HIV-positive patients taking ART with noninfectious diarrhea that required anti-diarrheal medication were given 250 mg crofelemer twice per day for 48 weeks. They were periodically monitored for treatment effectiveness, adverse reactions, and changes in HIV disease status. About 74% of the patients used an additional anti-diarrheal medication as well as the study drug. Drug efficacy was measured by assessing the frequency of watery stools and stool consistency.
The drug was effective in approximately three-quarters of the patients, with less than four percent reporting increasing or recurrent diarrhea. About 76% of patients experienced at least one adverse event, the most common being upper respiratory tract infections and intestinal parasitic infections. However, most of the events were mild or moderate in severity and were likely unrelated to the crofelemer, according to Clay. Constipation was the most common side effect potentially related to the drug and tended to occur in patients who were taking an additional anti-diarrheal medication. According to Clay, these patients may have overcompensated with their medication. However, no deaths occurred during the treatment period and the 8% of serious adverse effects were believed to be unrelated to the drug.
HIV status, as indicated by HIV RNA and CD4 cell count, remained unchanged throughout the treatment, indicating patients were able to maintain their ART regimen and the crofelemer did not interfere with ART, according to the authors.
All authors listed financial disclosures.