At the end of December 2012, the FDA approved the first medication (crofelemer/Fulyzaq) to relieve the symptoms of diarrhea in people who are taking HIV medications. Many people who take HIV meds experience diarrhea, which can lead to some stopping or switching their meds.
The approval stems from the FDA review of the ADVENT study of 374 HIV-positive individuals who took either crofelemer or a placebo to treat watery diarrhea lasting a month or more. None of the diarrhea in the study participants was due to an infectious agent or other gastrointestinal disease.
Study results showed that 17.6% of those who took crofelemer had improved diarrheal conditions, compared to 8.0% on placebo. This improvement was defined as two or fewer watery bowel movements per week for at least 2 out of 4 weeks per month. In some people, this anti-diarrheal effect continued for up to 20 weeks.
Crofelemer was safe and well-tolerated, while only 2% of participants had serious side effects. No one stopped the study. Common side effects included cough, flatulence, upper respiratory infections, bronchitis and increased bilirubin levels.
With this approval, crofelemer should be used in people with HIV whose watery diarrhea is not caused by bacteria, viruses or parasites. Before prescribing the drug for patients, doctors should rule out that the diarrhea is not caused by an infection or other gastrointestinal disease.
The drug is believed to work by stopping chloride from getting into the gut, which results in higher amounts of water loss. The drug is taken twice a day to manage watery diarrhea.
Read the product label for crofelemer here.
Read the FDA press release here.