Crofelemer for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy

Abstract

Chronic diarrhea remains a common condition that affects people infected with human immunodeficiency virus (HIV) despite the widespread use of potent antiretroviral therapy. It is important that providers control this condition, as the persistence of diarrhea affects the quality of life of patients and may contribute to decreased adherence to antiretroviral therapy. Strategies to control diarrhea in patients with HIV infection include switching to a new antiretroviral regimen and/or the use of specific medications to control the diarrhea. This review aims to provide a concise evaluation of a newly approved medication (crofelemer) that has a novel mechanism of action and has received approval for the symptomatic relief of non-infectious diarrhea in adult patients with HIV on anti-retroviral therapy.

Keywords:

• AIDS
• crofelemer
• diarrhea
• HIV
• secretory diarrhea
• side effects antiretrovirals
• treatment diarrhea

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Chronic diarrhea remains a common and significant co-morbidity in people infected with HIV, even in patients with good virological and immunological response to antiretroviral therapy.

• In people with HIV infection, chronic diarrhea, regardless of its etiology, leads to a substantial negative impact in the quality of life and can contribute to decreased adherence to antiretroviral therapy (ART).

• In people with HIV infection on treatment with antiretrovirals, the most common cause of chronic diarrhea is ART-associated diarrhea.

• The management of ART-associated diarrhea includes the option to modify the ART regimen and or the use of specific anti-diarrheal medications.

• Crofelemer was approved by the FDA (125 mg twice a day) in 2012 for the symptomatic relief of non-infectious diarrhea in adult patients with HIV infection taking ART.

• Crofelemer has a novel mechanism of action acting directly in the intestinal luminal chloride channel. It has minimal systemic absorption, low incidence of adverse events and no known clinically significant drug–drug interactions.

• The tolerability of crofelemer is good (similar to placebo in the pivotal registration trials) and no changes in viral load or CD4⁺ counts have been observed in studied patients.