HIV and Enteropathy: What You Need to Know about Recent Research
Enteropathy is frequently found in association with several human disease conditions, including HIV infection, and is caused by pathological changes in the lining of the intestinal tract. Such changes disrupt the homeostasis of the GI tract that leads to symptoms of abdominal discomfort, bloating, and abnormal bowel function (e.g., urgency, diarrhea, constipation). A prolonged cycle of events can occur in patients with HIV-associated enteropathy, including altered gut microbiota, immune activation, gut barrier dysfunction, nutrient malabsorption. Enteropathy associated with HIV infection may be related to direct infection of enterocytes by HIV, opportunistic infections or other intestinal dysbiosis, or host response to highly active anti-retroviral therapy (HAART). Finally, even with the introduction of new protease inhibitors which cause less diarrhea, chronic loose and frequent stools are still under reported. Nearly 30% of all HIV+ patients experience daily episodes of diarrhea.1
HIV-associated enteropathy has long been associated with inflammatory damage, decreased barrier function, increased permeability and malabsorption of nutrients.2-3 Altered tryptophan catabolism to kynurenine and intestinal dysbiosis has also been demonstrated in HIV patients.4 It is well known that inflammation or other aberrant immune responses can lead to changes in intestinal structure and function5 and may play a central role in enteropathy. The complex etiology of HIV-associated enteropathy has been proven difficult to manage in some patients.
A recent, small, open-label clinical study shows that oral serum-derived bovine immunoglobulin/protein isolate (SBI) can help manage HIV-associated enteropathy and chronic loose and frequent stools. 6
Participants in the study experienced the following results:
• Increased CD4 + counts in the gut
• Management of GI symptoms
• Management of chronic loose and frequent stools
• Improved nutrient uptake
The study showed SBI (a main ingredient in the prescription-only medical food EnteraGam™) significantly increases intestinal mucosal CD4+ lymphocyte counts, improves duodenal function, and shows evidence of promoting intestinal repair in the setting of HIV-related chronic loose and frequent stools. Marked improvements in GI-related symptoms were seen in all patients within 3 weeks.
The clinical study was an 8-week, open-label study with a 40-week extension of oral serum-derived bovine immunoglobulin administered at a dosage of 2.5 g 2X/daily to 8 patients who had severe HIV-related chronic loose and frequent stools with approximately 5 to 6 watery stools per day.
Read the full clinical study.
Indications and Usage
EnteraGam is indicated for HIV-associated enteropathy including chronic loose or frequent stools. Important facts about EnteraGam™:
• Used only under physician supervision.
• A powder that is easy for patients to take; mixes with non-acidic soft foods and liquids.
• A medical food* regulated by the FDA under the Orphan Drug Act7.
• Provides distinct nutrients required in patients with enteropathy infected with HIV.
Important Safety Information
EnteraGam™ contains beef protein; therefore, patients who have an allergy to beef or any component of EnteraGam™ should not take this product. The most commonly reported adverse events in clinical studies (incidence of 2-5%) include mild nausea, constipation, stomach cramps, headache, and increased urination. Patients who are pregnant or nursing should not take EnteraGam™, as there are no data regarding the effects of serum-derived bovine immunoglobulin/protein isolate (SBI) in these populations.
*Medical foods are regulated by the FDA under the Orphan Drug Act7; specifically formulated to be consumed or administered orally or enterally; to be used under physician supervision (e.g., dispensed by prescription) as part of ongoing care to ensure proper, safe use; specifically for management of distinctive nutrient needs, resulting from a specific chronic condition or disease; and specifically formulated and processed, as results are not achievable by normal dietary intake.
1. Siddiqui U, Bini EJ, Chandarana K, et al. Prevalence and impact of diarrhea on health-related quality of life in HIV-infected patients in the era of highly active antiretroviral therapy. J Clin Gastroenterol. 2007;41484-90.
2. Bjarnason I, Sharpstone DR, Francis N, Marker A, Taylor C, Barrett M, et al. Intestinal inflammation, ileal structure and function in HIV. Aids. 1996;10(12):1385-91.
3. Sharpstone D, Neild P, Crane R, Taylor C, Hodgson C, Sherwood R, et al. Small intestinal transit, absorption, and permeability in patients with AIDS with and without diarrhoea. Gut. 1999;45(1):70-6.
4. Vujkovic-Cvijin I, Dunham RM, Iwai S, Maher MC, Albright RG, Broadhurst MJ, et al. Dysbiosis of the gut microbiota is associated with hiv disease progression and tryptophan catabolism. Science translational medicine. 2013;5(193):193ra91.
5. Peuhkuri K, Vapaatalo H, Korpela R. Even low-grade inflammation impacts on small intestinal function. World journal of gastroenterology : WJG. 2010;16(9):1057-62.
6. Asmuth DM, Ma Z-M, Albanese A, et al. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS. doi:10.1097/QAD.0b013e328362e54c.
7. Orphan Drug Act. FDA website http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/orphandrugact/default.htm. Accessed December 16, 2013.
This content funded and developed by Entera Health, Inc., makers of EnteraGamTM.