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Bio-K+ ® to improve health of HIV patients on HAART A safe and effective solution

Bio-K+ ® to improve health of HIV patients on HAART A safe and effective solution. 6 th IAS conference on hiv pathogenesis, treatment and prevention NAPWA Treatment Horizons Satellite Symposium July, 17-20 2011; Rome, Italy Mathieu Millette , Ph.D.

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Bio-K+ ® to improve health of HIV patients on HAART A safe and effective solution

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  1. Bio-K+® to improve health of HIV patients on HAARTA safe and effective solution 6th IAS conference on hiv pathogenesis, treatment and prevention NAPWA Treatment Horizons Satellite Symposium July, 17-20 2011; Rome, Italy Mathieu Millette, Ph.D. Director of fundamental research, Bio-K Plus International inc Invited professor, INRS-Institut Armand-Frappier 2011

  2. Bacterial diarrhea in HIV-infected patients Sanchez et al. 2005. Bacterialdiarrhea in personswith HIV infection, United States, 1992-2002. Clin. Infect. Dis. 41:1621-1627.

  3. HIV enteropathy • 50% HIV-infected patients develop GI symptoms and almost 100% present GI complications • Diarrhea •  Intestinal permeability • Malabsorption • Villous atrophy • Abdominal pain • Weight loss • Dysphagia • Odynophagia • Opportunistic GI infections by: • Protozoans (Cryptosporidium, Giardia, Isospora...) • Fungi (Cryptococcus, Candida, Histoplasma,...) • Bacteria (Mycobacterium avium-intracellulare, Salmonella, Shigella, Clostridium difficile,...) • Virus (Cytomegalovirus, Herpesvirus) Montessori et al. 2004. CMAJ. 170(2):229-238. Bhaijeeet al. 2011. Humanimmunodeficiency virus-associatedgastrointestinaldisease: commonendoscopicbiopsy diagnoses. Patholog. Res. Int. 2011:247923

  4. HIV-associated insult to GI tract integrity Brenchley and Douek. 2008. HIV infection and the gastrointestinal immune response. Muc. Immunol. 1:23-30

  5. Bio-K+® treating GI SAEs in HIV-infected patients 1- Hummelenet al. 2010. Altered host-microbe interaction in HIV: a target for intervention with pro- and prebiotics. Int. Rev. Immunol. 29:485-513.

  6. Bio-K+®probiotic formula Probiotics are strains of bacteria that have beneficial effects on the gut flora, facilitating the growth of friendly bacteria and diminishing harmful bacteria • Lactobacillus acidophilus CL1285® + L. caseiLBC80R® • Fermented liquid product • Minimum of 50×109 CFU guaranteed for 140 days (refrigerated) • Capsules • Minimum of 50×109 CFU guaranteed for 2 years (refrigerated) • Enteric coating

  7. Summary of Bio-K+® clinical trials in GI pathologies

  8. Results of clinicalstudieswith Bio-K+® Dose-responseefficacy of Bio-K+® on AAD and CDAD incidence1 Incidence DACD (%) 65% 95% AAD incidence (%) CDAD incidence (%) Placebo 1 capsule 50B 2 capsules 50B Placebo 1 capsule 50B 2 capsules 50B 1- Gaoet al. 2010. Am J Gastroenterol. 105 (7): 1636-1641. 2- Wolvers et al. 2010. Guidance for substantiating the evidence for beneficial effects of probiotics: Prevention and management of infections by probiotics. J. Nutr. 140: 698-712.

  9. Clinicalstudieswith Bio-K+® Dose responseefficacy of Bio-K+® on AAD duration and GI symptoms 56% reduction in AAD duration (with 2 capsules) Reduction of GI symptoms (commonlyassociated to IBS) AAD duration (days) Placebo 1 capsule 50B 2 capsules 50B 1- Gaoet al. 2010. Am. J. Gastroenterol. 105 (7): 1636-1641.

  10. Pierre-Le Gardeur Hospitalexperience 7 years of Clostridium difficile infection prevention in a community hospital – Role of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus caseiLBC80R Maziade PJ, Andriessen A, Gagné D, Murray G, Jacob C, Pereira P and Méthot L. Protocol: Hospitalization + Antibiotics • CDI cases =  73% • Severe CDI cases =  94% • Mortality rate =  91% • Recurrent CDI =  39% Bio-K+® Maziadeet al. 2011. Submitted to Infect. Control Hosp. Epidemiol.

  11. Evolution of CDI incidence Pierre-Le Gardeur Hospital CDI/10,000 patient-days Maziadeet al. 2011. Submitted to Infect. Control Hosp. Epidemiol.

  12. Enhancing pharmacology of ARVs using evidence-based probiotics • HIV mediated loss of Th17 cells from GALT during acute infection4 • Impairs mucosal integrity and innate defense mechanisms • Microbial translocation correlates with chronic immune hyperactivation • Maintaining a healthy GALT may be key to reducing pathogenic potential of HIV due to compromised flora and subsequent barrier disruption resulting in elevation in inflammation

  13. Conclusion Intervention with therapeutic probiotics HIV\AIDS of drug absorption and  drug resistance  diarrhea and GI side-effects and other SAEs compliance to HAART

  14. Protocol synopsis X HIV-infected patients X on ART + Imodium + Placebo X on ART + Imodium + Bio-K+® • Outcomes •  diarrhea and SAEs •  OIs • Stabilization of CD4 • Suppression of viral load • Improvements of micronutrients level •  adherence and persistence to HAART • DEXA + BIA • Inclusion • Confirmed HIV infection • HIV-related anemia • PCP, thrush, vaginosis, vaginitis • Anal dysplasia • Hairy leucopenia

  15. References • Anukam, KC., Osazuwa, E., Osadolar, H., Bruce, A., Reid, G. Yogurt Containing Probiotic Lactobacillus rhamnosus GR-1and L. reuteri RC-14 Helps Resolve Moderate Diarrhea and Increases CD4 Counts in HIV Patients. Journal of Clinical Gastroenterology. March 2008; 42(3). • Trois, L., Cardoso, E., Mirua, E. Use of Probiotics in HIV-infected Children: A Randomized Double-blind Controlled Study. Journal of Tropical Pediatrics. 2008; 54(1). • Saavedra, JM., Tschernia, A. Human studies with probiotics and prebiotics: clinical implications. British Journal of Nutrition. 2002; 87. • Hofer, U., Speck, R. Disturbance of the gut-associated lymphoid tissue is associated with disease progression in chronic HIV infection. Semimars in Immunopathology. 2007; 31(2).

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