Update on Lubricant Safety & Rectal Microbicide Research/Advocacy

1. Update on Lubricant Safety & Rectal Microbicide Research/Advocacy CDC – TRIP – January 19, 2011 Jim PickettAIDS Foundation of Chicago - Director of Prevention Advocacy and Gay Men’s Health - IRMA Chair

2. In our time together… • Lube safety • What do/don’t we know? • What do we need to know? • How do we make sense of it all? • And how do we get there? • Snapshot – rectal microbicide research and advocacy

3. International Rectal Microbicide Advocates

4. Who is IRMA? • Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them • 1000+ advocates, scientists, funders, policymakers from 6 continents – S. America/Latin America and Nigeria chapters

5. IRMA, b.2005 4 people, 4 agencies, 2 countries

7. rectalmicrobicides.org Global context

8. Lubricants used for anal sex

9. IRMA lube survey • Why? • Encourage researchers to conduct more research on lubricant safety • 100’s of lubricants • Which are most widely used? • Other behaviors and practices rectalmicrobicides.org

10. IRMA lube survey • Internet-based • Survey Monkey with e-promotion • Ran 29 weeks in 2007 • 6 languages (EN/FR/SP/POR/GER/TUR) • 8,945 Responses from 107 countries • 6,273 reported AI within the past 6 months (70.1%) • 911 women, • 428 AI in past 6 mos. • Analysis by UCLA rectalmicrobicides.org

12. IRMA lube survey

13. IRMA lube survey • Well over 100 different lubes used • 15 most commonly named, alpha • Astroglide (all types including original) • Crisco, Durex • Elbow Grease, Gun Oil • ID (all types, including Glide and Millennium) • K-Y (all types), Liquid Silk, Pjur Eros • Probe, spit/saliva, Swiss Navy • Trojan, Vaseline • Wet (all types, including Wet original and Wet Platinum)

14. IRMA lube survey • Low condom use, but lube use relatively common • High acceptability of RMs as lubes? • No flavour, colour or smell • Consistency: Both thick and liquid • Base: both water and silicone • Take into account saliva, water and vaginal fluid

15. Lube safety – Welcome to Caveat City

16. Microbicides 2010 "Some lubes are probably better than others, but we don't know where any of the currently available products fall along the spectrum from good to bad. While we push for a safe and effective rectal microbicide, we must ensure that existing lubes don't facilitate HIV transmission. People have a right to this kind of information, and it's very past due." IRMA: Research on Lubricant Safety Very Past Due

17. The bottom line:More research is urgently needed to explore if there is a link between lube use and acquiring hiv and /or rectal stis IRMA Steering Committee, and Lube Safety Working Group

18. Unclear whether any particular type or brand of lube might increase, decrease, have no effect on acquiring HIV and/or rectal STIs • Using male or female condoms still considered best way to prevent acquiring HIV and STIs during AI Based on current evidence: IRMA Steering Committee, and Lube Safety Working Group

19. Condom-compatible lubesassociated with decreased risk of condoms breaking,slipping • Not possible at this time to recommend for/against using lubes if having AI w/ocondoms • Lube use on its own not proven method of HIV or STI prevention Based on current evidence: IRMA Steering Committee, and Lube Safety Working Group

20. Some level of inflammation occurs naturally in rectum, even w/o digestive or GI problems • AI itself, enemas, douching, cause temporary damage • Most of this damage repairs itself within minutes/hrs WE NEED TO CONSIDER: IRMA Steering Committee, and Lube Safety Working Group

21. Because normal levels inflammation and cell damage occur naturally, we need to compare • Levels of inflammation and damage that are result of AI alone, without lubes • Levels of inflammation and damage that are a result of AI alone, with lubes WE NEED TO COmpare: IRMA Steering Committee, and Lube Safety Working Group

22. A sample of the science

23. The science • Some studiestested lubes on rectal tissue in mice to see if they were toxic, irritating or caused damage. • Sudol KM, Phillips DM. “Relative safety of sexual lubricants for rectal intercourse”, Sex Transm Dis. 2004 Jun; 31:346-9. • Sudol KM, Wallace R, Ford BE, Phillips DM. “Relative safety of OTC lubricants for rectal intercourse,” Microbicides 2006 poster (unpublished). Short answer – yes, for most lubes

24. The science • Only one study has tested the effect of lubes on rectal tissue in humans • Fuchs EJ, et al. “Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmission”, J Infect Dis. 2007 Mar 1; 195(5): 703-10. • Single rectal application of a hyperosmolar lube can cause damage to the rectal tissue

25. The science

26. The science

27. The science

28. The science

29. The science

30. The science • Some studiestested lubes in a laboratory to see if they killed HIV in vitro. • Begay O, et al. “Preliminary evaluation of toxicity and antiviral properties of personal lubricants,” Microbicides 2010 poster (unpublished) • Russo J, Dezzutti C, et al. “Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels,” Microbicides 2010 presentation (unpublished). • Nguyen D, Lee H, Poast J, Cloyd MW, Baron S. “Preventing sexual transmission of HIV: anti-HIV bioregulatory and homeostatic components of commercial sexual lubricants,” J BiolRegulHomeost Agents. 2004 Jul-Dec; 18(3-4): 268-74. • Baron S, Poast J, Nguyen D, Cloyd MW. “Practical prevention of vaginal and rectal transmission of HIV by adapting the oral defense: use of commercial lubricants,” AIDS Res Hum Retroviruses. 2001 Jul 20; 17(11): 997-1002.

31. The science [Begay O, et al. “Preliminary evaluation of toxicity and antiviral properties of personal lubricants,” Microbicides 2010 poster (unpublished)] • A total of 41 lubricants were examined, compared to Gynol II® and Carraguard® as positive and negative controls for toxicity, respectively • Evaluated the in vitro toxicity, anti-HIV-1 activity, osmolality of popular lubes • Most of the lubricants were found to be hyperosmolar

32. The science [Begay O, et al. “Preliminary evaluation of toxicity and antiviral properties of personal lubricants,” Microbicides 2010 poster (unpublished)] • Most commercial lubricants had little/no antiviral activity against 2 laboratory strains of HIV-1 (CCR5 and CXCR4 viruses) • Four Astroglide lubricants (Astroglide® Liquid, Astroglide® Warming Liquid, Astroglide® Glycerin & Paraben-Free Liquid, Astroglide® Silken Secret™) enhanced HIV-1 infection in vitro • More rigorous safety testing may need to be performed on these products

33. The science • Some studies have used human tissue (taken from the vagina or rectum) and tested lubes in vitro to see if they were toxic, irritating or caused damage to the tissue • Russo J, Dezzutti C, et al. “Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels,” Microbicides 2010 presentation (unpublished)

34. The science [Russo J, Dezzutti C, et al. “Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels,” Microbicides 2010 presentation (unpublished)] • KY Jelly is toxic to lactobacilli • Elbow Grease, ID Glide, and KY Jelly have similar toxicity profiles for cells, cell lines, and tissues • Astroglide is most toxic • PRÉ and Wet Platinum appear safest • None of the lubricants have anti-HIV activity

35. The science • Another study looked at link between the use of lubes during AI and some sexually transmitted infections (STIs) in rectum • Gorbach PM, et al. “Rectal lubricant use and risk of rectal STIs,” Microbicides 2010 presentation (unpublished).

36. The science [Gorbach PM, et al. “Rectal lubricant use and risk of rectal STIs,” Microbicides 2010 presentation (unpublished)] • Women, men in two U.S. cities asked about lube use during AI, tested for STIs - gonorrhea and chlamydia • Lube use during AI in past mo. = more likely to test positive for rectal STI than those who reported not using lubes during AI— condoms used or not • Strong association between using lube and having a rectal STI – but… • Not designed to show if timing of lube use/acquiring rectal STI coincided • Not designed to show whether lubes caused the higher rate of rectal STIs • Didn’t indicate specific lubes used

37. The science [Gorbach PM, et al. “Rectal lubricant use and risk of rectal STIs,” Microbicides 2010 presentation (unpublished)] Frequency of Lube Use in Past Month n=380

38. The science – what’s on tap • FC2 data – unpublished – Dezzutti • Does the FC2 lube effect tissue viability? NO • Does the FC2 lube impact the epithelium? • Evaluate permeability of stratified epitheilium NO • Tissue histology NO • Does the FC2 lube have anti-HIV activity? NO • Gorbach – more analysis of existing lubricant data and new Project AWARE lube sub-study (part of a 9 U.S. clinic study on STDs) • Douche/enema data

39. Regulation

40. Regulation

41. Regulation IRMA Lube Safety Working Group

42. Regulation IRMA Lube Safety Working Group

43. Regulation IRMA Lube Safety Working Group

44. Regulation IRMA Lube Safety Working Group

45. Regulation – lack of clarity moment #1 IRMA Lube Safety Working Group

46. Lack of clarity moment #2 IRMA Lube Safety Working Group

47. What is IRMA doing?

48. What is IRMA doing? • Urge researchers to test lubes for rectal safety and to share findings • Facilitate dialogue leading researchers/advocates in Lube Safety Working Group (wanna join?) • Compile articles, studies, maintain background document

49. What is IRMA doing? • Make IRMA’s list of most widely-used lubes available to anyone interested in testing lubes • Monitor how regulatory agencies in various countries address lube safety • Engage with lube manufacturers • Keep IRMA membership updated

50. irma-rectalmicrobicides.blogspot.com • Safety of lubricants for rectal use: • A fact sheet for HIV educators and advocates • Safety of lubricants for rectal use: Questions & Answers for HIV educators and advocates rectalmicrobicides.org