1 Are Lubes Safe for Rectal Use? Next Steps for Researchers and Advocates Marc-André LeBlanc, Jim Pickett, Charlene Dezzutti, Edward Fuchs, Pamina Gorbach, Jose Fernandez-Romero Microbicides 2012 Sydney, Australia

Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them advocates, scientists, funders, policymakers from 6 continents – S. America/Latin America and Africa more active than ever! 2

Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them 3

Microbicides IRMA: Research on Lubricant Safety Very Past Due "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."

Studies conducted so far… Some studies tested lubes in a laboratory to see if they killed HIV in vitro or enhanced HIV-1 replication in vitro. Some studies tested lubes on rectal tissue in mice to see if they were toxic, irritating or caused damage. Some studies 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. Only one study has tested the effect of lubes on rectal tissue in humans. Another study looked at the link between self-reported lube use during anal intercourse and testing positive for some rectal STIs. 5

Studies conducted so far… Sudol KM, Phillips DM. “Relative safety of sexual lubricants for rectal intercourse”, Sex Transm Dis Jun; 31: Sudol KM, Wallace R, Ford BE, Phillips DM. “Relative safety of OTC lubricants for rectal intercourse,” Microbicides 2006 poster (unpublished). Fuchs EJ, et al. “Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmission”, J Infect Dis Mar 1; 195(5): Begay O, et al. “Identification of Personal Lubricants That Can Cause Rectal Epithelial Cell Damage and Enhance HIV Type 1 Replication in Vitro,” AIDS Res Hum Retroviruses Mar 8; 27(00). Russo J, Dezzutti C, et al. “Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels,” Microbicides 2010 presentation (unpublished). Nguyen D, et al. “Preventing sexual transmission of HIV: anti-HIV bioregulatory and homeostatic components of commercial sexual lubricants,” J Biol Regul Homeost Agents Jul-Dec; 18(3-4): 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 Jul 20; 17(11): Russo J, Dezzutti C, et al. “Safety and Anti-HIV Activity of Over-the-Counter Lubricant Gels,” Microbicides 2010 presentation (unpublished) Gorbach P, et al. “The Slippery Slope: Lubricant Use and Rectal Sexually Transmitted Infections: A Newly Identified Risk”, Sex Transm Dis. Vol 39, Number 1, Jan

What is IRMA doing? 7

Lube survey (2007)… the gift that keeps on giving! General findings: – Presented in our 2008 report – Published in 2010 – Used to decide which lubes to test 8

Data among women presented at AIDS2010 Data from L. America Qualitative data presented at M Lube survey (2007)… the gift that keeps on giving!

compile all available research data on lube safety monitor research on an ongoing basis develop basic materials on lube safety for HIV educators and advocates conduct a series of global teleconferences to disseminate key messages establish contact with regulators and manufacturers identify areas for further research researchers & advocates from around the world Lube Safety Working Group

11 Challenge of Consensus (5 months later…) Lube Safety Working Group Interpreting and describing implications – Lab, clinical, behavioural studies? – Petri dishes, animals, humans? – Which assays are more important? – Nonoxynol-9 Messaging – “Naming names” – Condom use; non-condom users? Wording – “Safety” How does all of this translate into real world use and real world risk?

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

BASED ON CURRENT EVIDENCE: 13 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 IRMA Steering Committee, and Lube Safety Working Group

14 Condom-compatible lubes associated with decreased risk of condoms breaking, slipping Not possible at this time to recommend for/against using lubes if having AI without condoms 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

15 IRMA Steering Committee, and Lube Safety Working Group

What are others doing? 16

WHO/UNFPA/FHI draft statement Female Condom Technical Review Committee requested recommendations 17

WHO/UNFPA/FHI draft statement Specific recommendations related to: – osmolality – lubricants containing polyquaternary compounds – pH levels according to primary intended target population – lubricants containing spermicides, medicinal and other active substances 18

U.S. CDC Time-limited internal Lube Safety WG looking at data, making recommendations to CDC: – potential data collection – potential research gaps to address – potential review of existing content and need for new messaging Testing lubes in monkeys Strong emphasis on rectal but also looking at vaginal and penile tissue, HIV/STI transmission 19

What next? 20

Upcoming study results Updated lube data from Charlene Dezzutti – Glycerin-free, aqueous-based lubes U.S. CDC testing lubes rectally in monkeys Project AWARE (9 clinics across U.S.) – Info on lubes used rectally – Lube-incident STI association in MSM Douche/enema survey (global; 3,000 people) – Info on douches/enemas used/use patterns 21

22 Identify assays needed to assess a broader range of products including oil- and silicone-based lubes Encourage more lab testing of more products Take into account use patterns and product combination including adding water, saliva, vaginal fluid Use of lubes and douches/enemas Eventually lubes and RMs LUBE SAFETY RESEARCH AGENDA

23 Support clinical studies to expand data based on testing in humans Determine research required to evaluate HIV and STI risks Support new epi and socio-behavioural studies to assess lube use patterns and HIV/STI links LUBE SAFETY RESEARCH AGENDA

24 LUBE SAFETY RESEARCH AGENDA Research roadmap: How does all of this translate into real world use and real world risk? Identify NEW resources to achieve this In-person consultation?

25 … And Lube !

Thank you Marc-André LeBlanc 26