1 Are Lubes Safe for Rectal Use? Next Steps for Researchers and Advocates Marc-André LeBlanc, Jim Pickett, Charlene Dezzutti, Edward Fuchs, Pamina Gorbach,

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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 2012Sydney, Australia

Mission: support development of safe, effective,

acceptable, and accessible

rectal microbicides for all that need them

1100+ advocates, scientists, funders,

policymakers from 6 continents – S.

America/Latin America and Africa more active

than ever!

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Mission: support development of safe, effective,

acceptable, and accessible

rectal microbicides for all that need them

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Microbicides 2010

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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.

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Studies conducted so far…• 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Microbicides 2006 poster (unpublished).• Fuchs EJ, et al.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.• 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. 2011 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. 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.

• 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 2012.

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What is IRMA doing?

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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

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• Data among women presented at AIDS2010

• Data from L. America• Qualitative data presented at

M2012

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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 10

50 researchers & advocates from around the world

Lube Safety Working Group

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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?

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oSafety of lubricants for rectal use: A fact sheet for HIV educators and advocates

oSafety of lubricants for rectal use: Questions & Answers for HIV educators and advocates

rectalmicrobicides.org

irma-rectalmicrobicides.blogspot.com

BASED ON CURRENT EVIDENCE:

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• 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

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• 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

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

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IRMA Steering Committee, and Lube Safety Working Group

What are others doing?

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WHO/UNFPA/FHI draft statement

• Female Condom Technical Review Committee requested recommendations

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The correct type of additional lubricant for male latex and female condoms can be

bulk procured with either male or female condoms, if justified by programmatic

requirements.

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

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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

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What next?

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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

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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 AGENDAPotential

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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 AGENDAPotential

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LUBE SAFETY RESEARCH AGENDAPotential

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?

Global Lube

Access Mobilizati

on (GLAM)

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… And Lube!

Thank you

• Marc-André LeBlanc• [email protected]• www.rectalmicrobicides.org

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