Transcript Are Lubes Safe for Rectal Use? Next Steps for Researchers and

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
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Mission: support
1100+
advocates,
development
of
scientists,
funders,
safe, effective,
policymakers
acceptable,from
and 6
continents
– S.
accessible
America/Latin
America
rectal microbicides
and
Africa
for all
thatmore
need active
them
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
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."
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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…
•
•
•
•
•
•
•
•
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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Microbicides 2006 poster (unpublished).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): 26874.
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
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Identified Risk”, Sex Transm Dis. Vol 39, Number 1, Jan 2012.
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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Lube survey (2007)…
the gift that keeps on giving!
• Data among women presented at
AIDS2010
• Data from L. America
• Qualitative data presented at
M2012
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Lube Safety Working Group
50 researchers & advocates
from around the world
• 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
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• identify areas for further research
Lube Safety Working Group
Challenge of Consensus (5 months later…)
• 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?
How does all of this
translate into real
world use and real
world risk?
• Wording
– “Safety”
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irma-rectalmicrobicides.blogspot.com
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
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BASED ON CURRENT EVIDENCE:
•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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BASED ON CURRENT EVIDENCE:
•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
IRMA Steering Committee, and Lube Safety Working Group
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IRMA Steering Committee, and Lube Safety Working Group
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What are others doing?
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WHO/UNFPA/FHI draft statement
• Female Condom Technical Review Committee
requested recommendations
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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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LUBE SAFETY RESEARCH AGENDA
 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
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LUBE SAFETY RESEARCH AGENDA
 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
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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?
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… And Lube!
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Thank you
• Marc-André LeBlanc
• [email protected]
• www.rectalmicrobicides.org
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