1	Rectal Microbicide Development FDA Antiviral Advisory Committee 20^th August, 2003 Ian McGowan M.D., Ph.D. Center for HIV & Digestive Diseases at David Geffen School of Medicine, UCLA
2	Three Questions Why develop rectal microbicides? What are the challenges in rectal microbicide development? What is the current status of rectal microbicide development?
3	Why Develop Rectal Microbicides? Anal intercourse (AI) is the primary risk factor for HIV transmission among MSM. The prevalence of AI among the heterosexual population is underappreciated and represents a significant risk for HIV transmission. Much AI is unprotected. The rectal mucosa is highly vulnerable to HIV infection. Based on the N-9 experience, vaginal products may not be suitable for rectal administration.
4	Prevalence of Anal Receptive Sex
5	What are the Challenges in Rectal Microbicide Development? Creating awareness that rectal microbicide development is needed Development strategy not defined Vaginal products Rectal products Combination Rectal & vaginal products Safety evaluation of candidate rectal microbicides not established
6	Vaginal Microbicide Pipeline
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8	What is the Current Status of Rectal Microbicide Development? N-9 has been shown to be unsafe as a rectal microbicide Carraguard™ did not induce epithelial damage No Phase 1 microbicide studies are currently planned
9	Summary There is an urgent need to develop rectal microbicides for the MSM population Anal intercourse is an underappreciated risk factor for HIV transmission in heterosexuals Vaginal microbicides need to be evaluated in the rectal compartment prior to NDA approval. Rectal microbicides require an appropriate preclinical and clinical development track