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Rectal Microbicide Development FDA Antiviral Advisory Committee 20 th August, 2003

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. Three Questions. Why develop rectal microbicides?

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Rectal Microbicide Development FDA Antiviral Advisory Committee 20 th August, 2003

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  1. Rectal Microbicide Development FDA Antiviral Advisory Committee20th 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. Screening for Phase1 rectal studies Are Phase1 rectal studies needed to support a vaginal microbicide NDA? Design of Phase1 rectal studies Vaginal Microbicide Pipeline

  7. Are Conventional Safety Studies Sufficient for Rectal Microbicides? CCR5 Expression

  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

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