Transcript FemCap
Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach Alfred Shihata, MD Current Problems • No Cure • No Vaccine • Condom is not an option for many women • So far Microbicides, have failed The Condom Microbicides • Kill the HIV virus in the in-vitro • So far microbicides are not proven to be effective in the vagina • N-9 and Cellulose sulfate increased the HIV transmission when compared to placebo • Pro-2000,Buffergel,and Carragaurd were safe but not effective Valuable Lessons from the Microbicides clinical trials We must not forget… • Anatomy • Physiology • Immunology of the cervix and the vagina Anatomy and Physiology of the Vagina Immunology Unlike all other viruses, the HIV virus attacks and destroys the immune cells. Therefore the more immune cells at the cervix, the higher the risk for HIV transmission. Microbicides irritate the cervix and provoke an immune response Objectives for STI/ HIV prevention by this new dual strategy • It must be woman-controlled, and coitally independent. • To kill the HIV virus before it enters the cervical or vaginal cells. • To shield the cervix and vagina from HIV invasion and microbicide irritation. • Eliminate or minimize contact of the HIV virus to the genital mucous membrane . • To prevent pregnancy. Microbicides still hold the best promise for HIV prevention The FemCap is designed to enhance the safety and efficacy of microbicides Criteria for the ideal Microbicide Should be gentle enough not to irritate the cervix or provoke an immune response It should be strong enough to kill the STIs and HIV microorganisms It should NOT disrupt the vaginal ecosystem. Stronger is not better The FemCap prevents sperm and STI/HIV from entering the cervix The FemCap’s Microbicide Delivery System Mimics Test Tube Condition This unique delivery system is facing the vaginal opening to protect the cervix. Uterus (Womb) The FemCap covering the cervix Vagina The FemCap effectively protects the cervix and prevents sperm, bacteria and viruses from entering the cervix New Delivery System FemCap FemCap with Microbicide & Gentian Violet Healthy Cervix and Vagina FemCap + Microbicide / Gentian Violet dye left in situ for 6 hours Microbicide / Gentian Violet dye in the FemCap Delivery System Cervix and Vagina after removal of FemCap Result, No stain was visible over the cervix Facts 1. HIV virus is very fragile in-vitro. 2. The cervix is the main portal of entry to the HIV virus. 3. Thus far all Microbicides have failed 4. Microbicides applied by applicator or diaphragm may elicit an immune response and disrupt the vaginal ecology. 5. Many people do not accept the condom due to interruption of spontaneity and reduced sexual sensations. FemCap • The FemCap does not interrupt spontaneity or reduce sexual pleasure to both partners. • It is a fit and forget for 48 hours. • It is woman-controlled and coitally independent. • It is re-usable for one-two years, and does not pose any environmental hazards • It is FDA approved, inexpensive and made of nonallergenic materials Feasibility and acceptability of cervical barriers (CB) among vulnerable youth: in Africa, A pilot study in Zimbabwe FemCap CB Practice Results (n=45) (n=16) Inserted properly at first attempt (%) 81.3 Removed properly (%) 93.8 Liked the device she tried (%) 87.5 February 7, 2007 (Revised) US Principal Investigator: Ariane van der Straten, PhD, MPH Women’s Global Health Imperative Department of Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco Zimbabwe Principal Investigator: Michael Chirenje, MD, MRCOG, FRCOG University of Zimbabwe: University of California, San Francisco Collaborative Programme in Women’s Health In Summary This dual strategy of FemCap/Microibicide can potentially achieve the three critical goals: 1. Prevent HIV transmission 2. STI infections 3. Prevent Pregnancy PREGNANCY HIV STI