Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach Alfred Shihata, MD.
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Transcript of Preventing Pregnancy and STIs/HIV, by Novel and Unique Approach Alfred Shihata, MD.
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 Lessonsfrom 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 MicrobicideDelivery 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
Facts1. 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 non-allergenic materials
February 7, 2007 (Revised)US Principal Investigator: Ariane van der Straten, PhD, MPHWomen’s Global Health ImperativeDepartment of Obstetrics, Gynecology and Reproductive SciencesUniversity of California, San Francisco
Zimbabwe Principal Investigator: Michael Chirenje, MD, MRCOG, FRCOGUniversity of Zimbabwe: University of California, San FranciscoCollaborative Programme in Women’s Health
Feasibility and acceptability of cervical barriers (CB) among vulnerable youth:in Africa, A pilot study in Zimbabwe
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
FemCap
In SummaryThis dual strategy of FemCap/Microibicide can potentially achieve the three critical goals:
1. Prevent HIV transmission2. STI infections3. Prevent Pregnancy
HIV
PREGNANCY STI