Microbicides for hiv prevention

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Microbicides for hiv prevention

  1. 1. UNIVERSITY OF GONDAR COLLEGE OF MEDCINE & HEALTH SCIENCES SCHOOL OF BIOMEDICAL & LABORATORY SCIENCES DEPARTMENT OF MEDICAL MICROBIOLOGY TOPIC: Microbicide drug candidates: A New hope for HIV prevention By: Setegn Eshetie (1st year MSc student)
  2. 2. Outline Introduction Rationale for devt of microbicide Microbicide classification & features Stages in microbicide devt Current status of microbicide trials Challenges in microbicide devt Conclusion, recommendation, references, & acknowledgment
  3. 3. Introduction Burden of HIV/AIDS  Sub-Saharan Africa - 22.5 million people  South East Asia - 4.1 million people Women  Globally = 52 %  Sub-Saharan Africa= 60 %  Asia ,approximately 35 % (UNAID, 2008)
  4. 4. Vaccines Male and female condoms PrEP PEP Microbicides PMTCT HIV Prevention Cervical barriers: vaginal diaphragms Male circumcision Clean injecting equipment Voluntary counselling and testing Source: www.global-campaign.org.
  5. 5. Mechanism of spread Direct Indirect CD4 cells Dendiritic cells CD4 cells
  6. 6. Rationale for development of Microbicide  Insufficiency of other prevention methods  Acceptability issues  User initiated vs partner initiated  Maintains skin on skin intimacy  HIV infection is higher among women  Women failure to comply to the use of condoms
  7. 7. Microbicide, Classification & features  A substance that can reduce the transmission of HIV and other STI pathogens when applied topically to genital mucosal surfaces - vaginally and, possibly, rectally. available. They are not yet
  8. 8. Microbicide could be…  Contraceptive Vs non- contraceptive  Broad activity  Safe, stable, cheaper/available  Can applied vaginally/rectally  Can be utilized in HIV positive individuals  Effective cell free/cell associated virus
  9. 9. How microbicides work? Membrane disruptor • N-9 • C31G • SLS Milieu protector • Buffer gel • Acidform/lime juice • Probiotic agents Entry inhibitor • Attachment inhibitor • Fusion inhibitor After entry inhibitor • 1% tenofovir gel • TMC120. UC781 Unknown mechanism • Praneem • Saponin
  10. 10. 1. boosts vagina’s natural defenses - Buffergel 2. surfactants 4. anti-retrovirals 3. entry inhibitors = =Tenofovir, UC781, TMC120 CS, Carraguard, Pro2000 Source: Shattock, R.; Moore, J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol 1, October 2003.
  11. 11. Microbicide development • Toxicity • potency Preclinical evaluation Phase I • Safety • 25 – 40 peoples • Safety • efficacy • 200 – 400 Phase II Phase III • Efficacy • 3,000 – 10,000
  12. 12. Current status of clinical trials  Outcome trials Study trial Location Investigator Efficacy N-9 Kenya, Cameroon, Benin, SA, … Kreiss et al. Roddy et al. Van Damme et al Nil/↑risk Buffer gel SA, Malawi, Zambia.. Abdool Karimet al Nil 0.5% PRO 2000 SA, USA, … Abdool Karimet al 36% pre protocol analysis. 1% Tenofovir gel SA Abdool Karimet al 40% protective Source: www.avac.org.
  13. 13. Some of ongoing & planned trials Trial name Study pon/area Phase Expected completion IPM027 1650 women/SA, Rwanda III 2015 CAPRISA008 700 women/SA III 2015 MTN014 28 women/SA I 2014 CONRAD118 54 women/USA I Late 2013 Effects of Tenofovir on CAPRISA samples TBD Preclinical planned Zinc salt gel study TBD Preclinical planned Source: www.avac.org.
  14. 14. Challenges in Microbicide dev’t  Variation of vitro vs vivo efficacy  Lack of validated animal model  Absence of markers  Time, cost  Ethical issues  Need of large scale study
  15. 15. Conclusion  Microbicides are an option to prevent HIV  Various mechanism of microbicide activity  Marjory women based prevention strategies  Promising trial results like 1% tenofovir gel  Ethical, methodological & implementation challenges
  16. 16. Recommendation  Need of continuous effort for the promise to be realized Governmental institution Public institution Private sectors GAO like UNAIDS  need of continuous researches on this optimistic area
  17. 17. References  De Cock KM, Jaffe HW, Curran JW. The evolving epidemiology of HIV/AIDS. AIDS. 2012;26(10):1205-13.  Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS medicine. 2005;2(11):e298.  Young MR, Odoyo-June E, Nordstrom SK, Irwin TE, Ongong’a DO, Ochomo B, et al. Factors associated with uptake of infant male circumcision for HIV prevention in Western Kenya. Pediatrics. 2012;130(1):e175-e82.  And more!!!
  18. 18. Acknowledment  To Dr. Feleke Moges Mr. Yitayal Shiferaw Mr. Abate Assefa SBMLS, DMM
  19. 19. Thank you !!!

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