0
Saudi – Belgian Collaboration in Health:
Improving Quality of Care: Methodology and Prevention
Tuesday, March 18, 2014
Cer...
2
FerlayJ, et al.GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide. IARC CancerBaseNo.10. Lyon, France. 2010
Every 2...
 Incidence of cervical cancer is low in Saudi Arabia
(2:100,000)
 Every year, 152 women are diagnosed with cervical canc...
The Nobel Prize in Physiology or Medicine 2008
Harald Zur Hausen for his discovery of human Papilloma
viruses causing cerv...
HPV18- Related
45, 39, 59, 51, 56
HPV16- Related
31, 33, 35, 52, 58
NatureVolume: 2012
Author No of patients HPV prevalence
Gazzaz 2007 100 5 (5%)
Bondoggi 2013 485 27 (5.6 %)
1-Ann Saudi Med. 2007 Jan-Feb;27(...
Secondary
Prevention:
Screening
Primary
Prevention:
Vaccination
Normal
Cervix
HPV
Infection
Cervical
Dysplasia
Cervical
Ca...
HPV
Cervical canal
Neutralizing antibodies
Blood vessel
Epithelial tear
Basement membrane
Cervical
epithelium
Stanley M. V...
Cervarix is a registered trade mark of the GlaxoSmithKline group of companies.
Cervarix ®
Antigen
Specificity of the immun...
Gardasil ® Merck
Gardasil ®
Adjuvant
Substances that potentiate the immune
response to antigen
(Al(OH)3)
Manufactured in r...
 Sustained high Antibodies for up to
9.7 years.
Reducing the
leep
procedure
from CIN2+.
Long term is
reduction in
cancer cervix
incidence.
Harper D; Expert Review Vaccines 2009
Gardasil(Merck)
Quadrivalent
Cervarix (GSK)
Bivalent
HPV 45
(related to 18)
V/P 3/2 V/P 1/17
Reduction 94%
HPV 31
(related...
No head-head efficacy studies were carried out – those
comparisons are only informative
Gardasil®
Combined protocols Futur...
 The vaccines do not contain any living virus.
 More than 79 million doses of the quadrivalent
vaccine have been distrib...
 Phase I/II study
 2-dose schedules of the Cervarix and Gardasil were
immunogenic and generally well-tolerated in girls ...
Joura et al. Eurogin Nov 2013
Nonavalent vaccine (Merck)
(HPV6/11/16/18/31/33/45/52/58)
Followed for 4.5 years
Similar imm...
Implementation
After given them an education material
about HPV and vaccination , 381/500
(76.2%) were happy with the introduction
of HP...
 A total of 85/200 (42.2%) will take the vaccine them
selves
 A total of 100/200 (50%) physicians will recommend
the vac...
Education and Awareness
If HPV vaccine will be implemented in
Saudi Arabia , it should be as part of
the MOH routine vacci...
Secondary
Prevention:
Screening
Primary
Prevention:
Vaccination
Normal
Cervix
HPV
Infection
Cervical
Dysplasia
Cervical
Ca...
PAP smear
HPV testing
 Very sensitive
 Hybrid Capture
(HC2)
 No national Screening
 If no action taken: The estimated number of
new cervical cancer cases and deaths in 2025
triple ...
 Proposal
 HPV testing HC2 (high risk)
 Data base with recalling system
 Quality assurance and frequent monitoring
Dr. Nisrin Anfinan
Early Detective Unit and
JCSP Coordinator
Rowaida Al Mehy
GOU Secretary
Maribi Marqueses
GOU Office Ass...
 Age 30-65 year.
 Married for three years.
 Saudi & non Saudi.
 Jeddah Cervical Screening program
JCSP
 www.jcsp.sa.com
HR-HPV DNA in women 30 + years old
Negative
Pap test
Negative Positive
Positive
Colposcopy
Positive
Repeat HR-DNA
testing ...
Campaign (Malls)
School
(approval from ministry of education)
Media and news papers
BasalamaSCGC Channel
http://www.youtube.com/user/BasalamaSCGC
Collecting sample at PHC
Collecting sample in our
hospital
 START DATE: January 2012
 Total Number: 4000
 Our aim to achieve : 10,000 in four years
0
50
100
150
200
250
300
350
400
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
138
210
260
344
294
144
38
78
254
292
390...
0
50
100
150
200
250
300
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
102
138 134
264
224
112
18
30
108
216
254 254
36
...
0
100
200
300
400
500
600
30-34 35-39 40-44 45-49 50-54 55-59 60-64 ≥65
302
416
522
576
512
322
122
34
Per Age GroupYear 2...
National
Cervical
Screening
Program
 Guideline meeting for cervical cancer
screening
‫المركز‬‫السعودي‬‫للرعايه‬‫الصحيه‬‫المبنيه‬‫على‬‫البراهين‬.
 Agreed amo...
Official opening of the JCSP program January
2014
Affects young
women and their
families
Al though not common
in KSA, incidence will
rise as it has done in
other areas
Scre...
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
Khalid sait saudi  belgium seminal march 18 2014
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Transcript of "Khalid sait saudi belgium seminal march 18 2014"

  1. 1. Saudi – Belgian Collaboration in Health: Improving Quality of Care: Methodology and Prevention Tuesday, March 18, 2014 Cervical Cancer Prevention in Saudi Arabia Prof. Khalid Sait Chairman of Scientific Chair of Prof. Abdullah Hussain Basalamah for Gynecological Cancer
  2. 2. 2 FerlayJ, et al.GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide. IARC CancerBaseNo.10. Lyon, France. 2010 Every 2 minutes a woman dies of cervical cancer.1 Every minute a woman is diagnosed with cervical cancer.1 New cases per year: ~ 530,000 Deaths per year: ~ 275,000 NA + Europe Africa Asia Latina 29,000 53,000 31,000 159,000 77,000 80,000 68,000 312,000 80% in developing countries = 2nd cause of cancer death in women
  3. 3.  Incidence of cervical cancer is low in Saudi Arabia (2:100,000)  Every year, 152 women are diagnosed with cervical cancer and 55 die from the disease. SCR Report 2009
  4. 4. The Nobel Prize in Physiology or Medicine 2008 Harald Zur Hausen for his discovery of human Papilloma viruses causing cervical cancer
  5. 5. HPV18- Related 45, 39, 59, 51, 56 HPV16- Related 31, 33, 35, 52, 58
  6. 6. NatureVolume: 2012
  7. 7. Author No of patients HPV prevalence Gazzaz 2007 100 5 (5%) Bondoggi 2013 485 27 (5.6 %) 1-Ann Saudi Med. 2007 Jan-Feb;27(1):1-5. 2- Saudi Med J. 2007 Dec;28(12) 3-Ann Saudi Med. 2013 Jan-Feb;33
  8. 8. Secondary Prevention: Screening Primary Prevention: Vaccination Normal Cervix HPV Infection Cervical Dysplasia Cervical Cancer
  9. 9. HPV Cervical canal Neutralizing antibodies Blood vessel Epithelial tear Basement membrane Cervical epithelium Stanley M. Vaccine 2006; 24:S16–S22; Giannini S, et al. Vaccine 2006; 24:5937–5949; Nardelli-Haefliger D, et al. J Natl Cancer Inst 2003; 95:1128–1137; Poncelet S, et al. IPvC 2007; Abstract.
  10. 10. Cervarix is a registered trade mark of the GlaxoSmithKline group of companies. Cervarix ® Antigen Specificity of the immune response Adjuvant Substances that potentiate the immune response to antigen Through MPL, AS04 Adjuvant System utilizes natural ‘danger’ signals AS04 Adjuvant System Aluminium salt + MPL (Al(OH)3) Giannini SL, et al. Vaccine 2006; 24:5937–5949. 20 µg L1 HPV 16 20 µg L1 HPV 18 + Manufactured in insect vector
  11. 11. Gardasil ® Merck Gardasil ® Adjuvant Substances that potentiate the immune response to antigen (Al(OH)3) Manufactured in recombinant Saccharomyces Cerevisiae (yeast) 40 µg L1 HPV 16 + 20 µg L1 HPV 6 40 µg L1 HPV 11 20 µg L1 HPV 18 Antigen Specificity of the immune response
  12. 12.  Sustained high Antibodies for up to 9.7 years.
  13. 13. Reducing the leep procedure from CIN2+. Long term is reduction in cancer cervix incidence.
  14. 14. Harper D; Expert Review Vaccines 2009
  15. 15. Gardasil(Merck) Quadrivalent Cervarix (GSK) Bivalent HPV 45 (related to 18) V/P 3/2 V/P 1/17 Reduction 94% HPV 31 (related to 16) V/P 5/21 Reduction 76% V/P 14/30 Reduction 54%
  16. 16. No head-head efficacy studies were carried out – those comparisons are only informative Gardasil® Combined protocols Future I, FutureII R-MITT-2 cohort (EOS* data)1 Lesion Gardasil® Control %Efficacy (95% CI)N n N n CIN2+, irrespective of causal HPV type 4616 77 4680 136 42.7 (23.7;57.3) CIN3+, irrespective of causal HPV type 4616 36 4680 64 43.0 (13.0;63.2)* Cervarix® Protocol 008 TVC-naïve cohort (48 months of FU)2 Cervarix® Control %Efficacy (95% CI)N n N n 5466 61 5452 172 64.9 (52.7;74.2) 5466 3 5452 44 93.2 (78.9;98.7) * for Gardasil® the endpoint was CIN3 N = number of evaluable women in each group; n = number of evaluable women reporting at least one event in each group; - : not available; Bold = statistically significant. * The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years after receipt of dose 1 and maximum of 4.9 years. 1. Munoz et al. J Natl Cancer Inst 2010; 102:1–15; 2. HPV-008 Month 48 analysis.
  17. 17.  The vaccines do not contain any living virus.  More than 79 million doses of the quadrivalent vaccine have been distributed globally, with no serious adverse events found to be associated with the vaccine and with no greater risk of adverse events than with placebo.  Approximately 7 million doses of the bivalent vaccine have been distributed worldwide. GARDASIL Product Monograph. Merck Canada Inc. August 2011. CERVARIX Product Monograph. GlaxoSmithKline Inc. August 2011. Data on file, Merck Canada Inc.
  18. 18.  Phase I/II study  2-dose schedules of the Cervarix and Gardasil were immunogenic and generally well-tolerated in girls aged 9–25  A 2-dose schedule may be more convenient for physicians and vaccinees, could facilitate implementation of HPV vaccination and may help optimise compliance in school- based immunisation programmes
  19. 19. Joura et al. Eurogin Nov 2013 Nonavalent vaccine (Merck) (HPV6/11/16/18/31/33/45/52/58) Followed for 4.5 years Similar immunological responses
  20. 20. Implementation
  21. 21. After given them an education material about HPV and vaccination , 381/500 (76.2%) were happy with the introduction of HPV vaccine to our community Sait , Saudi Med J. 2009
  22. 22.  A total of 85/200 (42.2%) will take the vaccine them selves  A total of 100/200 (50%) physicians will recommend the vaccine to their patients.  94 /200 (47%) will recommend HPV vaccine to there daughter Sait , Saudi Med J. 2011
  23. 23. Education and Awareness If HPV vaccine will be implemented in Saudi Arabia , it should be as part of the MOH routine vaccination program for all risk group Currently HPV vaccine in KSA is been given mostly for educated people and those whom can afforded it. (may be low risk group).
  24. 24. Secondary Prevention: Screening Primary Prevention: Vaccination Normal Cervix HPV Infection Cervical Dysplasia Cervical Cancer
  25. 25. PAP smear HPV testing
  26. 26.  Very sensitive  Hybrid Capture (HC2)
  27. 27.  No national Screening  If no action taken: The estimated number of new cervical cancer cases and deaths in 2025 triple (309 and 117, respectively) http://www.nationmaster.com/country/ sa-saudi-arabia/Age- _distribution
  28. 28.  Proposal  HPV testing HC2 (high risk)  Data base with recalling system  Quality assurance and frequent monitoring
  29. 29. Dr. Nisrin Anfinan Early Detective Unit and JCSP Coordinator Rowaida Al Mehy GOU Secretary Maribi Marqueses GOU Office Assistant Dr. Faten Gazzaz Director of Virology Laboratory Eman Tayba JCSP Laboratory Team Aseel Alsobehi JCSP Laboratory Team Soheel Melebari JCSP Laboratory Team Prof. Jim Bentley International Advisor Prof. Khalid Sait Director of Scientific Chair of Professor Abdullah Hussain Basalamah Prof. Abdullah Hussain Basalamah General Advisor Amal Al Montasheri Nurse JCSP Reem Qubaidi Health Educator
  30. 30.  Age 30-65 year.  Married for three years.  Saudi & non Saudi.
  31. 31.  Jeddah Cervical Screening program JCSP  www.jcsp.sa.com
  32. 32. HR-HPV DNA in women 30 + years old Negative Pap test Negative Positive Positive Colposcopy Positive Repeat HR-DNA testing @ 5 year intervals till age 65 Repeat HR- HPV testing at 12 months Negative
  33. 33. Campaign (Malls) School (approval from ministry of education) Media and news papers
  34. 34. BasalamaSCGC Channel http://www.youtube.com/user/BasalamaSCGC
  35. 35. Collecting sample at PHC Collecting sample in our hospital
  36. 36.  START DATE: January 2012  Total Number: 4000  Our aim to achieve : 10,000 in four years
  37. 37. 0 50 100 150 200 250 300 350 400 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 138 210 260 344 294 144 38 78 254 292 390 364 New Registration for Year 2012-2013
  38. 38. 0 50 100 150 200 250 300 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 102 138 134 264 224 112 18 30 108 216 254 254 36 72 126 80 62 32 20 48 146 76 136 148 New Registration forYear 2012-2013 Saudi vs. Non-Saudi Saudi Non-Saudi
  39. 39. 0 100 200 300 400 500 600 30-34 35-39 40-44 45-49 50-54 55-59 60-64 ≥65 302 416 522 576 512 322 122 34 Per Age GroupYear 2012-2013
  40. 40. National Cervical Screening Program
  41. 41.  Guideline meeting for cervical cancer screening ‫المركز‬‫السعودي‬‫للرعايه‬‫الصحيه‬‫المبنيه‬‫على‬‫البراهين‬.  Agreed among panel members that HPV testing will be used as primary screening for cervical cancer in Saudi Arabia.
  42. 42. Official opening of the JCSP program January 2014
  43. 43. Affects young women and their families Al though not common in KSA, incidence will rise as it has done in other areas Screening Program
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