This document discusses cervical cancer prevention strategies in Lesotho. It provides an overview of international conventions on cervical cancer and Lesotho's response. Key points include high rates of cervical cancer in Lesotho compared to other Southern African countries. Prevention strategies discussed include HPV vaccination, screening programs like VIA and Pap smears, and education initiatives targeting policymakers, health workers, and communities. Human papillomavirus (HPV) is identified as the cause of most cervical cancer cases worldwide.
Cancer Awareness - Kaplan University Dept. of Public Healthsmtibor
Cancer awareness, including general definitions, detection, prevention, treatment, and risk factors. Emphasis on skin and prostate cancers and at-risk populations.
Workshop
Pamela Oiler -‐ National Coalition for Cancer Survivorship, National Association of Social Workers, and Oncology Nursing Society Social Work, University of Wyoming Family Residency Program ABSTRACT: This is an introduction to the Cancer Survivor Toolbox which teaches professionals to care for cancer survivors in a geographically, culturally, and socio-‐economically sensitive manner. Upon completion of this course, participants will be aware of the entire scope of the cancer experience and have comprehensive resource information both for themselves and
Cancer Awareness - Kaplan University Dept. of Public Healthsmtibor
Cancer awareness, including general definitions, detection, prevention, treatment, and risk factors. Emphasis on skin and prostate cancers and at-risk populations.
Workshop
Pamela Oiler -‐ National Coalition for Cancer Survivorship, National Association of Social Workers, and Oncology Nursing Society Social Work, University of Wyoming Family Residency Program ABSTRACT: This is an introduction to the Cancer Survivor Toolbox which teaches professionals to care for cancer survivors in a geographically, culturally, and socio-‐economically sensitive manner. Upon completion of this course, participants will be aware of the entire scope of the cancer experience and have comprehensive resource information both for themselves and
Different types of diseases and infections have always threatened man.However, one disease that is considered almost deadly and has a very high rate of recurrence is cancer.Know more by visiting https://www.plus100years.com
World Cancer Day, established by the Union for International Cancer Control (UICC) in 2000, is observed every year on February 4th. Over 10 million people die each year from cancer, more than HIV/AIDS, malaria, and tuberculosis combined. This makes cancer a leading cause of death with a global impact; cancer is not specific to any one geographic region or any one demographic. Cancer can affect anyone of any age, but we are moving towards extraordinary medical breakthroughs in the fight against cancer...
South Carolina Childhood Cancer Research Lab PresentationGoing Places, Inc
Childhood Cancer Research at theMedical University of South CarolinaSeptember 12, 2014 Jacqueline M Kraveka, D.O.Associate ProfessorDirector, Pediatric Oncology Research LaboratoryDepartment of PediatricsDivision of Hematology-Oncology
Medooc is a search engine for researching medical information.It has been built by medical
professionals to help others in the community to research and share credible health information.
Doctors, Physcials and medical professionals participate in Medooc.com on day to day basis to help
each other.
For more information you can visit:-http://www.medooc.com/
Different types of diseases and infections have always threatened man.However, one disease that is considered almost deadly and has a very high rate of recurrence is cancer.Know more by visiting https://www.plus100years.com
World Cancer Day, established by the Union for International Cancer Control (UICC) in 2000, is observed every year on February 4th. Over 10 million people die each year from cancer, more than HIV/AIDS, malaria, and tuberculosis combined. This makes cancer a leading cause of death with a global impact; cancer is not specific to any one geographic region or any one demographic. Cancer can affect anyone of any age, but we are moving towards extraordinary medical breakthroughs in the fight against cancer...
South Carolina Childhood Cancer Research Lab PresentationGoing Places, Inc
Childhood Cancer Research at theMedical University of South CarolinaSeptember 12, 2014 Jacqueline M Kraveka, D.O.Associate ProfessorDirector, Pediatric Oncology Research LaboratoryDepartment of PediatricsDivision of Hematology-Oncology
Medooc is a search engine for researching medical information.It has been built by medical
professionals to help others in the community to research and share credible health information.
Doctors, Physcials and medical professionals participate in Medooc.com on day to day basis to help
each other.
For more information you can visit:-http://www.medooc.com/
a presentation that helps to educate us about the rising incidence of cancer in our environment. it also tells us about the silent nature of some cancers, which at the point of diagnosis is in the late stages
Best Practices in Cancer Survivorship and Supportive CareAkinAkinsanya
"Early detection, better diagnostic tools, and more effective treatments are resulting in long-term cancer survivorship, with 62% of adults and 77% of pediatric cancer patients now living more than 5 years beyond their initial diagnosis.
While survival rates are rising…according to the National Cancer Institute there are nearly 12 million cancer survivors in the United States. The hurdle now facing many cancer survivors is how to achieve long-term quality of life after treatment has ended. According to the National Action Plan for Cancer Survivorship, fully one-third of survivors say they experience ongoing physical, psychological, or financial consequences of their cancer diagnosis and treatment.
Recognizing the need for a comprehensive approach to long-term survivorship care, many academic medical centers, community hospitals and oncologists in private practices are developing survivorship care programs to manage the ongoing care of their patients. In planning survivorship services, however, we need to delineate survivorship from other periods of care, so we take a pragmatic approach and define survivorship as the period in which patients treated with curative intent have completed their initial therapy and require follow-up care.”
This lecture is about cervical cancer or cancer of the cervix. This malignancy is very common among women in the Philippines. Treatments may consist of radiation, surgery, chemotherapy or a combination modality. Prevention may be achieved by vaccination.
What Black Women Need to Know About Endometrial Cancerbkling
Dr. Kemi Doll, gynecologic oncologist at the University of Washington Medical Center, shares her passion for improving the lives of black women affected by this disease through her extensive research and knowledge about endometrial cancer.
This webinar is being put on in partnership with ECANA.
Downloadable slides highlighting key concepts in colorectal cancer screening and appropriate therapy selection and application in the adjuvant setting and beyond.
SICKELE CELL DISEASE MANAGEMENT INITIATIVE FOR LESOTHOSEJOJO PHAAROE
Sickle cell disease (SCD) is highly prevalent in sub-Saharan Africa, including Lesotho where it accounts for substantial morbidity and mortality. SCD is a life-threatening genetic disorder that is best managed when diagnosed early by newborn screening. The incidence and cases are not reported in Lesotho. Newborn screening which is paramount for early diagnosis and enrolment of affected children into a comprehensive care programme is not available in Lesotho. Up to now, this strategy has been greatly impaired in resource-poor countries, because screening methods are technologically and financially intensive; affordable, reliable, and accurate methods are needed. We aimed to test the feasibility of implementing a sickle cell disease screening programme using innovative point-of-care test devices into existing immunization programmes in primary health-care settings.
Goal; increase sickle cell disease awareness, diagnosis and management in Lesotho from 0- 20% by 25%
Mission: To improve care of all Sickle Cell Disease patients for their better future and to lower the prevalence of the disease through multi=sectoral, multi-faced coordinated approach towards screening and awareness strategies
Vision: Eliminate sickle cell disease as a public health problem in Lesotho. There is need for increasing the awareness about the disease in the community, implementation of mass screening activities for early identification, building a strong network of diagnosis and linkages, implementing robust monitoring system, strengthening the existing primary health care mechanism to incorporate SCD related strategies, capacity building of primary, secondary and tertiary health care teams and building cost-effective intensive interventions at higher care facilities.
SICKELE CELL DISEASE MODULE 3 SEJOJO.pptx TO BE PRESENTED. IN TRAININGS.pptxSEJOJO PHAAROE
Sickle cell anemia is a genetic disorder whereby red blood cells are abnormally shaped, causing problems with the flow of blood through the body as well as transport of oxygen throughout the body
inheritance is Autosomal because its a blood disorder and systemic disorder
its caused by mutation on B-chain of the globulin chain , where red blood cells (RBCs) become sickle/crescent shaped
Cells get destroyed in narrowed thin blood capillaries , RE system and cause anaemia Blockage in thin layers body
OVEARVIEW OF NON-COMMUNICABLE DISEASES IN LEOTHO SEJOJO PHAAROE
Chronic non infectious diseases that are silent and persecute mankind . non-communicable disease (NCD) is a disease that is not transmissible directly from one person to another. NCDs include Parkinson's disease, autoimmune diseases, strokes, heart diseases, cancers, diabetes, chronic kidney disease, osteoarthritis, osteoporosis, Alzheimer's disease, cataracts, and other
Demands for Haemophilia tratment centres to fullfull universal health access...SEJOJO PHAAROE
Haemophilia ia a rare disease that affect 1: 10 000 people. Demands for services, medication and access to cheap effective clotting factors is a human right for people living with haemophilia. A haemophilia registry is a demand from the Government at large .. Essential drug list should also contain haemophilia medication.
we need to be contacted for more information
www.thinktankent.com
resilience is the order of the day when life knocks you down
If you have been experiencing some of the following signs and symptoms most of the day, nearly every day, for at least two weeks, you may be suffering from depression:
Persistent sad, anxious, or “empty” mood
Feelings of hopelessness, or pessimism
Irritability
Feelings of guilt, worthlessness, or helplessness
Loss of interest or pleasure in hobbies and activities
Decreased energy or fatigue
Moving or talking more slowly
Feeling restless or having trouble sitting still
Difficulty concentrating, remembering, or making decisions
Difficulty sleeping, early-morning awakening, or oversleeping
Appetite and/or weight changes
Thoughts of death or suicide, or suicide attempts
Aches or pains, headaches, cramps, or digestive problems without a clear physical cause and/or that do not ease even with treatment
pump up your energy
www.thinktankent.com
info@thinktankent.com
‘Freedom from pain should be seen as a right of every cancer patient and access to pain therapy as a measure of respect for the right in Lesotho
There are several barriers to effective pain control in both A focus on essential pain medicationaccessibility and Pain management cancer and / or HIV/AIDS. Such barriers could be patient related; clinician-related; societal/health system; and political and/or legal-related.
The role of the government in strengthening accreditation readySEJOJO PHAAROE
June 9, 2015 marks World Accreditation Day as a global initiative, jointly established by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), to raise awareness of the importance of accreditation.
This year’s theme focuses on how accreditation can support the delivery of health and social care.
the day was celebrated across the world with the hosting of major national events, seminars, and press and media coverage, to communicate the value of accreditation to Government, Regulators and the leaders of the business community.
What international support for quality improvement is available to Lesotho national health care initiatives?
• To what extent do national governments around the world specify quality improvement in legislation and published policy?
• What are the distinguishing structures and activities of national approaches to quality improvement within countries?
• What resources (in the form of organizations, funding, training and information) are available nationally?
What maintenance or implementation pathways are available , to prove to the world that Lesotho health care services are of excellence???
Vector borne infectious diseases in the face of climate changeSEJOJO PHAAROE
To understand how climate might affect the incidence of vector-borne diseases, one must first examine the life cycles of the diseases and the environmental parameters associated with each stage
A vector-borne disease is one in which the pathogenic microorganism is transmitted from an infected individual to another individual by an arthropod or other agent, sometimes with other animals serving as intermediary hosts.
The transmission depends upon the attributes and requirements of at least three different living organisms:
- the pathologic agent,
-the vector, and the human host.
intermediary hosts such as domesticated and/or wild animals often serve as a reservoir for the pathogen until susceptible human populations are exposed
We recommend proactive planning
more surveillance of direct impacts, such as changes in the reproduction rate of the vector or the agent, the biting frequency of the vector, and the amount of time the host is exposed to the vector due to changes in temperature, rainfall, humidity, or storm patterns.
Even less information is available to evaluate the impacts of societal and individual activities on the transmission of vector-borne diseases.
Changes in hydrology, agriculture, forestry, and infrastructure in response to global warming may also indirectly affect the interrelationship among the disease agent, vectors, and hosts
Ist Think Tank Entreprenuers Forum in Lesotho ( invitation , call for papers ...SEJOJO PHAAROE
In front of the current main disruptive changes the world is facing, entrepreneurship, creating both wealth and social justice, is key for shaping the world.
It embraces the regionality of the entrepreneurial ecosystem
•Business Entrepreneurs
•Social Entrepreneurs
•Philosophers
•Policy Makers
•Experts
•Academics
•Youth empowerment
•Research scientists
•Health professionals
It is altogether a Think Tank and a Do Tank
•We will share the latest trends and issues about global entrepreneurship.
•We will develop ideas and recommendations aimed at promoting and spreading entrepreneurship regionally .
•We will facilitate and implement entrepreneurial initiatives on a local or global scale
•By Creating Innovative and High-Growth Companies, to generate millions of jobs around the planet;
•Developing Entrepreneurship at the Bottom of the Pyramid, to alleviate poverty and create new markets;
•Implementing Entrepreneurial Education, to disseminate entrepreneurial mindset, skills and competencies throughout society, on a lifelong basis
WE ARE CALLING FOR PAPERS, AND USE THE REGISTRATION FORM ATTACHED FOR YOUR TRAVEL , AND LEETES OF RELEASE AND ACCOMODATION
Post exposure prophylaxis- HEALTH SECTOR WELLNESS SERVICES SEJOJO PHAAROE
HIV and HIV transmission
Indicators for PEP
Pre—requisite for PEP
-baseline and follow up tests
Pre-requisite for PEP Provision
PEP package
ARV- Treatment and adherence
Formative study on hiv workplace for health workers - copySEJOJO PHAAROE
Heterogeneity of the HIV epidemic in Lesotho
Formative Assessment: MOHSW
SECTORAL RESPONSE -MOHSW
ACTIONS TAKEN AND TOOLS AVAILABLE - TO DATE
DISSEMINATION- tools
ADVOCACY FOR BUY IN- - PPP
WELLNESS CHAMPIONS AND STRUCTURES
ADVOCACY-WELLNESS ACTIVITIES
M/E Tools
Cost benefit analysis
Learning and sharing
Action Research : Sejojo Phaaroe
3D MEDIA
Overview of medical laboratory regulatory council, objectives 2013SEJOJO PHAAROE
There is an urgent need for professional regulation in the region , because of staff mobilty, and professional demands and aspirations for continous professional development and harmony in ethical practices. Lesotho Medical Regulatory Council is advocated , and this will operate within the Legal Framework of the Health Professional Council
Innovative Medicines Initiative, Call for Proposal 2013 for Health , Pharmacueticals, Nursing , and Laboratory Medicines in Lesotho- EU Horizon 2020 and FP7 Funding
General intro-presentation-of-2013-call-orientations en sejojo disseminate
HPV vaccination importance in Lesotho
1. Preventing Cervical Cancer
in Lesotho
Sejojo Phaaroe
Principal Biomedical Scientist, and a
Cytologist of International Academy of Cytology- # 6467
Health Research & Laboratory Services
Cytopathology unit – Lesotho
2. Learning out come
• Learn and share: comprehensive review
of international conventions on cervical
cancer prevention & Lesotho ‘ s response
• Cervical Cancer Prevention strategies
• Aetiology of cervical cancer
development and role of HPV
• HPV What is it ?
• HPV VACCINE – Gardasil , What is it?
• EPI challenges:
3. There is no need for you to catch the ball if you
do not know where the goal is
-
4. Comprehensive review of international
conventions on RH cancers
IUAC ( International union Against Cancer)
IUCR ( International Union on Cancer Research )
IAC (International Academy of Cytology)
WHO (2002) -
…AU ( Maputo SRH declaration)
…SADAC
…Lesotho Road map ( Maternal Mortality SRHR)
WHO, 2002
AFROX declaration (2007)
5. 1- WHO/ MOHSW – sponsor a baseline
study CACX 2006
2. Lesotho RH Cancer Screening Guidelines
3. Implementation of prevention guidelines
Gardasil ACCESS : 2009 Pilloting Leribe and
9. • •Lesotho strategy: Involve policymakers
(parliamentarians).
• • Financial resources for new technologies (i.e., HPV
DNA testing at point of care, vaccine).
• • Training and education.
• • Screening—VIA/cytology/DNA/colposcopy (pilot
studies and full-scale HPV Vaccine rollout).
11. Distribution Of Common Cancer Between the Sexes
IN Southern Africa to include Lesotho
Males Females
Lung Cervical
Prostate Breast
Stomach Lung
Liver Stomach
Colorectal Colorectal
Oesophagus
12. Cancer definition
Cancer is a neoplastic
proliferation of abnormal
cells, invading
surrounding tissue and
giving distance metastases
Cancer of the cervix is the
neoplastic proliferation of
cells and tissues in the
breast
Abnormal proliferation
starts with the genetic
aberration in a single cell
genetic material, which
grows and give a clone of
abnormal cells
A number of factors
contribute into the
cellular disturbance (
later )
13. Signs and symptoms/ clinical presentation
• Early signs:
• Abnormal vaginal bleeding which could be
• Intermenstrual
• Post coital bleeding
• Post menopausal bleeding
• Watery offensive vaginal discharge
• The cervix is friable , hard with contact bleeding
on examination( the dysplastic cells have poor
cohesiveness, so the underlining vascular system
in the lamina propriae become exposed.)
14. Late signs
• Pain
• Dyspareuria(pain during intercourse)
• Urinary symptoms: frequency in urination
• Dysurea
• Hematuria
• Vesico-vaginal and or recto-vaginal fistula
• Anaemia, Cachexia
• Bone pain, due to metastases
15. Cervical Cancer Worldwide
Disease Burden
• 2nd most common cancer in women worldwide
• Number one cause of cancer-related deaths in
women in the developing world
• Annual disease burden
– 493,000 cases
– 273,500 deaths
• 80% of cervical cancer cases in the developing world
22. Lesotho Disease Burden
• QEII data
– 1April2006 – 31March2007
– 680 cervical cancer referrals
– If 25-33% of population seek out treatment at the national referral
hospital then 2000-2800 women may have late stage disease in
Lesotho
• Leribe and Mohale’s Hoek Referrals*
– 1Jan2005 – 31March2006
– Retrospective analysis of cytology and hystology archives
– Age Standardized Incidence Rate (ASIR) 66.7:100,000 women
23. Cervical Cancer by Age
90% of cervical cancer cases were in women over age 39
27. Correlation of ASIR rates in Southern Africa
COUNTRY ASIR Sited Publication
South Africa 32.1 : 100 000 Freddy Sitas et al
1993
Mali 21.0 : 100 000 Bayo et al 1990
Uganda 43.6 : 100 000 Wabbinga et al 1993
Gambia 13 : 100 000 Bah 1990
Senegal 9 : 100 000 Bah et al 1988
Lesotho 66.7 : 100 000 S. Phaaroe et al 2007
Senegal & Gambia are Moslem areas
( Low in Gambia)
Zimbabwe 67:100 000 ( Dr Cronje – Oncology specialist : Sebeta
Memorial Lecture LMA AGM 8/7/06
28. Prevention Strategies
Education , BCC, condom distribution ,
and awareness campaigns
PAP smear screening
HPV DNA testing
Direct Visual Inspection
Acetic acid –VIA
VIAM
HPV vaccine- CAMPAIGN
29.
30. S. Phaaroe
National stake holders C.T(IAC), MIBMS
M.T
PSBH- REPORT Boston
Education/Information-Magnitude of cancer
University 2005
Well women
groups/ church/
Gyaenacology,
women in Law,
Oncology,
every body,
Radiology,
Support groups/
Pharmacy etc
men leagues
Chiefs, local
government,
FAMILY H, ED, CYTOPATHOLOGY village councils,
PLANNING & BIOMEDICAL NETWORKS
Men’s clinics, SCIENCE
private clinics RESEARCH LAB
linkage with is the central Technology
LBCN NGO’S in a health organ INCUBATION
system CENTRES,
SMME’s , Joined
Bilateral
LEGAL EMPLOYMENT commissions/
Education , agreements
Academic centers SYSTEMS, Policy FORCE/
of excellence & makers, Government
other Research International Institutions
institutions conventions, Insurance Levy,
Regional Businesses &
strategies Industry
31. Etiological factors behind cancer of the
Cervix .Hormonal contraceptives
• women -Early coitus /preparations like depo
[Stern et al 1977]
• Multiparious women
• STI’s- infection, etc.
• Multisexual partners
• Viral HIV,
• It varies with race [genetic 81% ?
susceptibility ,etc] • Viral HPV,
• High in low socio-economic stata • Viral H Herpes
•
[malnutrition,poor health facilities] Smoking [TARR/hetero]
• Poor hygiene[smegma factor] • Alcohol drinking
• Sperm factor[acridine histones] • Drugs (Diethylstilbestrol-
• Women with boyfriends with CA. DES),cyclophosphamide
penis • Pelvic irradiation.
• History of cancer from other
sites e.g uterus, colon.
32. Human Papillomavirus (HPV) and the Vaccine
•
• HPV is the most common sexually transmitted infection
• DNA VIRUS
• Causes 99% of cervical cancer cases worldwide
• 100 different types of HPV, 40 types affect the genital tract
• Types 16 & 18 cause 80% of cervical cancer cases
33.
34. Disease Burden
HPV types 6, 11, 16, & 18
HPV Type Approximate Disease Burden
70% of cervical cancer, AIS, CIN 3,
16 and 18 VIN 2/3, and VaIN 2/3 cases
50% of CIN 2 cases
35%–50% of all CIN 1, VIN 1,
6, 11, 16, and 18 and VaIN 1 cases
90% of genital warts cases
35. GARDASIL® (Quadrivalent Human Papillomavirus [HPV Types 6, 11, 16, 18] Recombinant Vaccine)
Classification of Histological Findings
CIN 1 CIN 2
CIN 1 (mild (moderate CIN 3 Invasive
CIN1 Normal (condyloma) dysplasia) dysplasia) (severe dysplasia/CIS) Cancer
Histology of
squamous
cervical
epithelium1
Basal cell
Basal membrane
CIN caused by HPV can clear without treatment; however, rates of
regression are dependent on grade of CIN.
36. Screening for cervical cancer
Dr. George N. Papanicolaou, who devised the "Pap" smear test for cancer,
examines a slide in his laboratory in 1958. NOVA, PBS
42. GARDASIL® (Quadrivalent Human Papillomavirus [HPV Types 6, 11, 16, 18] Recombinant Vaccine)
Cervical Transformation Zone
• Area of metaplasia at
squamocolumnar junction
• ~99% of HPV-related
genital cancers arise within
the transformation zone.
• The Pap test obtains cells
from the transformation
zone for cytology
screening.
1. Castle PE. J Low Genit Tract Dis. 2004;8:224–230. 2. American Cancer Society. Prevention and early detection. Pap test.
July 2006; Available at; http://www.cancer.org/docroot/PED/content/PED_2_3X_Pap_Test.asp?sitearea=PED
43. GARDASIL® (Quadrivalent Human Papillomavirus [HPV Types 6, 11, 16, 18] Recombinant Vaccine)
Appearance of the Normal Cervix
on VIAM
1. Sellors JW, Sankaranarayanan R, eds. Lyon, France: International Agency for Research on Cancer; 2003. Reprinted
from Colposcopy and Treatment of Cervical Intraepithelial Neoplasia. A Beginner’s Manual with permission of the
International Agency for Research on Cancer, World Health Organization.
45. GARDASIL® (Quadrivalent Human Papillomavirus [HPV Types 6, 11, 16, 18] Recombinant Vaccine)
Invasive Cervical Carcinoma
From IARC, 2003.1
46. Interpretation
• Pick up age for HPV _>19 -44 yrs
• Pick up age for other specific infections= ->19-44
• Peak age for CIN1= 20-39 yrs
• Peak age CIN2 = 30-49 yrs
• Peak age for CIN3= 35-44 yrs
• Pick up for invasive cancer= 30- 59 CYTOLOGICALLY
• Peak age for confirmed invasive cancer = 40-59 yrs
• Risk of women developing cancer= (36:4610)
• Risk = 1: 128 women
• ASIR: 66,7 : 100 000
49. HPV Type Prevalence Worldwide
Clifford GM, Smith JS, Plummer M, Munoz N, Franceschi S. Human papillomavirus types in invasive
cervical cancer worldwide: a meta-analysis. Br J Cancer. 2003;88: 63-73.
50. High prevalence of HPV 16 in South African women with cancer of the cervix and
cervical intraepithelial neoplasia
• Cervical cancer biopsies 82% contained type 16 and 10%
type 18
• 56.6% of CIN (cervical intraepithelial neoplaysia) lesions
contained type 16
Kay P, Soeter R, Nevin J, Denny L, et al. High prevalence of HPV 16 in South African
women with cancer of the cervix and cervical intraepithelial neoplasia. J Medical
Virology 2003;71:265-273.
51. Gardasil®
• Non-infectious, recombinant, quadrivalent vaccine
• Prepared from highly purified virus-like particles (VLPs) of the major capsid protein
(L1) protein
• Contains no DNA
• Protects against HPV types 6, 11, 16 & 18
• Three separate IM injections
– 1st dose: at elected date
– 2nd dose: 2 months after the 1st dose
– 3rd doses: 6 months after the 1st dose
52. Gardasil® Registration
• Registered in more than 100 countries
• U.S., all 27 member countries of the European Union, Mexico, Australia,
Taiwan, Canada, New Zealand, and Brazil
• U.S. FDA approval in June 2006
• Africa registration: South Africa, Togo, Chad, Uganda
• when we first stated vaccinating , 26 million doses distributed worldwide
• 11 million doses distributed in the U.S.
53. Clinical Trials
• FUTURE I & FUTURE II studies
• Phase III, prospective, double-blind, placebo
controlled trials in 29 countries
• Females ages 15 - 26
54. GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
GARDASIL Is Efficacious Against HPV 16– and
18–Related CIN 2/3 or AIS
GARDASIL Placebo
60
53
50
40 n=8,460
Related Cases
30
100%
20 Efficacy
10
n=8,487
0
0
CIN 2/3 or AIS
16- to 26-year-old females naïve to the relevant vaccine HPV type at enrollment and through
30 days Postdose 3
Over a period of 2 to 4 years
Analysis included Protocol 005.
CIN = cervical intraepithelial neoplasia; AIS = adenocarcinoma in situ. 54
55. GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
GARDASIL Is Efficacious Against
HPV 6/11/16/18–Related VIN and VaIN
GARDASIL Placebo
12
10
10
8
Related Cases
n=7,741
6
100%
4 Efficacy
2
n=7,769
0
0
VIN 2/3 or VaIN 2/3
16- to 26-year-old females naïve to the relevant vaccine HPV type at enrollment and through
30 days Postdose 3
Over a period of 2 to 4 years
VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia.
Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA
19486-0004. Please specify information package 20651717(3)-GRD. 55
56. GARDASIL® (Quadrivalent Human Papillomavirus [HPV Types 6, 11, 16, 18] Recombinant Vaccine)
HPV and Anogenital Warts
HPV 6 and 11 responsible
for >90% of anogenital warts
Infectivity >75%
Treatment can be painful and
embarrassing.4
Topical and surgical
therapies are available for
genital warts
Recurrence rates vary
greatly.
1. Jansen KU, Shaw AR. Annu Rev Med. 2004;55:319–331. 2. Soper DE. In: Berek JS, ed. Novak’s Gynecology. 13th ed.
Philadelphia, Pa: Lippincott Williams & Wilkins; 2002:453–470. 3. Lacey CJN. J Clin Virol. 2005;32(suppl):S82–S90. 4. Maw
RD, Reitano M, Roy M. Int J STD AIDS. 1998;9:571–578. 5. Kodner CM, Nasraty S. Am Fam Physician. 2004;70:2335–2342. 56
58. HPV Clearance
In a study of 608 college women,
70% of new HPV infections cleared within 1 year
and 91% within 2 years.
Median duration of infection = 8 months
Certain HPV types are more likely to persist (eg,
HPV 16 and HPV 18).
Women with HIV are unable to clear the infection
Schiffman J Natl Cancer Inst Monogr. 2003;31:14–19.
Ho N Engl J Med. 1998;338:423–428.
58
59. Cervical Cancer and HIV
CIN is common in HIV infected women because:
HIV infected women likely to have persistent HPV
Persistent infection leads to cervical cancer
Do ARTs Lower the Risk of Cervical Cancer?
Multiple studies yield mixed results
Incidence of cervical cancer appears to be unchanged in
the ART era
Those on ART are more likely to have persistent HPV
So, probably no . . . therefore other treatment needed
59
60. GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]
GARDASIL Is Efficacious Against
HPV 6/11/16/18–Related Lesions
GARDASIL Placebo
100
91
90 83
80
70
60 n=7,861 n=7,899
Related Cases
50
95% 99%
40 Efficacy Efficacy
30
20 n=7,858 n=7,897
10 4
1
0
CIN 1, CIN 2/3 or AIS Genital Warts
16- to 26-year-old females naïve to the relevant vaccine HPV type at enrollment and through
30 days Postdose 3
Over a period of 2 to 4 years
CIN = cervical intraepithelial neoplasia; AIS = adenocarcinoma in situ. 60
61.
62. Lesotho HPV Vaccination Strategy
• Application for Gardasil access 2008
• Establishing National HPV Guidelines, action plan, implementation
strategy
• The HPV Vaccine was be piloted in Leribe and Mohales’Hoek districts
• Target population: Females Aged 9-18 years, later 9-13 yrs
• School-based was used Estimated Starting period : February 2009
• Follow established vaccine distribution system
• Monitoring and evaluation- through current system