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CHRONIC HEPATITISGTB107 Epidemiology
GROUP MEMBERS
NUR SYAFARAH BT SHUHAIMINUDIN 117438
NUR ATIQAH BT NASARUDIN 117435
NUR IZZUL HUSNA BT ZAKARIA 117437
NURUL AINI BT MOHAMED IQBAL 117442
NURASYIKIN BT ISMAIL 117440
NURUL AIN BASIRAH BT MOHD SALLEH 117441
IZYANA BT MOHD RUSDIN 117428
NUR ANISAH BT ROSELAN 117434
NUR SHAFIQA BT MD SITH 112036
MOHAMMAD JAMEL MOHD ALWAI 112027
HEPATITIS
• Virus
 A microscopic particle that can infect the cell of biological
organism. Viruses can replicate themselves only by
infecting a host cell. Consist of genetic material contained
within a protective protein coat.
• Hepatotropic viruses
 Predominantly infect the liver
 Hepatitis A, B, C, D, and E
 Eg: HAV, HBV, HCV, HDV, HEV
NUR ATIQAH BT NASARUDIN 117435
HEPATITIS B
• One of the most common chronic infectious diseases worldwide
• Potentially serious form of liver inflammation due to infection
by the hepatitis B virus (HBV).
• It occurs in both rapidly developing (acute) and long-lasting
(chronic) forms.
• In its chronic form, HBV infection may destroy the liver through
a scarring process, called cirrhosis, or it may lead to cancer of
the liver.
• not very easily transmitted
• most who become chronic carriers of the virus live in Asia and
Africa, there are no fewer than 1.5 million carriers in the United
States
NUR ATIQAH BT NASARUDIN 117435
ETIOLOGY AND RISK FACTOR
[ Etiology of HEPATITIS B]
Occur when parenteral part of body
touched or contacted bodily fluid of
infected person such as blood, semen
HBV modes of transmission can survive
outside the body longer than HIV
Virus can spread by means of unsafe
injection practices, unprotected sexual
contact, from mother to baby at birth etc
Major infectious occupational hazard
among health workers.
NURASYIKIN BT ISMAIL 117440
RISK FACTORS OF HEPATITIS B
NURASYIKIN BT ISMAIL 117440
PREVALENCE AND INCIDENCE
PREVALENCE AND INCIDENCE
• Around 350 people are estimated to live with
chronic hepatitis B worldwide.
• This virus is quite popular in many areas across
the world especially Asian and African
countries.
http://www.cdc.gov/FEATURES/dsHepatitisAwareness
NUR SYAFARAH BT SHUHAIMINUDIN 117438
NUR SYAFARAH BT SHUHAIMINUDIN 117438
PREVALENCE AND INCIDENCE
• According to Sook-Fan Yap in her research in
Malaysia the chronic HBV carrier rate varies
between < 1% to about 10% depending on the
ethnic group studied.
• The highest frequency is seen among the
Chinese (36%) followed by the Malays (26%)
and lastly the Indians (15%), with a male
preponderance of between 2:1 and 3:1 .
• (UHKL blood donor statistics)
http://www.mjpath.org.my
NUR SYAFARAH BT SHUHAIMINUDIN 117438
HEPATITIS B VACCINATION
• Hepatitis B is 50-100 times more infectious than HIV
• According to Ministry record, 5% of Malaysian suffer from
hepatitis B whereas 2% carry the hepatitis C virus
• WHO estimated that chronic hepatitis B and C affect over 520
million people worldwide, which leading to more than one
million death per year. Thus making the viral hepatitis is one of
the world’s greater health threats.
• The hepatitis B vaccination program for children which was
introduced in 1989 has reduce the rate of infection among
Malaysian to 0.3% , exceeding WHO’s target of 1 %.
https://thestar.com.my
NURUL AINI BT MOHAMED IQBAL 117442
sources: Ministry of Health Malaysia, July 2012
Table of Vaccine Preventable Diseases
Communicable Disease Incidence Rate Mortality Rate
Acute Poliomyelitis 0 0
Diphtheria 0 0
Hepatitis B 4.32 0.02
Measles 5.42 0.01
Neonatal Tetanus 0.01 0
Other Tetanus 0.03 0
Whooping Cough 0.86 0
NURUL AINI BT MOHAMED IQBAL 117442
• Based on the Department of Public
Health, MoH in Malaysia, Hepatitis B is one of
the vaccine preventable diseases that shows
4.32 for the incidence rate and 0.02 for the
mortality rate.
• Hepatitis B was ranked as the second highest
incidence rate among the vaccine preventable
disease while the highest one is measles.
• However the mortality rate for hepatitis B is in
the first rank.
NURUL AINI BT MOHAMED IQBAL 117442
INTERVENTION STUDY
problem statement
one of the major mode of HBV
transmission is by prenatal
transmission
NUR SHAFIQA BT MD SITH 112036
research question
How can we prevent/reduce the risk of
prenatal transmission of HBV?
NUR SHAFIQA BT MD SITH 112036
Objectives
Primary:
To study the effectiveness of lamivudine
therapy in 2nd and 3rd trimester of
pregnancy to reduce the rate of HBV
prenatal transmission among pregnant
women having chronic hepatitis
NUR SHAFIQA BT MD SITH 112036
objectives
Secondary:
To study the effect of lamivudine therapy
in pregnant woman to reduce the rate of
viral load HBV chronic infection
NUR SHAFIQA BT MD SITH 112036
Study Background
Randomized Control Trial :
• Involve person that is already infected
• Involve exposure to treatment, new drug - Lamuvidine
• Patients are randomly grouped in case and control group
• Outcomes that we expect is the incidence hepatitis B in
the infants from mothers who are having chronic hepatitis
B.
– Whether the lamuvidine therapy can give therapeutic
effect in pregnant woman hence reduce the risk of
prenatal transmission of HBV
NURUL AIN BASIRAH BT MOHD SALLEH 117441
Population
In order to be eligible to participate in this study, a subject
must meet all of the following criteria:
• Gender: Pregnant mother in 2nd or 3rd trimester
• Age: 25-35 years old
• Laboratory results:
Chronic Hepatitis B (HBVsAg+ and HBeAg+)
• Ability to provide written informed consent form
indicating awareness of the investigational nature of this
study
• Willing to comply with all study procedures and be
available for the duration of the study
NUR IZZUL HUSNA BT ZAKARIA 117437
Population
Sample
Population
(n=1000)
Cases group
(n=500)
EPIVIR-HBV
Tablets
100mg
Control
group
(n=500)
Vitamin C
Tablets
100mg
NUR IZZUL HUSNA BT ZAKARIA 117437
Treatment Description
Product: EPIVIR-HBV Tablets 100mg (GlaxoSmithKline)
Dose: One tablet (100mg) daily
Composition: Each tablet contains 100 mg of lamivudine and
the inactive ingredients hypromellose, macrogol
400, magnesium stearate, microcrystalline
cellulose, polysorbate 80, red iron oxide, sodium starch
glycolate, titanium dioxide, and yellow iron oxide.
- Lamivudine is classified as FDA pregnancy risk category B.
- Lamivudine treatment for HBV carrier mothers should be
initiated at week 28 of gestation.
C. L. Lai, E. Gane, Y. F. Liaw et al., “Telbivudine versus lamivudine in patients
with chronic hepatitis B,” New England Journal of Medicine, vol. 357, no.
25, pp. 2576–2588, 2007.
NUR ANISAH BT ROSELAN 117434
Product Safety
According to W. Yi, M. Liu and and H. D. Cai (2012),
• Lamivudine treatment is also safe and effective for
chronic HBV-infected pregnant women in early
pregnancy or perinatal period.
• There are no complications or adverse events
associated with it. It has also got no effect on fertilization
or embryonic development.
• There is no evidence of increase in the incidence of
congenital abnormalities in infants. Importantly, it
enhances the blocking rate of mother to infant
transmission.
W. Yi, M. Liu, and H. D. Cai, “Safety of lamivudine treatment for chronic
hepatitis B in early pregnancy,” World Journal of Gastroenterology, vol.
18, no. 45, pp. 6645–6650, 2012.
NUR ANISAH BT ROSELAN 117434
Study schedule
• Screening phase
– Check suitability of patients
• Enrollment
• Visit
• Follow-ups
– Record physiological changes (if any)
– Take sample blood
IZYANA BT MOHD RUSDIN 117428
Visiting schedule
VISIT PHASE DURATION NOTES
*1st -6th
Primary
During second
and third
trimester
pregnancy
Begin lamivurdine therapy after the subject
are grouped
Follow the mother’s health conditions
Give medication to the subject if necessary.
7th Secondary Within 12 hours
after delivery
Infants delivery (hepatitis B immune globin
(HBIg,200IU)
8th
Tertiary
1st month First vaccination infants (recombinant HBV
vaccine, 20 mug)
9th 6th month Second vaccination infants (recombinant
HBV vaccine, 20 mug)
10th 7th month Blood test for hepatitis B surface antigen
(HBsAg) presence and hepatitis B
virus(HBV) DNA level
IZYANA BT MOHD RUSDIN 117428
Study procedure
• Diagnosis of sample by ELISA
MOHAMMAD JAMEL BIN MOHD ALWAI 112027
MOHAMMAD JAMEL BIN MOHD ALWAI 112027
Ethics
• Review Board to assess factors, consent
procedures etc follows guidelines
• Not waiving rights of subjects
• Confidentiality of patients
MOHAMMAD JAMEL BIN MOHD ALWAI 112027
Hepatitis - Epidemiology Assignment

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Hepatitis - Epidemiology Assignment

  • 2. GROUP MEMBERS NUR SYAFARAH BT SHUHAIMINUDIN 117438 NUR ATIQAH BT NASARUDIN 117435 NUR IZZUL HUSNA BT ZAKARIA 117437 NURUL AINI BT MOHAMED IQBAL 117442 NURASYIKIN BT ISMAIL 117440 NURUL AIN BASIRAH BT MOHD SALLEH 117441 IZYANA BT MOHD RUSDIN 117428 NUR ANISAH BT ROSELAN 117434 NUR SHAFIQA BT MD SITH 112036 MOHAMMAD JAMEL MOHD ALWAI 112027
  • 3. HEPATITIS • Virus  A microscopic particle that can infect the cell of biological organism. Viruses can replicate themselves only by infecting a host cell. Consist of genetic material contained within a protective protein coat. • Hepatotropic viruses  Predominantly infect the liver  Hepatitis A, B, C, D, and E  Eg: HAV, HBV, HCV, HDV, HEV NUR ATIQAH BT NASARUDIN 117435
  • 4. HEPATITIS B • One of the most common chronic infectious diseases worldwide • Potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). • It occurs in both rapidly developing (acute) and long-lasting (chronic) forms. • In its chronic form, HBV infection may destroy the liver through a scarring process, called cirrhosis, or it may lead to cancer of the liver. • not very easily transmitted • most who become chronic carriers of the virus live in Asia and Africa, there are no fewer than 1.5 million carriers in the United States NUR ATIQAH BT NASARUDIN 117435
  • 6. [ Etiology of HEPATITIS B] Occur when parenteral part of body touched or contacted bodily fluid of infected person such as blood, semen HBV modes of transmission can survive outside the body longer than HIV Virus can spread by means of unsafe injection practices, unprotected sexual contact, from mother to baby at birth etc Major infectious occupational hazard among health workers. NURASYIKIN BT ISMAIL 117440
  • 7. RISK FACTORS OF HEPATITIS B NURASYIKIN BT ISMAIL 117440
  • 9. PREVALENCE AND INCIDENCE • Around 350 people are estimated to live with chronic hepatitis B worldwide. • This virus is quite popular in many areas across the world especially Asian and African countries. http://www.cdc.gov/FEATURES/dsHepatitisAwareness NUR SYAFARAH BT SHUHAIMINUDIN 117438
  • 10. NUR SYAFARAH BT SHUHAIMINUDIN 117438
  • 11. PREVALENCE AND INCIDENCE • According to Sook-Fan Yap in her research in Malaysia the chronic HBV carrier rate varies between < 1% to about 10% depending on the ethnic group studied. • The highest frequency is seen among the Chinese (36%) followed by the Malays (26%) and lastly the Indians (15%), with a male preponderance of between 2:1 and 3:1 . • (UHKL blood donor statistics) http://www.mjpath.org.my NUR SYAFARAH BT SHUHAIMINUDIN 117438
  • 12. HEPATITIS B VACCINATION • Hepatitis B is 50-100 times more infectious than HIV • According to Ministry record, 5% of Malaysian suffer from hepatitis B whereas 2% carry the hepatitis C virus • WHO estimated that chronic hepatitis B and C affect over 520 million people worldwide, which leading to more than one million death per year. Thus making the viral hepatitis is one of the world’s greater health threats. • The hepatitis B vaccination program for children which was introduced in 1989 has reduce the rate of infection among Malaysian to 0.3% , exceeding WHO’s target of 1 %. https://thestar.com.my NURUL AINI BT MOHAMED IQBAL 117442
  • 13. sources: Ministry of Health Malaysia, July 2012 Table of Vaccine Preventable Diseases Communicable Disease Incidence Rate Mortality Rate Acute Poliomyelitis 0 0 Diphtheria 0 0 Hepatitis B 4.32 0.02 Measles 5.42 0.01 Neonatal Tetanus 0.01 0 Other Tetanus 0.03 0 Whooping Cough 0.86 0 NURUL AINI BT MOHAMED IQBAL 117442
  • 14. • Based on the Department of Public Health, MoH in Malaysia, Hepatitis B is one of the vaccine preventable diseases that shows 4.32 for the incidence rate and 0.02 for the mortality rate. • Hepatitis B was ranked as the second highest incidence rate among the vaccine preventable disease while the highest one is measles. • However the mortality rate for hepatitis B is in the first rank. NURUL AINI BT MOHAMED IQBAL 117442
  • 16. problem statement one of the major mode of HBV transmission is by prenatal transmission NUR SHAFIQA BT MD SITH 112036
  • 17. research question How can we prevent/reduce the risk of prenatal transmission of HBV? NUR SHAFIQA BT MD SITH 112036
  • 18. Objectives Primary: To study the effectiveness of lamivudine therapy in 2nd and 3rd trimester of pregnancy to reduce the rate of HBV prenatal transmission among pregnant women having chronic hepatitis NUR SHAFIQA BT MD SITH 112036
  • 19. objectives Secondary: To study the effect of lamivudine therapy in pregnant woman to reduce the rate of viral load HBV chronic infection NUR SHAFIQA BT MD SITH 112036
  • 20. Study Background Randomized Control Trial : • Involve person that is already infected • Involve exposure to treatment, new drug - Lamuvidine • Patients are randomly grouped in case and control group • Outcomes that we expect is the incidence hepatitis B in the infants from mothers who are having chronic hepatitis B. – Whether the lamuvidine therapy can give therapeutic effect in pregnant woman hence reduce the risk of prenatal transmission of HBV NURUL AIN BASIRAH BT MOHD SALLEH 117441
  • 21. Population In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Gender: Pregnant mother in 2nd or 3rd trimester • Age: 25-35 years old • Laboratory results: Chronic Hepatitis B (HBVsAg+ and HBeAg+) • Ability to provide written informed consent form indicating awareness of the investigational nature of this study • Willing to comply with all study procedures and be available for the duration of the study NUR IZZUL HUSNA BT ZAKARIA 117437
  • 23. Treatment Description Product: EPIVIR-HBV Tablets 100mg (GlaxoSmithKline) Dose: One tablet (100mg) daily Composition: Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide. - Lamivudine is classified as FDA pregnancy risk category B. - Lamivudine treatment for HBV carrier mothers should be initiated at week 28 of gestation. C. L. Lai, E. Gane, Y. F. Liaw et al., “Telbivudine versus lamivudine in patients with chronic hepatitis B,” New England Journal of Medicine, vol. 357, no. 25, pp. 2576–2588, 2007. NUR ANISAH BT ROSELAN 117434
  • 24. Product Safety According to W. Yi, M. Liu and and H. D. Cai (2012), • Lamivudine treatment is also safe and effective for chronic HBV-infected pregnant women in early pregnancy or perinatal period. • There are no complications or adverse events associated with it. It has also got no effect on fertilization or embryonic development. • There is no evidence of increase in the incidence of congenital abnormalities in infants. Importantly, it enhances the blocking rate of mother to infant transmission. W. Yi, M. Liu, and H. D. Cai, “Safety of lamivudine treatment for chronic hepatitis B in early pregnancy,” World Journal of Gastroenterology, vol. 18, no. 45, pp. 6645–6650, 2012. NUR ANISAH BT ROSELAN 117434
  • 25. Study schedule • Screening phase – Check suitability of patients • Enrollment • Visit • Follow-ups – Record physiological changes (if any) – Take sample blood IZYANA BT MOHD RUSDIN 117428
  • 26. Visiting schedule VISIT PHASE DURATION NOTES *1st -6th Primary During second and third trimester pregnancy Begin lamivurdine therapy after the subject are grouped Follow the mother’s health conditions Give medication to the subject if necessary. 7th Secondary Within 12 hours after delivery Infants delivery (hepatitis B immune globin (HBIg,200IU) 8th Tertiary 1st month First vaccination infants (recombinant HBV vaccine, 20 mug) 9th 6th month Second vaccination infants (recombinant HBV vaccine, 20 mug) 10th 7th month Blood test for hepatitis B surface antigen (HBsAg) presence and hepatitis B virus(HBV) DNA level IZYANA BT MOHD RUSDIN 117428
  • 27. Study procedure • Diagnosis of sample by ELISA MOHAMMAD JAMEL BIN MOHD ALWAI 112027
  • 28. MOHAMMAD JAMEL BIN MOHD ALWAI 112027
  • 29. Ethics • Review Board to assess factors, consent procedures etc follows guidelines • Not waiving rights of subjects • Confidentiality of patients MOHAMMAD JAMEL BIN MOHD ALWAI 112027