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
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
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
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