Liver Disease

&
Thalassemia
Causes of Liver Damage
in Thalassaemic Patients

 VIRUS C INFECTION
 VIRUS B INFECTION
 and/or Other infections
 Hepatotropic agents, e.g. HGV, GBVC, TTV

Iron overload resulting from Blood Transfusions and Hepatitis

⇒ SAFE BLOOD AND EFFECTIVE CHELATION ARE ESSENTIAL

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 Progression
of Liver Disease

HEALTHY LIVER FIBROSIS

CIRRHOSIS
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Clinical Course
Of Virus Related Liver Disease
Compensated
Resolution Stabilisation Cirrhosis

Acute Chronic Liver

Hepatitis Hepatitis Cirrhosis
Cancer

Decompensated
Cirrhosis
(Death)
20 - 40 Years
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HCV Infection:
Worldwide Prevalence

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Prevalence Of HCV Serum Markers
in cohorts of patients with transfusion-dependent
Thalassaemia born before 1990

Birth Cohort No. of Anti-HCV + HCV- Anti-HCV +

Anti-HCV +
(years of birth) subjects RNA + HCV-RNA -

(1980-1989) 69 38 (55%) 14 (20%) 24 (35%)

(1970-1979) 78 73 (93%) 44 (56%) 29 (37%)

(1964-1969) 20 18 (90%) 9 (45%) 9 (45%)

Overall 167 129 (77%) 67 (40%) 62 (37%)

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Hepatitis Virus Infections
In Thalassaemic Patients

Prevalence depends on
the quality and safety
of the blood as well as,
on how endemic the
virus is at the local
and/or regional level

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Hepatitis C
Virus (HCV) infection

 Hepatitis C virus is the most common viral infection.

 Worldwide 20%-90% of patients with Thalassaemia are
seropositive for anti-HCV antibodies (Variation is based on the country’s
blood service policy)

 Chronic HCV infection is more common in patients who had

a large number of blood transfusions before 1990.

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HCV Infection:
“The Facts”
Estimated global prevalence  3% (170 million persons)

Risk of chronicity (variable) 75% - 85% (2)

Early fibrosis progression rate : Low

Risk of cirrhosis: Up to 10% within 20 years;

20% within 30 years (2)

Cirrhosis-related mortality: 1% - 5%/year (3)

Incidence of HCC (Carcinoma) 1% - 4%/year (2)

in patients with cirrhosis:

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HCV Infection:
‘The Facts’
 ESTIMATED GLOBAL ~3% (170 million persons)
PREVALENCE
75%-85% (2)
 RISK OF CHRONICITY
(VARIABLE)
 EARLY FIBROSIS Low
PROGRESSION RATE:
Up to 10% within 20 years;
 RISK OF CIRRHOSIS:
20%within 30 years (2)
 CIRRHOSIS-RELATED 1%-5%/year (3)
MORTALITY:
 INCIDENCE OF HCC IN 1%-4%/year (2)
PATIENTS WITH CIRRHOSIS:

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Comparison
Of Virological Response
p= 0.04
80
70 77% 77%
60 64%
50 54% 54%
40 48% 46%
46%
30
20
10
0
PEG-IFN PEG-IFN plus Ribavirin
End of treatment
Early Virologic Response EVR 4 weeks 48 weeks
Virologic response ETR
Rapid Virologic Response RVR 12 weeks Sustained
Virologic Response SVR 72 weeks
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New Triple
Combination Therapy

Interferon
Once per week - 48 weeks
Ribavirin
Twice a day - 48 weeks
Telaprevir Three times a day - 12 weeks
(Boceprevir)

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Ribavirin:

Ribavirin, also known as tribavirin, is an antiviral

medication used to treat RSV infection, hepatitis C,
and viral hemorrhagic fever. For hepatitis C, it is
used in combination with other medications such as
simeprevir, sofosbuvir, peginterferon alfa-2b or
peginterferon alfa-2a.

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 Objective
Of Treatment

 RNA is non detectable (less than 140 IU/ml) within 4 -8

weeks of treatment .
 If this does not occur, then the treatment is stopped, as
it will not work.
 This is good news, as you will not have to endure 48
weeks of treatment, if it is not working.
(unless you are unlucky and the virus develops resistance to Interferon, which
will be revealed at the end of the treatment)

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 Candidates For The Early Access Programme:
Triple Therapy

 Patients who had relapsed from previous therapy

(Interferon + Ribavirin)
 Genotype 1 (Genotype 2 was also included, and it worked)
 Patients able to tolerate the many side effects

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 Side Effects:
 Increase in transfusion
frequency (50%-70% more)
Requiring increase in iron
chelation (30%-50% more)
 Loss of weight
 Fatigue / Extreme tiredness
 Interference with sugar
levels if you are diabetic.
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• Min 2+ days after the interferon
injection, you feel as if you are
getting the worse cold of your
life. (actually more like having been
run over by a lorry!)
• Psychological anxieties are
increased to intolerance levels
• Intolerance to daily minor
problems increases to
frightening levels
• Impacts aspects of everyday life
due to above
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 Conclusion
• Success rate: Sustained Viral Response (SVR) of non Thalassaemia
patients is 65-85 % (Studies?)
• So far, 2 Thalassaemia patients have been treated in the UK and a
3rd has just started
• The side effects, are as close to intolerable as can be (similar to the
double combination therapy)
Future therapies (such as)
Daclatasvir & GS-7977 Clinical Trial
This is an only, oral therapy, not using Interferon and/or Ribivirin

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