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Lcs pmarket
1. LCSP: The Market
Medical Unmet Need The Product Address
Market Analysis
Market opportunity
Benchmarking analysis
What is the competitive landscape
Burden of Disease
2. Natural history and progression of Chronic
Hepatitis C
The rate of hepatitis C chronic infection and
disease progression varies considerably. The
majority of people w ith hepatitis C will not
develop advanced liver disease. Of 100 people
with the hepatitis C virus (HCV), approximately 25
people w ill spontaneously clear the virus.
Between 30 and 40 people will continue to be
infected w ith the virus but w ill not develop
progressive liver disease.
3. Thirty five to 45 will develop some level of
progressive liver disease associated w ith their
hepatitis C. Symptoms related to hepatitis C and
quality of life impairment may be present in both
people with and without progressive liver disease.
Of the 35 to 45 people with progressive liver
disease, without treatment approximately 5 to 10
will develop cirrhosis (10 – 20% life time risk) and
1-3 will develop hepatocellular carcinoma. The
heterogeneity in disease progression and
symptomatic disease means that some people will
require limited contact with the health profession
and support systems associated with hepatitis C
whereas others will require constant and on going
contact. It is important to emphasise that high risk
patterns of alcohol consumption can accelerate
liver damage from hepatitis C.
5. Epidemiology of hepatitis C
–
Approximately 3% (170 million) of the world’s population has been infected with HCV.
For most countries, the prevalence of HCV infection is <3%. The prevalence is higher (up
to 15%) in some countries in Africa and Asia and highest (>15%) in Egypt. The most
frequent mode of transmission in the United States is through sharing drug-injecting
equipment among people who inject drugs. Travelers’ risk for contracting HCV infection
is generally low. For international travelers, the principal activities that can result in
blood exposure are the following:
·Receiving blood transfusions that have not been screened for HCV
·Having medical or dental procedures
·Engaging in activities (such as acupuncture, tattooing, or injecting drug use) in which
equipment has not been adequately sterilized or disinfected, or in which
contaminated equipment is reused
·Working in health care fields (medical, dental, or laboratory) that entail direct
exposure to human blood
6. Transmission risk
Hepatitis C is a blood-borne virus affecting the
liver. For successful transmission to occur the virus
must be present in the blood of a person w ith
hepatitis C in sufficient concentrations to present
an infection threat to another person (people with
even low viral loads may transmit HCV, depending
on the type of exposure), and directly enter the
bloodstream of another person by blood-to-blood
contact through a rupture or opening in the skin.
12. A sensitive search strategy was applied to several
electronic bibliographic databases. Relevant
studies were critically appraised and meta-
analyzed. A hypothetical cohort of 1,000 patients
entered a Markov model and were followed up for
a more than 30-year period to predict natural
history, duration spent in each health state, and
treatment costs.
Results: Two fully published Phase III randomized
controlled trials were included. Methodological
quality was generally good. Dual therapy with
pegylated interferon was significantly more
effective than nonpegylated dual therapy with a
pooled sustained virological response rate (SVR) of
55 percent (95 percent confidence interval [CI],
52–58 percent) compared with 46 percent (95
percent CI, 43–49 percent).
Conclusions: Pegylated interferon is clinically
effective, represents good value for the money,
and is a significant advance in the treatment of
this insidious disease.
