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HEPATITIS C PATIENT HANDOUT
Brief Facts about Hepatitis C
Approximately four million Americans are infected and 8-10,000 die each year.
Deaths are expected to triple in the next few decades.
Most patients have the infection for many years without symptoms.
Approximately 20% of untreated patients develop cirrhosis after 20 years and
50% after 50 years.
Hepatitis C is the leading reason for liver transplantation in the US.
Effective treatment with interferon and ribavirin can now eradicate the virus
in about
40% of patients. Pegylated interferon plus ribavirin eradicates the virus in
about 50-60%.
How do you get hepatitis C?
Blood transfusion before July,1992
Intravenous drug abuse (even one time)
Sexual Intercourse with an infected partner (5% chance with 20 years of sex).
Needle stick accident with a patient with Hepatitis C
Sharing a razor or a toothbrush with infected person
Hemodialysis
Miscellaneous (use of un sterile needle from a doctor or dentist, air gun vaccination
in the military, contaminated multi use vials of medications, improperly sterilized
endoscopic equipment, reuse of razors from a barbershop or beauty salon)
Who should be treated?
Patients with hepatitis C RNA in their blood. It is not possible to accurately
predict who will develop cirrhosis or liver cancer. Patients with
early cirrhosis can and should be treated. Patients with late (decompensated)
cirrhosis {history of ascites, (abdominal fluid) encephalopathy (sleepiness
or confusion from liver disease) or bleeding esophageal varices, (swollen
veins in the esophagus that bleed) should have a liver transplant evaluation.
There are not enough livers for everyone who needs one. Patients with decompensated
cirrhosis can be treated using initially small doses of interferon, but
very few doctors are willing to treat them. The risks and benefits of antiviral
treatment must be weighed in each patient.
How do you treat hepatitis C?
Pegylated interferons are superior to regular interferon because they last for
one week instead of a few hours. They are not excreted quickly by the kidneys
like regular interferons. Peg Intron is made by Schering-Plough and is 30% excreted
by the kidneys. Pegasys is made by Roche is less than 4% excreted
by the kidneys. Infergen works in some patients who do not respond to
Pegasys or Peg Intron. Thymosin (Zadaxin) is available now in Mexico and Panama
and is being studied in the US. Will it help some nonresponders to interferon?
Can you cure hepatitis C?
Yes, for many patients who become undetectable for the virus on treatment, it
is gone for good. About 15% of infected patients are able to clear
the virus without medication. These patients have a positive anti-HCV,
a positive HCV RIBA and persistently negative HCV-RNA. About 10-20% of patients
are able to clear the virus with one year of interferon, and their HCV-RNA
is negative 6-12 months after the end of treatment. This cure has been
proven to last at least thirteen years. About 40% of patients are
able to clear the virus with 48 weeks of interferon plus ribavirin, and their
HCV-RNA is negative 6 months after the end of treatment. Patients who
are successfully treated are cured of HCV. A cured patient has a zero viral
level for the rest of his or her life. A cured patient has a better prognosis
than untreated or unsuccessfully treated patients. The mortality rate is reduced.
The liver biopsy appearance improves. The liver tests, and other blood
tests improve. Their risk of liver cancer is reduced.. Their risk of needing
a liver transplant is reduced.
Should a liver biopsy be done?
Liver biopsy shows how much damage has occurred and if there is cirrhosis. It
is important in protocols but its use in routine practice may be reduced by
blood tests. Labcorp has a test called HCV FibroSure. This tests can give a very good idea of how much liver damage
is present without a biopsy. It can be checked every year to follow the progression
of liver damage. Liver biopsy has a small risk of bleeding or other complication. The risk
can be reduced but not eliminated by ultrasound or CT guidance of the biopsy.
Liver
biopsy is often uncomfortable but usually is well tolerated. Most patients can
be properly managed without a liver biopsy. Decisions about a liver biopsy must
be made jointly between the patient and his or her health care provider.
More information about HCV
Hepatitis C is a common viral infection of the liver. About four million Americans
have hepatitis C. The infection may have been acquired from a blood transfusion
before July 1992. It may be acquired from sharing needles or from snorting
drugs. It is not commonly spread sexually or from mother to baby, but this
does occur in 5%. Sharing razors or toothbrushes can transmit the virus,
as can unsterile tattoos. Shaving the neck at a barbershop or beauty salon
using an un sterile razor can transmit hepatitis C. There have been rare reports
of patients acquiring hepatitis C from their surgeon, unsterile glass syringes
or endoscopic procedures. Needle stick accidents can give the disease
to medical and laboratory personnel. Organ transplant recipients
before 1992 and hemodialysis patients are at increased risk as are patients
who received clotting factor concentrates before 1987. Police officers
and others who work with prisoners and are exposed to their blood can acquire
the infection since one third of prison inmates are infected with hepatitis
C. Many patients have no obvious source of infection. Most patients are discovered
to have hepatitis C because they try to donate blood or elevated liver
enzymes (ALT and AST) are found on routine blood tests. Patients with persistently
abnormal ALT (liver enzyme) should be screened for hepatitis C. Jaundice (yellow
color of the skin from liver malfunction) is unusual. Some patients
have fatigue as a result of hepatitis C but most patients have no symptoms
at all from the virus until they develop advanced cirrhosis. The virus is found
primarily in the blood and in the liver where is causes inflammation. Over a period
of ten to forty years the liver becomes progressively damaged and 20-50% of
patients eventually develop cirrhosis. Cirrhosis is severe scarring of
the liver which over many years results in the complications of ascites
(fluid in the abdominal cavity), bleeding from esophageal varices (large veins
in the esophagus), and encephalopathy (sleepiness and confusion from poor
liver function).
Each year about 1% of cirrhotic patients develop cancer of the liver called hepatocellular
carcinoma. The incidence of hepatocellular carcinoma is rising in the US because
of hepatitis C which causes approximately 30 to 50 percent of the cases
of liver cancer in the United States. It is very hard to predict which patients
will develop complications of hepatitis C and which patients will have
a normal life expectancy. The natural history of hepatitis C is still being
studied. Some facts are not in dispute. Patients older than 50 at
the onset of infection are more likely to develop cirrhosis. Patients with
a duration of more than 20 years are more likely to develop cirrhosis. Patients
who drink alcohol even in moderate amounts are more likely to develop cirrhosis.
Hepatitis C is the number one reason for liver transplantation in the United
States. About 8,000-10,00 Americans die from it each year and the number is
expected to triple in the next fifteen years. A Consensus Conference in
2002 recommended that most patients with abnormal liver tests and without
decompensated liver disease be offered treatment.
The only drug which can eliminate the hepatitis C virus from the blood and
liver of a patient with chronic hepatitis C (infection longer than 6 months)
is interferon. Interferon is a substance that our bodies make in small
amounts to boost the immune system to fight viral infections. Pegylated
interferons are long acting forms given once per week and have milder side effects
and better efficacy ( 25-36% sustained response rate) compared with interferon
given three times per week. Pegylated interferon and ribavirin push the
sustained response rates above 50%. If the treatment is working the viral
level should fall by at least 90% each month. For example, if the viral level is
2 million before treatment, it should fall to 200,000 by one month, 20,000 after
2 months, 2,000 after 3 months, 200 after 4 months etc. It has been my
experience in treating more than 3,000
patients that if the speed of the fall is slower than this, the chance of success
is very poor. If the viral level is not falling properly, I raise the dose of
interferon or change to a different type of interferon.
Ribavirin does not make the intererferon work, but it reduces the chance of
relapse after treatment is completed. I start with 600 mg per day in most patients.
Patients with genotype 2 or 3 will usually take 800 mg per day after the first
month. Patients with other genotypes with usually gradually go up to 1,000 or
1,200 mg per day. If you raise the dose too quickly, the red blood cell count
will fall too low causing anemia, fatigue and shortness of breath. If the patient
is not responding I usually stop treatment. If you cure the infection, the liver
will heal itself.
New drugs are being developed (protease inhibitors, polymerase
inhibitors)
to treat patients who do not clear the virus with combination interferon-ribavirin
therapy or do not want to suffer the side effects. These drugs may not
be strong enough to work alone without interferon. Triple and quadruple therapy will eventually be available
and will increase the cure rate. This is a very exciting and hopeful time for
hepatitis C patients.
Nearly all patients who take interferon develop side effects from treatment
especially in the first few weeks of therapy. About 5% have to discontinue treatment
because of severe side effects. Fever, headache, fatigue, and pain in the muscles
and joints are seen in virtually all patients. If acetaminophen is taken 30-60
minutes before the interferon injection the side effects are reduced. Interferon
can cause or worsen thyroid disease, and can unmask or worsen autoimmune diseases
such as rheumatoid arthritis and systemic lupus erythematosis. Interferon worsens
psoriasis and can rarely damage the eyes. Rare side effects include confusion,
psychosis and lung or kidney damage or death.
Ribavirin is an antiviral drug that together with interferon can eliminate
the hepatitis C virus from the blood in about 40% of patients. It does not kill
the hepatitis C virus if given alone. It causes hemolytic anemia (low red blood
cell count from bursting red blood cells) in all patients that is usually not
severe. The anemia is temporary and clears up a few weeks after the ribavirin
is discontinued. The hemoglobin level in the blood falls an average of 2 grams
per deciliter (from 14 to 12 in men and 12 to 10 in women). This anemia causes
fatigue and shortness of breath on exertion. If the anemia is severe (hemoglobin
less than 8) more serious side effects can occur including a heart attack. Rare
deaths have occurred because of anemia. Patients with known heart disease and
patients at high risk of heart disease should have an exercise stress EKG before
beginning treatment with ribavirin. High-risk patients include smokers, persons
with hypertension or diabetes, and persons with a strong family history of heart
disease. Ribavirin causes birth defects and female patients cannot get
pregnant during or six months following therapy. Male patients cannot
impregnate a women during or six months following therapy.
What information should a patient know?
A positive blood test for hepatitis C antibodies does not prove that a person
is currently infected with the virus. About 15% of patients infected with hepatitis
C are able to clear the infection on their own. These patients may have a positive
hepatitis C antibody because of the previous infection, but their level of HCV
RNA is persistently zero. These patients do not need treatment for hepatitis
C because their immune system has already cleared the infection. The diagnosis
of current HCV infection must always be confirmed before treatment since false
positive hepatitis C antibody tests occur. The actual level of the hepatitis
C virus in the blood is measured called HCV-RNA. Normal is less than 5 IU per
ml of blood (considered zero). Typical patients with hepatitis C have levels
between 100,000 and 20,000,000 IU per ml. With successful treatment the level
falls to less than 5 IU per ml. Frequently a repeat level is obtained after
4-12 weeks of therapy to see if the therapy is likely to be successful.
If the level does not drop by more than 90% each month, then therapy may not
be effective (for example from 200,000 IU per ml to 20,000 IU per ml). If the
4-week viral level is less than 10 IU per ml there is a good chance that either
24 or 48 weeks of therapy will eliminate the virus from the blood. It
is necessary to get the viral load to undetectable with treatment and to keep
it there for many months to obtain a sustained remission. Higher doses and
or longer duration of treatment may be needed to obtain a sustained remission
in African American patients who have a poor response to standard combination
therapy. I confirm that the HCV-RNA is still negative at the end of therapy,
and check it 1, 3,and 6 months after completion of treatment. If it is negative
6 months after treatment the patient is a sustained responder and has a 99%
chance that the hepatitis C will not return.
Because interferon and ribavirin are toxic drugs, patients must be followed
closely. Frequent clinic visits and blood tests are required at first, then
monthly. The patient must be willing to actively participate in the treatment
program in order to get the best possible results. Liver biopsy is often performed
in patients with hepatitis C to determine how much damage has occurred to the
liver. It is very important in clinical trials and is often done in patients
outside of trials. This policy is being questioned by hepatologists who don't
think routine liver biopsies are necessary in all patients. Liver biopsy
is uncomfortable and can be complicated by bleeding or puncture of the colon,
gallbladder or lung. If the biopsy site is selected using ultrasound or CT guidance,
the complication rate can be reduced. Just as patients with pneumonia can be
treated without a lung biopsy, patients can usually be treated for hepatitis
C without a liver biopsy. Decisions concerning biopsy should be made in each
individual case, weighing the risks and benefits.
Patients with early cirrhosis can and should be safely treated with interferon
plus ribavirin. These are the most important patients to treat because they
are in danger of needing a liver transplant to survive. Patients with
advanced cirrhosis have decompensation of their liver disease. This group should
be offered low dose interferon plus ribavirin while they are waiting for liver
transplantation. Decompensated cirrhotic patients develop ascites (fluid
in the abdominal cavity), bleeding esophageal varices (large veins in the esophagus),
and encephalopathy (sleepiness and confusion from liver disease). Cirrhotic
patients often have a prolonged prothrombin time( often about 14 seconds, a
low serum albumin (often about 3.2, a low white blood cell count (often about
3,200, a low platelet count (often about 70,000, and anemia (hemoglobin often
about 11.50). Alcohol has been shown in many large studies to increase the amount
of liver damage from hepatitis C.
Patients with hepatitis C should not drink alcohol since it increases their
chance of developing cirrhosis and liver cancer. If a patient is an alcoholic
and cannot quit drinking on his or her own, a formal alcohol rehabilitation
program is strongly recommended before beginning treatment for hepatitis C.
The antiviral treatment is not as effective if the patient actively drinks alcohol.
Patients who are addicted to drugs should be treated for drug addiction before
antiviral treatment. Patients who are cured of hepatitis C are not immune to
hepatitis C and can be re infected with another strain of the virus.
They must address their drug problem first and should be drug free before treatment
of the hepatitis C. Some patients with hepatitis C also have other viral infections,
notably hepatitis B and HIV. Hepatitis B is a different virus than hepatitis
C and is treated differently. Blood tests for hepatitis B are necessary in all
patients with hepatitis C to rule out co infection. Treating patients with hepatitis
B and C co infection is not difficult. HIV antibodies should also be checked.
There is excellent effective treatment for HIV and screening is recommended.
Patients with the human immunodeficiency virus infection can be treated successfully
if co infected with hepatitis C. If a person has hepatitis C and is not immune
to hepatitis B he or she should be vaccinated against hepatitis B. Vaccination
for hepatitis A is also strongly recommended if the patient does not have natural
immunity. The treatment of hepatitis C has made major advances in the last four
years, and the future is very hopeful.
The United States government has recognized the importance of this disease
and is mobilizing resources to deal with it. Pharmaceutical companies
are developing new drugs to treat hepatitis C. Today it is possible to permanently
eliminate the virus from the blood in about half of patients who complete 48
weeks of treatment with pegylated interferon and ribavirin. It is advisable
to treat as many patients as possible with interferon and ribavirin to prevent
progression of disease in responding patients. This will save lives, prevent
liver cancer and reduce the number of liver transplants for hepatitis C.
We need the US Congress to fund research for a hepatitis C vaccine and to pay
for universal vaccination of all Americans against hepatitis A and B. Contact
your Senators and Representatives in Washington D.C. They will spend money
to wipe out hepatitis A, B and C in America if only you take a few minutes to
ask them to do it.
Bennet Cecil, MD.
5-17-05
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