Liver biopsy can provide direct histologic assessment of liver injury due to HCV but
cannot be used to diagnose HCV infection.
Hepatocellular Carcinoma Screening
HCC complicates cirrhosis secondary to HCV. It is estimated that HCC occurs after the
development of cirrhosis at a rate varying from 0 to 3 percent per year. Alpha-fetoprotein
(AFP) and ultrasound every 6 months were used in a single study of patients with
cirrhosis secondary to HCV. Identification ofHCC was not significantly increased in the
screened population. The value of screening for AFP is uncertain because there are no
available data to demonstrate the clinical impact of this screening on the management of
HCC or associated mortality. Studies of the performance characteristics of AFP and
hepatic ultrasound show that AFP has a poor sensitivity and a high rate of false-positive
reactions. Hepatic ultrasound is more sensitive than AFP testing but is also more
expensive, and it can lead to invasive and unnecessary evaluations of lesions (e.g.,
regenerative nodules, hemangiomas, hepatic cysts) that are not HCc. However, such
routine AFP or imaging screening should not be performed in patients with HCV in the
absence of cirrhosis because HCC is so rare in this group.
What is the most effective therapy for hepatitis C?
Currently the best indicator of effective treatment is an SVR, defined by the absence of
detectable HCV RNA in the serum as shown by a qualitative HCV RNA assay with
lower limit of detection of 50 IU/mL or less at 24 weeks after the end oftreatment.
Treatment of Naive Patients
Three large pivotal trials have examined the efficacy of pegylated interferon plus
ribavirin in the treatment of chronic HCV infection. Overall, pegylated interferon plus
ribavirin was more effective than standard interferon-ribavirin combination or pegylated
interferon alone. Among patients with genotypes 2 or 3, SVRs with standard interferon
and ribavirin were comparable to those with pegylated interferon and ribavirin, and thus
standard interferon and ribavirin could be used in treating patients with these genotypes.
In a recent study, a 24-week course of pegylated interferon and ribavirin was found to be
as effective as a 48-week course in patients with genotypes 2 and 3 (SVR rates of 73 to
78 percent), but not in patients with genotype 1 (SVR rates of 41% with 24 weeks and
51% with 48 weeks). Similarly, a reduced ribavirin dosage of 800 mg daily appeared to
be adequate for patients with genotypes 2 and 3, but the higher, standard dosage of 1000
to 1200 mg daily yielded better response rates in patients with genotype 1. Thus, 24
weeks of treatment and an 800 mg dose of ribavirin appear to be sufficient for persons
with genotypes 2 and 3, while patients with genotype 1 need 48 weeks of treatment and
standard doses of ribavirin.
Early viral response (EVR) defined, as a minimum 2-log decrease in viral load during the
first 12 weeks of treatment, is predictive of SVR and should be a routine part of
monitoring patients with genotype 1. Patients who fail to achieve an EVR at week 12 of
treatment have only a small chance of achieving an SVR even if therapy is continued for
Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

Page 4 of 8
February, 2003

a full year. Treatment need not be extended beyond 12 weeks in these patients. Although
an SVR is difficult to correlate with improved survival because ofthe necessity for longterm follow-up, the absence of detectable serum HCV RNA has been associated with
resolution of liver injury, reduction in hepatic fibrosis, and a low likelihood of a relapse
of the HCV infection. Additionally, in two large but uncontrolled long-term follow-up
studies from Japan, SVR after interferon treatment was associated with a lower risk of
BCe. Conversely, one observational Italian study with long-term follow-up found no
difference in development ofHCC between those with and without interferon treatment.
Re-treatment of Patients
Studies are currently being conducted with pegylated interferon and ribavirin therapy in
patients who relapsed after interferon monotherapy or standard interferon and ribavirin
therapy.
Failure to respond to optimal therapy with pegylated interferon and ribavirin presents a
significant problem, particularly in the presence of advanced fibrosis or cirrhosis.
Currently, several large-scale, multicenter u.s. trials are evaluating the role of
maintenance therapy with pegylated interferon alone in preventing further progression of
cirrhosis, clinical decompensation, or development of HCe. Until the results of these
studies are available, the role of long-term, continuous therapy with pegylated interferon
(or ribavirin or both) for nonresponders should be considered experimental.
Adherence
Patient adherence is critical to the success of treatment of HCV.Physicians should
discuss the importance of adherence with patients before embarking on therapy and
regularly assess and take steps to help their patients maximize their adherence. Such
measures include management of side effects, depression, and substance abuse.
Side Effects of Treatment
In registration trials of pegylated interferon and ribavirin, significant side effects resulted
in discontinuation of treatment in approximately 10 to 14 percent of patients. Major side
effects of combination therapy include influenza-like symptoms, hematologic
abnormalities, and neuropsychiatric symptoms. The education of patients, their family
members, and caregivers about side effects and their prospective management is an
integral aspect of treatment. Frequent monitoring of neuropsychiatric side effects,
cytopenia, and adherence to HCV therapy is necessary. Psychological conditions,
particularly depression, are common among persons with HCV and are frequent side
effects of interferon. The patient's mental health status should be assessed before
beginning antiviral therapy and monitored regularly during therapy.
It is not known if the use of hematopoietic growth factors will enhance the likelihood of
SVR. Thus, the benefits of such treatment need to be proven prospectively before it can
be recommended.

Hepatitis C Position Statement - Alabama Department of Corrections
Summary of NIB Statement

Page 5 of 8
February, 2003

Which patients with hepatitis C should be treated?

All patients with chronic HCV are potential candidates for antiviral therapy. Treatment is
recommended for patients with an increased risk of developing cirrhosis. These patients
are characterized by:
>- Detectable HCV RNA levels higher than 50 IU/mL,
>- A liver biopsy with findings of portal or bridging fibrosis, and at least Moderate
inflammation and necrosis, and
>- Persistently elevated ALT values.
Because a large number of HCV-infected persons in the United States are incarcerated,
programs should be implemented to prevent, diagnose, and treat HCV infection in these
individuals. Patients with chronic HCV should be vaccinated against hepatitis A, and
seronegative persons with risk factors for hepatitis B virus (HBV) should be vaccinated
against HBV.
Normal ALT Levels

Approximately 30 percent of patients with chronic HCV infection have normal ALT
levels, and another 40 percent have ALT levels less than two times the upper limit of
normal (70% have <2x the upper limit). Although most of these patients have mild
disease, histologically, some may progress to advanced fibrosis and cirrhosis. Experts
differ on whether to biopsy and treat these patients.
Studies of pegylated interferon with ribavirin have not been completed in patients with
normal ALT levels.
Mild Liver Disease

Progression to cirrhosis is likely to be slow in patients who have persistent ALT
elevations but no fibrosis and minimal necroinflammatory changes. These patients may
not need treatment and should be monitored periodically.
Recurrence After Transplantation
Hepatitis C frequently recurs following liver transplantation, and disease progression is
accelerated compared with immunocompetent patients with HCV disease. Once cirrhosis
develops in the allograft, the risk of complications is high. While recurrence of HCV
replication is almost universal after liver transplantation, the severity of the recurrence of
HCV after transplant correlates with the degree of immunosuppression in the
posttransplantation period. Treatment of HCV recurrence after liver transplantation
should be considered experimental and carried out in the context of clinical trials.

Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

--

--

Page 6 of 8
February, 2003

Active Injection Drug Users
Recent, albeit limited, experience has demonstrated the feasibility and effectiveness of
treating chronic HCV in people who use illicit injection drugs, known as injection drug
users (IDUs). Treatment for drug and alcohol abuse should be made available to all
patients who want and need it. However, few data are available on HCV treatment in
active IDUs who are not in drug treatment programs. Thus, it is recommended that
treatment of active injection drug use be considered on a case-by-case basis, and that
active injection drug use in and of itself not be used to exclude such patients from
antiviral therapy.
HIV Co-infection
Although there are no HCV therapies specifically approved for patients co-infected with
HIV, these patients should be considered for treatment.
Alcohol and HCV
Alcohol is an important cofactor in the progression of HCV liver disease to cirrhosis and
HCC. A history of alcohol abuse is not a contraindication to therapy; however, continued
alcohol use during therapy adversely affects response to treatment, and alcohol
abstinence is strongly recommended before and during antiviral therapy. Heavy alcohol
consumption of >80 g/day seriously compromises HCV treatment. Furthermore, safe
levels of alcohol consumption are still unclear, and even moderate levels of consumption
may accelerate disease progression in some patients.
Recommendations

to be made to patients to prevent transmission of hepatitis C

The large reservoir of individuals infected with HCV provides a source of transmission to
others at risk. Direct percutaneous exposure is the most efficient method for transmitting
HCV, and injection drug use accounts for more than two-thirds of all new infections in
the United States. Methadone treatment programs, needle and syringe exchange
programs, and comprehensive risk-modifying educational programs have been shown to
be effective in preventing HIV transmission and are likely to be useful for decreasing
HCV transmission. Ensuring access to sterile syringes through physician prescription and
pharmacy sales of syringes to IDUs can also be helpful. IDUs should be educated about
the importance of hand washing before and after giving injections, not using the others'
injection equipment, and avoiding any contact with blood from other persons. HCV
prevention education should be a high priority in correctional settings.
In the United States, the estimated seroprevalence of HCV is 2 to 3 percent among
partners of HCV-infected persons who are in long-term monogamous relationships and is
4 to 6 percent among persons with multiple sex partners, sex workers, and men who have
sex with men (those at risk for sexually transmitted diseases). One study found the risk of
HCV infection to be threefold higher for female than male sexual partners. Because of
the low risk of HCV transmission, monogamous couples do not need to use barrier
protection (condoms) although they should be advised that condoms may reduce the risk
of transmission. There is no evidence that kissing, hugging, sneezing, coughing, food,
Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

Page 7 of 8
February, 2003

water, sharing eating utensils or drinking glasses, casual contact, or other contact without
exposure to blood is associated with HCV transmission for correctional staff.
Body piercing and tattooing are other potential sources of transmission if contaminated
equipment or supplies are used. However, transmission through these activities is rare
and confounded by other risk factors.
RECOMMENDATIONS

~

Educate the American public on the transmission of HCV in order to better
identify affected individuals and to institute preventive measures.

~

Promote the establishment of screening tests for all groups at high risk of HCV
infection, including mus and incarcerated individuals.

~

Institute measures to reduce transmission of HCV among mus, including
providing access to sterile syringes through needle exchange, physician
prescription, and pharmacy sales; and expanding the Nation's capacity to provide
treatment for substance abuse. Physicians and pharmacists should be educated to
recognize that providing mus with access to sterile syringes and education in
safe injection practices may be lifesaving.

~

Encourage a comprehensive approach to promote the collaboration among health
professionals concerned with management of addiction. Primary care physicians,
and specialists should be involved in various aspects of HCV management - to
deal with the complex societal, medical, and psychiatric issues of mus afflicted
by the disease.

AttachmentJ

Summary
National Institutes of Health
Consensus Development Conference Statement
Management of Hepatitis C
Final Statement
*The complete 44-page document can be found at http://www.nih.gov/.

The NIH Consensus Development Conference on Management of Hepatitis C: 2002
was held June 10 -12,2002.
The final statement was published September 12, 2002.
The "Final Statement" contains the following disclaimers:

1. "This statement is not a policy statement of the Nlli or the Federal Government"
and
2. "Thus, it provides a "snapshot in time" of the state of knowledge".
The Virus
The lack of a vigorous T-Iymphocyte response and the high propensity of the virus to
mutate appear to promote a high rate of chronic infection. The extensive genetic
heterogeneity of Hepatitis C virus (HCY) has important diagnostic and clinical
implications, perhaps explaining difficulties in vaccine development and the lack of
response to therapy. Genotype 1 accounts for 70 to 75 percent of all HCY infections in
_Jhe United States and is associated with a lower rate ofresponse to treatment.
HCY replicates preferentially in hepatocytes but is not directly cytopathic. During
chronic infection, HCV RNA reaches high levels, generally ranging from 105 to 107
international units (IU)/mL, but the levels can fluctuate widely. However, within the
same individual, RNA levels are usually relatively stable.
Epidemiology

Although difficult to assess accurately, the incidence ofllCY infections declined sharply
in the late 1980s. However, the estimated prevalence of HCY in the US. is at least 1.8
percent of the population and a fourfold increase in the number of adults diagnosed with
chronic HCY infection is projected from 1990 to 2015. Currently, persons aged 40 to 59
years have the highest prevalence of HCY infection, and in this age group, the prevalence
is highest in African Americans (6.1%). High HCV seroprevalence rates (from 15-50
percent) have occurred in specific subpopulation, such as homeless, incarcerated persons,
injection drug users, and persons with hemophilia who were treated with clotting factors
before 1992. The highest seroprevalence rates (70 to more than 90 percent) have been
reported in the last of these two groups
Chronic Infection

Hepatitis C Position Statement
Summary ofNlli Statement

,--

- Alabama Department of Corrections

Page 1 of 8
February, 2003

Persistence ofHCV infection is diagnosed by the detection ofHCV RNA in the blood for
at least 6 months. In general, prospective studies have shown that 60 to 85 percent of
HCV-infected persons develop chronic infection.
The most important sequelae of chronic HCY infection are progressive liver fibrosis
leading to cirrhosis, end-stage liver disease, and Hepatocellular Carcinoma (HCC).
Estimates of the proportion of chronically infected persons who develop cirrhosis 20
years after initial infection vary widely from 2 to 4 percent in studies of children and
young women to as high as 20 to 30 percent in middle-aged transfused subjects. The
actual risk is likely intermediate between these two ranges, on the order of 10 to 15
percent. There is little evidence that virologic factors, including viral load, viral genotype,
and quasi-species diversity significantly affect the risk of progression of liver disease.
However, many host factors increase this risk, including:
~
~
~
>>-

Older age at time of infection,
Male gender,
Immunosuppression such as that associated with HIV infection, and
Concurrent chronic hepatitis B infection.
Higher levels of alcohol use play an important role in promoting the development of
progressive liver disease, with strong evidence for the detrimental effects of 30 glday
in men (~equivalent to 2 beers, 2 glasses of wine, or 2 mixed drinks) and 20 g/day in
women.
>- Conversely, individuals infected at a younger age have little or no disease progression
over several decades.

Hepatocellular

Carcinoma

HCC rarely occurs in the absence of cirrhosis or advanced fibrosis. Risk factors for HCC
in persons with chronic HCV infection are largely the same as those for the development
of decompensated cirrhosis. Some but not all studies suggest that treatment with
interferon and ribavirin may reduce the risk of developing HCC in HCV patients with
cirrhosis, but more data are needed.
HCY Serologic Assays
Enzyme immunoassay (ErA) tests are reproducible, inexpensive, and FDA-approved for
use in the diagnosis of HCV infection. The very high sensitivity (low rate of false
negative) and specificity (low rate of false positive) of the version 3 (third-generation)
BIAs (sensitivity of greater than 99 percent, specificity of 99 percent in
immunocompetent patients) obviate the need for a confirmatory immunoblot assay in the
diagnosis of individual patients with clinical liver disease, particularly those with risk
factors for HCV infection.
Qualitative HCY RNA Assays
Chronic HCV infection in a patient with a positive EIA test should be confirmed by a
qualitative HCV RNA assay with a lower limit of detection of 50 IU/mL or less
(approximately 100 viral genes/mL). A single positive qualitative assay for HCV RNA
Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement
Ii

Page 2 of 8
February, 2003

confirms active HCV replication, but a single negative assay does not exclude viremia
and may reflect only a transient decline in viral level below the level of detection of the
assay.
Until future studies determine whether the sustained virological response (SVR) will be
sustained over the long term following successful antiviral treatment, periodic
measurements of HCV RNA may need to be performed.
Quantitative HCV RNA Assays
Testing for HCV RNA level (or viral load) with a quantitative assay provides accurate
information on HCV viral levels. Significant variability exists between available assays.
The clinical utility of serial HCV viral levels in a patient is predicated on continued use
of the same specific quantitative assay that was used in the initial determination of the
viral level. While there is little correlation between disease severity or disease
progression with the absolute level of HCV RNA, quantitative determination of the HCY
level provides important information on the likelihood of response to treatment in
patients undergoing antiviral therapy.
ALT
Testing for serum ALT levels is the most inexpensive and noninvasive, but relatively
insensitive, means of assessing disease activity. Serial determinations of ALT levels over
time may provide a better means of assessing liver injury, but the accuracy of this
approach has not been well documented. Patients who initially have a normal ALT level
should undergo serial measurements over several months to confirm the persistence of
normal ALT levels. Although loss or reduction in HCV RNA is the primary indicator of
response to antiviral therapy, the resolution of elevated ALT levels with antiviral therapy
appears to be an important indicator of disease response.
Noninvasive Tests of Fibrosis
No single test or panel of serologic markers can provide an accurate assessment of
intermediate stages of hepatic fibrosis. Similarly, quantitative tests of liver function and
radiologic imaging of the liver are sensitive for diagnosing advanced cirrhosis but are not
useful in assessing hepatic fibrosis and early cirrhosis.
Liver Biopsy
Liver biopsy provides a unique source of information on fibrosis and assessment of
histology. The information obtained on liver biopsy allows affected individuals to make
more informed choices about the initiation or postponement of antiviral treatment. Thus,
the liver biopsy is a useful part of the informed consent process.
In general, a baseline assessment of liver histology offers a valuable standard for
subsequent comparisons. However, the appropriate interval for subsequent evaluations is
yet to be determined.

Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

Page 3 of 8
February, 2003

Liver biopsy can provide direct histologic assessment of liver injury due to HCV but
cannot be used to diagnose HCV infection.
Hepatocellular Carcinoma Screening
HCC complicates cirrhosis secondary to HCV. It is estimated that HCC occurs after the
development of cirrhosis at a rate varying ITom0 to 3 percent per year. Alpha-fetoprotein
(AFP) and ultrasound every 6 months were used in a single study of patients with
cirrhosis secondary to HCV. Identification of HCC was not significantly increased in the
screened population. The value of screening for AFP is uncertain because there are no
available data to demonstrate the clinical impact of this screening on the management of
HCC or associated mortality. Studies of the performance characteristics of AFP and
hepatic ultrasound show that AFP has a poor sensitivity and a high rate of false-positive
reactions. Hepatic ultrasound is more sensitive than AFP testing but is also more
expensive, and it can lead to invasive and unnecessary evaluations of lesions (e.g.,
regenerative nodules, hemangiomas, hepatic cysts) that are not HCc. However, such
routine AFP or imaging screening should not be performed in patients with HCV in the
absence of cirrhosis because HCC is so rare in this group.
What is the most effective therapy for hepatitis C?

Currently the best indicator of effective treatment is an SVR, defined by the absence of
detectable HCV RNA in the serum as shown by a qualitative HCV RNA assay with
lower limit of detection of 50 IU/mL or less at 24 weeks after the end oftreatment.
Treatment of Naive Patients

Three large pivotal trials have examined the efficacy of pegylated interferon plus
ribavirin in the treatment of chronic HCV infection. Overall, pegylated interferon plus
ribavirin was more effective than standard interferon-ribavirin combination or pegylated
interferon alone. Among patients with genotypes 2 or 3, SVRs with standard interferon
and ribavirin were comparable to those with pegylated interferon and ribavirin, and thus
standard interferon and ribavirin could be used in treating patients with these genotypes.
In a recent study, a 24-week course ofpegylated interferon and ribavirin was found to be
as effective as a 48-week course in patients with genotypes 2 and 3 (SVR rates of 73 to
78 percent), but not in patients with genotype 1 (SVR rates of 41% with 24 weeks and
51% with 48 weeks). Similarly, a reduced ribavirin dosage of 800 mg daily appeared to
be adequate for patients with genotypes 2 and 3, but the higher, standard dosage of 1000
to 1200 mg daily yielded better response rates in patients with genotype 1. Thus, 24
weeks of treatment and an 800 mg dose of ribavirin appear to be sufficient for persons
with genotypes 2 and 3, while patients with genotype 1 need 48 weeks of treatment and
standard doses ofribavirin.
Early viral response (EVR) defined, as a minimum 2-log decrease in viral load during the
first 12 weeks of treatment, is predictive of SVR and should be a routine part of
monitoring patients with genotype 1. Patients who fail to achieve an EVR at week 12 of
treatment have only a small chance of achieving an SVR even if therapy is continued for
Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement
IIiII

Page 4 of 8
February, 2003

a full year. Treatment need not be extended beyond 12 weeks in these patients. Although
an SVR is difficult to correlate with improved survival because of the necessity for longterm follow-up, the absence of detectable serum HCV RNA has been associated with
resolution of liver injury, reduction in hepatic fibrosis, and a low likelihood of a relapse
of the HCV infection. Additionally, in two large but uncontrolled long-term follow-up
studies ITom Japan, SVR after interferon treatment was associated with a lower risk of
HCC. Conversely, one observational Italian study with long-term follow-up found no
difference in development ofHCC between those with and without interferon treatment.
Re-treatment

of Patients

Studies are currently being conducted with pegylated interferon and ribavirin therapy in
patients who relapsed after interferon monotherapy or standard interferon and ribavirin
therapy.
Failure to respond to optimal therapy with pegylated interferon and ribavirin presents a
significant problem, particularly in the presence of advanced fibrosis or cirrhosis.
Currently, several large-scale, multicenter u.S. trials are evaluating the role of
maintenance therapy with pegylated interferon alone in preventing further progression of
cirrhosis, clinical decompensation, or development of HCc. Until the results of these
studies are available, the role of long-term, continuous therapy with pegylated interferon
(or ribavirin or both) for nonresponders should be considered experimental.
Adherence

Patient adherence is critical to the success of treatment of HCV. Physicians should
discuss the importance of adherence with patients before embarking on therapy and
regularly assess and take steps to help their patients maximize their adherence. Such
measures include management of side effects, depression, and substance abuse.
Side Effects of Treatment

In registration trials of pegylated interferon and ribavirin, significant side effects resulted
in discontinuation of treatment in approximately 10 to 14 percent of patients. Major side
effects of combination therapy include influenza-like s)'l11ptoms, hematologic
abnormalities, and neuropsychiatric symptoms. The education of patients, their family
members, and caregivers about side effects and their prospective management is an
integral aspect of treatment. Frequent monitoring of neuropsychiatric side effects,
cytopenia, and adherence to HCV therapy is necessary. Psychological conditions,
particularly depression, are common among persons with HCV and are frequent side
effects of interferon. The patient's mental health status should be assessed before
beginning antiviral therapy and monitored regularly during therapy.
It is not known if the use of hematopoietic growth factors will enhance the likelihood of
SVR. Thus, the 1:>enefitsof such treatment need to be proven prospectively before it can
be recommended.

Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

Page 5 of 8
February, 2003

---~

Which patients with hepatitis C should be treated?
All patients with chronic HCV are potential candidates for antiviral therapy. Treatment is
recommended for patients with an increased risk of developing cirrhosis. These patients
are characterized by:

» DetectableHCVRNA levelshigherthan 50 IU/mL,
» A liver biopsy with findings of portal or bridging fibrosis, and at least Moderate
inflammationand necrosis, and
» PersistentlyelevatedALT values.
Because a large number of HCV-infected persons in the United States are incarcerated,
programs should be implemented to prevent, diagnose, and treat HCV infection in these
individuals. Patients with chronic HCV should be vaccinated against hepatitis A, and
seronegative persons with risk factors for hepatitis B virus (HBV) should be vaccinated
against HBV.
Normal ALT Levels
Approximately 30 percent of patients with chronic HCV infection have normal ALT
levels, and another 40 percent have ALT levels less than two times the upper limit of
normal (70% have <2x the upper limit). Although most of these patients have mild
disease, histologically, some may progress to advanced fibrosis and cirrhosis. Experts
differ on whether to biopsy and treat these patients.
Studies of pegylatedinterferon with ribavirin have not been completed in patients witfi~
normal ALT levels.
Mild Liver Disease
Progression to cirrhosis is likely to be slow in patients who have persistent ALT
elevations but no fibrosis and minimal necroinflammatory changes. These patients may
not need treatment and should be monitored periodically.
Recurrence After Transplantation
Hepatitis C fTequently recurs following liver transplantation, and disease progression is
accelerated compared with immunocompetent patients with HCV disease. Once cirrhosis
develops in the allograft, the risk of complications is high. While recurrence of HCV
replication is almost universal after liver transplantation, the severity of the recurrence of
HCV after transplant correlates with the degree of immunosuppression in the
posttransplantation period. Treatment of HCV recurrence after liver transplantation
should be considered experimental and carried out in the context of clinical trials.

Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNIH Statement

Page 6 of 8
February, 2003

Active Injection Drug Users
Recent, albeit limited, experience has demonstrated the feasibility and effectiveness of
treating chronic HCV in people who use illicit injection drugs, known as injection drug
users (IDUs). Treatment for drug and alcohol abuse should be made available to all
patients who want and need it. However, few data are available on HCV treatment in
active IDUs who are not in drug treatment programs. Thus, it is recommended that
treatment of active injection drug use be considered on a case-by-case basis, and that
active injection drug use in and of itself not be used to exclude such patients from
antiviral therapy.
HIV Co-infection
Although there are no HCV therapies specifically approved for patients co-infected with
HIV, these patients should be considered for treatment.
Alcohol and HCV
Alcohol is an important cofactor in the progression ofHCV liver disease to cirrhosis and
HCC. A history of alcohol abuse is not a contraindication to therapy; however, continued
alcohol use during therapy adversely affects response to treatment, and alcohol
abstinence is strongly recommended before and during antiviral therapy. Heavy alcohol
consumption of >80 g/day seriously compromises HCV treatment. Furthermore, safe
levels of alcohol consumption are still unclear, and even moderate levels of consumption
may accelerate disease progression in some patients.
Recommendations

to be made to patients to prevent transmission of hepatitis C

The large reservoir of individuals infected with HCV provides a source of transmission to
others at risk. Direct percutaneous exposure is the most efficient method for transmitting
HCV, and injection drug use accounts for more than two-thirds of all new infections in
the United States. Methadone treatment programs, needle and syringe exchange
programs, and comprehensive risk-modifying educational programs have been shown to
be effective in preventing HIV transmission and are likely to be useful for decreasing
HCV transmission. Ensuring access to sterile syringes through physician prescription and
pharmacy sales of syringes to roUs can also be helpful. roUs should be educated about
the importance of hand washing before and after giving injections, not using the others'
injection equipment, and avoiding any contact with blood from other persons. HCY
prevention education should be a high priority in correctional settings.
In the United States, the estimated seroprevalence of HCV is 2 to 3 percent among
partners of HCV-infected persons who are in long-term monogamous relationships and is
4 to 6 percent among persons with multiple sex partners, sex workers, and men who have
sex with men (those at risk for sexually transmitted diseases). One study found the risk of
HCV infection to be threefold higher for female than male sexual partners. Because of
the low risk of HCV transmission, monogamous couples do not need to use barrier
protection (condoms) although they should be advised that condoms may reduce the risk
of transmission. There is no evidence that kissing, hugging, sneezing, coughing, food,
Hepatitis C Position Statement - Alabama Department of Corrections
Summary ofNlli Statement

Page 7 of8
February, 2003

water, sharing eating utensils or drinking glasses, casual contact, or other contact without
exposure to blood is associated with HCV transmission for correctional staff.
Body piercing and tattooing are other potential sources of transmission if contaminated
equipment or supplies are used. However, transmission through these activities is rare
and confounded by other risk factors.
RECOMMENDATIONS

~

Educate the Ame11canpublic on the transmission of HCV in order to better
identify affected individualsand to institutepreventivemeasures.

~

Promote the establishment of screening tests for all groups at high risk of HCV
infection, including IDUs and incarcerated individuals.

~

Institute measures to reduce transmission of HCV among IDUs, including
providing access to sterile syringes through needle exchange, physician
prescription, and pharmacy sales; and expanding the Nation's capacity to provide
treatment for substance abuse. Physicians and pharmacists should be educated to
recognize that providing mus with access to sterile syringes and education in
safe injection practices may be lifesaving.

~

Encourage a comprehensive approach to promote the collaboration among health
professionals concerned with management of addiction. Primary care physicians,
and specialists should be involved in various aspects of HCV management - to
deal with the complex societal, medical, and psychiatri-c issues of mus afflicted
by the disease.