Treatment in Special Patient populations: HIV, IVDUs, children, alcohol
users, advanced liver disease
excerpt from NIH HCV Consensus Development Conference draft report
Reported by Jules Levin
Patients with Advanced Liver Disease
Data on safety and efficacy of interferon (standard or pegylated) with or
in patients with advanced fibrosis or compensated cirrhosis have been largely
subgroup analyses of larger trials. SVR is lower in patients with advanced
liver disease than in
patients without cirrhosis. An important goal of treatment in advanced liver
disease is to delay
histological disease progression, which is being evaluated in the
NIH-sponsored HALT-C trial.
Patients with decompensated cirrhosis should be referred to clinical trials
until safety and
efficacy data of treatment are established, or they should be considered for
In patients with ESLD, the main treatment option is liver transplantation.
There are ongoing
studies of antiviral therapy of patients awaiting liver transplantation, but
this approach may be
limited by potentially life-threatening side effects of antivirals.
Transplants for HIV coinfected patients are being conducted and preliminary
results suggest these patients may respond as well to transplant as HIV
negative patients. But there is an increasing shortage of livers available
and waiting lists are long.
Recurrence After Transplantation
Hepatitis C frequently recurs following liver transplantation, and disease
accelerated compared to immunocompetent patients with HCV disease. Once
in the allograft, the risk of complications is higher than in immunocompetent
Recurrence of hepatitis C after transplant correlates with HCV RNA level at
the time of
transplantation, the age of the organ donor, and the degree of
immunosuppression in the post-
Few data are available on the treatment of children and adolescents, and
is needed. Studies of interferon monotherapy in children have been largely
small numbers of highly selected patients. SVR rates are similar to or even
better than those in
adults, ranging from 33 to 45 percent (26 percent for genotype 1 and 70
percent for other
genotypes). Several studies of combination therapy in children are under way.
therapies should also be studied in children.
Acute Hepatitis C
Acute hepatitis C is uncommonly recognized and diagnosed. Studies of
treatment for acute hepatitis C have been very heterogeneous and limited by
small sample size,
lack of randomization, variability in the timing of therapy after onset of
infection, dose and
schedule, and endpoints and followup. Although high SVRs have been seen in
uncontrolled trials with interferon monotherapy, recommendations on whether
necessary, the timing of therapy, and which regimen to use remain open.
Injection Drug Users
Recent experience has demonstrated the feasibility and effectiveness of
treating HCV in 20
people who use illicit injection drugs (known as injection drug users or
IDUs). This is important
because IDUs comprise the largest group of hepatitis C patients in the United
successful treatment may reduce transmission. Management of HCV-infected IDUs
by linking IDUs to drug-treatment programs. Efforts should be made to promote
between experts in HCV and substance-abuse providers. HCV therapy has been
when the patients have not been abstinent from continued drug use or are on
Few data are available on HCV treatment in active IDUs who are not in drug
All HIV infected persons should be screened for HCV. Patients with chronic
and concurrent HIV infection may have an accelerated course of HCV disease.
although there are no HCV therapies specifically approved for patients
coinfected with HIV,
these patients should be considered for treatment. Thus far, studies have
enrolled only patients with stable HIV infection and well-compensated liver
disease. In coinfected persons, an SVR can be achieved with HCV treatment.
Preliminary data suggest better responses to PEG-interferon with ribavirin
than to standard interferon with ribavirin. Although treatment of HCV has not
jeopardized control of the HIV infection, additional data are needed.
Alcohol and HCV
Alcohol is an important cofactor in the progression of HCV liver disease to
HCC. A history of alcohol abuse is not an absolute contraindication to
continued alcohol use during therapy adversely affects the response to
treatment. Treatment of HCV should be performed in conjunction with efforts
to treat alcohol abuse or dependence.
Heavy alcohol consumption of >80 g/day seriously compromises HCV treatment.
Safe levels of
alcohol consumption are still unclear.