icon-folder.gif   Conference Reports for NATAP  
  NIH HCV Consensus Development Conference
June 10-12, 2002
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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 without ribavirin in patients with advanced fibrosis or compensated cirrhosis have been largely derived from 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 liver transplantation.
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 progression is accelerated compared to immunocompetent patients with HCV disease. Once cirrhosis develops in the allograft, the risk of complications is higher than in immunocompetent cirrhotic patients. 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- transplantation period.
Few data are available on the treatment of children and adolescents, and further research is needed. Studies of interferon monotherapy in children have been largely uncontrolled, with 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. Promising new therapies should also be studied in children.
Acute Hepatitis C
Acute hepatitis C is uncommonly recognized and diagnosed. Studies of interferon 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 small uncontrolled trials with interferon monotherapy, recommendations on whether treatment is 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 States, and successful treatment may reduce transmission. Management of HCV-infected IDUs is enhanced by linking IDUs to drug-treatment programs. Efforts should be made to promote collaboration between experts in HCV and substance-abuse providers. HCV therapy has been successful even when the patients have not been abstinent from continued drug use or are on daily methadone.
Few data are available on HCV treatment in active IDUs who are not in drug treatment programs.
HIV Coinfection
All HIV infected persons should be screened for HCV. Patients with chronic hepatitis C and concurrent HIV infection may have an accelerated course of HCV disease. Therefore, 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 cirrhosis and HCC. A history of alcohol abuse is not an absolute contraindication to therapy; however, 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.