Treatment of hepatitis C in hemodialysis patients with pegylated interferon alpha-2a as monotherapy.
ABSTRACT The high prevalence of hepatitis C virus (HCV) infection in hemodialysis patients is of great concern because they have a higher rate of mortality than HCV-negative hemodialysis patients. The aim of the study was to evaluate the efficacy and safety of pegylated interferon alpha-2a monotherapy in hemodialysis patients with chronic HCV infection.
Fourteen dialysis patients with chronic HCV infection were scheduled to receive 135 mug pegylated interferon alpha-2a subcutaneously, once a week, after dialysis session for a period of 48 weeks. Efficacy and safety were assessed by end of treatment viral response, sustained viral response, biochemical response, and adverse events. Serum HCV RNA levels were assessed using reverse transcriptase polymerase chain reaction (RT-PCR), while HCV genotype was analyzed by RT-PCR followed by hybridization of amplified products.
Of the 14 patients enrolled in the study, 9 completed treatment. Eight patients (57%) had undetectable levels of HCV RNA at the end of treatment, while one patient remained positive. Two (14.3%) patients were discontinued because of insufficient therapeutic response. Three patients (21.34%) did not finish treatment because serious adverse events occurred: one patient with bronchopneumonia and one with pericarditis were discontinued from treatment, while one patient died due to cerebral hemorrhage. Sustained viral response was present in 36% of the patients (5/8 patients) at the end of the follow up period. Biochemical response with normalization of serum ALT levels during treatment was observed in all treated patients (83 +/- 20.1 U/L at baseline vs. 23.4 +/- 4.6 U/L at week 48). The most common adverse events were flu-like syndrome, myalgia, arthralgia, and pancytopenia. Most of the adverse events were manageable. The serious adverse events were believed to be unrelated to the therapy, but rather to the co-morbidities of the hemodialysis patients.
Pegylated interferon alpha-2a treatment was effective in a considerable proportion of the treated hemodialysis patients with hepatitis C, and it was reasonably safe to use.
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ABSTRACT: Hepatitis C is both a cause and a complication of chronic renal disease. Chronic infection with hepatitis C virus (HCV) can lead to the immune complex syndromes of cryoglobulinemia and membranoproliferative glomerulonephritis (MPGN). The pathogenetic mechanisms for these conditions have not been defined, although they are clearly caused by the chronic viral infection. Management of HCV-related cryoglobulinemia and MPGN is difficult; antiviral therapy is effective in clearing HCV infection in a proportion of patients, but these conditions can be severe and resistant to antiviral therapy. Hepatitis C also is a complicating factor among patients with end-stage renal disease and renal transplants. The source of HCV infection in these patients can be nosocomial. Screening and careful attention to infection control precautions are mandatory for dialysis units to prevent the spread of hepatitis C. Prevention of spread is particularly important in these patients because HCV infection is associated with significant worsening of survival on dialysis therapy, as well as after kidney transplantation. Furthermore, therapy for hepatitis C is problematic, only partially effective, and associated with significant side effects in this population. There are significant needs in both basic and clinical research in the pathogenesis, natural history, prevention, and therapy for hepatitis C in patients with renal disease.American Journal of Kidney Diseases 11/2003; 42(4):631-57. · 5.29 Impact Factor
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ABSTRACT: Hepatitis C virus (HCV) is prevalent in patients with end stage renal disease who are on dialysis. Liver disease from HCV is a cause of substantial morbidity and mortality after kidney transplantation in infected recipients. Effective treatment of chronic HCV is needed in this group of patients. We aimed to determine from the literature the efficacy and safety of interferon monotherapy in dialysis patients with chronic HCV. We reviewed the literature from 1986 to 2001 on the efficacy of interferon monotherapy in patients with HCV and end stage renal disease who were on dialysis. The outcomes measured were sustained viral response (SVR) and drop-out rate. We reviewed 17 studies, of which 11 studies with a total of 213 patients met criteria for our analysis. Eight studies evaluated 3 million units (MU) three times/wk (t.i.w.), and three studies evaluated higher doses. The pooled SVR for 3 MU was 33% (95% CI = 21-51%). The pooled SVR for genotype 1 patients was 26% (95% CI = 15-37%). Of 152 patients in eight studies treated with 3 MU t.i.w. of interferon monotherapy, 45 patients (29.6%) discontinued therapy because of side effects. Our analysis suggests that interferon monotherapy is more effective in patients on dialysis than in patients with normal renal function. Interferon monotherapy is associated with more adverse events in dialysis patients. The optimal dose and duration of interferon monotherapy and selection criteria of dialysis patients need to be studied further in clinical trials.The American Journal of Gastroenterology 08/2003; 98(7):1610-5. · 7.55 Impact Factor
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ABSTRACT: Hepatitis C virus (HCV) remains common in patients with end-stage renal disease (ESRD) and is an important cause of liver disease in this population. Acquisition of HCV infection continues to occur in dialysis patients because of nosocomial spread. The natural history of HCV in dialysis patients remains controversial because the course of HCV typically extends over decades, whereas dialysis patients have higher morbidity and mortality rates than those of the general population limiting long-term follow-up. However, recent reports suggest that HCV infection affects the survival of chronic dialysis patients as well as renal transplant (RT) recipients. The severity of preexisting liver disease on pretransplantation liver biopsy may provide useful prognostic information about clinical outcome after RT; liver biopsy should be incorporated in the evaluation and management of RT candidates with HCV. Recent surveys with long-term follow-up have documented adverse effects of HCV on patient and graft survival. Use of renal grafts from HCV-infected donors in recipients with HCV does not appear to result in a greater burden of liver disease albeit with short-term follow-up. There is only limited data about interferon (IFN) therapy in chronic dialysis patients, although sustained responses are reported. Preliminary data on IFN plus ribavirin therapy in dialysis patients with hepatitis C have given encouraging results, but randomized trials are needed. Interferon remains contraindicated post-RT because of concern about precipitating graft dysfunction.Hepatology 08/2002; 36(1):3-10. · 12.00 Impact Factor