There has been an increase in the number of patients treated with pegylated interferon (PEG-IFN) and ribavirin due to the better antiviral efficacy. The main serious adverse events of PEG-IFN plus ribavirin combination therapy are bone marrow suppression and hemolytic anemia. However, there are few reports of vasculitis occurring during PEG-IFN therapy. We describe a patient who developed vasculitis during the treatment of chronic hepatitis C with PEG-IFN and ribavirin.
Antiviral Agents/*adverse effects ; Drug Therapy, Combination ; Female ; Hepatitis C, Chronic/*drug therapy ; Humans ; Interferon Alfa-2a/*adverse effects ; Liver Function Tests ; Middle Aged ; Polyethylene Glycols/*adverse effects ; Ribavirin/*adverse effects ; Skin/drug effects ; Vasculitis/*chemically induced

BACKGROUND/AIMS: Combination therapy with peginterferon and ribavirin is a standard therapy for western patients with chronic hepatitis C; however, its efficacy remains unclear in East Asian patients. We evaluated the efficacy and safety of administering peginterferon alfa-2a plus ribavirin in native Korean patients with chronic hepatitis C. METHODS: Seventy-five patients with detectable HCV RNA (52.0% male, median age: 50.8 years) were eligible for the study. The patients were treated with peginterferon alfa-2a 180 mcg/week plus ribavirin 800 mg/day for 24 weeks (for genotype non-1, n=46) or 1000-1200 mg/day for 48 weeks (for genotype 1, n=29). The early virologic response (EVR), the end of treatment virologic response (ETVR), the sustained virologic response (SVR), the biochemical response and the adverse event were analyzed. RESULTS: EVR was seen in 86.2% of the patients with genotype 1. The ETVR was 58.6% in the genotype 1 group and 84.8% in the genotype non-1 group (P=0.02). The overall SVR was 70.7%: 55.2% in the genotype 1 group and 80.4% in the non-1 group (P=0.04). The sustained biochemical response was 64.0%. Multivariate analysis showed that the baseline HCV RNA level (Odds ratio: 0.045, 95% CI: 0.011-0.183, P<0.001) and genotype (Odds ratio: 0.247, 95% CI: 0.063-0.969, P=0.045) had an independent effect on the SVR. Neutropenia, anemia, flu-like symptoms and itching were the common adverse events. Aggravated liver function led to discontinuation of therapy for six patients. Dose modification in twenty-nine patients was effective without producing a significant reduction of the SVR. CONCLUSIONS: Our data suggest that the efficacy of peginterferon plus ribavirin therapy in Koreans is comparable to those from studies on Western patients as an initial treatment for chronic hepatitis C patients. The baseline HCV RNA level and the genotype can be significant factors influencing the SVR.
Ribavirin/*administration & dosage/adverse effects ; Polyethylene Glycols/*administration & dosage/adverse effects ; Middle Aged ; Male ; Korea ; Interferon Alfa-2a/*administration & dosage/adverse effects ; Humans ; Hepatitis C, Chronic/*drug therapy/virology ; Female ; Drug Therapy, Combination ; Antiviral Agents/*administration & dosage/adverse effects ; Adult

BACKGROUND/AIMS: The combination therapy of peginterferon (PEG-IFN) and ribavirin is the standard treatment for hepatitis C virus (HCV) infection. However, few trials have involved patients with cirrhosis. The purpose of this study was to elucidate the efficacy and safety of treatment with PEG-IFN and ribavirin in patients with cirrhosis associated with HCV infection. METHOD: A total of 65 patients were treated with PEG-IFN alpha-2a/ribavirin (n=32) or PEG-IFN alpha-2b/ribavirin (n=33). PEG-IFN alpha-2a and PEG-IFN alpha-2b were administered at doses of 180 microg/week and 1.5 microg/kg/week, respectively, and ribavirin was administered orally at doses of 800-200 mg. Patients with HCV genotype 1 and genotype non-1 were treated for 48 and 24 weeks, respectively. The treatment response was assessed based on the sustained virologic response (SVR). RESULTS: The early virologic response (EVR), end-of-treatment response (ETR), and SVR were 70.0%, 52.0%, and 24.0%, respectively, in genotype 1 (n=50). In genotype non-1 (n=15), the ETR was 53.3% and the SVR was 33.3%. The overall SVR did not differ with genotype (1 vs non-1, 24.0% vs. 33.3%; P=0.471) or between decompensated cirrhosis and compensated cirrhosis (20.0% vs. 27.3%, P=0.630). Ten patients developed cirrhotic complications during the treatment, and 11 stopped treatment due to treatment-related adverse events. CONCLUSION: The combination therapy of PEG-IFN and ribavirin exhibited a low efficacy in cirrhotic patients with HCV infection and was associated with frequent serious complications. However, with careful management of complications, the therapy may have a considerable efficacy in some patients with cirrhosis and HCV infection.
Aged ; Antiviral Agents/adverse effects/*therapeutic use ; Drug Therapy, Combination ; Female ; Genotype ; Hepatitis C, Chronic/complications/*drug therapy ; Humans ; Interferon Alfa-2a/adverse effects/*therapeutic use ; Interferon Alfa-2b/adverse effects/*therapeutic use ; Liver Cirrhosis/*complications ; Male ; Middle Aged ; Neutropenia/etiology ; Platelet Count ; Polyethylene Glycols/adverse effects/*therapeutic use ; RNA, Viral/blood ; Retrospective Studies ; Ribavirin/adverse effects/*therapeutic use ; Severity of Illness Index ; Treatment Outcome

Pegylated interferon alfa-2a (PEG-IFN) and ribavirin combination therapy is the first line treatment for chronic HCV infection. There are four reports of Bell's palsy associated with interferon-alpha (IFN-alpha) and ribavirin therapy. We report here a case of Bell's palsy that occurred in a patient with chronic HCV infection during combination PEG-IFN and ribavirin therapy. The patient was 49-year-old man with chronic hepatitis C for 2 years. The liver biopsy showed grade 1 and stage 1. Therapy with PEG-IFN (Pegasys) 180 microgram/week and ribavirin 1200 mg/day was initiated. After 3 weeks of treatment, the patient showed a loss of muscular tone on the left side of his face. A diagnosis of Bell's palsy was made, and the PEG-IFN and ribavirin therapy was stopped. Prednisolone 45 mg/d was given and then tapered for 8 weeks. His palsy improved over 6 weeks.
Adult ; Antiviral Agents/*adverse effects ; Bell Palsy/*etiology/immunology ; Hepatitis C, Chronic/complications/*drug therapy/virology ; Humans ; Interferon Alfa-2a/*adverse effects/therapeutic use ; Male ; Middle Aged ; Polyethylene Glycols/*adverse effects/therapeutic use ; Ribavirin/administration & dosage/*adverse effects/therapeutic use ; Treatment Outcome

BACKGROUND/AIMS: The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to westerns; however, dose modification occurs more frequently in Koreans. We evaluated the rates of peginterferon alpha-2a and ribavirin dose modifications and their effect on the virologic response in Koreans. METHODS: Patients with detectable HCV RNA and enrolled from multicenters were treated with peginterferon alpha-2a (180 microgram/week) and ribavirin (800 mg/day) for 24 weeks (genotype non-1, n=37) or peginterferon alpha-2a (180 microgram/week) and ribavirin (1,000-1,200 mg/day) for 48 weeks (genotype 1, n=55). RESULTS: Early virologic response (EVR) and sustained virologic response (SVR) were 77.2% (genotype 1, 75%; non-1, 81%) and 66.3% (genotype 1, 56%; non-1, 81%), respectively. The frequency of dose modification was 32.6% within the first 12 weeks and 52.2% during the entire treatment period. No difference was found in SVR regardless of dose modification. However, the SVR for patients using > or =80% of the peginterferon dose was significantly higher than for those using <80% (81.3 vs. 50.0%, p=0.007), despite varying ribavirin doses. No difference was found in SVR regardless of whether the ribavirin dose was <80% or not. These results did not change based on genotype. CONCLUSIONS: We suggest that using at least 80% of the peginterferon alpha-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period. A lower dose of ribavirin may be as efficacious as a standard dose.
Adult ; Aged ; Antiviral Agents/*administration & dosage ; Drug Therapy, Combination ; Female ; Hepatitis C, Chronic/*drug therapy/virology ; Humans ; Interferon Alfa-2a/*administration & dosage/adverse effects ; Male ; Middle Aged ; Polyethylene Glycols/*administration & dosage/adverse effects ; RNA, Viral/blood ; Ribavirin/*administration & dosage/adverse effects

The combination therapy with pegylated interferon alpha and ribavirin has increasingly prescribed for chronic hepatitis C. Although many side effects of interferon such as flu-like symptoms, gastrointestinal and neuropsychiatric symptoms are well known, only several cases of interferon-induced pulmonary toxicity have been reported. Interferon-induced pulmonary toxicity usually develops from 2 weeks to 12 weeks after treatment for HCV infection. Diagnosis is commonly based on clinical findings such as a dry cough, dyspnea, hypoxemia, and a restrictive pattern in pulmonary function testing, bilateral diffuse parenchymal infiltrations, histopathological findings of interstitial pneumonitis, and exclusion of any other causative agents. Prompt withdrawal of the drug is the cornerstone of treatment. We report a case of PEG-IFN alpha-2a induced pulmonary toxicity in a 50-year-old male patient with hepatitis C. To our knowledge, this is the first case of pegylated interferon alpha-2a induced pulmonary toxicity in Korea.
Antiviral Agents/administration & dosage/*adverse effects/therapeutic use ; Hepatitis C, Chronic/*drug therapy ; Humans ; Interferon Alfa-2a/administration & dosage/*adverse effects/therapeutic use ; Lung Diseases/*chemically induced/diagnosis/pathology ; Male ; Middle Aged ; Polyethylene Glycols/administration & dosage/*adverse effects/therapeutic use ; Ribavirin/administration & dosage/therapeutic use ; Treatment Outcome