HCV - three more studies
New findings in hepatitis C virus described from the United States, Canada and Germany
World Disease Weekly - Jun. 06, 2006
Data on hepatitis C virus are outlined in reports from the United States, Canada and Germany.
Study 1: According to recent research from the United States, early interferon therapy produces sustained hepatitis C virus (HCV) virologic response.
"Pegylated interferon therapy has not been adequately evaluated in acute HCV infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C," wrote S.M. Kamal and colleagues, Harvard University.
They explained, "One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 mcg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR])."
"All patients were followed for 48 weeks after cessation of therapy. One hundred twenty-nine subjects started treatment at week 8 (group A, n=43), week 12 (group B, n=43), or week 20 (group C, n=43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1.
"Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy," wrote the researchers.
The scientists concluded, "Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20."
Kamal and colleagues published their study in Gastroenterology (Peginterferon alfa-2b therapy in acute hepatitis C: Impact of onset of therapy on sustained virologic response. Gastroenterology, 2006;130(3):632-638).
For additional information, contact S.M. Kamal, Harvard University, Beth Israel Deaconess Medical Center, School of Medicine, Liver Diseases Center, 4 Blackfan Circle, Boston, MA 02115, USA.
Study 2: According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.
"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."
The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.
"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment." "Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors. They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences." Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111). For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada. Study 3: A study from Germany has reported that early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection leads to high virological response rates.
"Early treatment of acute hepatitis C with interferon alpha-2b for 24 weeks prevents chronic infection in almost all patients. Because pegylated interferons have replaced conventional interferon in the therapy of chronic hepatitis C, the aim of this study was to analyze the efficacy of an early treatment of acute hepatitis C with peginterferon alpha-2b," wrote J. Wiegand and colleagues, Hannover Medical School.
They continued, "Between February 2001 and February 2004, 89 individuals with acute HCV infection were recruited at 53 different centers in Germany. Patients received 1.5 mcg/kg peginterferon alpha-2b for 24 weeks; treatment was initiated after a median of 76 days after infection (range 14-150)."
The researchers explained, "End-of-treatment response and sustained virological response were defined as undetectable HCV RNA at the end of therapy and after 24 weeks of follow-up, respectively.
"In the total study population, virological response was 82% at the end of treatment and 71% at the end of follow-up. Of 89 individuals, 65 (73%) were adherent to therapy, receiving 80% of the interferon dosage within 80% of the scheduled treatment duration. End-of-treatment and sustained virological response rates in this subpopulation. were 94% and 89%, respectively."
"A maximum Ala aminotransferase level of more than 500 U/L prior to therapy was the only factor associated with successful treatment," the scientists explained.
"In acute HCV infection, early treatment with peginterferon alpha 2b leads to high virological response rates in individuals who are adherent to treatment. The high number of dropouts underlines the importance of thorough patient selection and dose monitoring during therapy," concluded the authors.
"Thus," they further noted, "future studies should identify factors predicting spontaneous viral clearance to avoid unnecessary therapy."
Wiegand and colleagues published their study in Hepatology (Early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection: the HEP-NET Acute-HCV-II Study. Hepatology, 2006;43(2):250-256).
Additional information can be obtained by contacting M.P. Manns, Hannover Medical School, Department of Gastroenterology, Hepatology & Endocrinology, Carl Neuberg Str 1, D-30625 Hannover, Germany.
Keywords: Hannover, Germany, Hepatitis C Virus, Pegylated Interferon, Ribavirin, Viral Clearance, Virological Response Rates.
This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.
World Disease Weekly - Jun. 06, 2006
Data on hepatitis C virus are outlined in reports from the United States, Canada and Germany.
Study 1: According to recent research from the United States, early interferon therapy produces sustained hepatitis C virus (HCV) virologic response.
"Pegylated interferon therapy has not been adequately evaluated in acute HCV infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C," wrote S.M. Kamal and colleagues, Harvard University.
They explained, "One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 mcg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR])."
"All patients were followed for 48 weeks after cessation of therapy. One hundred twenty-nine subjects started treatment at week 8 (group A, n=43), week 12 (group B, n=43), or week 20 (group C, n=43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1.
"Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy," wrote the researchers.
The scientists concluded, "Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20."
Kamal and colleagues published their study in Gastroenterology (Peginterferon alfa-2b therapy in acute hepatitis C: Impact of onset of therapy on sustained virologic response. Gastroenterology, 2006;130(3):632-638).
For additional information, contact S.M. Kamal, Harvard University, Beth Israel Deaconess Medical Center, School of Medicine, Liver Diseases Center, 4 Blackfan Circle, Boston, MA 02115, USA.
Study 2: According to scientists from Canada, hepatitis C virus treatment efficacy can be predicted.
"In the past, antiviral therapy has been given to 15% to 30% of patients infected with hepatitis C virus (HCV). The efficacy of therapy has recently improved with the addition of ribavirin and pegylated interferon. The aim of the present study was to identify the clinical, socioeconomic and health-system predictors of antiviral treatment for HCV," wrote M. Witkos and colleagues, University of Toronto. "A retrospective analysis of compensation claims data of patients who acquired HCV through blood transfusions between 1986 and 1990 was performed. The patients consisted of 2456 Canadian HCV-positive individuals."
The researchers wrote, "The authors reviewed narrative comments from physicians, and constructed univariate and multivariate logistic regression models, using receipt of antiviral therapy with interferon or interferon/ribavirin as the primary outcome. Of the 2456 patients, approximately 30% appeared to be eligible, but only 16% received treatment.
"Univariate analyses suggested that the disease severity, age, HIV status and province of residence were associated with the likelihood of receiving treatment (p<.01). The final, multivariable model indicated that in patients with HCV. Intermediate disease severity (eg, fibrosis, p<.0001); middle age (p<.0001); HIV-negative status (p<.0001); and province of residence (Quebec, p<.0001; and Saskatchewan, p<.0001) were independent predictors of treatment." "Narrative comments of physicians emphasized the importance of age, HIV status and patient preferences in clinical decision-making. Given the efficacy and cost-effectiveness of current antiviral therapy, treatment rates of HCV patients may be suboptimal," reported the authors. They concluded, "Further work is required to understand barriers to treatment related to geography, organization of medical care, age, medical provider and patient preferences." Witkos and colleagues published their study in Canadian Journal of Gastroenterology (Predictors of antiviral therapy in a post-transfusion cohort of hepatitis C patients. Can J Gastroenterol, 2006;20(2):107-111). For additional information, contact M.D. Krahn, University of Toronto, Toronto General Hospital, Department of Health Policy Management & Evaluation, 200 Elizabeth St., EN 14-207, Toronto, ON M5G 2C4, Canada. Study 3: A study from Germany has reported that early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection leads to high virological response rates.
"Early treatment of acute hepatitis C with interferon alpha-2b for 24 weeks prevents chronic infection in almost all patients. Because pegylated interferons have replaced conventional interferon in the therapy of chronic hepatitis C, the aim of this study was to analyze the efficacy of an early treatment of acute hepatitis C with peginterferon alpha-2b," wrote J. Wiegand and colleagues, Hannover Medical School.
They continued, "Between February 2001 and February 2004, 89 individuals with acute HCV infection were recruited at 53 different centers in Germany. Patients received 1.5 mcg/kg peginterferon alpha-2b for 24 weeks; treatment was initiated after a median of 76 days after infection (range 14-150)."
The researchers explained, "End-of-treatment response and sustained virological response were defined as undetectable HCV RNA at the end of therapy and after 24 weeks of follow-up, respectively.
"In the total study population, virological response was 82% at the end of treatment and 71% at the end of follow-up. Of 89 individuals, 65 (73%) were adherent to therapy, receiving 80% of the interferon dosage within 80% of the scheduled treatment duration. End-of-treatment and sustained virological response rates in this subpopulation. were 94% and 89%, respectively."
"A maximum Ala aminotransferase level of more than 500 U/L prior to therapy was the only factor associated with successful treatment," the scientists explained.
"In acute HCV infection, early treatment with peginterferon alpha 2b leads to high virological response rates in individuals who are adherent to treatment. The high number of dropouts underlines the importance of thorough patient selection and dose monitoring during therapy," concluded the authors.
"Thus," they further noted, "future studies should identify factors predicting spontaneous viral clearance to avoid unnecessary therapy."
Wiegand and colleagues published their study in Hepatology (Early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection: the HEP-NET Acute-HCV-II Study. Hepatology, 2006;43(2):250-256).
Additional information can be obtained by contacting M.P. Manns, Hannover Medical School, Department of Gastroenterology, Hepatology & Endocrinology, Carl Neuberg Str 1, D-30625 Hannover, Germany.
Keywords: Hannover, Germany, Hepatitis C Virus, Pegylated Interferon, Ribavirin, Viral Clearance, Virological Response Rates.
This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2006, World Disease Weekly via NewsRx.com.
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