Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial
Background: In patients with chronic hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepato-cellular carcinoma, and death. Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain...
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| Format: | Article |
| Language: | English |
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Elsevier
2009-01-01
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| Series: | Annals of Hepatology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1665268119318186 |
| _version_ | 1818588229984583680 |
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| author | Mazhar Haque Eric M. Yoshida, MD, MHSc, FRCP(C), FACP, FACG |
| author_facet | Mazhar Haque Eric M. Yoshida, MD, MHSc, FRCP(C), FACP, FACG |
| author_sort | Mazhar Haque |
| collection | DOAJ |
| description | Background: In patients with chronic hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepato-cellular carcinoma, and death. Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain.Methods: We conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 μg per week for 3.5 years, as compared with no treatment, in 1,050 patients with chronic hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin. The patients, who were stratified according to stage of fibrosis (622 with non-cirrhotic fibrosis and 428 with cirrhosis), were seen at 3-month intervals and underwent liver biopsy at 1.5 and 3.5 years after randomization. The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points.Results: We randomly assigned the patients to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. The level of serum ami-notransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly (P < 0.001) with treatment, but there was no significant difference between the groups in the rate of any primary outcome (34.1% in the treatment group and 33.8% in the control group; hazard ratio, 1.01; 95% confidence interval, 0.81 to 1.27; P = 0.90). The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (P = 0.07).Conclusions: Long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin. |
| first_indexed | 2024-12-16T09:21:27Z |
| format | Article |
| id | doaj.art-eacd0e60c8344ecc843a88836bd73953 |
| institution | Directory Open Access Journal |
| issn | 1665-2681 |
| language | English |
| last_indexed | 2024-12-16T09:21:27Z |
| publishDate | 2009-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Annals of Hepatology |
| spelling | doaj.art-eacd0e60c8344ecc843a88836bd739532022-12-21T22:36:45ZengElsevierAnnals of Hepatology1665-26812009-01-01817879Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trialMazhar Haque0Eric M. Yoshida, MD, MHSc, FRCP(C), FACP, FACG1Hepatology Fellow. From the Division of Gastroenterology, the University of British Columbia, CanadaProfessor and Head. From the Division of Gastroenterology, the University of British Columbia, Canada; Address for correspondenceBackground: In patients with chronic hepatitis C who do not have a response to antiviral treatment, the disease may progress to cirrhosis, liver failure, hepato-cellular carcinoma, and death. Whether long-term antiviral therapy can prevent progressive liver disease in such patients remains uncertain.Methods: We conducted a randomized, controlled trial of peginterferon alfa-2a at a dosage of 90 μg per week for 3.5 years, as compared with no treatment, in 1,050 patients with chronic hepatitis C and advanced fibrosis who had not had a response to previous therapy with peginterferon and ribavirin. The patients, who were stratified according to stage of fibrosis (622 with non-cirrhotic fibrosis and 428 with cirrhosis), were seen at 3-month intervals and underwent liver biopsy at 1.5 and 3.5 years after randomization. The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points.Results: We randomly assigned the patients to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. The level of serum ami-notransferases, the level of serum hepatitis C virus RNA, and histologic necroinflammatory scores all decreased significantly (P < 0.001) with treatment, but there was no significant difference between the groups in the rate of any primary outcome (34.1% in the treatment group and 33.8% in the control group; hazard ratio, 1.01; 95% confidence interval, 0.81 to 1.27; P = 0.90). The percentage of patients with at least one serious adverse event was 38.6% in the treatment group and 31.8% in the control group (P = 0.07).Conclusions: Long-term therapy with peginterferon did not reduce the rate of disease progression in patients with chronic hepatitis C and advanced fibrosis, with or without cirrhosis, who had not had a response to initial treatment with peginterferon and ribavirin.http://www.sciencedirect.com/science/article/pii/S1665268119318186Hepatitis Cpeginterferonmaintenance therapycirrhosis |
| spellingShingle | Mazhar Haque Eric M. Yoshida, MD, MHSc, FRCP(C), FACP, FACG Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial Annals of Hepatology Hepatitis C peginterferon maintenance therapy cirrhosis |
| title | Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial |
| title_full | Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial |
| title_fullStr | Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial |
| title_full_unstemmed | Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial |
| title_short | Hepatitis C antiviral long-term treatment against cirrhosis (HALT-C) trial |
| title_sort | hepatitis c antiviral long term treatment against cirrhosis halt c trial |
| topic | Hepatitis C peginterferon maintenance therapy cirrhosis |
| url | http://www.sciencedirect.com/science/article/pii/S1665268119318186 |
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