Peg Interferon Plus Ribavirin vs Interferon Plus Ribavirin for Hep C
Peg Interferon Plus Ribavirin vs Interferon Plus Ribavirin for Hep C
Background: About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy.
Aim: To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection.
Methods: We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, Science Citation Index Expanded and contacted pharmaceutical companies and authors of trials (to March 2005).
Results: We included 18 randomized clinical trials with 4811 patients. Eleven trials (61%) had allocation bias risks and all had assessment bias risk because of lack of blinding. Compared with interferon plus ribavirin, pegylated interferon plus ribavirin had significant beneficial effects on sustained virological response [risk ratio (RR): 0.80; 95% CI: 0.74-0.88]. Data were insufficient to determine impact on long-term outcomes. Pegylated interferon plus ribavirin significantly increased dose reductions (RR: 1.44; 95% CI: 1.14-1.82) and adverse events including neutropenia (RR: 2.25; 95% CI: 1.58-3.21), thrombocytopenia (RR: 2.28; 95% CI: 1.14-4.54), arthralgia (RR: 1.19; 95% CI: 1.05-1.35), and injection-site reaction (RR: 2.56; 95% CI: 1.06-6.22).
Conclusions: Pegylated interferon plus ribavirin compared with interferon plus ribavirin increased the proportion of patients with sustained virological response, but at the cost of more adverse events.
Hepatitis C virus is a blood-born RNA virus with six genotypes and belonging to the Flaviviridae family. Up to 85% of acutely infected patients develop chronic hepatitis C. Globally, an estimated 170 million people are chronically infected with hepatitis C. The large majority of them will never develop end-stage liver disease. Among the small subgroup that does develop this complication, it has been estimated that, on average, it takes about 30 years for the cirrhosis to occur. Annually, 2-4% of patients with cirrhosis develop hepatocellular carcinoma. Chronic hepatitis C is the most common indication for liver transplantation.
Sustained virological response, i.e. viral clearance six months after treatment, is the standard measure of treatment response. However, it is an intermediate outcome measure and it is unclear if its response to treatment actually predicts the treatments effect on liver-related morbidity and mortality. Interferon was the main therapy for chronic hepatitis C infection for years, but only 20% of patients showed sustained virological response. The efficacy was doubled by adding ribavirin to interferon. Pegylated interferon has recently been developed to further improve response rates. Its advantage is a prolonged half-life by covalent bonding of polyethylene glycol to interferon. Randomized trials have found that pegylated interferon increased the number of patients with sustained virological response, without increasing the risk of adverse events. Pegylated interferon plus ribavirin was superior to pegylated interferon monotherapy and is considered the standard treatment for chronic hepatitis C. We conducted a systematic Cochrane review and meta-analysis of randomized trials on pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection.
Summary and Introduction
Summary
Background: About 170 million patients worldwide have chronic hepatitis C. Pegylated interferon plus ribavirin is currently the recommended therapy.
Aim: To evaluate the beneficial and harmful effects of pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection.
Methods: We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, Science Citation Index Expanded and contacted pharmaceutical companies and authors of trials (to March 2005).
Results: We included 18 randomized clinical trials with 4811 patients. Eleven trials (61%) had allocation bias risks and all had assessment bias risk because of lack of blinding. Compared with interferon plus ribavirin, pegylated interferon plus ribavirin had significant beneficial effects on sustained virological response [risk ratio (RR): 0.80; 95% CI: 0.74-0.88]. Data were insufficient to determine impact on long-term outcomes. Pegylated interferon plus ribavirin significantly increased dose reductions (RR: 1.44; 95% CI: 1.14-1.82) and adverse events including neutropenia (RR: 2.25; 95% CI: 1.58-3.21), thrombocytopenia (RR: 2.28; 95% CI: 1.14-4.54), arthralgia (RR: 1.19; 95% CI: 1.05-1.35), and injection-site reaction (RR: 2.56; 95% CI: 1.06-6.22).
Conclusions: Pegylated interferon plus ribavirin compared with interferon plus ribavirin increased the proportion of patients with sustained virological response, but at the cost of more adverse events.
Introduction
Hepatitis C virus is a blood-born RNA virus with six genotypes and belonging to the Flaviviridae family. Up to 85% of acutely infected patients develop chronic hepatitis C. Globally, an estimated 170 million people are chronically infected with hepatitis C. The large majority of them will never develop end-stage liver disease. Among the small subgroup that does develop this complication, it has been estimated that, on average, it takes about 30 years for the cirrhosis to occur. Annually, 2-4% of patients with cirrhosis develop hepatocellular carcinoma. Chronic hepatitis C is the most common indication for liver transplantation.
Sustained virological response, i.e. viral clearance six months after treatment, is the standard measure of treatment response. However, it is an intermediate outcome measure and it is unclear if its response to treatment actually predicts the treatments effect on liver-related morbidity and mortality. Interferon was the main therapy for chronic hepatitis C infection for years, but only 20% of patients showed sustained virological response. The efficacy was doubled by adding ribavirin to interferon. Pegylated interferon has recently been developed to further improve response rates. Its advantage is a prolonged half-life by covalent bonding of polyethylene glycol to interferon. Randomized trials have found that pegylated interferon increased the number of patients with sustained virological response, without increasing the risk of adverse events. Pegylated interferon plus ribavirin was superior to pegylated interferon monotherapy and is considered the standard treatment for chronic hepatitis C. We conducted a systematic Cochrane review and meta-analysis of randomized trials on pegylated interferon plus ribavirin vs. interferon plus ribavirin for chronic hepatitis C infection.
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