Entecavir Achieves High Response Rate In Real-life Clinical Management Of Patients With Chronic Hepatitis B

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Main Category: Liver Disease / Hepatitis
Also Included In: Medical Practice Management
Article Date: 04 Nov 2009 - 9:00 PST

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The nucleoside analogue entecavir (Baraclude, Bristol-Myers Squibb) achieves a high response rate and progressive decline in liver stiffness in patients with chronic hepatitis B, according to results from the first study in 'real-life' clinical practice reported at the Annual Meeting of the American Association for the Study of Liver Diseases (31 October - 3 November, 2009).

Clinical trials have shown that entecavir is an effective and safe treatment for patients with chronic hepatitis B who have not previously been treated with a nucleoside analogue, but the long-term efficacy has not previously been reported. Italian researchers followed 376 consecutive patients, recruited from 16 centres across Italy during 2007-08, who were treated with entecavir (0.5mg once daily). The patients were generally older than those included in previous clinical trials, with a median age of 58 years, and had more severe liver disease (47% had cirrhosis). More than half (54%) had concomitant disease.

Results showed that nearly two-thirds (64%) of the patients achieved undetectable virus levels (HBV DNA < 12 U/ml) by 24 weeks. This increased to 91% of patients by 48 weeks and to 96% at 72 weeks. Patients with a low level of viraemia at baseline (DNA < 5 log U) were more likely to achieve undetectable virus levels (100% by 12 months), than those with higher viral loads. However, 96% of patients with medium levels of viraemia (DNA 5-8 log U) achieved a virological response by 18 months. And more than three-quarters (77%) of patients with high baseline viral load (DNA > 8 log U) reached this by 18 months.

The lead researcher, Dr Pietro Lampertico, from the University of Milan, Italy, said: "We found we can stop replication of the virus in most patients, which we found surprising as many of these patients would be considered difficult to treat because of the severity of their liver disease," he reported. "An important message for clinicians is not to stop treating patients after one year even if they have residual virus, because the drug will continue to reduce viral levels."

Further results showed that patients' liver enzyme levels (alanine aminotransferase, ALT) improved with entecavir, with the proportion of patients with ALT levels below the upper limit of normal increasing from 14% at baseline to 85% after 72 weeks of treatment. "This is very important. If we can stop the disease, and stop the inflammation of the liver, we may be able to stop disease progression and reduce the risk of liver cancer."

Liver stiffness, assessed by Fibroscan in 73 patients, decreased from 9.3 to 7.0KPa, independently of cirrhosis. More than two-thirds (68%) of patients who had a baseline liver stiffness greater than 12.5KPa achieved a level below this cut-off at their last visit.

A further study showed that entecavir (1.0mg once daily) was superior to adefovir (10mg once daily) in achieving undetectable HBV DNA levels (< 300 copies/ml) in patients with chronic hepatitis B and hepatic decompensation (severe disease, where the liver is no longer functioning adequately). After 48 weeks, 57% of patients treated with entecavir achieved undetectable viral levels, compared to 20% of those on adefovir (p<0.0001).

Nearly two-thirds of patients on entecavir showed improvement or no worsening in the severity of hepatic decompensation, and one-third (35%) showed a two-point or more reduction at 48 weeks. Adverse events were comparable with the two treatments.

Reporting the findings, Dr Hugo Cheinquer, Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil, said: "Entecavir demonstrated greater antiviral efficacy compared to adefovir. This improved potency is important because suppressing the virus improves outcomes. We also saw clinical benefit, with many patients showing improvement in the severity of hepatic decompensation. We are very hopeful that this medication could avoid the need for a liver transplant for a great many patients."

Written by
Susan Mayor, PhD
susanmayor(at)mac.com


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