Long-Term Benefits of Hepatitis B Treatment in HBeAg-Negative Patients

It is well known that chronic hepatitis B infection can lead to long-term adverse consequences such as cirrhosis and liver cancer. Hepatitis B treatment can reduce the risk of severe liver damage, but the exact magnitude of this benefit remains unknown.

At the recent Digestive Disease Week conference in Los Angeles, researchers presented a model to estimate the long-term benefits of treatment with entecavir (Baraclude) or adefovir (Hepsera) in patients with chronic HBeAg-negative hepatitis B.

The analysis included data about the association between liver disease progression and level of HBV viral replication from REVEAL-HBV, a large hepatitis B epidemiology study. These results were matched to data from two randomized clinical trials, the BMS AI-463027 entecavir study and the GS 438 adefovir trial (plus its five-year open-label extension).

Projections of liver complications over a 10-year period were based on a hypothetical cohort of 1000 patients on continuous treatment with either entecavir or adefovir for five years. For adefovir, data from the most recent five-year analysis were used. The researchers assumed no additional incremental benefit from entecavir beyond the first year of therapy.

Results

Among the subjects treated with entecavir in BMS AI-463027, 96% had HBV DNA below 1000 copies/mL after 48 weeks of therapy, compared with 67% of patients treated with adefovir after five years.

Of the 1000 hypothetical patients, projected numbers of adverse outcomes over ten years were as follows:

For entecavir:  29 cases of hepatocellular carcinoma (HCC)  80 cases of liver cirrhosis  88 patients with at least one event

For adefovir:  75 cases of HCC  157 cases of cirrhosis  178 patients with at least one event

The projected 10-year rates of HCC and cirrhosis were 2.9% and 8.0%, respectively, for patients taking entecavir. The corresponding rates for patients taking adefovir were 7.5% for HCC and 15.7% for cirrhosis. The projected 10-year risk of developing any severe liver complication were 8.8% for entecavir and 17.8% for adefovir

Conclusion

The researchers concluded that the results of this model of HBeAg-negative chronic hepatitis B patients suggests "a very favorable clinical benefit profile for entecavir" in this patient population.

6/13/06

Reference
U Iloeje, Y Yuan, K. Klesczewski, JW Hay. Modeling clinical benefits of suppressing viral replications in HBeAg-negative chronic hepatitis B (CHB) patients: a number-needed-to-treat (NNT) analysis of entecavir and adefovir. Abstract T1835. Digestive Disease Week 2006. May 20-25, 2006. Los Angeles, CA.