Entecavir ( Baraclude ) is effective and safe in patients with chronic hepatitis B in the short term, but its long term efficacy and safety has not been established.
Researchers have evaluated HBV DNA clearance, HBeAg/antiHBe and HBsAg/antiHBs seroconversion rates in HBeAg-positive and negative nucleoside analog-naïve HBV patients treated with Entecavir for more than 6 months, and predictors of response.
A hundred and sixty nine consecutive patients were treated with Entecavir for a median of 181 weeks. 61% were HBeAg positive, 23% were cirrhotics, and mean HBV-DNA levels were 6,88 ± 1,74 log10 IU/mL.
Overall, 156 ( 92% ) patients became HBV DNA undetectable, 92 ( 88% ) HBeAg positive and 64 ( 98% ) HBeAg negative patients.
Seventy four ( 71% ) patients cleared HBeAg after a median of 48 weeks of treatment, 23 ( 14% ) patients cleared HBsAg ( 19 HBeAg positive and 4 HBeAg negative, p 0.025 ) after a median of 96 weeks of treatment, and 22 ( 13% ) patients developed protective titers of anti-HBs.
At the end of the study, 35 ( 20% ) patients had discontinued therapy: 33 HBeAg positive and 2 HBeAg negative; 9 of them ( 26% ) developed virological relapse after a median of 48 weeks of stopping treatment.
None of the patients had primary non response and one patient developed breakthrough.
Two patients developed hepatocellular carcinoma, three underwent liver transplantation and 3 deaths were attributable to liver-related events.
No serious adverse event was reported.
In conclusion, long term Entecavir treatment has shown high virological response rates, and a favorable safety profile for nucleoside analog-naive HBeAg-positive and negative patients treated in clinical practice. ( Xagena )
Ridruejo E et al, Ann Hepatol 2014;13:327-336