臨床感染症と実践

抽象的な

Retrospective-Prospective Study on Efficacy & Safety of Entecavir in Chronic Hepatitis B West Asian Patients with Genotype D

Akrouf K ,Gad A *,Ibraheem E ,Kassem M ,Abdul Monem FM ,El Kholy N

Aim: To assess the long term efficacy and safety of Entecavir in the treatment of CHB in Asian-Arabic patients with genotype D, for both nucleoside-naïve as well as experienced, comparing HBeAg positive and negative group.

Methods: This study included 70 CHB consecutive patients who were maintained on Entecavir for at least 36 months retrospectively and followed up prospectively every 3 months for a total of 18 months, at 2 centers in Kuwait (October 2012 and April 2014).

Results: It showed that 23 (32.8%) were HBeAg +ve. All were found to be HBV genotype D, 47.1% naive, 22 (31.4%) females, with a mean age of 42.9 ± (13), 14 (20%) cirrhotic and 1(1.4%) decompensated. There were no significant differences in the pre-treatment HBV-DNA level among HBeAg+ve and HBeAg-ve group, with a mean± SD log 10 of 7.9 ± 5.4 and 7.4 ± 5.0 respectively (P=0.237). There was a significant viral load reduction in both groups after 6 months of treatment with Entecavir. The reduction was more pronounced in the HBeAg–ve compared to HBeAg +ve group. In HBeAg +ve, 19 patients (82.61%) had complete HBV-DNA suppression after a median period of 7 month, while in HBeAg –ve group; all (100%) had complete HBV-DNA suppression after a median period of 5 month duration (P<0.05). None showed primary non response to Entecavir in both groups. In the HBeAg-ve group; one (2.13%) had HBsAg loss at 45 month compared to non in HBeAg+ve group (P<0.001), while in the HBeAg+ve group; 5 (21.74%) showed HBeAg clearance after a median of 16 month during Entecavir treatment. Multivariate analysis identified HBeAg negative status, pre-treatment as the only independent factor affecting complete viral suppression on Entecavir treatment. The drug showed 100% safety, as there were no serious adverse events throughout 54 month of follow up. None showed hepatic decompensation, HCC or need for liver transplantation during follow up. Also, there was no reported death throughout study period in both groups.

Conclusions: In real life data; long term Entecavir treatment for up to 54 months in West Asian CHB patients, with genotype D suppressed HBV-DNA to an undetectable level in 100% of HBeAg-ve, compared to 82% in HBeAg +ve group. Entecavir is considered an effective and safe choice on long term use for treatment CHB patients.