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Antivir Ther. 2018 Feb 13. doi: 10.3851/IMP3225. [Epub ahead of print]
Sustained antiviral effects and clearance of hepatitis surface antigen after combination therapy with entecavir and pegylated interferon in chronic hepatitis B.Hagiwara S1, Nishida N1, Watanabe T1, Ida H1, Sakurai T1, Ueshima K1, Takita M1, Komeda Y1, Nishijima N2, Osaki Y2, Kudo M1.
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1Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.2Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
AbstractBACKGROUND: Although the efficacy of combination therapy with lamivudine or tenofovir and pegylated-interferon (Peg-IFN) has been reported in patients with chronic hepatitis B (CHB), the long-term effect of the combination based on the observation of clinical course remains to be clarified. We previously reported the efficacy of combination therapy with entecavir (ETV) and Peg-IFN. Here, we investigated the long-term effect of this combination in patients with CHB.
METHODS: We administered both ETV and Peg-IFN α-2a or -2b simultaneously to 26 patients with hepatitis B virus genotype C infection. Treatment was continued for 48 weeks followed by 24 weeks of observation period; we examined the virological and biochemical responses. We also analyzed characteristics related to the post-treatment relapse. Finally, we investigated the long-term therapeutic effects.
RESULTS: Average reduction of intra-hepatic cccDNA level was 1.2-log copies/μg at the completion of administration. Pretreatment hepatitis B surface antigen (HBsAg) level with more than 3.5 log U/mL was identified as a predictive factor for relapse. Furthermore, the cumulative rates of HBsAg-negative patients at 1, 3, and 5 years after the completion of administration were 3.8, 8.4, and 15%, respectively (mean follow-up period: 4.8 years).
CONCLUSIONS: Baseline HBsAg level with more than 3.5 log U/mL is a useful predictor for relapse 24 weeks after the completion of administration in patients treated with combination therapy. Combination with ETV and Peg-IFN could be an option for treatment of CHB patients especially in those with baseline HBs Ag levels of less than 3.5 log U/mL.
PMID:29438098DOI:10.3851/IMP3225
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