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Clinical efficacy of a 24-months course of lamivudine therapy in patients with HBeAg negative chronic hepatitis B: a long-term prospective study.

Paik YH, Kim JK, Kim do Y, Park JY, Ahn SH, Han KH, Chon CY, Lee KS - J. Korean Med. Sci. (2010)

Bottom Line: The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months.The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively.In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Institute of Gastroenterology, Liver Cirrhosis Clinical Research Center, Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT
The optimal duration of oral nucleos(t)ide analogue therapy for HBeAg negative chronic hepatitis B (CHB) has not been defined. The aim of this study was to investigate the clinical efficacy of 24-months course of lamivudine therapy in patients with HBeAg negative CHB in Korea. A total of 50 Korean patients with HBeAg negative CHB were prospectively enrolled. The patients received 100 mg/day of lamivudine orally for 24 months. Patients who showed complete response at 24 months to lamivudine therapy stopped treatment, and regular follow-up was done thereafter. The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months. The complete response rate at months 12 and 24 were 86.0% (43/50) and 86.0% (43/50), respectively, and the clinical breakthrough at months 12 and 24 were 4.0% (2/50) and 14.0% (7/50), respectively. The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively. In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

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Complete response during re-treatment in patients who relapsed after stopping lamivudine therapy. Complete response rate at 12 and 24 months of re-treatment was 100% and 70.0%, respectively.
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Figure 3: Complete response during re-treatment in patients who relapsed after stopping lamivudine therapy. Complete response rate at 12 and 24 months of re-treatment was 100% and 70.0%, respectively.

Mentions: Fourteen patients among 18 patients who relapsed after cessation of lamivudine therapy were retreated with lamivudine. Complete response rates at 3, 6, 12, 18, and 24 months of lamivudine re-treatment were 64.2% (9 of 14 patients), 92.8% (13 of 14 patients), 100.0% (14 of 14 patients), 83.3% (10 of 12 patients), 70.0% (7 of 10 patients), respectively (Fig. 3). Clinical breakthrough (HBV DNA positive conversion with ALT re-elevation) occurred in 30.0% of patients during the second year of the re-treatment period (Fig. 3). The flow chart of the 24-months course of lamivudine therapy in HBeAg negative CHB patients is illustrated in Fig. 4.


Clinical efficacy of a 24-months course of lamivudine therapy in patients with HBeAg negative chronic hepatitis B: a long-term prospective study.

Paik YH, Kim JK, Kim do Y, Park JY, Ahn SH, Han KH, Chon CY, Lee KS - J. Korean Med. Sci. (2010)

Complete response during re-treatment in patients who relapsed after stopping lamivudine therapy. Complete response rate at 12 and 24 months of re-treatment was 100% and 70.0%, respectively.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2877218&req=5

Figure 3: Complete response during re-treatment in patients who relapsed after stopping lamivudine therapy. Complete response rate at 12 and 24 months of re-treatment was 100% and 70.0%, respectively.
Mentions: Fourteen patients among 18 patients who relapsed after cessation of lamivudine therapy were retreated with lamivudine. Complete response rates at 3, 6, 12, 18, and 24 months of lamivudine re-treatment were 64.2% (9 of 14 patients), 92.8% (13 of 14 patients), 100.0% (14 of 14 patients), 83.3% (10 of 12 patients), 70.0% (7 of 10 patients), respectively (Fig. 3). Clinical breakthrough (HBV DNA positive conversion with ALT re-elevation) occurred in 30.0% of patients during the second year of the re-treatment period (Fig. 3). The flow chart of the 24-months course of lamivudine therapy in HBeAg negative CHB patients is illustrated in Fig. 4.

Bottom Line: The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months.The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively.In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Institute of Gastroenterology, Liver Cirrhosis Clinical Research Center, Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine, Seoul, Korea.

ABSTRACT
The optimal duration of oral nucleos(t)ide analogue therapy for HBeAg negative chronic hepatitis B (CHB) has not been defined. The aim of this study was to investigate the clinical efficacy of 24-months course of lamivudine therapy in patients with HBeAg negative CHB in Korea. A total of 50 Korean patients with HBeAg negative CHB were prospectively enrolled. The patients received 100 mg/day of lamivudine orally for 24 months. Patients who showed complete response at 24 months to lamivudine therapy stopped treatment, and regular follow-up was done thereafter. The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months. The complete response rate at months 12 and 24 were 86.0% (43/50) and 86.0% (43/50), respectively, and the clinical breakthrough at months 12 and 24 were 4.0% (2/50) and 14.0% (7/50), respectively. The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively. In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

Show MeSH
Related in: MedlinePlus