라미부딘 내성 만성 B형 간염환자에서 아데포비어 단독과 라미부딘 아데포비어 병합치료와의 비교 : Comparison of adefovir monotherapy vs. adefovir lamivudine combination therapy in lamivudine resistant chronic hepatitis B patients
- 발행기관 고려대학교
- 발행년도 2007
- 학위수여년월 2007. 8
- 학위명 석사
- 학과 대학원 의학과 내과학전공
- 식별자(기타) DL:000018570705
- 서지제어번호 000045395403
초록/요약
Background: Lamivudine (LAM), an nucleoside analogue, has been widely prescribed as first-choice therapy for chronic hepatitis B (CHB) patients. However, approximately 70% of CHB patients in long-term lamivudine therapy develop resistance to the drug within 5 years of treatment. In comparison adefovir (ADV) monotherapy with ADV+LAM combination therapy, antiviral response is not significantly different in lamivudine-resistant patients. But, it has been reported that ADV-resistant mutations occurs earlier and more frequently in LAM-resistant HBeAg-negative CHB patients who were switched to ADV monotherapy than to ADV+LAM combination therapy. Purpose of this study is to evaluate the efficacy and antiviral resistance to ADV in ADV monotherapy and ADV+LMV combination therapy in LAM resistant chronic hepatitis B patients. Methods: We randomly assigned 157 LAM-resistant chronic hepatitis B patients to either ADV monotherapy (Group A, n=126) or ADV+LAM combination therapy (Group B, n=31). Serum HBV DNA was quantified by bDNA (branched DNA, detection limit: 2000 copies/ml). Biochemical liver function test, HBeAg, anti-HBe antibody was measured every two or three months. Genotypic resistance to ADV or LAM were measured by RFMP analysis. Results: Baseline characteristics (ALT, baseline HBV DNA, severity of liver disease, duration of previous LAM treatment) between group A and group B has no significant difference (P = NS). 88% of HBeAg positive patients were included in group B (P < 0.01). In group A and B, ALT was normalized in 88% vs. 97% (P = NS). Serum HBV DNA become undetectable in 62% vs. 42% (P = NS). Although it has no statistical significance, genotypic resistance tends to develop more common in group A than group B (21% vs. 0%, P = 0.76). Also, virological breakthrough (V-BT) tends to develop more common in group A than group B (6.0% vs. 0%, P = 0.61). Conclusion: In short term observational period, cumulative probability of biochemical, virological response between the two treatment groups shows no difference. Genotypic resistance to ADV and V-BT tends to develop in group A than group B. Further long-term study is warranted to confirm the clinical outcome between two groups.
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