HBeAg 음성의 대상성 간경변증, HBsAg 소실 시 TDF 사용은?
Q. 50대/남자, 만성 B형 간염 바이러스 감염으로 인한 HBeAg 음성의 대상성 간경변증을 앓고 있으며, 테노포비르 디소프록실 (TDF)로 치료를 받아 왔다 (HBV-DNA는 검출되지 않고, 아미노전이효소 수치가 5년 이상 정상으로 유지됨). TDF 치료 중 마지막 혈액 검사에서 HBsAg가 소실되었다. 당신의 권고는?
A. 간경변이 있기 때문에 HBsAg 소실과 관계없이 장기간 TDF를 계속해야 한다.
B. HBsAg 소실이 확인된 후, anti-HBs 혈청전환과 관계없이 TDF를 중단해야 한다.
C. HBsAg 소실로 인해 간세포암(HCC) 감시를 중단할 수 있다.
D. A와 B 둘 다 합리적인 선택이며, 가이드라인 간 합의가 없다.
정답 : D. A와 B 둘 다 합리적인 선택이며, 가이드라인 간 합의가 없다.
해설 : HBsAg 소실 시, B형 간염 바이러스(HBV) 감염으로 인한 간경변증 환자에서 TDF 중단의 최적 시점에 대한 가이드라인 간 합의가 없습니다.
참고문헌: EASL B형 간염 바이러스 감염 관리에 대한 임상 진료 지침. Journal of Hepatology 2017; 67:370-398.
가이드라인 다운로드
Since NA therapy does not usually achieve HBV eradication and rarely results even in HBsAg loss, long-term therapeutic regimens are given in the majority of NA treated CHB patients.
1) HBeAg-positive CHB patients에서 중단할 수 있는 경우
A widely accepted stopping rule exists only for a proportion of patients with HBeAg-positive CHB who can discontinue NAs if they achieve HBeAg seroconversion and HBV DNA undetectability and have completed 6 or preferentially 12 months of ensuing consolidation therapy. According to the existing data, HBeAg seroconversion will remain in the majority (approximately 90%) and virological remission defined as HBV DNA <2,000– 20,000 IU/ml will be maintained in 50% of such patients at 3 years after NAs cessation. Alternatively, clinicans may choose to continue NA therapy until HBsAg clearance, which represents the safest current treatment endpoint.
2) HBeAg-negative CHB patients에서 중단할 수 있는 경우
Long-term, perhaps indefinite, NA therapy is usually given in HBeAg-negative CHB patients, who are considered to be able to safely stop NAs only if they achieve HBsAg loss.
Recent evidence, accumulating mainly from Asian countries, in which NAs can be discontinued in HBeAg-negative CHB patients who achieve serum HBV DNA undetectability on three separate occasions 6 months apart, suggests that the discontinuation of NAs might be also feasible in this setting. An important factor affecting the probability of off-NA virological remission appears to be the duration of on-therapy HBV DNA undetectability. According to the existing data, virological remission defined as HBV DNA <2,000– 20,000 IU/ml will be maintained in approximately 50% of such patients 3 years after NAs cessation if they have remained for more than two years on virological remission during therapy. Since such findings are based on studies with durations of ontherapy virological remission of[2 to 5 years, the optimal duration of on NAs remission before discontinuation remains unclear.
Since overt hepatitis flares and life-threatening episodes have been rarely reported in patients with pre-existing cirrhosis who discontinue NAs, treatment discontinuation is currently discouraged in patients with cirrhosis. Moreover, NAs may be discontinued only in patients who can be followed closely with ALT and HBV DNA determinations at least during the first year following NAs cessation. Unfortunately, no reliable predictor of post-NAs remission has been identified to date. Retreatment criteria are also important, but have yet to be determined. Based on reasonable clinical judgment, treatment indications for naïve CHB patients may be also applied in patients who discontinue NAs.
참고문헌: EASL B형 간염 바이러스 감염 관리에 대한 임상 진료 지침. Journal of Hepatology 2017; 67:370-398.
