Hepatology Unit, Tor Vergata University, Rome, Italy.
Liver Transplant Unit, Tor Vergata University, Rome, Italy.
Clin Transplant. 2023 Jun;37(6):e14971. doi: 10.1111/ctr.14971. Epub 2023 Mar 17.
Indefinite, long-term administration of hepatitis B immunoglobulins (HBIg), together with a third generation nucleos(t)ide analog (NA), is the currently recommended prophylactic strategy to prevent viral recurrence after liver transplantation (LT) for Hepatitis Delta virus (HDV)/Hepatitis B virus (HBV)-related disease.
We retrospectively analyzed the safety and long-term clinical and virological outcomes of a consecutive cohort of 16 patients (10 males, median age 64.5, range 41-75) transplanted for HDV/HBV-related cirrhosis at our Institution, who discontinued HBIg after a median of 24.5 months (range 15-116) after transplant. All patients continued prophylaxis with same NA used before LT. Recurrence of HDV/HBV infection was defined as reappearance of serum HDV-RNA with detectable serum HBsAg and/or HBV-DNA.
The median follow-up after LT was 138 months (range 73-316) and 110 months (range 52-200) after HBIg withdrawal. All patients were HBsAg-positive, HBV-DNA negative, and anti-HDV positive at the time of LT and without coinfections with HCV or HIV. Patients were followed with biochemical and virological tests every 3-6 months after HBIg withdrawal. No recurrences of HDV/HBV infection or disease were observed during monoprophylaxis with NA. In addition, eight patients (50%) spontaneously developed anti-HBs titers above 10 IU/L at a median of 74 months (range 58-140) following HBIG discontinuation.
HBIg withdrawal after LT is a safe and efficacious strategy in patients transplanted for HDV/HBV disease and is frequently associated with the spontaneous development of serological immunity against HBV. These data call for a revision of current prophylactic recommendations in this setting.
目前推荐使用乙型肝炎免疫球蛋白(HBIg)联合第三代核苷(酸)类似物(NA)进行无限期、长期治疗,作为预防乙型肝炎病毒(HBV)/δ 肝炎病毒(HDV)相关疾病肝移植(LT)后病毒复发的预防性策略。
我们回顾性分析了我院连续 16 例(10 例男性,中位年龄 64.5 岁,范围 41-75 岁)因 HDV/HBV 相关肝硬化而接受 LT 的患者的安全性和长期临床及病毒学结果,这些患者在 LT 后中位 24.5 个月(范围 15-116 个月)后停止 HBIg 治疗。所有患者均继续使用 LT 前使用的相同 NA 进行预防。HDV/HBV 感染的复发定义为血清 HBV-RNA 再次出现,伴有可检测的血清 HBsAg 和/或 HBV-DNA。
LT 后的中位随访时间为 138 个月(范围 73-316 个月),HBIG 停药后的中位随访时间为 110 个月(范围 52-200 个月)。所有患者在 LT 时均为 HBsAg 阳性、HBV-DNA 阴性和抗-HDV 阳性,且无 HCV 或 HIV 合并感染。HBIG 停药后,患者每 3-6 个月进行一次生化和病毒学检测。在 NA 单药预防期间,未观察到 HDV/HBV 感染或疾病的复发。此外,8 例(50%)患者在 HBIG 停药后中位 74 个月(范围 58-140 个月)时自发产生抗-HBs 滴度>10IU/L。
在 HDV/HBV 疾病患者 LT 后停止 HBIg 治疗是一种安全有效的策略,并且经常与针对 HBV 的血清免疫的自发产生相关。这些数据呼吁修订该治疗方案中的预防建议。