Niro G A, Smedile A, Fontana R, Olivero A, Ciancio A, Valvano M R, Pittaluga F, Coppola N, Wedemeyer H, Zachou K, Marrone A, Fasano M, Lotti G, Andreone P, Iacobellis A, Andriulli A, Rizzetto M
Gastroenterology Unit, IRCCS 'Casa Sollievo Sofferenza' Hospital, San Giovanni Rotondo (FG), Italy.
Department of Medical Sciences University of Turin, Division of Gastroenterology and Hepatology, Città della Salute e della Scienza University Hospital, Turin, Italy.
Aliment Pharmacol Ther. 2016 Sep;44(6):620-8. doi: 10.1111/apt.13734. Epub 2016 Jul 22.
Therapy of chronic hepatitis D with Interferon is successful when testing for HDV-RNA turns negative. This end-point is disputed.
To assess the role of serum hepatitis B surface antigen (HBsAg) in the clearance of HDV-RNA in pegylated interferon (Peg-IFN)-treated chronic hepatitis D (CHD).
Sixty-two patients with CHD, treated with Peg-IFN, were considered. The patients belonged to three groups: 14 patients cleared the HBsAg and HDV-RNA (responders, R), 12 cleared the HDV-RNA remaining positive for HBsAg (partial responders, PR) and 36 cleared neither the HBsAg nor the HDV-RNA (nonresponders, NR).
In responders, at baseline the median value (mv) of HBsAg and HDV-RNA was 1187 and 188 663 IU/mL. By month 6 of therapy, HBsAg declined to less than 1000 IU/mL and HDV-RNA was undetectable in 12 patients. In NR, the pre-therapy median value of HBsAg and HDV viremia was 6577 and 676 319 IU/mL. There was no significant reduction of antigen at month 6; after a decline, HDV-RNA rebounded to baseline levels. In PR, the median value of baseline HBsAg was 7031 IU/mL; it declined at month 6 in the majority. HDV-RNA progressively declined from an initial median value of 171 405 IU/mL. HBsAg <1000 IU/mL at month 6 discriminated responders and PR from NR (P < 0.001). By ROC curve, the threshold of 0.105 log reduction of HBsAg associated with 1.610 log reduction of HDV-RNA from baseline to month 6 predicted the clearance of this marker.
A reduction of serum HBsAg is mandatory for the definitive clearance of the HDV-RNA. Quantitative HBsAg may predict the long-term response to Peg-IFN therapy and provide a guide to prolong or stop treatment.
当检测到丁型肝炎病毒核糖核酸(HDV-RNA)转为阴性时,用干扰素治疗慢性丁型肝炎是成功的。这一终点存在争议。
评估血清乙肝表面抗原(HBsAg)在聚乙二醇干扰素(Peg-IFN)治疗慢性丁型肝炎(CHD)过程中对HDV-RNA清除的作用。
纳入62例接受Peg-IFN治疗的CHD患者。这些患者分为三组:14例患者清除了HBsAg和HDV-RNA(应答者,R),12例清除了HDV-RNA但HBsAg仍为阳性(部分应答者,PR),36例既未清除HBsAg也未清除HDV-RNA(无应答者,NR)。
在应答者中,基线时HBsAg和HDV-RNA的中位数(mv)分别为1187和188663 IU/mL。治疗至第6个月时,12例患者的HBsAg降至低于1000 IU/mL且HDV-RNA检测不到。在无应答者中,治疗前HBsAg和HDV病毒血症的中位数分别为6577和676319 IU/mL。第6个月时抗原无显著降低;HDV-RNA在下降后又反弹至基线水平。在部分应答者中,基线HBsAg的中位数为7031 IU/mL;多数患者在第6个月时下降。HDV-RNA从初始中位数171405 IU/mL逐渐下降。第6个月时HBsAg<1000 IU/mL可区分应答者、部分应答者与无应答者(P<0.001)。通过ROC曲线,从基线到第6个月HBsAg降低0.105 log且HDV-RNA降低1.610 log的阈值可预测该标志物的清除情况。
血清HBsAg降低是HDV-RNA最终清除的必要条件。定量HBsAg可预测对Peg-IFN治疗的长期反应,并为延长或停止治疗提供指导。