Abstract：
OBJECTIVE: We aimed to study hepatitis D virus (HDV) prevalence and risk of progression to severe liver-related events (SLRE) in HBsAg positive people living with HIV (PLWH) in Italy; role of HDV-RNA copy levels, HCV coinfection and nadir CD4 counts were also investigated.
METHODS: People living with HIV (PLWH) from Italian Foundation cohort Naïve antiretrovirals (ICONA) with available HBsAg and HDV Ab were enrolled. HBsAg, HDV Ab, HDV-RNA and HDV genotypes were tested.
METHODS: time from first HDV screening to Severe Liver Related Events (SLRE: decompensated cirrhosis, liver transplantation, HCC). Fine-grey regression models were used to evaluate the association of HDV Ab, HDV-RNA, HDV/HCV coinfection, CD4 nadir and outcome. Secondary end-points: time to SLRE or death; HDV Ab and HDV-RNA prevalence.
RESULTS: A total of 152/809 (18.8%) HBsAg positive PLWH showed HDV Ab reactivity; 63/93 (67.7%) were HDV-RNA positive. Being male, persons who inject drugs (PWID), HCV Ab positive, with FIB-4 > 3.25 were independent factors of HDV Ab positivity. In a median follow-up of 5 years, 37 PLWH (4.1% at 5-year) developed SLRE and 97 (12.0%) reached the SLRE or death end-point. HDV-RNA positive (independently from HDV-RNA copy level) PLWH had a 4.6-fold (95%CI 2.0-10.5) higher risk of SLRE than HDV negatives. PLWH positive for both HCV Ab and HDV Ab showed the highest independent risk of SLRE (ASHR: 11.9, 95%CI: 4.6-30.9 vs. HCV neg/HDV neg). Nadir CD4 < 200/mL was associated with SLRE (ASHR: 3.9, 95% 1.0-14.5).
CONCLUSIONS: One-fifth of the HBsAg positive PLWH harbour HDV infection, and are at high risk of progression to advanced liver disease. HCV contributes to worse outcomes. This population needs urgently effective treatments.
METHODS: People living with HIV (PLWH) from Italian Foundation cohort Naïve antiretrovirals (ICONA) with available HBsAg and HDV Ab were enrolled. HBsAg, HDV Ab, HDV-RNA and HDV genotypes were tested.
METHODS: time from first HDV screening to Severe Liver Related Events (SLRE: decompensated cirrhosis, liver transplantation, HCC). Fine-grey regression models were used to evaluate the association of HDV Ab, HDV-RNA, HDV/HCV coinfection, CD4 nadir and outcome. Secondary end-points: time to SLRE or death; HDV Ab and HDV-RNA prevalence.
RESULTS: A total of 152/809 (18.8%) HBsAg positive PLWH showed HDV Ab reactivity; 63/93 (67.7%) were HDV-RNA positive. Being male, persons who inject drugs (PWID), HCV Ab positive, with FIB-4 > 3.25 were independent factors of HDV Ab positivity. In a median follow-up of 5 years, 37 PLWH (4.1% at 5-year) developed SLRE and 97 (12.0%) reached the SLRE or death end-point. HDV-RNA positive (independently from HDV-RNA copy level) PLWH had a 4.6-fold (95%CI 2.0-10.5) higher risk of SLRE than HDV negatives. PLWH positive for both HCV Ab and HDV Ab showed the highest independent risk of SLRE (ASHR: 11.9, 95%CI: 4.6-30.9 vs. HCV neg/HDV neg). Nadir CD4 < 200/mL was associated with SLRE (ASHR: 3.9, 95% 1.0-14.5).
CONCLUSIONS: One-fifth of the HBsAg positive PLWH harbour HDV infection, and are at high risk of progression to advanced liver disease. HCV contributes to worse outcomes. This population needs urgently effective treatments.
摘要：
目的：我们的目的是研究丁型肝炎病毒（HDV）的患病率和进展为严重肝脏相关事件（SLRE）的风险在HBsAg阳性的人与艾滋病毒（PLWH）在意大利;HDV-RNA拷贝水平的作用，还研究了HCV合并感染和最低点CD4计数。
方法：招募来自意大利基金会队列的HIV感染者（PLWH）与可用HBsAg和HDVAb的初始抗逆转录病毒药物（ICONA）。HBsAg,HDVAb,检测HDV-RNA和HDV基因型。
方法：从首次HDV筛查到严重肝脏相关事件的时间（SLRE：失代偿期肝硬化，肝移植,HCC）。使用精细灰色回归模型来评估HDVAb的关联，HDV-RNA,HDV/HCV合并感染，CD4最低点和结果。次要终点：SLRE或死亡时间；HDVAb和HDV-RNA患病率。
结果：共有152/809（18.8％）HBsAg阳性PLWH显示HDVAb反应性；63/93（67.7％）为HDV-RNA阳性。作为男性，注射毒品（PWID）的人，HCVAb阳性,FIB-4>3.25是HDVAb阳性的独立因素。在5年的中位随访中，37PLWH（5年时4.1%）出现SLRE，97（12.0%）达到SLRE或死亡终点。HDV-RNA阳性（独立于HDV-RNA拷贝水平）PLWH的SLRE风险比HDV阴性高4.6倍（95CI2.0-10.5）。HCVAb和HDVAb的PLWH阳性显示SLRE的独立风险最高（ASHR：11.9，95CI：4.6-30.9vs.HCVneg/HDVneg)。最低CD4<200/mL与SLRE相关（ASHR：3.9，95％1.0-14.5）。
结论：五分之一的HBsAg阳性PLWH港HDV感染，并且有进展为晚期肝病的高风险。HCV导致更坏的结果。这个群体迫切需要有效的治疗。
方法：招募来自意大利基金会队列的HIV感染者（PLWH）与可用HBsAg和HDVAb的初始抗逆转录病毒药物（ICONA）。HBsAg,HDVAb,检测HDV-RNA和HDV基因型。
方法：从首次HDV筛查到严重肝脏相关事件的时间（SLRE：失代偿期肝硬化，肝移植,HCC）。使用精细灰色回归模型来评估HDVAb的关联，HDV-RNA,HDV/HCV合并感染，CD4最低点和结果。次要终点：SLRE或死亡时间；HDVAb和HDV-RNA患病率。
结果：共有152/809（18.8％）HBsAg阳性PLWH显示HDVAb反应性；63/93（67.7％）为HDV-RNA阳性。作为男性，注射毒品（PWID）的人，HCVAb阳性,FIB-4>3.25是HDVAb阳性的独立因素。在5年的中位随访中，37PLWH（5年时4.1%）出现SLRE，97（12.0%）达到SLRE或死亡终点。HDV-RNA阳性（独立于HDV-RNA拷贝水平）PLWH的SLRE风险比HDV阴性高4.6倍（95CI2.0-10.5）。HCVAb和HDVAb的PLWH阳性显示SLRE的独立风险最高（ASHR：11.9，95CI：4.6-30.9vs.HCVneg/HDVneg)。最低CD4<200/mL与SLRE相关（ASHR：3.9，95％1.0-14.5）。
结论：五分之一的HBsAg阳性PLWH港HDV感染，并且有进展为晚期肝病的高风险。HCV导致更坏的结果。这个群体迫切需要有效的治疗。
