Department of Medicine, Feinberg School of Medicine, Northwestern University CRS, Chicago, Illinois.
Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.
AIDS. 2022 Jun 1;36(7):975-984. doi: 10.1097/QAD.0000000000003193. Epub 2022 Feb 14.
With advances in hepatitis B virus (HBV) therapies, there is a need to identify serum biomarkers that assess the HBV covalently closed circular DNA (cccDNA) reservoir and predict functional cure in HIV/HBV co-infection.
In this retrospective study, combining samples from HIV/HBV co-infected participants enrolled in two ACTG interventional trials, proportions achieving HBsAg less than 0.05 log10 IU/ml and HBV RNA less than log10 1.65 U/ml or not detected (LLoQ/NEG) in response to DUAL [tenofovir TDF+emtricitabine (FTC)] vs. MONO [FTC or lamivudine (3TC)] HBV-active ART, were measured. Predictors of qHBsAg less than 0.05 log10 IU/ml were evaluated in logistic regression models.
There were 88 participants [58% women, median age 34; 47 on DUAL vs. 41 on MONO HBV-active ART]. Twenty-one percent achieved HBsAg less than 0.05 log10 IU/ml (30% DUAL vs. 10% MONO). Time to HBsAg less than 0.05 log10 IU/ml was lower (P = 0.02) and the odds of achieving HBsAg less than 0.05 log10 IU/ml were higher (P = 0.07) in DUAL participants. HBV RNA became less than LLoQ/NEG in 47% (DUAL 60% vs. MONO 33%). qHBsAg less than 3 log10 IU/ml was the strongest predictor of HBsAg less than 0.05 log10 IU/ml.
This study supports current recommendations of TDF-based DUAL-HBV active ART for initial use in HIV/HBV co-infection. HBV RNA could be a useful marker of treatment response in HIV/HBV co-infected patients on HBV-active ART.
随着乙型肝炎病毒 (HBV) 治疗方法的进步,需要确定评估 HBV 共价闭合环状 DNA (cccDNA) 库并预测 HIV/HBV 合并感染中功能性治愈的血清生物标志物。
在这项回顾性研究中,结合了两项 ACTG 干预性试验中入组的 HIV/HBV 合并感染参与者的样本,测量了对 DUAL [替诺福韦 TDF+恩曲他滨 (FTC)] 与 MONO [FTC 或拉米夫定 (3TC)] 抗 HBV 活性 ART 的反应中,达到 HBsAg 小于 0.05 log10IU/ml 和 HBV RNA 小于 log10 1.65 U/ml 或未检测到(LLOQ/NEG)的比例。使用逻辑回归模型评估 qHBsAg 小于 0.05 log10IU/ml 的预测因素。
共有 88 名参与者[58%为女性,中位年龄 34 岁;47 名接受 DUAL,41 名接受 MONO 抗 HBV 活性 ART]。21%的患者达到 HBsAg 小于 0.05 log10IU/ml(30%的 DUAL 组 vs. 10%的 MONO 组)。HBsAg 小于 0.05 log10IU/ml 的时间更短(P=0.02),在 DUAL 组中实现 HBsAg 小于 0.05 log10IU/ml 的几率更高(P=0.07)。HBV RNA 有 47%(DUAL 组为 60%,MONO 组为 33%)变得小于 LLOQ/NEG。qHBsAg 小于 3 log10IU/ml 是 HBsAg 小于 0.05 log10IU/ml 的最强预测因子。
本研究支持当前推荐在 HIV/HBV 合并感染初始治疗中使用 TDF 为基础的 DUAL-HBV 活性 ART。HBV RNA 可能是接受 HBV 活性 ART 的 HIV/HBV 合并感染患者治疗反应的有用标志物。