Mezzadri Luca, Soria Alessandro Guido, Ranzani Alice, Malandrin Sergio, Sabbatini Francesca, Limonta Silvia, Cappelletti Anna, Colella Elisa, Squillace Nicola, Caramma Ilaria Chiara Giuseppina, Monti Bianca, Rugova Alban, Cavallero Annalisa, Bonfanti Paolo, Lapadula Giuseppe
School of Medicine and Surgery, University of Milano-Bicocca, Milan.
Infectious Diseases Unit.
AIDS. 2025 Aug 1;39(10):1344-1352. doi: 10.1097/QAD.0000000000004227. Epub 2025 Jul 1.
To evaluate whether hepatitis B core antibodies, indicative of possible occult hepatitis B virus (HBV) infection (pOBI), are associated with an increased risk of transaminase elevation in people with HIV (PWH) switching to two-drug regimens (2DR).
Cohort study.
We included PWH who switched to 2DR since 2018, if they discontinued at least one anti-HBV drug and were HBsAg-negative at baseline. Two cohorts were analyzed: cohort 1 discontinued tenofovir (TFV) but continued lamivudine (3TC), Cohort 2 switched to regimens without HBV-active drugs. Survival analysis, including Cox regression adjusting for potential confounders, was conducted to compare time to grade ≥1 transaminase increase in those with and without pOBI.
Among 167 patients in cohort 1 (35.2% with pOBI), the rate of transaminitis was 4.59 vs. 7.47 per 100 person-years for those with and without pOBI [incidence rate ratio (IRR) 0.61; 95% confidence interval (CI) 0.17-1.83; P = 0.259]. Cox multivariable analysis found no significant association between pOBI and transaminitis (hazard ratio 0.56; 95% CI 0.2-1.5; P = 0.266), with adjusted models confirming these results. Among 118 individuals in cohort 2 (33.9% with pOBI), transaminitis rates were 8.04 vs. 8.68 per 100 person-years for those with and without pOBI (IRR 0.93; 95% CI 0.19-3.91; P = 0.763). Cox regression showed no significant association between pOBI and transaminitis (hazard ratio 1.18; 95% CI 0.4-3.6; P = 0.769), with consistent findings in adjusted models. No HBV reactivation occurred in either cohort.
pOBI was not associated with risk of transaminase elevation in PWH switching to dual therapies lacking anti-HBV agents.
评估乙型肝炎核心抗体（提示可能存在隐匿性乙型肝炎病毒感染，即pOBI）是否与换用双药方案（2DR）的HIV感染者（PWH）转氨酶升高风险增加相关。
队列研究。
我们纳入了自2018年起换用2DR的PWH，条件是他们至少停用了一种抗HBV药物且基线时HBsAg阴性。分析了两个队列：队列1停用替诺福韦（TFV）但继续使用拉米夫定（3TC），队列2换用不含HBV活性药物的方案。进行生存分析，包括对潜在混杂因素进行校正的Cox回归，以比较有和无pOBI者发生≥1级转氨酶升高的时间。
在队列1的167例患者中（35.2%有pOBI），有和无pOBI者的转氨酶炎发生率分别为每100人年4.59例和7.47例[发病率比（IRR）0.61；95%置信区间（CI）0.17 - 1.83；P = 0.259]。Cox多变量分析发现pOBI与转氨酶炎之间无显著关联（风险比0.56；95% CI 0.2 - 1.5；P = 0.266），校正模型证实了这些结果。在队列2的118例个体中（33.9%有pOBI），有和无pOBI者的转氨酶炎发生率分别为每100人年8.04例和8.68例（IRR 0.93；95% CI 0.19 - 3.91；P = 0.763）。Cox回归显示pOBI与转氨酶炎之间无显著关联（风险比1.18；95% CI 0.4 - 3.6；P = 0.769），校正模型结果一致。两个队列均未发生HBV再激活。
pOBI与换用缺乏抗HBV药物的双联疗法的PWH转氨酶升高风险无关。
