d'Arminio Monforte Antonella, Cozzi-Lepri Alessandro, Maggiolo Franco, Rizzardini Giuliano, Manconi Paolo Emilio, Gianotti Nicola, Quirino Tiziana, Pinnetti Carmela, Rusconi Stefano, De Luca Andrea, Antinori Andrea
University of Milan, Department of Health Sciences, Clinic of Infectious and Tropical Diseases, ASST Santi Paolo e Carlo, Milan, Italy.
University College, London, United Kingdom.
PLoS One. 2016 Jun 27;11(6):e0156360. doi: 10.1371/journal.pone.0156360. eCollection 2016.
There are no data comparing the response to PI/r-based regimens in people presenting for care with low CD4 counts or AIDS (LC).
To compare the response to LPV/r-, DRV/r- or ATV/r-based cART regimens in LC initiating cART from ART-naive.
We included people enrolled in Icona with either CD4 counts ≤350 cells/mm3 (low CD4-LC) or CD4 counts ≤200 cells/mm3 (very low CD4-VLC) and/or AIDS, starting their first PI/r-based regimen after 2008. Initial regimens were compared by intention-to-treat: i) time to viral failure (VF) (first of 2 consecutive VL>200 copies/mL after≥6 months); II) time to PI/r discontinuation/switching for any cause (TD) and for toxicity (TDT); III) treatment failure (TF) (VF or TD). Kaplan-Meier and Cox analyses were used.
1,362 LC patients were included (DRV/r 607; ATV/r 552; LPV/r 203); 813 VLC. In a median of 18 months (IQR:7-35), the 1-year probability of VF and TF were 2.8% (1.9-3.8) and 21.1% (18.7-23.4). In the adjusted analysis, patients initiating ATV/r had a 53% lower chance, and those initiating DRV/r a 61% lower chance of TD, as compared to LPV/r; the risk of TF was more likely in people starting LPV/r. Results were similar among VLC; in this subgroup LPV/r including regimens demonstrated a lower chance of VF.
We confirmed in LC a low chance of virological failure by 1 year, with small differences according to PI/r. However, larger differences were observed when comparing longer-term endpoints such as treatment failure. These results are important for people presenting late for care.
目前尚无数据比较低 CD4 计数或艾滋病（LC）患者对基于蛋白酶抑制剂/利托那韦（PI/r）方案的反应。
比较初治的 LC 患者启动基于洛匹那韦/利托那韦（LPV/r）、达芦那韦/利托那韦（DRV/r）或阿扎那韦/利托那韦（ATV/r）的抗逆转录病毒治疗（cART）方案后的反应。
我们纳入了 Icona 研究中 CD4 计数≤350 个细胞/mm³（低 CD4-LC）或 CD4 计数≤200 个细胞/mm³（极低 CD4-VLC）和/或患有艾滋病的患者，这些患者在 2008 年后开始他们的首个基于 PI/r 的方案。按意向性治疗比较初始方案：i）病毒学失败（VF）时间（连续 2 次病毒载量>200 拷贝/mL 且持续≥6 个月中的首次）；ii）因任何原因（TD）和因毒性（TDT）停用/更换 PI/r 的时间；iii）治疗失败（TF）（VF 或 TD）。采用 Kaplan-Meier 分析和 Cox 分析。
纳入 1362 例 LC 患者（DRV/r 组 607 例；ATV/r 组 552 例；LPV/r 组 203 例）；813 例 VLC 患者。在中位 18 个月（四分位间距：7 - 35）时，1 年的 VF 概率和 TF 概率分别为 2.8%（1.9 - 3.8）和 21.1%（18.7 - 23.4）。在多因素分析中，与 LPV/r 相比，启动 ATV/r 的患者发生 TD 的可能性低 53%，启动 DRV/r 的患者低 61%；启动 LPV/r 的患者发生 TF 的风险更高。VLC 患者中的结果相似；在该亚组中，含 LPV/r 的方案显示 VF 的可能性更低。
我们证实在 LC 患者中 1 年时病毒学失败的可能性较低，根据 PI/r 的不同存在微小差异。然而，在比较诸如治疗失败等长期终点时观察到更大差异。这些结果对就诊较晚的患者很重要。
