Infektiologikum Frankfurt, Stresemannallee 3, 60596, Frankfurt, Germany.
ICH Study Center, Hamburg, Germany.
Infection. 2020 Jun;48(3):453-461. doi: 10.1007/s15010-020-01428-1. Epub 2020 May 11.
Current German/Austrian antiretroviral treatment guidelines recommend more than 20 combination regimens for first-line therapy, without a preference. Regimens include two nucleoside reverse transcriptase inhibitors (NRTIs) plus either an integrase strand transfer inhibitor (INSTI), a non-NRTI (NNRTI) or a boosted protease inhibitor (PI). The objective was to examine the outcomes of recommended first-line ART in Germany.
This nationwide observational study included treatment-naïve chronically HIV-1 infected patients receiving one of the recommended first-line regimens. Patients were allocated to three arms (INSTI, NNRTI, PI) and were prospectively followed for 24 months. Delayed treatment initiation was defined by a baseline CD4 T-cell count of < 350/µl or CDC clinical stage C.
Among a total of 434 patients enrolled, virologic failure was rare and occurred in 4.3% (6/141) in the PI arm, in 3.3% (4/122) in the NNRTI arm and in 0.6% (1/171) in the INSTI arm (p = 0.10). De novo drug resistance mutations developed in only two patients in the NNRTI arm. Nonetheless, treatment modifications were frequent (51%) and mostly performed for strategic reasons. Retention on all initial compounds at month 24 was 64%, 49%, and 22% in the INSTI, NNRTI and PI arms respectively. Delayed treatment initiation was common (47%) and more frequently observed in patients in the PI arm. It was not associated with virological failure.
High efficacy and low virological failure rates were observed with recommended first-line regimens independent of delayed treatment initiation, chosen regimen and subsequent treatment modifications, demonstrating the validity of the current treatment guidelines.
目前德国/奥地利的抗逆转录病毒治疗指南建议有超过 20 种联合方案作为一线治疗，没有首选方案。方案包括两种核苷逆转录酶抑制剂（NRTIs），加上整合酶链转移抑制剂（INSTI）、非核苷逆转录酶抑制剂（NNRTI）或增效蛋白酶抑制剂（PI）。本研究旨在观察德国推荐的一线 ART 治疗结果。
这是一项全国性的观察性研究，纳入了接受推荐的一线方案之一治疗的初治慢性 HIV-1 感染患者。患者被分为三组（INSTI、NNRTI、PI），并前瞻性随访 24 个月。延迟治疗开始的定义为基线 CD4 T 细胞计数<350/µl 或 CDC 临床分期 C。
在总共纳入的 434 名患者中，病毒学失败很少见，PI 组中为 4.3%（6/141），NNRTI 组中为 3.3%（4/122），INSTI 组中为 0.6%（1/171）（p=0.10）。仅有两名 NNRTI 组患者出现新的耐药突变。尽管如此，治疗调整仍很频繁（51%），主要是出于策略原因。在第 24 个月时，INSTI、NNRTI 和 PI 组保留所有初始药物的比例分别为 64%、49%和 22%。延迟治疗开始很常见（47%），在 PI 组患者中更为常见。它与病毒学失败无关。
与延迟治疗开始、选择的方案和随后的治疗调整无关，推荐的一线方案具有高效性和低病毒学失败率，证明了当前治疗指南的有效性。
