Background: 

The SWORD trials showed that in participants who achieved virologic suppression taking 3-drug or 4-drug regimens, switching to the 2-drug regimen dolutegravir plus rilpivirine was noninferior in maintaining HIV-1 RNA <50 copies/mL at the week 48 primary endpoint. We present pooled week 148 analysis results from both studies.

Setting: 

SWORD-1: 65 centers, 13 countries; SWORD-2: 60 centers, 11 countries.

Methods: 

SWORD-1 and SWORD-2 are identical, open-label, phase III studies. Participants with screening HIV-1 RNA <50 copies/mL for ≥6 months; no prior virologic failure; and no documented resistance-associated major protease inhibitor, integrase inhibitor, nucleoside reverse transcriptase inhibitor (NRTI), or non-NRTI mutations or integrase resistance-associated substitution R263K were randomly assigned 1:1 to switch to once-daily dolutegravir 50 mg plus rilpivirine 25 mg on day 1 (early-switch group) or to continue their current antiretroviral regimen and, if virologically suppressed at week 48, switch to dolutegravir plus rilpivirine at week 52 (late-switch group) until week 148.

Results: 

Using snapshot algorithm at week 148, 432 of 513 (84%) early-switch participants (148 weeks of exposure) and 428 of 477 (90%) late-switch participants (96 weeks of exposure) maintained HIV-1 RNA <50 copies/mL. Eleven participants (1%) on dolutegravir plus rilpivirine met the confirmed virologic withdrawal criterion through week 148 (early-switch group, n = 8; late-switch group, n = 3) with no integrase resistance identified. Non-NRTI resistance-associated mutations were identified in 6 participants (<1%). Drug-related adverse events (grades 2–4) were observed in 31 (6%) early-switch and 16 (3%) late-switch participants. Significant improvements in bone biomarkers were observed. Significant improvements were observed in renal biomarkers in participants taking tenofovir disoproxil fumarate pre‐switch.

Conclusion: 

Switching to the 2-drug regimen dolutegravir plus rilpivirine maintained virologic suppression for a high proportion of participants through 3 years, with low rates of virologic failure and a well-tolerated safety profile.

中文翻译：

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简要报告：改用Dolutegravir + Rilpivirine 2药物治疗3年后，持久抑制和病毒学失败率低：SWORD-1和SWORD-2随机临床试验的148周结果

背景： 

SWORD试验显示，在接受3药物或4药物治疗的患者中达到病毒学抑制的参与者中，切换至2药物治疗的方法dolutegravir加rilpivirine在第48周的主要终点维持HIV-1 RNA <50拷贝/ mL的情况不差。我们提出了两项​​研究的第148周汇总分析结果。

设置： 

SWORD-1：13个国家/地区的65个中心；SWORD-2：11个国家/地区的60个中心。

方法： 

SWORD-1和SWORD-2是相同的，开放标签的III期研究。筛查HIV-1 RNA <50拷贝/ mL≥6个月的参与者；没有先前的病毒学故障；没有随机记录的耐药相关主要蛋白酶抑制剂，整合酶抑制剂，核苷逆转录酶抑制剂（NRTI）或非NRTI突变或整合酶耐药相关取代R263K分配为1：1切换至每日一次多洛格韦50 mg加利匹韦林第1天服用25 mg（早期转换组），或继续其当前的抗逆转录病毒疗法，如果在第48周被病毒抑制，则在第52周转换为dolutegravir加rilpivirine（晚期转换组），直到148周。

结果： 

在第148周时使用快照算法，513名（84％）早​​期转换参与者（暴露148周）中的432名和477名（90％）晚期转换参与者（暴露96周）中的428名维持了HIV-1 RNA <50份/毫升 在第148周时，接受dolutegravir加上rilpivirine的11名参与者（1％）达到了确认的病毒学戒断标准（早期转换组，n = 8；晚期转换组，n = 3），未发现整合酶耐药性。在6名参与者中发现了非NRTI耐药相关突变（<1％）。在31名（6％）早期转换参与者和16名（3％）晚期转换参与者中发现了与药物相关的不良事件（2-4级）。观察到骨生物标志物的显着改善。服用替诺福韦酯富马酸替诺福韦的参与者在肾脏生物标志物方面观察到显着改善。

结论： 

切换到2种药物方案dolutegravir加利匹韦林经过三年保持病毒学抑制了参与者的比例很高，与病毒治疗失败和耐受性良好的安全性的低利率。