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首页> 外文期刊>JAIDS: Journal of acquired immune deficiency syndromes >Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis.
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Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis.

机译：洛匹那韦-利托那韦单药治疗与洛匹那韦-利托那韦和2种核苷用于HIV维持治疗：96周分析。

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BACKGROUND: The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, it is still uncertain if this experimental strategy can maintain suppression in the long term. METHODS: Patients entered this noninferiority trial (upper limit 95% confidence interval: +12%) with no history of virological failure while receiving a protease inhibitor and receiving 2 nucleosides plus lopinavir/ritonavir, with HIV RNA <50 copies per milliliter for more than 6 months. Primary end point was percent of patients without therapeutic failure, defined as confirmed HIV RNA >500 copies per milliliter with exclusion of monotherapy patients who resuppressed to <50 copies per milliliter after resuming baseline nucleosides, or loss to follow-up, or change of randomized therapy other than reinduction. RESULTS: Through 96 weeks, percentage of patient without therapeutic failure was 87% (monotherapy, n = 100) vs. 78% (triple therapy, n = 98; 95% confidence interval: -20% to +1.2%). Percentage with HIV RNA <50 copies per milliliter (intention to treat, missing = failure, reinduction = failure): 77% (monotherapy) vs. 78% (triple therapy). Low-level viral rebound was more frequent in the monotherapy group. Twelve patients in the monotherapy group (12%) needed reinduction with nucleosides. Discontinuations due to adverse events were significantly more frequent in the triple therapy group (8%) than in the monotherapy group (0%); P = 0.003. CONCLUSIONS: At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy. Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).
机译：背景：OK04试验表明，在已有稳定抑制的患者中，洛匹那韦-利托那韦单药治疗48周并根据需要重新引入核苷并不逊于继续使用2种核苷和洛匹那韦-利托那韦的三联疗法。但是，仍不确定该实验策略能否长期维持抑制作用。方法：患者参加了这项非劣效性试验（上限95％置信区间：+ 12％），无病毒学史，同时接受蛋白酶抑制剂并接受2种核苷加洛匹那韦/利托那韦的治疗，HIV RNA <每毫升50拷贝≥ 6个月。主要终点是没有治疗失败的患者的百分比，定义为已确诊的HIV RNA> 500毫升/毫升，排除单一疗法的患者，这些患者在恢复基线核苷后或在随访中丢失或随机改变后重新升高至<50毫升/毫升除还原疗法外。结果：到96周，无治疗失败的患者百分比为87％（单一疗法，n = 100）与78％（三联疗法，n = 98; 95％置信区间：-20％至+ 1.2％）。 HIV RNA <每毫升50个拷贝的百分比（治疗意向，缺失=失败，再诱导=失败）：77％（单一疗法）对78％（三联疗法）。在单一疗法组中，低水平的病毒反弹更为频繁。单一疗法组中有12名患者（占12％）需要使用核苷进行还原。三联疗法组（8％）比单药疗法组（0％）因不良事件引起的停药明显更多。 P ＝ 0.003。结论：在96周的洛匹那韦/利托那韦单药治疗中，根据需要重新引入核苷并不逊色于三联疗法的继续治疗。单一治疗导致不良事件发生的发生率显着降低。 （ClinicalTrials.gov编号，NCT00114933）。

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