第 96 周，在两项 III 期随机试验中，初治 HIV-1 患者中利匹韦林的疗效和安全性。
Week 96 efficacy and safety of rilpivirine in treatment-naive, HIV-1 patients in two Phase III randomized trials.
机构信息
aCommunity Research Initiative of New England, Boston, Massachusetts, USA bDepartment of Infectious Diseases, Saint-Louis Hospital, University of Paris Diderot, Paris 7, Paris, France cHelios Salud, Buenos Aires, Argentina dFaculty of Medicine, Khon Kaen University, Khon Kaen, Thailand eVita-Salute,San Raffaele University, Milan, Italy fBarts and the London NHS Trust, London, UK gAbbott Northwestern Hospital, Minneapolis, Minnesota, USA hICH Study Center, Hamburg, Germany iDepartment of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China jJanssen Infectious Diseases BVBA, Beerse, Belgium kJanssen Research and Development, LLC, Titusville, New Jersey, USA.
出版信息
AIDS. 2013 Mar 27;27(6):939-950. doi: 10.1097/QAD.0b013e32835cee6e.
BACKGROUND
In the week 48 primary analysis of ECHO and THRIVE, rilpivirine demonstrated noninferior efficacy and more favourable tolerability versus efavirenz in treatment-naive, HIV-1-infected adults. Pooled 96-week results are presented.
METHODS
Patients (N = 1368) received rilpivirine 25 mg once-daily (q.d.) or efavirenz 600 mg q.d., with two background nucleoside/nucleotide reverse transcriptase inhibitors, in two randomized, double-blind, double-dummy Phase III trials.
RESULTS
At week 96, response rate (% confirmed viral load <50 copies/ml; intent-to-treat, time-to-loss-of-virologic response) was 78% in both groups. Responses were similar for both treatments by background regimen, sex, race, and in patients with more than 95% adherence (M-MASRI) or baseline viral load 100,000 copies/ml or less. Responses were lower and virologic failure higher for rilpivirine versus efavirenz in patients with 95% or less adherence or baseline viral load more than 100,000 copies/ml. Beyond week 48, the incidence of virologic failure was comparable (3 versus 2%) between treatment groups, rilpivirine resistance-associated mutations were consistent with those observed in year 1, there were few adverse events in both groups and no new safety concerns. Over 96 weeks, discontinuations due to adverse events (4 versus 9%), treatment-related grade 2-4 adverse events (17 versus 33%), rash (4 versus 15%), dizziness (8 versus 27%) and abnormal dreams/nightmares (8 versus 13%), and grade 2-4 lipid abnormalities were lower with rilpivirine than efavirenz. Only 2 and 4% of patients in the rilpivirine and efavirenz treatment groups, respectively, reported at least possibly treatment-related grade 2-4 adverse events during the second year of treatment.
CONCLUSIONS
Rilpivirine 25 mg q.d. and efavirenz 600 mg q.d. had comparable responses at week 96. Rilpivirine had more virologic failures but improved tolerability versus efavirenz. The majority of virologic failures occurred in the first 48 weeks.
背景
在 ECHO 和 THRIVE 的第 48 周主要分析中，与依非韦伦相比，利匹韦林在初治的 HIV-1 感染成人中显示出非劣效性和更好的耐受性。现将汇总的 96 周结果呈现。
方法
患者（N=1368）在两项随机、双盲、双模拟 III 期试验中接受每日一次利匹韦林 25mg 或依非韦伦 600mg，联合两种背景核苷/核苷酸逆转录酶抑制剂。
结果
第 96 周时，两组的应答率（%确认病毒载量<50 拷贝/ml；意向治疗，病毒学应答丧失时间）均为 78%。两种治疗方案的应答情况相似，与背景治疗方案、性别、种族以及 95%以上（M-MASRI）或基线病毒载量<100000 拷贝/ml 的患者有关。在 95%或以下依从性或基线病毒载量>100000 拷贝/ml 的患者中，与依非韦伦相比，利匹韦林的应答率较低，病毒学失败率较高。在第 48 周之后，两组的病毒学失败发生率相当（3%比 2%），利匹韦林耐药相关突变与第 1 年观察到的一致，两组均有少数不良事件，无新的安全性问题。96 周时，因不良事件（4%比 9%）、与治疗相关的 2-4 级不良事件（17%比 33%）、皮疹（4%比 15%）、头晕（8%比 27%）和异常梦境/噩梦（8%比 13%）停药率以及 2-4 级血脂异常率较低。利匹韦林和依非韦伦治疗组分别只有 2%和 4%的患者报告至少可能与治疗相关的 2-4 级不良事件在治疗第二年发生。
结论
利匹韦林 25mg q.d.和依非韦伦 600mg q.d.在第 96 周时应答相似。与依非韦伦相比，利匹韦林的病毒学失败更多，但耐受性更好。大多数病毒学失败发生在第 48 周之前。
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