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Article(id=1322627357089841870, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1598198400000, acceptedDateStr=2020-08-24, onlineDate=1793268535157, onlineDateStr=2026-10-29, pubDate=1611936000000, pubDateStr=2021-01-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793268535157, onlineIssueDateStr=2026-10-29, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793268535157, creator=13701087609, updateTime=1793268535157, updator=13701087609, issue=Issue{id=1322627316266680781, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='2', pageStart='97', pageEnd='192', issueExtLink='null', onlineDate='null', pubDate='1611936000000', pubDateStr='2021-01-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793268525425, creator='13701087609', updateTime=1793269089393, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322629681875108722, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322629681879303027, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322627316266680781, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=145, endPage=149, ext={EN=ArticleExt(id=1322627357253419727, articleId=1322627357089841870, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Long-term efficacy, safety and tolerability of rilpivirine-based ART regimen in HIV-1 infected Chinese patients, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To evaluate the long-term safety, tolerability, and efficacy of antiretroviral therapy (ART) regimen with rilpivirine (RPV) combined with two nucleoside reverse transcriptase inhibitors (N[t]RTIs) in human immunodeficiency virus (HIV)-infected Chinese subjects.

Methods:

This is a Chinese subgroup study derived from the clinical study, TMC278-TiDP6-C222, which is a phase Ⅲ open-label multicenter, roll-over study. Patients received RPV 25 mg once daily (qd) in combination with two N[t]RTLs. The benefits from RPV treatment were evaluated by efficacy (HIV-1 RNA and CD4+ cell count) and safety (AE, SAE).

Results:

Overall, 26 HIV-1 infected Chinese subjects were treated in this extended C222 study. AE leading to permanent discontinuation of study drug were reported in one (3.8%) subject. Most AEs were grade 1 or 2 in severity. Grade 3 or 4 AEs were reported in two (7.7%) subjects. No RPV-related serious AEs (SAEs) were reported. During follow-up, only one (3.8%) subject experienced a blip between week 96 to week 120 (242 copies·mL-1) and then returned to VL<50 copies·mL-1 subsequently. All patients had at least one time of CD4>500 cell·mL-1 and the CD4+ cell count gradually increased over time until week 336 except a decrease occurred between week 192 to week 240.

Conclusion:

Long-term treatment with RPV 25 mg qd in combination with two N(t) RTIs is effective, generally safe and well tolerated in Chinese adult patients with HIV-1 infection.

, authors=Hong-wei ZHANG1, Wei-ping CAI2, Hao-lan HE2, Hong-zhou LU3, Ren-fang ZHANG3, Xing-wang LI4, Yan WU4, Xiao-jie HUANG1, Hao WU1, authorsList=Hong-wei ZHANG, Wei-ping CAI, Hao-lan HE, Hong-zhou LU, Ren-fang ZHANG, Xing-wang LI, Yan WU, Xiao-jie HUANG, Hao WU, authorCompany=null, correspAuthors=Hao WU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322627357517660880, articleId=1322627357089841870, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中国HIV-1患者使用利匹韦林为基础抗病毒方案的长期疗效和安全性及耐受性, columnId=1236331162205999476, journalTitle=中国新药杂志, columnName=临床研究, runingTitle=null, highlight=null, articleAbstract=
目的：

评估利匹韦林（rilpivirine，RPV）联合2种核苷类逆转录酶抑制剂（NRTIs）对中国HIV-1型感染者的长期安全性、耐受性和疗效。

方法：

本研究为RPV开放多中心Ⅲ期延长研究TMC278-TiDP6-C222的中国亚组分析，入组患者在既往RPV Ⅱb和Ⅲ期研究结束后签署知情同意自愿纳入延长研究，继续接受RPV 25 mg（qd）联合2 N[t]RTLs. RPV治疗的获益通过疗效以及安全性进行评估。

结果：

2011年2月25日起来自RPV Ⅱb和Ⅲ期研究共26例中国HIV-1型感染者进入C222延长研究，数据收录截止日期为2018年2月8日，平均随访6.07年。随访期间大部分不良反应为1或2级，只有2例（7.7%）患者报告出现3或4级不良反应，没有RPV相关严重不良反应报告。随访期间只有1例（3.8%）患者在96~120周出现一过性低病毒血症（242 copies·mL-1），并在后面随访中恢复病毒载量（VL）<50 copies·mL-1。所有患者在随访期间至少有一次CD4>500 cell·mL-1，除了192~240周之间短暂下降，整体CD4细胞计数持续缓慢增加到336周。

结论：

使用RPV 25 mg（qd）联合2 N（t）RTIs治疗，对于中国HIV-1型感染者有效，整体来讲安全性和耐受性良好。

, authors=张宏伟1, 蔡卫平2, 何浩岚2, 卢洪洲3, 张仁芳3, 李兴旺4, 吴焱4, 黄晓婕1, 吴昊1, authorsList=张宏伟, 蔡卫平, 何浩岚, 卢洪洲, 张仁芳, 李兴旺, 吴焱, 黄晓婕, 吴昊, authorCompany=null, correspAuthors=吴昊, authorNote=

张宏伟，男，主任医师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。

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吴昊，男，主任医师，博士生导师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。
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张宏伟，男，主任医师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。

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张宏伟，男，主任医师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。

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Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults[J]. Aids, 2014, 28(7): 989-997., articleTitle=null, refAbstract=null), Reference(id=1322627362496299797, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1322627357089841870, doi=null, pmid=null, pmcid=null, year=null, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=null, journalName=null, refType=null, unstructuredReference=COHEN CJ, ANDRADE-VILLANUEVA J, CLOTET B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial[J]. 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中国HIV-1患者使用利匹韦林为基础抗病毒方案的长期疗效和安全性及耐受性
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张宏伟 1 , 蔡卫平 2 , 何浩岚 2 , 卢洪洲 3 , 张仁芳 3 , 李兴旺 4 , 吴焱 4 , 黄晓婕 1 , 吴昊 1
中国新药杂志 | 临床研究 2021,30(2): 145-149
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中国新药杂志 |临床研究 2021 , 30 (2) : 145 -149
中国HIV-1患者使用利匹韦林为基础抗病毒方案的长期疗效和安全性及耐受性
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张宏伟1 , 蔡卫平2, 何浩岚2, 卢洪洲3, 张仁芳3, 李兴旺4, 吴焱4, 黄晓婕1, 吴昊1
作者信息
  • 1首都医科大学附属北京佑安医院感染中心，北京　100069
  • 2广州市第八人民医院感染科，广州　510060
  • 3上海公共卫生临床中心感染科，上海　201500
  • 4首都医科大学附属北京地坛医院，北京　100011
通讯作者:
吴昊，男，主任医师，博士生导师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。
作者简介:

张宏伟，男，主任医师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。

Long-term efficacy, safety and tolerability of rilpivirine-based ART regimen in HIV-1 infected Chinese patients
Hong-wei ZHANG1 , Wei-ping CAI2, Hao-lan HE2, Hong-zhou LU3, Ren-fang ZHANG3, Xing-wang LI4, Yan WU4, Xiao-jie HUANG1, Hao WU1
Affiliations
  • 1Infectious Center, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
  • 2Department of Infectious Disease, Guangzhou Eighth People's Hospital, Guangzhou 510060, China
  • 3Department of Infectious Disease, Shanghai Public Health Clinical Center, Shanghai 201500, China
  • 4Beijing Ditan Hospital, Capital Medical University, Beijing 100011, China
出版时间: 2021-01-30
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摘要
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目的：

评估利匹韦林（rilpivirine，RPV）联合2种核苷类逆转录酶抑制剂（NRTIs）对中国HIV-1型感染者的长期安全性、耐受性和疗效。

方法：

本研究为RPV开放多中心Ⅲ期延长研究TMC278-TiDP6-C222的中国亚组分析，入组患者在既往RPV Ⅱb和Ⅲ期研究结束后签署知情同意自愿纳入延长研究，继续接受RPV 25 mg（qd）联合2 N[t]RTLs. RPV治疗的获益通过疗效以及安全性进行评估。

结果：

2011年2月25日起来自RPV Ⅱb和Ⅲ期研究共26例中国HIV-1型感染者进入C222延长研究，数据收录截止日期为2018年2月8日，平均随访6.07年。随访期间大部分不良反应为1或2级，只有2例（7.7%）患者报告出现3或4级不良反应，没有RPV相关严重不良反应报告。随访期间只有1例（3.8%）患者在96~120周出现一过性低病毒血症（242 copies·mL-1），并在后面随访中恢复病毒载量（VL）<50 copies·mL-1。所有患者在随访期间至少有一次CD4>500 cell·mL-1，除了192~240周之间短暂下降，整体CD4细胞计数持续缓慢增加到336周。

结论：

使用RPV 25 mg（qd）联合2 N（t）RTIs治疗，对于中国HIV-1型感染者有效，整体来讲安全性和耐受性良好。

利匹韦林  /  长期疗效  /  耐受性  /  安全性
Objective:

To evaluate the long-term safety, tolerability, and efficacy of antiretroviral therapy (ART) regimen with rilpivirine (RPV) combined with two nucleoside reverse transcriptase inhibitors (N[t]RTIs) in human immunodeficiency virus (HIV)-infected Chinese subjects.

Methods:

This is a Chinese subgroup study derived from the clinical study, TMC278-TiDP6-C222, which is a phase Ⅲ open-label multicenter, roll-over study. Patients received RPV 25 mg once daily (qd) in combination with two N[t]RTLs. The benefits from RPV treatment were evaluated by efficacy (HIV-1 RNA and CD4+ cell count) and safety (AE, SAE).

Results:

Overall, 26 HIV-1 infected Chinese subjects were treated in this extended C222 study. AE leading to permanent discontinuation of study drug were reported in one (3.8%) subject. Most AEs were grade 1 or 2 in severity. Grade 3 or 4 AEs were reported in two (7.7%) subjects. No RPV-related serious AEs (SAEs) were reported. During follow-up, only one (3.8%) subject experienced a blip between week 96 to week 120 (242 copies·mL-1) and then returned to VL<50 copies·mL-1 subsequently. All patients had at least one time of CD4>500 cell·mL-1 and the CD4+ cell count gradually increased over time until week 336 except a decrease occurred between week 192 to week 240.

Conclusion:

Long-term treatment with RPV 25 mg qd in combination with two N(t) RTIs is effective, generally safe and well tolerated in Chinese adult patients with HIV-1 infection.

rilpivirine  /  long-term efficacy  /  safety  /  tolerability
张宏伟, 蔡卫平, 何浩岚, 卢洪洲, 张仁芳, 李兴旺, 吴焱, 黄晓婕, 吴昊. 中国HIV-1患者使用利匹韦林为基础抗病毒方案的长期疗效和安全性及耐受性. 中国新药杂志, 2021 , 30 (2) : 145 -149 .
Hong-wei ZHANG, Wei-ping CAI, Hao-lan HE, Hong-zhou LU, Ren-fang ZHANG, Xing-wang LI, Yan WU, Xiao-jie HUANG, Hao WU. Long-term efficacy, safety and tolerability of rilpivirine-based ART regimen in HIV-1 infected Chinese patients[J]. Chinese Journal of New Drugs, 2021 , 30 (2) : 145 -149 .

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2021年第30卷第2期
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  • 首发时间：2026-10-29
  • 出版时间：2021-01-30
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  • 录用日期：2020-08-24
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    1首都医科大学附属北京佑安医院感染中心，北京　100069
    2广州市第八人民医院感染科，广州　510060
    3上海公共卫生临床中心感染科，上海　201500
    4首都医科大学附属北京地坛医院，北京　100011

通讯作者:

吴昊，男，主任医师，博士生导师，研究方向：艾滋病基础和临床研究。联系电话：（010）83997431，E-mail：。
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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