An antiretroviral regimen containing 6 months of stavudine followed by long-term zidovudine for first-fine HIV therapy is optimal in resource-limited settings： a prospective, multicenter study in China  

作　　者：Li Taisheng Guo Fuping Li Yijia Zhang Chengda Han Yang Lye Wei He Yun Lu Hongzhou Xie Jing Huang Aiqiong Li Yanling Tang Xiaoping Wang Hui Zhang Tong Gao Guiju Lei Junkang Zhang Xiaoying Wu Xinhua Sun Yongtao Bai Jinsong Luo Ling Wang Huanlmg 

机构地区：[1]Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730,China [2]The infectious Disease Hospital of Henan Province, Zhengzhou,Henan 450061, China [3]Shanghai Public Health Clinical Center, Fudan University, Shanghai201508, China [4]Fuzhou Infectious Diseases Hospital, Fujian Medical University,Fuzhou, Fujian 350002, China [5]Guangzhou No. 8 People's Hospital, Guangzhou, Guangdong 510060, China [6]Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112,China [7]Beijing You'an Hospital, Capital Medical University, Beijing 100054,China [8]Beijing Ditan Hospital, Capital Medical University, Beijing 100011,China [9]Yunnan AIDS Care Center, Kunming, Yunnan 650000, China [10]The First People's Hospital of Honghe State, Honghe, Yunnan 650000, China [11]Tangdu Hospital Affiliated to the Fourth Military Medical University,Xi'an, Shaanxi 710038, China [12]Kunming Third People's Hospital, Kunming, Yunnan 650041, China

出　　处：《Chinese Medical Journal》2014年第1期59-65,共7页中华医学杂志（英文版）

摘　　要：Background An zidovudine （AZT）-substitution regimen containing 24-week stavudine （d4T） followed by long-term AZT for HIV therapy is potential to trade off short-term AZT-related anemia and long-term risks associated with d4T in resourcelimited settings.However,evidence is scarce.This study aims to assess the efficacy and safety of AZT-substitution regimen,aiming to find a regimen with better efficacy,less adverse events,and more affordability in resource-limited settings.Methods This prospective,multicenter study enrolled 499 （190 on d4T regimen,172 on AZT regimen,and 137 on AZT-substitution regimen） HIV-1-infected subjects who initiated combined antiretroviral therapy and attended follow-up visits over 96 weeks from 2009 to 2011.Lamivudine （3TC） and either nevirapine （NVP） or efavirenz （EFV） were the other two drugs in the antiretroviral regimens.Virologic and immunologic responses and adverse events were monitored at baseline and at weeks 4,12,24,36,48,60,72,84,and 96.Results In terms of hematological adverse effects,AZT-substitution group had similar safety profiles to d4T group and was superior to AZT group.In comparison with AZT-substitution group,AZT group was associated with higher risk of developing anemia （adjusted hazard ratio （aHR）for anemia ≥ grade Ⅱ,8.44,95％ CI 1.81-39.46） and neutropenia （aHR for neutropenia ≥ grade Ⅱ,1.86,95％ CI 1.19-2.93）.The prevalence of lipodystrophy in d4T group was 19.5％,while that in AZT-substitution group was zero.As to antiretroviral efficacy,these three groups showed no differences.Conclusion AZT-substitution regimen provides a relatively safe and effective first-line antiretroviral strategy in resource-limited settings.Background An zidovudine （AZT）-substitution regimen containing 24-week stavudine （d4T） followed by long-term AZT for HIV therapy is potential to trade off short-term AZT-related anemia and long-term risks associated with d4T in resourcelimited settings.However,evidence is scarce.This study aims to assess the efficacy and safety of AZT-substitution regimen,aiming to find a regimen with better efficacy,less adverse events,and more affordability in resource-limited settings.Methods This prospective,multicenter study enrolled 499 （190 on d4T regimen,172 on AZT regimen,and 137 on AZT-substitution regimen） HIV-1-infected subjects who initiated combined antiretroviral therapy and attended follow-up visits over 96 weeks from 2009 to 2011.Lamivudine （3TC） and either nevirapine （NVP） or efavirenz （EFV） were the other two drugs in the antiretroviral regimens.Virologic and immunologic responses and adverse events were monitored at baseline and at weeks 4,12,24,36,48,60,72,84,and 96.Results In terms of hematological adverse effects,AZT-substitution group had similar safety profiles to d4T group and was superior to AZT group.In comparison with AZT-substitution group,AZT group was associated with higher risk of developing anemia （adjusted hazard ratio （aHR）for anemia ≥ grade Ⅱ,8.44,95％ CI 1.81-39.46） and neutropenia （aHR for neutropenia ≥ grade Ⅱ,1.86,95％ CI 1.19-2.93）.The prevalence of lipodystrophy in d4T group was 19.5％,while that in AZT-substitution group was zero.As to antiretroviral efficacy,these three groups showed no differences.Conclusion AZT-substitution regimen provides a relatively safe and effective first-line antiretroviral strategy in resource-limited settings.

关 键 词：human immunodeficiency virus acquired immunodeficiency syndrome antiretroviral therapy ZIDOVUDINE STAVUDINE anemia LIPODYSTROPHY 

分 类 号：Q782[生物学—分子生物学] O224[理学—运筹学与控制论]