title: An antiretroviral regimen containing 6 months of stavudine followed by long-term zidovudine for first-line HIV therapy is optimal in resource-limited settings: a prospective, multicenter study in China.
abstract: 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 resource-limited 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.
  
  
  CONCLUSIONS
  AZT-substitution regimen provides a relatively safe and effective first-line antiretroviral strategy in resource-limited settings.
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China. Email: litsh@263.net.
authors.forename: Taisheng
authors.initials: T
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Fuping
authors.initials: F
authors.lastname: Guo
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Yijia
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Chengda
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Han
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Lye
authors.affiliation: The Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: He
authors.affiliation: Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.
authors.forename: Hongzhou
authors.initials: H
authors.lastname: Lu
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Xie
authors.affiliation: Fuzhou Infectious Diseases Hospital, Fujian Medical University, Fuzhou, Fujian 350002, China.
authors.forename: Aiqiong
authors.initials: A
authors.lastname: Huang
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Yanling
authors.initials: Y
authors.lastname: Li
authors.affiliation: Guangzhou No. 8 People's Hospital, Guangzhou, Guangdong 510060, China.
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Tang
authors.affiliation: Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.affiliation: Beijing You'an Hospital, Capital Medical University, Beijing 100054, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Zhang
authors.affiliation: Beijing Ditan Hospital, Capital Medical University, Beijing 100011, China.
authors.forename: Guiju
authors.initials: G
authors.lastname: Gao
authors.affiliation: Yunnan AIDS Care Center, Kunming, Yunnan 650000, China.
authors.forename: Junkang
authors.initials: J
authors.lastname: Lei
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Xiaoying
authors.initials: X
authors.lastname: Zhang
authors.affiliation: The First People's Hospital of Honghe State, Honghe, Yunnan 650000, China.
authors.forename: Xinhua
authors.initials: X
authors.lastname: Wu
authors.affiliation: Tangdu Hospital Affiliated to the Fourth Military Medical University, Xi'an, Shaanxi 710038, China.
authors.forename: Yongtao
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Kunming Third People's Hospital, Kunming, Yunnan 650041, China.
authors.forename: Jinsong
authors.initials: J
authors.lastname: Bai
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Luo
authors.affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Huanling
authors.initials: H
authors.lastname: Wang
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018119:Stavudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D015215:Zidovudine; D018119:Stavudine