title: The effect of antiretroviral therapy on all-cause mortality, generalized to persons diagnosed with HIV in the USA, 2009-11.
abstract: BACKGROUND
  Although antiretroviral therapy (ART) is known to be protective against HIV-related mortality, the expected magnitude of effect is unclear because existing estimates of the effect of ART may not directly generalize to recently HIV-diagnosed persons.
  
  
  METHODS
  In this study, we estimated 5-year mortality risks for immediate versus no ART initiation among patients (n = 12,547) in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) using the complement of adjusted Kaplan-Meier survival functions. We subsequently standardized estimates to persons diagnosed with HIV in the USA between 2009 and 2011, who were enumerated using national surveillance data.
  
  
  RESULTS
  The 5-year mortality, had all patients in the CNICS immediately initiated ART, was 10.6% [95% confidence interval (CI): 9.3%, 11.9%] compared with 28.3% (95% CI: 19.1%, 37.5%) had ART initiation been delayed at least 5 years. The 5-year mortality risk difference due to ART among patients in the CNICS was -17.7% (95% CI: -27.0%, -8.4%). Based on methods for generalizing an estimate from a study sample to a different target population, the expected risk difference due to ART initiation among recently HIV-diagnosed persons in the USA was -19.1% (95% CI: -30.5%, -7.8%).
  
  
  CONCLUSIONS
  Immediate ART initiation substantially lowers mortality among persons in the CNICS and this benefit is expected to be similar among persons recently diagnosed with HIV in the USA. We demonstrate a method by which concerns about generalizability can be addressed and evaluated quantitatively.
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, NC, USA, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, clesko2@jhu.edu.
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Lesko
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, NC, USA.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Cole
authors.affiliation: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: H Irene
authors.initials: HI
authors.lastname: Hall
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, NC, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Westreich
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, NC, USA, Department of Medicine, Division of Infectious Diseases, University of North Carolina, NC, USA and.
authors.forename: William C
authors.initials: WC
authors.lastname: Miller
authors.affiliation: Department of Medicine, Division of Infectious Diseases, University of North Carolina, NC, USA and.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.affiliation: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Jianmin
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Medicine, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mugavero
mesh_terms: D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009026:Mortality; D012367:RNA, Viral / Q000097:blood*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D012367:RNA, Viral
keywords: HIV; antiretroviral therapy; effect modification; external validity; generalizability; mortality; survival analysis