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Multicenter Study
. 2016 Feb;45(1):140-50.
doi: 10.1093/ije/dyv352. Epub 2016 Jan 15.

The Effect of Antiretroviral Therapy on All-Cause Mortality, Generalized to Persons Diagnosed With HIV in the USA, 2009-11

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Free PMC article
Multicenter Study

The Effect of Antiretroviral Therapy on All-Cause Mortality, Generalized to Persons Diagnosed With HIV in the USA, 2009-11

Catherine R Lesko et al. Int J Epidemiol. .
Free PMC article

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.

Keywords: HIV; antiretroviral therapy; effect modification; external validity; generalizability; mortality; survival analysis.

Figures

Figure 1
Figure 1
5-year all-cause mortality under two potential interventions: always treat versus never treat with three or more antiretroviral medications (ART) among: (i) persons enrolled in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS) during 1998–2012; and (ii) persons diagnosed with HIV in the United States during 2009–11. All estimates were adjusted for: race/ethnicity; sex; age at engagement in care; calendar year of engagement in care; CD4 cell count and viral load most proximate to CNICS enrolment; history of injection drug use; history of male-to-male sexual contact; study site; and time-varying CD4 cell count, viral load, AIDS diagnosis and hepatitis C virus infection. Estimates for persons newly diagnosed with HIV in the USA were further standardized to the distribution of sex, age group, race/ethnicity, male-to-male sexual contact, injection drug use and AIDS at baseline in the target populationdx, diagnosis.

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