Date of Award

2013

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department Chair

John Cavenagh, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not starting antiretroviral therapy (ART) in HIV positive adults with CD4 cell count of /µl within four weeks of initiating new tuberculosis therapy more effective in reducing mortality rates than starting ART four weeks or later after initiating new tuberculosis therapy.

STUDY DESIGN: Systematic review of three English language primary studies published in the New England Journal of Medicine in 2011.

DATA SOURCES: Three open label, randomized, controlled trials published in 2011, comparing the timing of ART for HIV+ adults with confirmed or suspected new TB infections to reduce mortality rates in reference to initiating TB therapy were obtained using PubMed, Medline and OVID databases.

OUTCOME MEASURED: Outcomes measured include mortality rate, new AIDS defining illness, and immune reconstitution inflammatory syndrome (IRIS).

RESULTS: Karim et. al. (2011) found in patients with a CD4+ cell count less than 300 cells/µl the incidence rate of death was 7.0% in the earlier ART group compared to 6.9% in the later ART group, with IRIS occurring in 20.0% in the early ART and 8.4% in the late ART group. In groups with CD4+ cell counts of less than 50 cells/µl the mortality rates were 8.1% and 20.0% and incidence rates of IRIS as 37.8% and 11.4% for early and late ART respectively. Blanc et. al. (2011) found in patients with CD4+ cell counts of 200 or less cells/µl a 17.8% mortality rate in the early ART group compared to a 27.4% mortality rate in the late ART group. They also found a significant increase in IRIS in the early ART group, 42.5% compared to just 20.0%. Havlir et. al. (2011) found a 7.7% mortality
rate in the early ART group and 9.2% in the late ART group with both groups starting with a CD4+ count of less than 200 cells/µl. For patients with CD4+ T-cell count of less than 50 cells/µl, they found the mortality rate and incidence of new AIDS-defining illnesses was significantly lower in the early ART group 15.5% vs. 26.6% in the later group.

CONCLUSIONS: Karim et al. and Havlir et al. both found that starting ART early in TB therapy showed no significant statistical difference in mortality outcomes in patient with a CD4+ cell count less than 300 cells/µl, but if the group has a CD4+ count of less than 50 cells/µl, new AIDS related illness and death were reduced. Blanc et al. found that survival improved when ART was initiated within 2 weeks of starting TB therapy in HIV + adults with a CD4+ count of 200 or less cells/µl. All three studies showed an increase incidence of IRIS when ART was started within four weeks of initiating TB therapy.

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