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This presentation provides a research update on the impact of empiric TB treatment on PLHIV (People Living with HIV) on ART (Antiretroviral Therapy) with advanced HIV infection. It discusses the REMEMBER trial and the Temprano trial, as well as the TB/HIV policy guidelines.
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TB/HIV research update Katsunori Osuga Medical Officer WHO, Viet Nam (TB)
Contents of the presentation • Research update (IAS 2015) • REMEMBER trial • Temprano trial 2. TB/HIV policy guidelines • Consolidated guidelines on HIV testing services
High mortality in PLHIV in Sub-Saharan Africa(1 year mortality: Sub-Saharan Africa 17%, Asia 11%) Proportion of TB among PLHIV on ART (autopsy study)
Empiric (presumptive) TB treatment? TB in PLHIV is difficult to diagnose, especially with advanced disease Even with evolving TB diagnostics, access, quality, cost, and implementation issues exist Patients are lost in the diagnostic workout As a result, many people die with un-diagnosed active TB even with ART Empiric TB treatment may reduce the mortality? Pill burden (ART and ATT) to PLHIV will be too high? No evidence of the impact of the empiric TB treatment for PLHIV on ART with advanced HIV?
Research questions for TB/HIV? What is the impact of “empiric TB (presumptive) treatment” on TB mortality in PLHIV with advanced HIV infection? 2010
REMEMBER trialReducing Early Mortality and Early Morbidity by Empiric TB Treatment Regimens (*) TB symptoms and physical exam + Xpert, AFB, and Culture CD4>50 Active TB Lab issue Others ART* + IPT (6H) ART* + 2HRZE/4HR ART* (Efavirenz + Truvada(Tenofovir/Emtricitibine)
REMEMBER Trial Conclusion • Empiric TB therapy did not reduce mortality at 24 weeks compared to IPT • Empiric TB therapy had similar safety to IPT • Adverse events similar • HIV RNA and CD4 trends similar • Adherence to ART and TB treatment similar • Current WHO policy advocating routine TB screening and IPT use is sufficient • No added benefit of empiric TB treatment in settings of systematic TB screening
Research questions for TB/HIV? What are the benefits of early ART, IPT (6 months), or both among PLHIV with high CD4 (>500)? 2010
Temprano Trial (Ivory Coast) 2962 screened 886 excluded 2076 CD4 count > 500 Group 1 Group 2 Group 3 Group 4 518 Deferred ART no IPT 517 Deferred ART with IPT 521 Early ART with IPT 520 Early ART no IPT
Temprano Trial Conclusion 6-month IPT combined with early ART led to improved outcomes (severe HIV-related illness 44%, and death 35% lower) among patients with higher CD4+ counts (>500) Early ART and IPT(6M) is beneficial for PLHIV