Volume 384, Issue 9944, Pages (August 2014)

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Volume 384, Issue 9944, Pages 682-690 (August 2014) Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised double-blind, placebo-controlled trial Dr Molebogeng X Rangaka, PhD, Prof Robert J Wilkinson, PhD, Andrew Boulle, PhD, Prof Judith R Glynn, PhD, Katherine Fielding, PhD, Gilles van Cutsem, MD, Katalin A Wilkinson, PhD, Rene Goliath, RN, Shaheed Mathee, MBChB, Eric Goemaere, MD, Prof Gary Maartens, MMed The Lancet Volume 384, Issue 9944, Pages 682-690 (August 2014) DOI: 10.1016/S0140-6736(14)60162-8 Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile ART=antiretroviral therapy. Start-ART=just started ART. On-ART=established on ART. *Reasons for excluding 291 individuals that did not meet the inclusion criteria: 211 prevalent tuberculosis diagnosed, 13 previous isoniazid preventive therapy, 19 pregnancy, 23 pre-existing grade 3 toxicity (alanine transaminase concentration, peripheral neuropathy, or rash), one younger than 18 years, 24 already on tuberculosis treatment. †Drug toxic effects include: alanine transaminase grade 3 or worse, clinical hepatitis, grade 2 or worse rash or peripheral neuropathy. The Lancet 2014 384, 682-690DOI: (10.1016/S0140-6736(14)60162-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 2 Time to tuberculosis from randomisation The placebo group was given antiretroviral therapy plus placebo and the isoniazid group was given antiretroviral therapy plus isoniazid. Numbers show the number of participants followed up at each timepoint, and the numbers in parentheses show new tuberculosis cases in each period. Log-rank test p value for equality of survival curves=0·02. The Lancet 2014 384, 682-690DOI: (10.1016/S0140-6736(14)60162-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 3 Cumulative hazard plot for antiretroviral therapy versus antiretroviral therapy plus isoniazid preventive therapy effect by time since randomisation Nelson-Aalen cumulative hazard plot on a logarithmic y-scale to show proportionality of hazards over time periods. HRs shown are unadjusted. Treatment ended 1 year after participants were randomly assigned. Likelihood ratio test for interaction of treatment group with study time p=0·61, and assuming linear trend for study time p=0·34. HR=hazard ratio. The Lancet 2014 384, 682-690DOI: (10.1016/S0140-6736(14)60162-8) Copyright © 2014 Elsevier Ltd Terms and Conditions

Figure 4 Time to death from randomisation The placebo group was given antiretroviral therapy plus placebo, and the isoniazid group was given antiretroviral therapy plus isoniazid. Log-rank test p value for equality of survival curves=0·32. The Lancet 2014 384, 682-690DOI: (10.1016/S0140-6736(14)60162-8) Copyright © 2014 Elsevier Ltd Terms and Conditions