MedicalResearch: What are the main findings of the study?
Dr. Chanda: The main findings are that in this cohort of relatively healthy patients, with a median CD4 of 367, ART can be delayed till the end of TB short course chemotherapy without deleterious effects. This differs from studies that looked at cohorts with very low median CD4 ( around 25-150 in most cases) in which early cART was found to reduce mortality and other AIDS defining events.
MedicalResearch: Were any of the findings unexpected?
Dr. Chanda: Our primary question was focused of TB treatment outcomes of treatment failure, relapse and death; and we did not see a statistically significant finding between arms i.e early versus late. One reason is that in this cohort of relatively healthy individuals with a median CD4 of 367 a short delay in ART should not result in clinically deleterious effects. However we observed a higher default rate in first 6 months of follow-up; and higher mortality between 12 and 24 months follow-up in the early ART group. We postulate that the higher default rate is related to a high pill burden and this could possibly explain the higher mortality in year 2 of the follow-up. We also did observe a trend towards higher relapses in the early ART arm.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Chanda: For clinicians we propose a cautious approach in patients with high CD4 and relatively preserved immunity. Consideration should be given to pill burden and how it would affect adherence and outcomes. Patients should consult with their doctors on the best options taking evidence from other trials and observational studies in totality.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Chanda: We observed a statistically significant higher mortality in year 2 of follow-up. This is a topic for further investigation. Also the association of ART and non-communicable diseases is of interest. Programmatic ART cohorts around the world provide an ongoing opportunity to analyze treatment outcomes in TB/HIV co-infected patients initiated on ART and different CD4 counts. I think we still have a lot to learn on the topic of co-management of TB/HIV and indeed other opportunistic infections and the long term out comes.
Early versus delayed initiation of highly active antiretroviral therapy for HIV-positive adults with newly diagnosed pulmonary tuberculosis (TB-HAART): a prospective, international, randomised, placebo-controlled trial
Sayoki G Mfinanga PhD,Bruce J Kirenga MMed,Dr Duncan M Chanda MD,Beatrice Mutayoba MPhil,Thuli Mthiyane MPH,Getnet Yimer PhD,Oliver Ezechi MPH,Cathy Connolly MPH,Vincent Kapotwe DipDM,Catherine Muwonge MSc,Julius Massaga PhD,Edford Sinkala MMed,Wanze Kohi MPH,Lucinda Lyantumba BA,Grace Nyakoojo BA,Henry Luwaga MA,Basra Doulla BSc,Judith Mzyece BSc,Nathan Kapata MBChB,Mahnaz Vahedi MBBS,Peter Mwaba FRCP,Saidi Egwaga MMed,Francis Adatu MSc,Alex Pym PhD,Prof Moses Joloba PhD,Roxana Rustomjee MD,Prof Alimuddin Zumla FRCP,Philip Onyebujoh FRCP
The Lancet Infectious Diseases – 6 May 2014