ADVERSE OUTCOMES OF TREATING HIV-TB CDB0088 ADVERSE OUTCOMES OF TREATING HIV-TB Sashindran V K*, Kumar Suman**, Kumar Ashwani# *HOD Medicine, Air Force Central Medical Establishment, Subroto Park, New Delhi, **Dept of Haematology, All India Institute of Medical Sciences, Aurobindo Marg,New Delhi, #Military Hospital Dinjan

Background TB is the commonest opportunistic infection (OI) associated with HIV-AIDS & caused 23% of the 2 million HIV deaths in 2007. Drug interactions between ART & ATT are well documented. Suboptimal immune reconstitution & high incidence of immuno-logical failure reported in new incident TB in patients starting ART in sub-Saharan Africa Long term outcome of HIV-TB not studied in India which has the highest number of incident TB cases in the world.

Aims & Objectives Objectives Hypothesis To study prevalence of adverse outcomes (AO) in patients on concurrent ATT- ART To study factors influencing adverse outcomes Hypothesis Concurrent ATT-ART will be associated with increased adverse outcomes (secondary ART failure & death)

Materials & Methods Prospective cohort study with nested controls Inclusion criteria Subjects starting ART < 2 months (m) of starting ATT Minimum duration of follow up 18m Optimal adherence to ART (at least 95%) Full course of ATT taken Statistical analysis using R 2.10.0. (R Development Core Team 2009) Subjects examined at enrollment, 6 weeks, then 6 monthly & SOS. TB cure, adverse effects (AEs) of ATT & ART and ART failure looked for Evaluation on visits: BMI, haemogram, CD4/8, biochemical profile, CXR, USG abdomen

Results Adverse outcomes noted in 26 (27.4%) subjects 95 subjects followed up over a mean duration of 32.9 (+ 13.9) m Mean age 35.9 (+ 7.5) yrs. 94.7% subjects were males Adverse outcomes noted in 26 (27.4%) subjects One adverse outcome noted for every 10 PY of follow up All had secondary ART failure. Median time to ART failure 24m (IQR 19 – 34m) 4 of these died due to wasting & septicaemia Mean baseline BMI was 18.4 (+ 3.1) kg/m2 Mean baseline CD4 count was 120.9 (+ 93.5) cells/µL 49.5% received efavirenz & the rest nevirapine

Age, baseline BMI & CD4 count, & change in BMI / CD4 did not significantly affect AO Type of TB did not influence AO NRTI components of therapy had no bearing Efavirenz therapy is related to adverse outcome (OR 0.27, 95% CI: 0.1 – 0.72). AEs to ATT seen in 27.4% subjects with hepatitis being the commonest (21.1%). AE to ATT had no bearing on AO (Fischer’s exact test 0.88)

AEs to ART seen in 18.9%. AZT-induced anaemia – commonest (9.47%) AE to ART. Baseline Hb had a bearing on occurrence of anaemia but not on AO AEs to ART significantly related to AO (Fischer’s exact test 0.038). Odds ratio for ART failure in subjects with an AE to ART was 3.53, 95%CI: 1.21 – 10.28). Conclusion Secondary ART failure occurs in 27.4% of patients being concurrently treated with ATT-ART with median time to ART failure / death being 24m. AOs are significantly related to occurrence of AEs to ART & use of efavirenz - both findings being reported for the first time.