1. Sashindran V K, Sashwat S, Kumar Suman,
Kumar Ashwani, Namgyal K
Armed Forces Medical College, Pune, India

2. TB cases in 2007 – 9. 27 million (55% in Asia, 31% in Africa)
TB cases in 2007 – 9.27 million (55% in Asia, 31% in Africa). India had highest number of incident TB cases – 2 million
TB accounted for 23% of the 2 million HIV deaths in 2007
Risk of developing TB in HIV+ people 20.6% in countries with HIV epidemic
cART has decreased incidence of TB in HIV+ by > 80%

3. 269/632 (42.56%) had TB at some point during their follow up
39/269 h/o tb before ART started, 17/269 developed TB while on ART and of these 11/17 had reactivation of TB after start of ART with 8 manifesting TB within first 3 m of ART and the rest between 8 – 11m. 176/269 were put on ATT and ART concurrently. 3

4. cART alone is better than concurrent ATT & ART
Concurrent ATT-ART leads to many adverse effects (AE) & early treatment failure of ART owing to drug interactions & poor drug compliance.

5. To study the effect of factors like: age
To study the clinical efficacy and adverse effects (AEs) of concurrent ATT-ART
To study the effect of factors like:
age
baseline BMI and CD4 count
changes in BMI & CD4 count with therapy
ART regimen
Timing of ART vis a vis ATT

6. Prospective case-control study Cases
HIV-TB patients on concurrent ATT-ART ( already on ART or ATT started by 2 m of starting ATT)
Controls
Age-matched HIV patients without TB initiating ART
Follow up minimum 12 m after starting therapy
Patients with < 95% adherence to ART excluded

7. Case definition of TB based on WHO TB/HIV Clinical Manual
TB cure – clinical resolution/radiological clearance/ sputum conversion
ART failure as defined by API & DHHS guidelines
IRIS – diagnostic criteria as proposed by MA French
ATT regimen 2EHRZ HR

8. Statistical programme - R 2.9.1 (R Development Core Team (2009).
Linear mixed effects model, Fisher’s exact test, t test for difference between two means & Wilcoxon rank sum test for difference between two median were used

9. Parameter
ART only
(n = 50)
ATT-ART
(n = 92)
Total
p Value
Statistical Test
Median age (IQR)
37.5 (33.2,41.8)
36 (31.8, 41)
36 (32, 41)
0.274
Rank sum
Sex M (%)
F (%)
43(86)
7(14)
89(96.7)
3(3.3)
132(93)
10 (7)
0.033
Fischer’s exact test
Median duration of follow up in months (IQR)
24.5 (16.5, 32.8)
22 (16, 34.2)
24 (16, 33)
0.472
Baseline median CD4 count
cells/µL (IQR)
138 (109, 161.8)
108 (56.5, 154.5)
123 (66, 158)
<0.031
Baseline BMI kg/m2
20.7(3.6)
18.5 (3.1)
19.2(3.4)
<0.001
tTest (140 dF) = 3.7

10. Timing of ART vis a vis ATT
Type of TB in subjects
Disseminated TB - 53/92(57.61%)
Localized TB - 39/92 (42.39%) had localized TB, 14.13% had sputum negative pulmonary TB
Timing of ART vis a vis ATT
Simultaneously %
At 2m of ATT – 31.52%
At 2 weeks of ATT %
Already on ART – 8.69%

11. Linear Mixed –effect modeling used Effect on BMI
Duration of therapy – significant bearing (p = 0.01)
ART regimen (p = 0.03)
Significant difference between cases & controls after nullifying effect of duration of therapy & ART regimen. BMI increase was 66% more in cases as compared to controls
Effect on CD4 count
Duration of therapy had an effect (p=0.02)
No difference in change in CD4 cell count in cases & controls

12. ART failure commoner in HIV-TB group ( 14. 13% vs 4. 1%, p=0. 1)
ART failure commoner in HIV-TB group ( 14.13% vs 4.1%, p=0.1). Mean time to treatment failure 27m
Mortality in the 2 groups not significantly different
Recurrence of TB seen in 5.43% cases. Mean time of recurrence 26.6m
Timing of ART – no bearing on outcome

13. To ATT
31.52%
Drug – induced hepatitis 23.9%, peripheral neuropathy (4.35%), rash (3.26%)
To ART
Cases 25%, controls 14%
AZT –induced anaemia in 14% of cases & controls, mean time for anaemia 12m
Not influenced by type of TB or timing of ART

15. Commoner in HIV-TB than HIV alone - 19.6% vs 6%, (p=0.045)

16. Temporal distribution of the two main types of IRIS in the study group

18. T1W Axial
T1W Sagittal

19. ATT does not significantly worsen the success of concurrently administered ART
IRIS is commoner suggesting good immediate immune recovery
Despite IRIS being commoner in the ATT-ART group, the immune restitution though present was not significantly different from the ART-only group. Explanation?