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The study of immune reconstitution inflammatory syndrome(IRIS) in resource limited settings. Dr Milind Bhrushundi M D Dr Pradeep Mishra M D Lata Mangeshkar Hospital Nagpur India. Objectives.
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The study of immune reconstitution inflammatory syndrome(IRIS) in resource limited settings Dr Milind Bhrushundi M D Dr Pradeep Mishra M D Lata Mangeshkar Hospital Nagpur India
Objectives • To assess proportion of patients developing IRIS after initiation of antiretroviral therapy attending Lata Mangeshkar Hospital (LMH) in Nagpur, India • To describe pattern of IRIS • To identify factors associated with development of IRIS
Methods • 720 consecutive patients attending LMH, Nagpur between 2002- 2005 were recruited • Patients were examined clinically & investigated for presence of OI before initiating ART & treated wherever necessary • Since patients had to pay for complete/ part of tests, package of investigations differed.
Case definition • Appearance of new OI or deterioration in patients treated for OI who showed signs & symptoms of clinical improvement initially within 3 months of initiating ART with increase in CD4+ counts • Worsening of the symptoms without significant rise in CD4+ T-helper were excluded by the definition .
Demographic profile n=720 • Age- Mean- 35.6 years ( range; 21-75 yrs) • Sex- 582 Males and 138 females • Baseline Investigations: Essential – 230 (32%); Optional -366 (51%), Ideal - 124 (17%) • Of them, 549 (76%) were ARV-naïve. • Of the 171 ARV-experienced patients, 26 (17%) had received two ARVs & 143 (83%) received 3 ARVs • Of the ARV-naïve patients, 71 ( 13%) received EFV-based regime & remaining received NVP-based regimen.
Results • Univariate analysis revealed • IRIS was not associated with any age group (p=0.06) • However, females were found to be less likely to develop IRIS (p=0.001) • Patients who were offered essential (minimal tests) package at baseline were more likely to develop IRIS (p= 0.001)
Results • Patients with CD4 < 50 cells & between 50-100 cells/cm were likely to develop IRIS (p=0.0001) • Patients with past history or current OI were more likely to develop IRIS (p=0.0001) • Patients with CD4 counts of <50 cells were 40 times more likely to develop IRIS. (p= .0001),CD4 counts of <100 cells were 12 times more likely to develop IRIS. (p= 0.0001)
Results • Multivariate analysis revealed that the likelihood of development of IRIS was; • Males were 3.1 ( 95% CI – 0.92-11.1) times more likely to develop IRIS than females. (P=0.06) • Patients with CD4 counts of <50 cells were 4.3 times more likely to develop IRIS. (p= 0.0001) • Those who could only afford a minimal (essential) package of base line laboratory tests were 1.4 times more likely to develop IRIS (p=0.05)
Treatment of IRIS • TB-DOTS,NVP changed to EFV • PCP- TMP/SMX, Steroids used in 3 cases, one mortality • Cryptococcal Meningitis-Amphotericin-B, one mortality, two had Amphotericin toxicity • CMV retinitis- Rx not affordable-Optic Atrophy, otherwise normal. • Hepatitis C- Pegylated interferon+ Ribavarin • PML-ART, Still having neurological symptoms
FOLLOW-UP IRIS CASES Mortality
Conclusions • IRIS occurred in 9.4% patients initiated on ART in Nagpur India • All those who have developed IRIS had prior history of OI • Limited investigations prior to initiation of ART is associated with increased risk of IRIS • Proportion of IRIS is less in Government run free ART clinic because of strict protocol for the investigation prior to ART .
Conclusion • Proportion of cases is significantly high with low baseline CD4+ counts(<50) • % increase in CD4+ cells was significantly high (192%) with low CD4+ • Tuberculosis continues to predominate in IRIS in India (in 54% cases) • Need to educate the Physicians for proper ART(16.66% were on double drug therapy)
Thanks • Dr R R Gangakhedkar • Dr Suresh Ughade • Dr Urmila Varadpande • All My patients • My wife and daughter • Sanjeevan – Nagpur- India