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Dr Samsuddin Khan
MSF Mumbai
HIV/DRTB Project
 Study design: prospective, observational cohort study
 Setting and study population: Mumbai, Patient on ART and MDR-
TB treatment between May 2007 and September 2011
 Treatment protocol and follow-up: Individualized
therapy, ambulatory, community-based program, WHO Guideline
 Patient characteristics: 67 HIV/MDR-TB co-infected patients (53
bacteriologically confirmed and 14 unconfirmed) who had received
at least two weeks of anti-MDR-TB therapy, Twenty-nine (43.3%) of
them were female and two (3.0%) were transgender individuals. The
median age of these patients was 35.5 years (Interquartile Range
[IQR] 30.5–42) and the median duration of MDR-TB therapy at the
time of analysis was 10 (range 0.5–30) months.
71%, 63% and 40% of patients experienced one
or
more mild, moderate or severe AE respectively
151 episodes of AE
Life-threatening
events were rare in
this Mumbai cohort
27 patients (40%)
required
permanent
discontinuation of
at least one drug
Eleven
were
hospit
alized
for AE
 adverse reactions occurred frequently but were
managed mostly on an out-patient basis.
 no co-infected patient in this cohort required
permanent discontinuation of anti-TB treatment
or ART
 Specific AE, such as
hypothyroidism, hypokalaemia, loss of
hearing, seizures, tendonitis and arthralgia, were
most likely due to second-line TB drugs. No
hepatitis occurred in this cohort
 Co-administration of ART and second-line TB
treatment rarely causes life-threatening AE or
leads to permanent discontinuation of treatment
HIV/DRTB Project Study Shows High AE Rates but Low Discontinuation

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HIV/DRTB Project Study Shows High AE Rates but Low Discontinuation

  • 1. Dr Samsuddin Khan MSF Mumbai HIV/DRTB Project
  • 2.  Study design: prospective, observational cohort study  Setting and study population: Mumbai, Patient on ART and MDR- TB treatment between May 2007 and September 2011  Treatment protocol and follow-up: Individualized therapy, ambulatory, community-based program, WHO Guideline  Patient characteristics: 67 HIV/MDR-TB co-infected patients (53 bacteriologically confirmed and 14 unconfirmed) who had received at least two weeks of anti-MDR-TB therapy, Twenty-nine (43.3%) of them were female and two (3.0%) were transgender individuals. The median age of these patients was 35.5 years (Interquartile Range [IQR] 30.5–42) and the median duration of MDR-TB therapy at the time of analysis was 10 (range 0.5–30) months.
  • 3.
  • 4. 71%, 63% and 40% of patients experienced one or more mild, moderate or severe AE respectively 151 episodes of AE Life-threatening events were rare in this Mumbai cohort 27 patients (40%) required permanent discontinuation of at least one drug Eleven were hospit alized for AE
  • 5.  adverse reactions occurred frequently but were managed mostly on an out-patient basis.  no co-infected patient in this cohort required permanent discontinuation of anti-TB treatment or ART  Specific AE, such as hypothyroidism, hypokalaemia, loss of hearing, seizures, tendonitis and arthralgia, were most likely due to second-line TB drugs. No hepatitis occurred in this cohort  Co-administration of ART and second-line TB treatment rarely causes life-threatening AE or leads to permanent discontinuation of treatment