Prf. Margareth Dalcolmo

1
Changing Regimens to TB in Brazil A national
experience From short course (RHZ) in 1981 to
FDCs (RHZE)in 2009

• Prf. Margareth Dalcolmo
• Reference Center Helio Fraga FIOCRUZ, Rio de
  Janeiro

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Background Tuberculosis (TB) in Brazil

• Brazil is one of the 22 high TB burden countries
• With Peru 50 of TB cases in Latin America
• Reported 78,000 new TB cases/year. Estimated
  90tho
• More than 2 million patients have been treated
  with short course RHZ regimen ? Low rates
  of MDR TB, except in hospitals
• 50 million infected with M. tuberculosis
• DOTS coverage 65 of population with DOTS access
• 1996 First national drug resistance (DR) survey
• 4.4 primary resistance to izoniazid
• Low rates of primary MDR-TB (1.1)

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Milestones in the NPTC

• Years 70s
• Closing of sanatoria
• Diagnostic and treatment in out patient units
• Early 80s
• Implementation of Short course (RHZ) regimen
  with RH FDC
• Second line regimen SM PZA EMB ETH 12mo
• 2000
• Standard MDRTB regimen with 5 drugs validated
  (CM, OfLX, AMIC, TRZ, CLZ, EMB)
• 2003
• DOTS officialy adopted as governmental policy to
  control TB
• Patients treated with DOTS from 10 to 70
• 2008
• Based on II National Survey and other indicators
  MoH Changing treatment system to FDCs RHZE to all
  Category 1

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Spacial distribution of TB-HIV cases in Brazil
municipalities that reported at least one case in
three diferent periods (Brazil 1980-2005)
TB urban disease !!
1994-2005
1987-93
1980-86
MoH. PNDST/aids, 2006.
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National Guidelines Edited by SBPT and
Ministry of Health Adopted by SBPediatrics and
SB Infectology 2009 III edition In press
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Mortality due to TB in Brazil - 2005
Rio Janeiro e São Paulo gt50 do total de casos
de TB no Brasil Reduction in the last three
years 2007 lt 4.500 deaths
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Sensitive TB in Brazil Outcome of treatment

• Sucess of treatment 73,6

Challenge gt85 CURE
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II national survey - Methods

• 7 out of 27 Brazilian states surveyed
• Rio de Janeiro, Rio Grande do Sul, Bahia, Federal
  District, Santa Catarina, Minas Gerais, and São
  Paulo.
• 46.2 of all TB cases in Brazil
• Period of the study 2006-2008
• Sampling Population proportionate cluster
  sampling
• Population TB patient confirmed by positive
  culture or sputum smear
• Sample size 4,421 patients
• Total number of new sputum smear-positive cases
  detected e
• Expected prevalence of resistance to rifampicin
• Precision of 1.5 for new cases

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Results

• Primary resistance
• Isoniazid 5.96
• Rifampicin 1.53
• MDR-TB
• New cases 1.38
• Re-treatment cases 7.54
• Predictor of MDR-TB (multivariate analysis)
  prior TB treatment Relative Risk (RR) 1.8 95
  Confidence Interval (CI) 1.4 to 2.2 p lt 0.001)

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Conclusions

• Low prevalence of MDR
• Previous treatment was an important determinant
  of MDR-TB (risk factor)
• A study of the reasons for inadequate treatment
  would help to improve control strategies

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II National survey of Resistence - 2008

• Resistence to at least one drug

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Results
Resistence to Isoniazide
Resistence to Rifampin
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Results

• MDR TB

I national survey, in 1997 1,1 of MDR
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State of the art in changing

• Adopted RHZE 6 months regimen for all Category 1
  cases

MoH is buying FDCs adult and pediatric from WHO
qualified producer, with buffer stock for all
country, with transfer of technology agreement
MoH is buying FDCs adult and pediatric
formulation from WHO qualified producer, with
buffer stock for all country, with transfer of
technology
Single drugs will remain available, produced by
local official producers
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Centro de Referência Helio Fraga FIOCRUZ -
MS Margareth Dalcolmo TEL [phone] margareth.d
alcolmo_at_saude.gov.br