Epidemiology of Tuberculosis in Northeastern United

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					        Northeast TB Controllers Meeting
             Princeton, New Jersey
                October 24, 2006


  Epidemiology of Tuberculosis in
Northeastern United States, 1993-2005

                  Kenneth G. Castro, M.D.
            Assistant Surgeon General, USPHS
       Director, Division of Tuberculosis Elimination
 National Center for HIV, Hepatitis, STD, and TB Prevention*
        Coordinating Center for Infectious Diseases
 * Proposed
              Acknowledgements
•   United States TB controllers, state and local health
    departments

•   CDC, DTBE, SEOIB and FSEB
     – Lori Armstrong        − Sandy Althomsons
     – Elvin Magee           − Val Robison
     – Tom Navin             − Dave Crowder
     – Dan Ruggiero          − John Jereb
     – Mark Lobato           − Margaret Oxtoby
     – Edwin Rodriguez       − Tracy Agerton
     – Farah Parvez          − Sonal Munsiff
     – Vernard Green         − Tom Privett
     – Zach Taylor
            TB Cases Analyzed
• National TB Surveillance System
• Reported 1993 to 2005
• Northeastern States: Maine, New Hampshire,
    Vermont, Connecticut, Massachusetts,
    Rhode Island, New York, New Jersey
•   Compared to all other states in the U.S.
TB Case Rates,* United States, 2005
                                                  NE states


                                                 D.C.




                      < 3.5 (year 2000 target)
                      3.6–4.8
                      > 4.8 (national average)
*Cases per 100,000.
                               Reported TB Case Rates in U.S.,
                               NE vs. Other States, 1993-2005
                         8.0
Rate TB Cases/ 100,000




                         7.0
                         6.0
                         5.0
                         4.0
                         3.0
                         2.0
                         1.0
                         0.0
                                2000    2001       2002       2003      2004        2005

                                       NE States    All other states   Nationwide
                                                      Year
              Reported TB Cases by Age Group,
               NE States vs. Others, 1993–2005
                        50
Percent of Case Count




                        40

                        30

                        20

                        10

                        0
                             0-14   15-24        25-44      45-64   65+
                                            Age at Diagnosis

                                      NE States      Other states
    Reported TB Cases by Race/Ethnicity,*
      NE States vs. Others, 1993–2005
                Amer Indian/Nat Alaskan                                Amer Indian/Nat Alaskan
                         (<1%)                                                  (1%)

  Nat
Hawaiian/       White         Asian
                                                                                      Asian
 Pacific        (18%)         (20%)                                    White
                                                                                      (19%)
 (<1%)                                                Nat              (25%)
                                                    Hawaiian/
            Hispanic                                 Pacific
             (25%)          Black                    (<1%)                           Black
                                                                     Hispanic
                            (36%)                                     (23%)          (31%)




                  NE States                                              Other States
             *All races are non-Hispanic. Persons reporting two or more races
             accounted for less than 1% of all cases. Unknown not included.
 Reported TB Cases by Birth Origin,
NE States vs. Others, U.S., 1993–2005*
Birth Origin                 NE States     Other States
                               n (%)          n (%)

US-Born                    21,051 (49.2)   116,601 (59.7)


Foreign-born               21,769 (50.8)   78,741 (40.3)

     Note: Unknown not included
  TB Cases, by Previous Diagnosis,
NE States vs. Others, U.S., 1993–2005*
                               NE States            Other states
                                 n (%)                 n (%)

Previous
                                      1,695 (4.0)       10,785 (5.5)
diagnosis of TB

No previous
                                  41,153 (96.0)       183,777 (94.5)
diagnosis of TB

       Note: Unknown and missing not included
       *Updated as of March 29, 2006.
      HIV Test Results of TB Cases,
  NE States vs. Others, U.S., 1993–2005*
HIV Status     NE States        Other states
                 n (%)             n (%)

HIV Positive     8,357 (19.4)       18,025 (9.2)


HIV Negative    15,180 (35.3)     64,023 (32.6)

Missing or
                19,456 (45.3)    114,511 (58.2)
Unknown
 Mode of Treatment Administration in
     Persons Reported with TB,
NE States vs. Others, U.S., 1993–2003*
         100%

           80%

           60%
           40%

           20%

            0%
                    NE States                            Other
                                                         States

                              DOT only           DOT + SA         SA only
* Excludes unknown and missing.
Directly observed therapy (DOT); Self-administered therapy (SA)
   Percent Completion of TB Therapy,*
   NE States vs. Others, U.S., 1993-2005
Percent
  100
   80

   60
   40

   20
    0
          1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003

                                                 NE States           Other US
                                                         Year
   *Healthy People 2010 target: 90% completed in 1 yr or less.
   Note: Excludes persons with initial isolate resistant to rifampin and children <15 years old with
   meningeal, bone or joint, or miliary disease excluded.
  Reason Therapy Stopped in TB Cases,
  NE States vs. Others, U.S., 1993–2005*
Percent
 80
 70
 60
 50
 40
 30
 20
 10
  0
                  NE States                       Other States
      Completed   Moved   Lost   Uncoop/Refused   Died   Other   Missing/Unk
             MDR TB* in NE States vs. Others,
           8
                    U.S., 1993-2005
           7
           6
% MDR TB




           5
           4
           3
           2
           1
           0
              93

              94

              95

              96

              97

              98

              99

              00

              01

              02

              03

              04

              05
           19

           19

           19

           19

           19

           19

           19

           20

           20

           20

           20

           20

           20
                                              NE States            Other US
                                                   Year of Reporting
               %MDR TB cases = no. of TB cases with Mycobacterium tuberculosis isolates
               resistant to isoniazid and rifampin, among all cases tested to isoniazid and rifampin
      MDR TB by Birth Origin,
NE States vs. Others, U.S., 1993-2005
Birth Origin     NE States        Other US
                   n (%)            n (%)
Foreign-born        390 (34.5)     1082 (64.2)

U.S.-born           735 (65.1)      589 (35.0)

Unknown origin          4 (0.4)        13 (0.8)

Total             1129 (100.0)    1684 (100.0)
TB Epidemiology Summary in NE States*
• Heterogeneous states (high, medium, low incidence)
• Consistently higher rates
• Majority (58.6%) younger than 44 years
• Most (82%) racial/ethnic minorities
• Lower proportion (49.2%) U.S.-born
• Higher prevalence (19.2%) HIV infection
• Larger proportion on DOT+SA and SA only treatment
• COT improving (82%), room for improvement
• MDR decreased 1993-2000, recent stagnation
  * Compared with other states, U.S., 1993-2005
Second-Line Drug Classes for MDR TB Treatment

                      Aminoglycosides                 Amikacin, Kanamycin


                          Polypeptides                Capreomycin


                      Fluoroquinolones                Ciprofloxacin, Ofloxacin
First line
 drugs
              +
                           Thioamides                 Ethionamide, Prothionamide

                      Serine analogues                Cycloserine

                                PAS
     WHO. Guidelines for the programmatic management of drug-resistant tuberculosis. 2006.
 Characteristics of KZN XDRTB Patients
    Characteristics                                                                No. (%)
    • No prior TB Treatment                                                        26 (51)
    • Prior TB treatment
      – Cure or Completed treatment                                                14 (28)
      – Treatment Default or Failure                                                7 (14)

    • HIV-infected (44 tested)                                                     44 (100)
    • Dead (Includes 34% on ARV)                                                   52 (98)
    • Identical M. tb spoligotype                                                  26/30
* Moll A, Gandhi NR, Pawinski R, Lalloo U, Sturm AW, Zeller K, Andrews J, Friedland G.
HIV associated Extensively Drug-Resistant TB (XDR-TB) in Rural KwaZulu-Natal
 (South Africa MRC Expert Consultation Sept 8, 2006)
HIV-related MDR TB Outbreak Investigations
by CDC & Health Departments, USA, 1988–92
             Total     % HIV        %    Median Wks
 Hospital   Cases    Infected   Deaths   Dx to Death
     A         65         93       72       7
     B         51        100       89       16
     C         70         95       77       4
     D         29         91       83       4
     E          7         14       43       4
     F         16         82       82       4
     I         13        100       85       4
     J         28         96       93       4
 Prison        42         98       79       4
    U.S. Response to TB Resurgence
                                                      Updated Diagnostic Labs,
National MDR-TB Action Plan     Improved Case         Real-time Drug Resistance,
     & New Resources        Identification & Training   & Strain Fingerprinting




   Rebuilt Research                                DOT & Improved Rx Completion
      Capacity
                           Updated Infection Control
                           and Rx Recommendations




                                    AJRCCM 1994;149:1359-74
Global 7-point Action Plan to Combat XDR TB
    Emphasizes Essentials of Proper TB Control
1. Conduct rapid surveys of XDR-TB (determine burden)
2. Enhance laboratory capacity (emphasis on rapid DST)
3. Improve technical capacity of clinical and public
   health practitioners to effectively respond to XDR-TB
   outbreaks and manage patients
4. Implement infection control precautions (PLHA focus)
5. Increase research support for anti-TB drug
   development
6. Increase research support for rapid diagnostic test
   development
7. Promote universal access to ARVs under joint TB/HIV
   activities
         MRC Consultation, Johannesburg, South Africa. Sept 7, 2006
 Revised WHO Case Definition for
      XDR TB (Oct 10, 2006)
Goals
• Public health surveillance
• Reliable DST methodology
• Clinical relevance
• Relatively simple
Resistance to at least isoniazid and rifampin
(MDR) plus resistance to fluoroquinolones
and one of the second-line injectable drugs
(amikacin, kanamycin, or capreomycin)
   TB Treatment Outcomes, by Selected Drug
    Resistance Patterns, Latvia, 2000-2003*

        Cure     Completion      Death     Default     Failed    Continue Tx       HIV+

HR+AG+FQ



HR+INJ+FQ



 HR+3SLD



MDR-TB All


             0       10         20         30         40        50         60         70
                                         Percent
 * Leimane V, et al. WHO XDR TB Task Force Meeting. Oct 9, 2006 (from N = 820 evaluated)
                     (WHO)
            XDR       TB Cases in U.S.,
       Northeast vs. Other States, 1993-2005
No. XDR TB Cases
  14

  12

  10

   8
                                                         Other States
   6                                                     NE States
   4

   2

   0
       1993   1995   1997   1999    2001   2003   2005

                        Year of Report
                      (WHO)
            XDR      TB Cases in U.S.,
       Foreign-born vs. U.S.-born, 1993-2005
No. XDR TB Cases
  14

  12

  10

   8
                                                        Foreign-born
   6                                                    US-born
   4

   2

   0
       1993   1995   1997   1999   2001   2003   2005

                       Year of Report
               (WHO)
    XDR      TB Cases in Northeast States,
     Foreign-born vs. U.S.-born,1993-2005
No. XDR TB Cases
   14

   12

   10

    8                                                     Foreign-born
    6                                                     US-born

    4

    2

    0
        1993    1995   1997   1999   2001   2003   2005

                         Year of Report
               (WHO)
        XDR      TB Cases in Other States,
       Foreign-born vs. U.S.-born,1993-2005
No. XDR TB Cases
14

12

10

 8                                                        Foreign-born
 6                                                        US-born

 4

 2

 0
     1993   1995   1997   1999       2001   2003   2005

                    Year of Report
    (WHO)
XDR      TB Cases in U.S.-born vs.
 Foreign-born Persons, 1993-2005

                 1993-1998 2000-2005

  U.S.-born         19         3

  Foreign-born      12        12
          TB Clinical Development Pipeline
    Compound                  Development Stage                      Sponsor / Coordinator
                                                        EC / OFLOTUB Consortium; IRD*;
Gatifloxacin             Phase III                      WHO TDR; Lupin Ltd.
                                                        Bayer; TB Alliance; CDC;
                                                        University College of London;
Moxifloxacin             Phase II / III                 Johns Hopkins University
Diarylquinoline TMC207   Early Bactericidal Activity    Johnson & Johnson (Tibotec)
Nitroimidazo-oxazole
OPC-67683
                         Early Bactericidal Activity    Otsuka Pharmaceutical Co., Ltd.
Nitroimidazole PA-824    Phase I                        TB Alliance
Pyrrole LL-3858          Phase I                        Lupin Ltd.

                                                       * Institut de Recherche pour le Developement
                                                        World   Health Organization, Tropical Disease Research
Novel compounds, highlighted in blue boxes,             Centers   for Disease Control and Prevention
are active against MDR/XDR TB
Examples of Rapid Drug Resistance Methods
Test                         GenoType® MTBDR   INNO-LiPA Rif.TB

Company                     Hain Lifescience    Innogenetics

M. tuberculosis detection        Yes              Yes
Detection RMP resistance         Yes              Yes
Detection INH resistance         Yes               No
Strip Assay                      Yes              Yes
DNA basis: PCR                   Yes              Yes
Direct assay                     No            Yes (modified
                                                   version)
RMP resistance:rpoB gene         Yes                Yes
INH resistance:katG gene         Yes                No
Microscopic-Observation Drug Susceptibility
      Assay for the Diagnosis of TB*




        Moore DAJ, et al. N Engl J Med 2006;355:1539-50
                     Actual and BRDPI-Adjusted
                Federal Funds for TB*, CDC, 1990-2006
                $200
($ x million)




                $150
  Funding




                              Actual $
                $100                                       112




                 $50

                   $0
                     90

                              92

                                      94

                                              96

                                                       98

                                                                  00

                                                                        02

                                                                              04

                                                                                    06
                   19

                           19

                                   19

                                           19

                                                      19

                                                                 20

                                                                       20

                                                                             20

                                                                                   20
                 * Adjusted to 1990 US$ by Biomedical Research & Development Price Index
                 ** Includes TB/HIV and lab dollars