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Dr. SERİR AKTOĞU ÖZKAN I zmir Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi [email protected] THE TRIALS RELATED TO TREATMENT OF LTB INFECTION. THE CONTROL OF T UBERCULOSIS. to detect of patients with active tuberculosis to cure the patients with active TB

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Dr. SERİR AKTOĞU ÖZKAN

Izmir Göğüs Hastalıkları ve CerrahisiEğitim ve Araştırma Hastanesi

[email protected]

THE TRIALS RELATED TO TREATMENT OF LTB INFECTION
the control of t uberculosis
THE CONTROLOF TUBERCULOSIS
  • to detect of patients with active tuberculosis
  • to cure the patients with active TB
  • to detect and treatment of persons with LTBI at high risk for developing to active TB
treatment of latent tb infection
TREATMENT OF LATENT TB INFECTION
  • to detect LTBI with high risk for

developing TB

  • to start standart treatment of LTBI
  • to complete of standart treatment of LTBI
persons with increased risk for developing tb
Persons with increased risk for developing TB
  • Recent infection with M. tuberculosis
  • Clinical conditions that are associated with an increased risk for progression of LTBI to active TB (several factors that are associated with decreased cell-based immunity).
several factors associated with impaired cell based immunity
Several factors associated with impaired cell-based immunity
  • Younger than 5 yr of age, adolescents and

young adults

  • HIV infection, who are receiving immunosuppressive theapy (anti-TNF-α drugs, systemic corticosteroids, solid organ transplantation),
  • chronic renal failure, leukemias, lymphomas, carcinoma of the head or neck and lung v.s
treatment of ltb i
TREATMENT OF LTBI
  • Isoniazid has been the mainstay of LTBI treatment

for >40 years.

  • The preferred treatment for LTBI is 9 months of

daily H

Effectiveness of the drug 25- 93 %

  • Disadvantages: hepatotoxicity, poor completion

rate, high H resistance

randomized treatment trials in hiv infected subjects
RANDOMIZED TREATMENT TRIALS IN HIV INFECTED SUBJECTS

2 months of R (600mg) and Z (15-20mg/kg) in

combination (RZ) proved to be as effective as 6

months of (H) treatment for prevention of TB

Disease and was well tolerated.

Halsey NA, Coberly JS, Desormeaux J et al. Randomized trials of isoniazid

Versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1

İnfection. Lancet 1998; 351: 786-92.

ltbi treatment in hiv infected subjects
LTBI TREATMENT IN HIV INFECTED SUBJECTS

2-3 months of RZ for LTBI treatment in HIV

infected patients was recommended by The

Centers for Disease Control and Prevention (CDC)

in 1998.

slide11
The person with positive tuberculin reaction who

are considerd to be at high risk for developing for

active TB should be offered treatment of LTBI

treatment regimens for ltbi
TREATMENT REGIMENS FOR LTBI

ATS, CDC, AM J Respir Crit Care Med 2000;161: S221-S247

severe or fatal hepatotoxicity in patients taking rz for ltbi
Severe or fatal hepatotoxicity in patients taking RZ for LTBI
  • 21 hepatotoxicity between 12 Feb- 24 Ağust 2001
  • 5 of whom died
  • The preferred treatment is 9 months of daily H
  • The regimen of 2RZ should generally not be

offered for treatment of LTBI and intensive

monitoring is required

MMWR 2001; 50: 733-735

JAMA; 2001: 286: 1445-1446.

slide15
High risk of hepatotoxicity
  • Intensive monitoring is required
  • 2RZ is not cost-effective for tuberculosis control

programs

  • Standart therapy for LTBI is 9 months H
a meta analysis r plus z versus h for treating ltbi
A Meta-analysis : R plus Z versus H for treating LTBI

6 trials: Haiti, Mexico, USA, Brazil, Spain, Zambia, Hong-Kong

2-3 months RZ versus standart 6-12 ay H regimens

randomizedcontrolledtrials.

Incidence of TB:

0% 2RZ

0.4% 6H

Severe hepatotoxicity

8.2% 2RZ

1.7% 6H

Severe advers events

11.4% 2RZ

2.9% 6H Gao et al. Int. J Tuberc Lung Dis 2006; 10: 1-11

slide18

Recommendations and Reports

July 7, 2006 / 55(RR09);1-44

Prevention and Control of Tuberculosis in Correctional and Detention Facilities: Recommendations from CDC

Endorsed by the Advisory Council for the Elimination of Tuberculosis, the National Commission on Correctional Health Care, and the American Correctional Association

The material in this report originated in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (proposed), Kevin Fenton, MD, PhD, Director, and the Division of Tuberculosis Elimination, Kenneth G. Castro, MD, Director.

Corresponding address: Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (proposed), CDC, 1600 Clifton Road, NE, MS E-10, Atlanta, GA 30333. Telephone: 404-639-8120; Fax: 404-639-8604.

Summary

slide19

Drugs

Dura

tion

Interval

No of doses

RatingEvidence

HIV- HIV+

H

H

R

9

6

4

Daily

Twicewkly

Daily

Twice wkly

Daily

270

78

180

52

120

A(II) A(II)

B(II) B(II)

B(I) C(I)

B(II) C(I)

B(II) B(III)

TREATMENT REGIMENS FOR LTBI

L

www.cdc.gov/mmvr/preview/mmwrhtml/ 2006

slide20
Retrospective design
  • Treatment completion 9H (62 %), 4R (86 %)
  • Hepatotoxicity 9H (1.4 %), 4R (0 %)
  • Side effects and drug reactions 9H (6.1 %),

4R (3.1%)

  • Conclusions: Patients receiving 4R were

significantly more likely to complete therapy than

those receiving 9H

efitorial comment consider rifampin but be cautious
Efitorial CommentConsider Rifampin BUT be cautious
  • Rifampin must be used with caution
  • Rifampin monotherapy can relaese

Rifampin resistance

  • Randomized controlled trials is required for

medical and public health recommendations.

Chest 2006; 130: 1638-1639

slide22
Treatment for LTBI in people who exposed to MDR-TB
  • Z plus E or Z ve Quinolone 6-12 months ,if M. Tuberculosis strain isolated from the index case is susceptible to these drugs )
slide23
Preventing TB in people at risk of MDR
  • No randomized controlled trials
  • The balance of benefits and harms

associated with treatment for LTBI in

people exposed to MDR-TB is far from

clear.

anti tnf alfa treatment and tb infliximab etanercept adalimumab
Anti TNF- alfa Treatment and TB(infliximab, etanercept, adalimumab)
  • RA patients is at incresed risk of TB versus the

general population

  • RA patients treated with TNF antagonists has a

4-20-fold incresed risk of TB versus RA patients not

treated withTNF antagonists

Arthritis and Rheumatism 2005; 52: 1986-1992

Arthritis and Rheumatism 2003; 48: 2122-2127

slide25
The increase in TB is associated with Anti-TNF-alfa.
  • Prior of commencing of anti-TNF-alfa, all patients

should have their risk of TB assessed: history of TB

infection and treatment, a clinical examination, a

chest x-ray, Tuberculin testing

  • It is important to exclude of active TB
  • If the patient has active TB, full course of standart

chemotherapy is required.

slide26
For patients with an normal chest x-ray and no

immunosuppressant therapy,Tuberculin testing is

useful

  • The accuracy and reliability of Tuberculin testing is

affected by immunsupressant therapy.

slide27
For patients with normal chest x-ray and BCG, no

history of TB, no immunosuppressant thrapy,

Tuberculin testing of 0-14, no further action is

needed and anti-TNF-alfa theray can be

commenced.

  • No BCG, and tuberculin testing of 0-5, no further

action is needed and anti-TNF-alfa therapy can be

commenced.

ii raed the statement of consensus meeting 7 may 2005 zmir
II. RAED The Statement of ConsensusMeeting 7 May 2005 / İzmir
  • Anti TB therapy must be completed prior to

commencing anti TNF-alfa therapy.

  • Prior of commencing of anti-TNF-alfa, all patients

should have their risk of TB assessed: history of

TB infection and treatment, chest x-ray and,

tuberculin skin testing.

ii raed the statement of consensus meeting 7 may 2005 zmir1
II. RAED The Statement of ConsensusMeeting 7 May 2005 / İzmir
  • If the patient with tuberculin testing of 1-4 mm

(negative), no fibrocalcific lesions in chest x ray,

and no contact with TB within last year, it is

recommended to repeat tuberculin testing

If the second tuberculin testinf is 1-4 mm, there is

no need for LTBI treatment

  • However, the risk of TB outweighs the risk of

chemoprophylaxis, therapy for LTBI may be

started.

ii raed the statement of consensus meeting 7 may 2005 zmir2
II. RAED The Statement of ConsensusMeeting 7 May 2005 / İzmir

Following conditions are required standart

treatment with H 9 month:

  • The patients with normal chest x-ray but

tuberculin test of ≥ 5 mm

  • The patient with abnormal chest x-ray

(fibrocalcific lesions and/or tuberculin

testing ≥ 5 mm and excluding active TB

  • The patient who contact with active TB patients

within last year

  • Health care workers with high risk ofTB
turkish thoracic society 10 th annual congress mini symposia 2007 tuberculosis and anti tnf therapy
Turkish Thoracic Society 10 th Annual CongressMini Symposia 2007 Tuberculosis and anti-TNF-α Therapy
  • Most of patients (72%) had BCG mark
  • Most of patients (69%) were currently taking ≥1

immunosuppressive drug other than anti TNF-α

at the initiation of treatment.

  • %9 had taken none of them
conclusions
CONCLUSIONS
  • It is important to detect of persons with LTBI at

high risk for developing to active TB

  • Standart treatment for LTBI is 9 months of H daily
  • Treatment completion is of paramount importance

to the success of LTBI therapy

  • No standart treatment for close contacts of

MDR-TB cases

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