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THE TRIALS RELATED TO TREATMENT OF LTB INFECTION

Dr. SERİR AKTOĞU ÖZKAN I zmir Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi aktogu@yahoo.com. 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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THE TRIALS RELATED TO TREATMENT OF LTB INFECTION

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  1. Dr. SERİR AKTOĞU ÖZKAN Izmir Göğüs Hastalıkları ve CerrahisiEğitim ve Araştırma Hastanesi aktogu@yahoo.com THE TRIALS RELATED TO TREATMENT OF LTB INFECTION

  2. 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

  3. 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

  4. 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).

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. TREATMENT REGIMENS FOR LTBI ATS, CDC, AM J Respir Crit Care Med 2000;161: S221-S247

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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 )

  19. 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.

  20. 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

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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

  27. 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

  28. 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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