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PROPHYLAXIS; INDICATIONS AND DIFFICULTIES

PROPHYLAXIS; INDICATIONS AND DIFFICULTIES. CONGRESS COURSE RECENT ADVANCES IN TUBERCULOSIS CONTROL AND PROPHYLAXIS. Dr. Suha ÖZKAN. No conflict of interest. Presentation flow What is “Prophylactic therapy”? World experience about prophylaxis

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PROPHYLAXIS; INDICATIONS AND DIFFICULTIES

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  1. PROPHYLAXIS; INDICATIONS AND DIFFICULTIES CONGRESS COURSE RECENT ADVANCES IN TUBERCULOSIS CONTROL AND PROPHYLAXIS Dr. Suha ÖZKAN

  2. No conflict of interest

  3. Presentation flow • What is “Prophylactic therapy”? • World experience about prophylaxis • Prophylaxis in “Turkey National TB Guidelines” • Practices and experiences from our country • Problems of prophylaxis

  4. Prophylactic Therapy ChemoprophylaxisLatent tuberculosis infection treatmentPreventive treatment of TB

  5. Protection from Tuberculosis • Treatment of infectious patients • Prophylaxis • BCG vaccination • Prevent the transmission of TB bacillus

  6. Aim of Prophylaxis Contact of TB patient  prevent the development of infection (No randomised studies) TB infected person  prevent the development of TB disease (numerous double blind, randomised plasebo-controlled studies) Iseman MD. Klinisyenler için Tüberküloz Kılavuzu. Çeviren: Ş. Özkara. (Tüberkülozun koruyucu tedavisi). Nobel Tıp Kitabevleri, İstanbul. 2002: s. 355-398.

  7. PROPHYLACTIC THERAPY

  8. Target person for prophylaxis: All TB infected person in the community Is it possible? NO Let us then, prophylaxis for whom? Groups with a high risk of developing TB disease Benefits? To avoid development of disease from Latent TB infection To prevent the emergence of a new bacillis source Epidemiological importance in TB Control

  9. High risk of developing active disease groups HIV infection, AIDS 113, 170 Silicosis 30 Tranplantation of kidney 37 Terminal stage renal disease 10 - 25.3 Newly infected person< 2 years 15 Iatrogenic immunosuppression 4 - 16 Age (< 5 or >60) 3 - 5 Diabetes 2 - 3.6

  10. Details of preventive drug therapy • Dose • Isoniazid, daily in adults; 5 mg/kg (max. 300 mg) • For children; 10 mg/kg/day (max. 300 mg) • Period • At least for 6 months. • 9 months treatment recommended for the these groups; HIV positives, with silicosis, anti TNF treatment or other immunosuppression teatments. If the source patient is resistant to INH or the person can not use isoniazid; rifampicin 10 mg/kg/day, maximum 600 mg/day (4 months)

  11. Details of preventive drug therapy If the source patient is resistant to H and R (MDR) Pyrazinamide + ethambutol or Pyrazinamide + quinolone can be used. But there is no large studies for efficacy and safety

  12. In prophylaxis: • Medications should be used regularly and completed the period • To educate and support is important • Uninterrupted therapy is essential • Short term intervals, the time is added to the end of treatment In case of the six month preventive therapy within 9 months, the nine month preventive therapy within 12 months completed, treatment can be considered OK. A Joint Statement of the American Thoracic Society (ATS) and the Centers for Disease Control and Prevention (CDC). Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000; 161(4 Pt 2):S221-47.

  13. Pyridoxine (vitamin B6) in prophylaxis • Diabetes Mellitus • Renal failure, dialysis • Malnutrition • Alcoholism • Pregnancy • Pyridoxine deficiency epileptic seizures 10 mg. Pyridoxine (Vitamin B6) daily used with isoniazid Snider DE Jr. Pyridoxine supplementation during isoniazid therapy. Tubercle 1980; 61:191-196.

  14. Hepatitis due to Isoniazid Normally during the use of H may be temporary transaminase heights. • • Whether or not symptoms transaminase values ​​exceed 5 times the upper limit of normal • Upper limit of normal in a patient with symptoms of hepatitis, transaminase values ​​exceeding 3 times• Without apparent cause other than bilirubin 1.5 mg / dL rise above. STOP “H” Saukkonen JJ, Cohn DL, Jasmer RM, et al. An official ATS statement: hepatotoxicity of antituberculosis therapy. Am J Respir Crit Care Med 2006; 174: 935-952.

  15. After stopping Isoniazid (H), if the person used lower drug doses then planned, prophylaxis can be continued with rifampicin (R).

  16. H is contraindicated in the presence of H allergy or a history of liver disease formed by H. • Patients with chronic liver disease, and regular alcohol use, not to use H would be more appropriate. • If the patient carries a high risk of side-effects are evaluated. • People had to informed about the side effects of drugs.

  17. Before starting prophylaxis • Be sure that the person has not TB disease • Medical history of patient • Physical examination and findings • Chest x-ray must be evaluated • If you think TB disease Bacteriological examination is done If the person has TB disease and is not detected, the result of preventive treatment may be drug resistance

  18. Preventive treatment may be as effective as 19 years. • At the end of preventive therapy, alteration of the tuberculin skin test is not expected. Comstock GW, Baum C, Snider DE Jr. Isoniazid prophylaxis among Alaskan Eskimos: a final report of the Bethel studies. Am Rev Respir Dis 1979; 119:827-830.

  19. World experience in preventive therapy

  20. Preventive treatment studies-USPHS* 1) Household contacts of new diagnosed patients: • 25.033 contacts of 5677 source cases, • Randomised, double-blind, placebo controlled, • H for 12 months, daily 5-6 mg/kg. ACTIVITY: Reduction of 70% in pulmonary TB, 72% in extrapulmonary TB in two years. *USPHS = United States Public Health Service 2) mental health institutions • Total 25.210 people • Randomised, double-blind, placebo controlled, • Hfor 12 months, daily 4,2-5,0 mg/kg, watching for 10 years. ACTIVITY: Reduction of 63% in two years, >60% prevention in long-term follow-up M.D. Iseman, Klinisyenler İçin Tüberküloz Kılavuzu. Çev: Özkara Ş.

  21. 3) People in Alaska: • Total of 6054 people, • Age distribution: 0-14age (49%), 15-34 age (30%), 35-54 age (16%), 55 age and upper (5%). RESULTS: 59% decrease in morbidity for 6 years, preventive effect has seen for 19 years. 4) Inaktive lesions: • Total 4575 people, • People with inactive TB lesions in chest x-ray. RESULTS: • The rate of developing TB disease in placebo group 6.86%, H preventive group 2.57% within two years. • Total prevention is 63% in five years. M.D. Iseman, Klinisyenler İçin Tüberküloz Kılavuzu. Çev: Özkara Ş.

  22. Studies in Europe about Prophylaxis - IUAT* • Compatible with pulmonary tuberculosis cured films were studied nearly 28,000 people. • Divided into groups of placebo, 3 months H, 6 months H, 12 months H and ve radiological abnormalities were graded. RESULTS: • Compared to placebo, the incidence of TB had decreased 65% with 6 months regime, 75% with 12 months regime in 5 years. • If the radiological abnormalities are smaller than 2 cm, the preventive activity of 6 months regime and 12 months regime were similar. *IUAT = International Union Against Tuberculosis M.D. Iseman, Klinisyenler İçin Tüberküloz Kılavuzu. Çev: Özkara Ş.

  23. Prophylaxis in TB Control • Every year, people infected with infectious tuberculosis patients will result in a new society, along with other infected people, and also similar numbers of patients will be seen again a year later. • Whether early treatment of TB patients effectively, reduce the number of those who are newly infected. However, the large population of people who have been infected previously not treated, the disease will be limited to a reduction in the number of those arrested. * Ferebee and friends (USPHS)

  24. Prophylaxis in TB Control • Especially those who are at risk for the disease and contacts, chemoprophylaxis is given within the program, assuming the protection efficiency of 60%, less patient will be seen in the next year. • More than 50% decrease in the incidence of the disease in the United States within 15 years, largely because widespread drug preventive program run (2 million people each year, the drug was intended to protect). * * Ferebee and friends (USPHS)

  25. The model of Ferebee and friends from USPHS

  26. 19 controlled trials in 11 countries: United States Canada Greenland Mexico Japan Netherlands France Over 100,000 participants 25%-92% protection HEPATITIS NOT REPORTED OR NOT RECOGNIZED INH: Placebo-Controlled Trials of Isoniazid for Treatment of Latent TB Infection, 1955-1965 Tunisia Kenya India Philippines Dick Menzies MD, MSc, Tuberculosis Contact Investigations; TTS Meeting 2011

  27. Prophylaxis in ATS- CDC Guideline- 2000 • HIV + • Contacts of TB patient • TB liked inactive lesions in chest x-ray • Solid organ transplantations and immunosupressed people Tuberculin Skin Test >5mm

  28. Prophylaxis in ATS- CDC Guideline- 2000 • Immigrants from high-prevalence countries in the last 5 years • IV drug users • Poeple working or living in high risk institutions • Mycobactery laboratory staff • Co-morbid situtations: silicosis, CRF, DM, hematological diseases, malignencies, gastrectomy, 10% weight loss • Children under age of 4 years who are Contact in high-risk adults Tuberculin skin test >10mm

  29. Prophylaxis in ATS- CDC Guideline- 2000 • Person who has not any risk factor Tuberculin skin test >15mm

  30. ? Is it really difficult to treat and prevent TB? Dr. Feridun Kunak’tan VEREM için özel karışım – 2 Ocak 2013 (Kanal 7) Verem hastaları için Feridun Kunak, kendi show programında vereme iyi gelecek ve verem hastalığını tedavi edecek özel bir kür tarifi vererek, verem hastalarının yaşam kalitelerin yükseltmelerine muavenet ediyor. Verem için Feridun Kunak’ın vermiş olduğu bu kürü düzenli olarak uyguladığınız zaman hem kısa sürede bu rahatsızlığınızı geride bırakacak hem de veremden dolayı yaşadığınız bir takım sıkıntılardan kurtularak sağlıklı bir bünyeye sahip olmanın keyfini süreceksiniz. www.sagliksiteniz.com

  31. PREVENTIVE THERAPY IN “TURKEY NATIONAL GUIDELINE FOR TB CONTROL”

  32. The risk groups for preventive therapy in Turkey TST positive smaller then age 15 Conversion of TST Immunosuppressed people with positive TST Contacts of infectious TB patient, age <35

  33. It is necessary to screen house-hold contacts before prophylaxis. • If there are suspected contact people outside home, they are suitable for screening.

  34. Doğrudan Gözetimli Tedavi ya da Koruyucu Tedavi Fotoğrafları (Bu Fotoğrafların bilimsel amaçlı sunularda kullanılması için hastalardan onay alınmıştır.)  verem.org.tr Prophylaxis with DOT in a school

  35. Registered TB patients in TB dispansaries, 2002-2009 Number of preventive therapy Contact examination per patient Preventive therapy per patient Number of TB patients Contact examination years

  36. TB patients, contact examinations, prophylaxis, 2002-2009

  37. Due to preventive treatment practices in our country, the rate of completion treatment is high. In 2008, 75% of the people who started preventive treatment, completed their regime in our country.* It is shown that prophylaxis is effective in the age groups 0-14, 15-34, and over 35. In the recent years, some studies have shown to be effective in immunocompromised patients.** *Bozkurt H ve ark. Tüberkülozda koruyucu tedavi alanların değerlendirmesi. XXVI. Ulusal Tüberküloz ve Göğüs Hastalıkları Kongresi Bildiri Özetleri Kitabı, 2011. **Sayıcı Ş ve ark. Akciğer tüberkülozu temaslılarında hastalanma ve koruyucu tedavinin etkinliği. XXVI. Ulusal Tüberküloz ve Göğüs Hastalıkları Kongresi Bildiri Özetleri Kitabı, 2011.

  38. A Critical Approach to Preventive treatment; Doubts and Problems • Error in the determination of latent infection (TST?) • The risk of treatment-related hepatitis • The possible presence of resistance to Isoniazid • Treatment compliance problems • Being TB patient before prophylaxis or TB disease during preventive treatment • Efficacy of preventive treatment • Recurrent infection • Priorities in planning resource and health staff

  39. The evidence of treatment regimes Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection ATS/CDC Statement Committee on Latent Tuberculosis Infection Membership List, June 2000, MMWR, June 09, 2000 / 49(RR06);1-54

  40. TB Patient Progressive symptoms Infectious Radiological findings Positive TST Latent infection No symptoms Not infectious No radiological findings Positive TST Treatment period 9 months (evidence A) 6 months (evidence B) 6 months “ Evaluation of tolerance and cost-benefit, 6 months treatment is optimal”

  41. LAST WORDS: • Studies show the effect of preventive therapy in the prevention of TB disease. • Preventive treatment is a main component of TB Control Program in some countries. • The discussion is whether preventive therapy has priority according to the situation in the country. • The insidence of TB has reduced in Turkey, recent years. • Preventive treatment has been used widely.

  42. Kaynaklar • Tüberküloz Tanı ve Tedavi Rehberi Sağlık Bakanlığı, 2011 • Türkiye’de Tüberkülozun Kontrolü için Başvuru Kitabı, Sağlık Bakanlığı Verem Savaşı Daire Başkanlığı, 2003 • Klinisyenler İçin Tüberküloz Kılavuzu, Michael D. Iseman, Çeviri: Şeref Özkara Nobel Tıp Kitabevi, 2002 • Tüberkülozdan Korunma, G. Kıter, E. S. Uçan, Toraks Dergisi, 2001:2(1):85-90 • Tüberkülozda İlaçla Koruma, E, Erdinç, Tüberküloz Kliniği ve Kontrolü, 391-397

  43. Thanks !

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