1. Tuberculosis in Children: Treatment and Monitoring Module 10B - March 2010

2. Project Partners Funded by the Health Resources and Services Administration (HRSA)

3. Module Overview  Treating childhood TB  Monitoring the pediatric patient on TB treatment

4. Learning Objective Upon completion of this session, participants will be able to:  Determine the appropriate treatment regimen for a child with tuberculosis  State the circumstances under which corticosteroids should be added to the regimen  Name the essential monitoring that should occur when a child is under treatment for tuberculosis

5. Treating Childhood TB

6.  Treatment regimens for children are based on prior treatment history and clinical presentation  Most children with TB have uncomplicated (smear-negative) pulmonary/intrathoracic TB or non-severe forms of EPTB  The principles for TB treatment in the HIV-infected child are the same as in the HIV-uninfected child

7. Treating Childhood TB (2)  WHO has updated dosage recommendations for children based on pharmacokinetic studies and expert consultation  Weight should be monitored throughout treatment and dose adjusted for weight increases  Pediatric intermittent dosing recommendations are under review  Ethambutol and streptomycin are the only drugs with approved pediatric thrice weekly dosing

8. Pediatric Dosing Table

9. Recommended Regimens H= isoniazid; R= rifampicin; Z= pyrazinamide; E= ethambutol; PTB= pulmonary TB; EPTB= extra-pulmonary TB; HIV= human immunodeficiency virus

10. Recommended Regimens (2) H= isoniazid; R= rifampicin; Z= pyrazinamide; E= ethambutol; S= streptomycin; PTB= pulmonary TB; EPTB= extra-pulmonary TB; MDR-TB= multidrug resistant tuberculosis

11. Treating TB Meningitis H = isoniazid; R = rifampicin; Z = pyrazinamide; S = streptomycin; Eth = ethionamide; WHO = World Health Organization

12. Use of Corticosteroids  Recommended in all cases of TB meningitis Dosage= 2mg/kg daily x 4 weeks then gradually reduced (tapered) over 1-2 weeks  Corticosteroids may be used for the management of other complicated forms of TB such as: Complications of airway obstruction from lymphatic TB TB pericarditis

13. Monitoring the Pediatric Patient on TB Treatment

14. Monitoring Challenges  Bacteriological monitoring of treatment response is not practical in most children  Monitoring for toxicity is more difficult  Need to find ways to get the child to take the treatment as the taste is often not pleasant to the child

15. Dosing Tips  Anticipate a trial-and-error period at start  Layer vehicle and drug on a spoon  Possible vehicles to hide drug in: syrup, chili, jam, baby food, pudding, etc.  Teach child to take contents of spoon without chewing  Follow medication with a liquid or other food the child likes to clear palate  Be prepared to try new methods or incentives  Never let the child think the dose is optional

16. Treatment Adherence  Educate about TB and the importance of completing treatment  Encourage and support the child, parent(s) and immediate family  Observe administration of treatment (DOT)

17. Treatment Adherence (2)  All children should receive treatment free of charge, whether or not the child is smear- positive at diagnosis  When they become available, pediatric fixed- dose combinations should be used whenever possible to improve simplicity and adherence  Patient treatment cards are recommended for documenting treatment adherence

18. Hospitalization  Children with severe forms of TB should be hospitalized for intensive management where possible  Conditions that merit hospitalization include: TB meningitis and miliary TB, preferably for the first 2 months Any child with respiratory distress Spinal TB Severe adverse events, such as clinical signs of hepatotoxicity (e.g., jaundice)

19. Monitoring Throughout Treatment  Ideally, each child should be assessed by the National Tuberculosis Program (NTP) (or those designated by the NTP to provide treatment) at least at the following intervals: 2 weeks after treatment initiation Monthly until end of the intensive phase Every 2 months until treatment completion

20. Monitoring Throughout Treatment (2)  The assessment should include, at a minimum: Review of symptoms Review of adherence Enquiry about any adverse events Weight measurement Review of the patient treatment card Follow-up sputum for AFB smear microscopy, especially at 2 months for any child who was sputum smear-positive at diagnosis

21. Monitoring Throughout Treatment (3)  The NTP is responsible for organizing treatment in line with the Stop TB Strategy, and ensuring the recording and reporting of cases and their outcomes  Good communication is necessary between the NTP and clinicians treating children with TB  Adverse events noted by clinicians should be reported to the NTP

22. Immune Reconstitution  This temporary exacerbation of symptoms, signs, or radiographic manifestations sometimes occurs after beginning anti-TB treatment  Can simulate worsening disease with fever and increased size of lymph nodes or tuberculomas  Can be brought about by improved nutritional status or by the anti-TB treatment itself  Can occur after initiation of antiretroviral therapy (ART) in HIV-infected children with TB, and is known as the immune reconstitution inflammatory syndrome (IRIS)

23. Summary  Treatment regimens for children are based on prior treatment history and clinical presentation  Pediatric dosages for the first-line anti-TB drugs have changed based on new pharmacokinetic evidence  Use of pediatric FDC formulations when available along with other treatment adherence strategies should be used to simplify standard regimen administration and improve adherence  Regular monitoring throughout treatment should occur as described to ensure clinical improvement and adherence