Guidelines on the Prevention and Control of Tuberculosis in Ireland

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<strong>Guidelines</strong> on the Prevention and Control of Tuberculosis in Ireland 2010HSE/HPSC3.4 Treatment of LTBIThe choice of treatment regimen for LTBI will depend on:• The presence or absence of risk factors for progression to TB disease• An assessment of the likely adherence level of the patient and the amount of time available forcompletion of the patient’s treatment• The antibiotic susceptibility of the presumed source case• Drug tolerance of the patient.Poor adherence is the most important reason for the failure of LTBI treatment. Many people with LTBI donot complete treatment as most are not sick and may not feel the urgency to complete the prolongedtherapy. Directly observed therapy (DOT) for LTBI is an excellent method for promoting adherence totreatment. 77 Because of limited resources, DOT (supervised therapy) for LTBI cannot be offered to allpersons on LTBI treatment, however, it should be provided to those in the priority groups 6, 7 and 8mentioned above.However, for all others receiving LTBI treatment, a great deal can be accomplished to improve adherenceby developing a relationship based on trust and support between the healthcare worker and patient. 30Barriers to adherence should be addressed and overcome (appendix 4) 77Recommendation:Directly observed therapy (DOT) should be provided for those being treated for LTBI in groups6, 7 and 8 above i.e. immigrants from areas of high TB endemnicity, homeless persons andintravenous drug users.Recommendation:It is recommended that audits of compliance with LTBI therapy are undertaken.Treatment of LTBI in adultsThe effectiveness of isoniazid in preventing progression from LTBI to active TB disease was first reported in1957 and has been confirmed by many studies since. Isoniazid is the most widely used anti-TB agent as it isrelatively non-toxic, easily administered and inexpensive.Similar treatment regimens for LTBI in adults are recommended by the UK 26 and New Zealand. 52The NICE guidelines 26 recommend that non HIV-infected adults are treated with either (i) six months ofisoniazid or (ii) three months of rifampicin and isoniazid or six months of rifampicin for contacts of isoniazidresistant TB cases. This recommendation applies to persons aged 16-35 years and to persons older than35 years for whom treatment of LTBI is recommended. These recommendations are based on a Cochranereview of randomised trials of isoniazid of at least six months duration which were placebo controlled withat least two years follow up. 101 This review states that the efficacy of treatment increased with the durationof treatment but that the efficacy of six months or 12 months did not vary significantly. In fact, the smalladvantage of 12 months over six months may not be worthwhile except in those individuals at high risk ofdeveloping TB.The American Thoracic Society (ATS) 2000 34 , Canadian (2007) 30 and New York guidance (2008) 77recommend similar treatment regimes of daily isoniazid for nine months. Alternatively, a regime ofrifampicin for four months may be used if isoniazid is contraindicated due to a history of an isoniazid--31-
<strong>Guidelines</strong> on the Prevention and Control of Tuberculosis in Ireland 2010HSE/HPSCinduced reaction or for a contact of an isoniazid resistant-TB case or if the patient may not be able toadhere to therapy for a six to nine month period.ATS guidelines state that although nine months of isoniazid was the preferred regimen for the treatmentof LTBI, a six month regimen also provides substantial protection and has been shown to be superior toplacebo in both HIV negative and HIV positive persons. However, treatment for six months rather than ninemonths may provide more favourable outcomes from a cost effectiveness standpoint. 34The rationale for the ATS recommendations was based on evidence from randomised controlled clinicaltrials that assessed the benefits of isoniazid. These studies showed that isoniazid was effective inpreventing TB disease. Most of the studies compared isoniazid for 12 months with placebo. However, onetrial, conducted by the International Union Against Tuberculosis and Lung Disease (IUATLD), was designedto evaluate various durations of isoniazid and this indicated that a 12 month regimen provided a substantialreduction in risk compared with a six month regimen among compliant persons with small lesions. 102 Afurther reanalysis of data from community studies in Alaska indicated that the protection conferred bytaking at least nine months of isoniazid was considered greater than taking six months but it was not likelythat further protection was conferred by extending the duration of treatment from nine to 12 months. 103Based on a review of the evidence and guidance in the international literature and by consensus of theNational TB Advisory Committee, the following are the recommended treatment regimens for LTBI inadults:Recommendation:The recommended treatment regimens for LTBI in adults are:(i) Isoniazid for a minimum of six months with an optimum duration of nine monthsor(ii) Rifampicin for four monthsor(iii) A combination of rifampicin and isoniazid for a duration of at least three months with anoptimum of four months.Treatment of LTBI in childrenThe US Centers for Disease Prevention and Control (CDC) defines paediatric TB as occurring in personsaged less than 15 years. 104 LTBI in a child can be defined as a child or adolescent with a positive TST whohas no evidence of TB disease.Infants and young children under the age of five years with LTBI have been only recently infected andtherefore are at a higher risk of progressing to active TB disease. The literature suggests that 40% ofuntreated infants will develop active TB disease although the risk of progression decreases throughoutchildhood. 105 These children are also more likely than older children and adults to develop life-threateningforms of TB disease in particular meningeal and disseminated disease. Among children the efficacy oftreatment of LTBI with isoniazid approaches 100% with appropriate adherence to therapy. Hepatotoxicityfrom isoniazid in infants and children is rare and in general children tolerate the drug better than adults. 106International recommendations for treatment of LTBI in childrenThe American Academy of Pediatrics and CDC convened the Pediatric Tuberculosis Collaborative Group.This group produced a consensus document which stated that treatment is recommended for all childrenand adolescents diagnosed with LTBI because: 105• The drugs used are safe in the paediatric population• Infection with M. tuberculosis is more likely to have been recent-32-
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Guidelines on the Prevention and Control of Tuberculosis in Ireland

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