4.5 Monitoring and evaluation

Patients who receive the (H)REZ–levofloxacin regimen need to be monitored during treatment, using schedules of clinical and laboratory testing. The definitions to use when assigning outcomes are the same as those used for drug-susceptible TB (79). Signs of non-response or treatment failure should be followed up with DST for rifampicin resistance and, if possible, for fluoroquinolones and pyrazinamide. To limit the risk of acquisition of additional resistance, the addition of single TB medicines should be avoided in patients who remain smear positive or culture positive after month 2 of treatment, those who do not show a favourable clinical response and those without recent DST results.

As with any other TB medicine and regimen, safety precautions are required to ensure the rapid identification and proper management of any serious adverse event. Close clinical monitoring is essential for all patients receiving this regimen, particularly liver function tests, given the hepatotoxic potential of prolonged pyrazinamide use. If possible, all patients should be tested each month for levels of AST (also known as serum glutamic oxaloacetic transaminase, SGOT). If resources are not available to monitor all patients on the Hr-TB treatment regimen, monthly monitoring of patients at high risk (e.g. patients coinfected with viral hepatitis or with a history of heavy alcohol use) is strongly advised. Additionally, to prevent and manage the potential toxic effects of ethambutol in children (e.g. retrobulbar neuritis), it is necessary to adhere to the correct doses recommended for paediatric populations. Early signs of ethambutol toxicity can be tested in older children through red–green colour discrimination. Monitoring for retrobulbar neuritis can be undertaken early when appropriate (104).

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