Since the Malaysian Clinical Practice Guideline recommendation of FDC as the first-line pharmacotherapy for pulmonary TB patients, there has yet to be any real-world analysis to compare its overall treatment outcome against conventional separate-pill EHRZ. The FDC brands that are currently used in Malaysia are Forecox-Trac film-coated tablet and Akurit-4, both are proven to be bioequivalent to separate-drug regime EHRZ at the same dose level. A meta-analysis claimed that FDC has better patient acceptability and reduced the risk of medicine noncompliance by 26% due to its simplicity in drug administration. Both the studies reported insignificant difference in adverse events such as mild-to-moderate gastrointestinal and dermatological disorder when comparing both drug regimes. This recommendation was based on two multicentered randomized controlled trials (RCTs), involving countries in Africa, Asia, and Latin America between 20 that have demonstrated noninferiority on efficacy and safety of FDC against conventional separate-drug regime that consists of ethambutol, isoniazid, rifampicin, and pyrazinamide (EHRZ). Pressurized by the high TB prevalence and the urge to improve patient's adherence, in 2012, the Ministry of Health, Malaysia, has launched the 3 rd TB clinical practice guideline to make a Grade A recommendation that prefers fixed-dose combination (FDC) anti-TB drug as the first-line regime for intensive phase treatment for newly diagnosed pulmonary TB patient, unless patients developed toxicity, intolerance, or contraindication to specific component drugs. Among Malaysia states, Sabah state has the highest prevalence of TB. In 2015, treatment success rate among the new and relapse cases in Malaysia is 78%, a rate that is similar to that of South East Asia region but lower than the global rate.

According to the WHO Global Tuberculosis (TB) Report 2017, Malaysia has 29,000 TB case notifications/year, and the incidence of TB is 92 cases/100,000 population.

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