The clinical therapeutic efficacy and safety of Bedaquiline in combination with background regimen in the treatment of patients with multi-drug resistant pulmonary tuberculosis

Abstract

Objective To evaluate the therapeutic efficacy, tolerability, and safety of Bedaquiline in combination with background regimen (BR) in the treatment of patients with multi-drug resistant pulmonary tuberculosis (MDR-TB). Methods From March 2010 to March 2013, Nanjing Chest Hospital participated a Phase 2, open-label, multicenter, single-arm study to evaluate the therapeutic efficacy, tolerability and safety of Bedaquiline in combination with BR of MDR-TB medications in the treatment of patients with MDR-TB, who had sputum smear or culture positive for M. tuberculosis. All participants were followed up for 3 years after their last intake of medications. Results 225 MDR-TB patients were recruited around the world. Nanjing Chest Hospital, as one of the 5 sub-centers in China, had enrolled 6 patients. There were 4 males and 2 females participants, aged from 21 to 65 years old, who had received 96 weeks of treatment cycles and were followed up for 3 years. 5 of the 6 patients achieved well prognosis whose lesions showed obviously absorbed, and the sputum culture converted in 8, 8, 12, 12 and 36 weeks after their initial treatment, respectively. The only patient had confirmed resistance to isoniazid and rifampicin by culture-based drug susceptibility testing, had consecutively sputum positive for M. tuberculosis, and the CT scan findings showed several cavitation in right lung. The most common adverse events were leucopenia, liver dysfunction, hyperuricaemia, hypopotassaemia, gastrointestinal side effects, fatigue, and arthralgia. Conclusion Bedaquiline achieved significant therapeutic efficacy in patients with MDR-TB, as well as high security. Bedaquiline as a new drug is expected to be an important component in the treatment of multi-drug resistant pulmonary tuberculosis. Key words: Bedaquiline; Treatment; Multi-drug resistant pulmonary tuberculosis; Clinical safety; Efficacy