2025-03-24
MDR-TB: 9 months to change everything?
Infectiology
#Tuberculosis #MDRTB #OralTreatment #Bedaquiline #Efficacy #Safety
Multidrug-resistant tuberculosis (MDR-TB) is a particularly concerning form of TB, defined by resistance to isoniazid and rifampicin—the two cornerstone drugs in standard TB treatment. It causes hundreds of thousands of cases worldwide each year and poses a growing threat to public health, especially in high-burden or resource-limited countries.
Standard treatments for MDR-TB are long, complex, and often poorly tolerated. They typically last 18 to 24 months, involve multiple medications, and frequently include prolonged use of injectable drugs, which are associated with severe side effects. Despite these efforts, treatment success rates remain low—around 60%—and adherence is often compromised due to the treatment burden.
To address this challenge, the World Health Organization (WHO) updated its guidelines in 2020, recommending all-oral regimens lasting 9 to 11 months without injectables for patients whose TB strain is not resistant to fluoroquinolones. These new strategies aim to improve treatment acceptability, safety, and efficacy while reducing duration and toxicity.
This study explores the efficacy and safety of a short, all-oral regimen based on bedaquiline—a newer, highly bactericidal drug—combined with other next-generation agents (linezolid, clofazimine, moxifloxacin, cycloserine). The new regimen is compared with traditional treatments that include either toxic injectables or high-dose isoniazid, in a cohort of MDR-TB patients in China—a country where disease burden remains high and treatment options limited.
In this study, 360 patients were enrolled and divided into three groups:
Treatment efficacy was assessed by the treatment success rate (cure or treatment completion). Sputum culture conversion and closure of pulmonary cavities were also evaluated, along with adverse events.
The findings show that Group C achieved the best clinical outcomes. The success rate (cure or treatment completed) reached 90.3%, compared to 75.0% in Group B and 57.1% in Group A. Additionally, sputum culture conversion and cavity closure occurred more rapidly and more frequently in Group C, indicating a more effective therapeutic response. Loss to follow-up was also significantly lower in Groups B and C, suggesting better treatment adherence with oral regimens.
In terms of safety, Group C demonstrated an overall favorable profile, although some side effects were reported. Hyperuricemia was less common in Groups B and C than in Group A. However, QTc prolongation was observed in 24.3% of patients in Group C, requiring cardiac monitoring. Peripheral neuropathy was reported in 25.2% of patients in Group C. Importantly, no serious adverse events were reported across the study, reinforcing the overall safety of the all-oral regimen.
Multidrug-resistant tuberculosis (MDR-TB) is a severe and hard-to-treat form of TB, associated with high morbidity. The main challenge lies in the toxicity of injectable drugs and the prolonged treatment duration, which hinder both patient adherence and therapeutic success. These issues highlight the urgent need for shorter, better-tolerated, and fully oral treatment regimens.
This study aimed to assess the efficacy and safety of a 9-month injection-free regimen based on bedaquiline, compared to traditional treatments in MDR-TB patients. The results demonstrate that the all-oral regimen is more effective, better tolerated, and more acceptable to patients—with a success rate exceeding 90% and better adherence than conventional regimens.
Further multicenter, long-term controlled trials are needed to validate these findings and support broader adoption of this treatment approach, especially in countries where access to bedaquiline remains limited. If confirmed, this short-course regimen could revolutionize MDR-TB management by shortening treatment duration, reducing side effects, and improving patient quality of life.
Multidrug-resistant tuberculosis (MDR-TB) is a particularly concerning form of TB, defined by resistance to isoniazid and rifampicin—the two cornerstone drugs in standard TB treatment. It causes hundreds of thousands of cases worldwide each year and poses a growing threat to public health, especially in high-burden or resource-limited countries.
Standard treatments for MDR-TB are long, complex, and often poorly tolerated. They typically last 18 to 24 months, involve multiple medications, and frequently include prolonged use of injectable drugs, which are associated with severe side effects. Despite these efforts, treatment success rates remain low—around 60%—and adherence is often compromised due to the treatment burden.
To address this challenge, the World Health Organization (WHO) updated its guidelines in 2020, recommending all-oral regimens lasting 9 to 11 months without injectables for patients whose TB strain is not resistant to fluoroquinolones. These new strategies aim to improve treatment acceptability, safety, and efficacy while reducing duration and toxicity.
This study explores the efficacy and safety of a short, all-oral regimen based on bedaquiline—a newer, highly bactericidal drug—combined with other next-generation agents (linezolid, clofazimine, moxifloxacin, cycloserine). The new regimen is compared with traditional treatments that include either toxic injectables or high-dose isoniazid, in a cohort of MDR-TB patients in China—a country where disease burden remains high and treatment options limited.
Read next: 4 months to change everything?
MDR-TB: has the miracle pill been found?
In this study, 360 patients were enrolled and divided into three groups:
- Group A (control, injectable): High-dose isoniazid + amikacin (injectable) + other conventional anti-TB drugs (duration: 9–11 months)
- Group B (oral without bedaquiline): Same regimen as Group A, but with linezolid replacing amikacin
- Group C (new all-oral regimen): Bedaquiline + linezolid + clofazimine + moxifloxacin + cycloserine (intensive phase: 4–6 months), followed by moxifloxacin + clofazimine + cycloserine (5 months)
Treatment efficacy was assessed by the treatment success rate (cure or treatment completion). Sputum culture conversion and closure of pulmonary cavities were also evaluated, along with adverse events.
The findings show that Group C achieved the best clinical outcomes. The success rate (cure or treatment completed) reached 90.3%, compared to 75.0% in Group B and 57.1% in Group A. Additionally, sputum culture conversion and cavity closure occurred more rapidly and more frequently in Group C, indicating a more effective therapeutic response. Loss to follow-up was also significantly lower in Groups B and C, suggesting better treatment adherence with oral regimens.
In terms of safety, Group C demonstrated an overall favorable profile, although some side effects were reported. Hyperuricemia was less common in Groups B and C than in Group A. However, QTc prolongation was observed in 24.3% of patients in Group C, requiring cardiac monitoring. Peripheral neuropathy was reported in 25.2% of patients in Group C. Importantly, no serious adverse events were reported across the study, reinforcing the overall safety of the all-oral regimen.
A future without injections for drug-resistant TB?
Multidrug-resistant tuberculosis (MDR-TB) is a severe and hard-to-treat form of TB, associated with high morbidity. The main challenge lies in the toxicity of injectable drugs and the prolonged treatment duration, which hinder both patient adherence and therapeutic success. These issues highlight the urgent need for shorter, better-tolerated, and fully oral treatment regimens.
This study aimed to assess the efficacy and safety of a 9-month injection-free regimen based on bedaquiline, compared to traditional treatments in MDR-TB patients. The results demonstrate that the all-oral regimen is more effective, better tolerated, and more acceptable to patients—with a success rate exceeding 90% and better adherence than conventional regimens.
Further multicenter, long-term controlled trials are needed to validate these findings and support broader adoption of this treatment approach, especially in countries where access to bedaquiline remains limited. If confirmed, this short-course regimen could revolutionize MDR-TB management by shortening treatment duration, reducing side effects, and improving patient quality of life.
Read next: The burden of tuberculosis in adolescents and young adults
Last press reviews
MDR-TB: 9 months to change everything?
#Tuberculosis #MDRTB #OralTreatment #Bedaquiline #Efficacy #Safety
4 months to change everything?
#Tuberculosis #Diabetes #Rifapentine #ShortCourseTreat...