EFFICACY AND SAFETY OF NEWLY APPROVED ANTI-TUBERCULOSIS DRUGS IN MDR-TUBERCULOSIS, TB-HIV, AND TB-CANCER POPULATIONS: A SYSTEMATIC REVIEW AND META-ANALYSIS
Author(s)
Rathod Mahesh, PharmD, PhD, Krishna Undela, PhD;
NIPER Guwahati Assam, Guwahati, India
NIPER Guwahati Assam, Guwahati, India
OBJECTIVES: To systematically evaluate the efficacy and safety of novel anti-TB agents, with a specific focus on their performance across MDR-TB, TB-HIV, and TB-cancer patient populations.
METHODS: A systematic search of PubMed, Embase, ClinicalTrials.gov, World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP) was conducted for the period from January 2024 to September 2025. Eligible studies included randomised controlled trials and high-quality observational cohorts reporting microbiological cure, mortality, relapse, adverse events (AEs), and treatment discontinuation. A meta-analysis was performed, with subgroup analyses conducted for the MDR-TB, TB-HIV, and TB-cancer subgroups. Statistical heterogeneity was quantified using I², and publication bias was assessed via funnel plots and Egger’s test. RevMan web was used for conducting meta-analysis.
RESULTS: Eighteen studies comprising 4,152 patients met the inclusion criteria. New agents, including optimised bedaquiline formulations, pretomanid-based regimens, and third-generation oxazolidinones, demonstrated significantly higher microbiological cure rates than standard therapy (RR 1.31; 95% CI 1.18-1.45; p<0.001). Subgroup effects were consistent across MDR-TB (RR 1.29), TB-HIV (RR 1.35), and TB-cancer (RR 1.28) populations. Grade 3/4 AEs were significantly reduced (RR 0.74; 95% CI 0.63-0.87; p=0.002), accompanied by improved adherence and fewer treatment discontinuations. Overall mortality decreased by 22% (RR 0.78; 95% CI 0.65-0.92), with the greatest benefit observed in patients co-infected with both conditions. Heterogeneity was low-to-moderate (I² 30-42%), and no significant publication bias was detected.
CONCLUSIONS: Anti-TB drugs show substantial and statistically robust improvements in treatment efficacy, safety, and survival among MDR-TB, TB-HIV, and TB-cancer populations. These findings strongly support their integration into updated global treatment guidelines. Continued real-world surveillance is warranted to evaluate the durability of therapeutic benefit and long-term safety.
METHODS: A systematic search of PubMed, Embase, ClinicalTrials.gov, World Health Organisation International Clinical Trials Registry Platform (WHO ICTRP) was conducted for the period from January 2024 to September 2025. Eligible studies included randomised controlled trials and high-quality observational cohorts reporting microbiological cure, mortality, relapse, adverse events (AEs), and treatment discontinuation. A meta-analysis was performed, with subgroup analyses conducted for the MDR-TB, TB-HIV, and TB-cancer subgroups. Statistical heterogeneity was quantified using I², and publication bias was assessed via funnel plots and Egger’s test. RevMan web was used for conducting meta-analysis.
RESULTS: Eighteen studies comprising 4,152 patients met the inclusion criteria. New agents, including optimised bedaquiline formulations, pretomanid-based regimens, and third-generation oxazolidinones, demonstrated significantly higher microbiological cure rates than standard therapy (RR 1.31; 95% CI 1.18-1.45; p<0.001). Subgroup effects were consistent across MDR-TB (RR 1.29), TB-HIV (RR 1.35), and TB-cancer (RR 1.28) populations. Grade 3/4 AEs were significantly reduced (RR 0.74; 95% CI 0.63-0.87; p=0.002), accompanied by improved adherence and fewer treatment discontinuations. Overall mortality decreased by 22% (RR 0.78; 95% CI 0.65-0.92), with the greatest benefit observed in patients co-infected with both conditions. Heterogeneity was low-to-moderate (I² 30-42%), and no significant publication bias was detected.
CONCLUSIONS: Anti-TB drugs show substantial and statistically robust improvements in treatment efficacy, safety, and survival among MDR-TB, TB-HIV, and TB-cancer populations. These findings strongly support their integration into updated global treatment guidelines. Continued real-world surveillance is warranted to evaluate the durability of therapeutic benefit and long-term safety.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EPH170
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
SDC: Infectious Disease (non-vaccine), SDC: Oncology, SDC: Reproductive & Sexual Health, SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)