Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for drug-sensitive Tuberculosis
Can a strategy of treating patients with drug-sensitive TB for 2 months, with combinations which include new drugs or optimised doses of currently available drugs, be as effective long term as standard treatment given for 6 months?
What was this study about?
For more than 40 years, the global standard treatment for tuberculosis (TB) has been a six-month regimen based around the antibiotic rifampicin (or rifampin). However, the success of treatment is often limited, as sticking to treatment over such a long period of time can be difficult for some people.
The primary aim of TRUNCATE-TB is to test whether the two-month TRUNCATE-TB management strategy is at least as effective as (non-inferior to) the standard tuberculosis (TB) management strategy. This was assessed by the proportion of patients with unsatisfactory outcome at 2 years (96 weeks) after randomisation.
Participants were randomised to either:
- standard treatment for six months using rifampicin and isoniazid (with pyrazinamide and ethambutol for the first two months)
- the TRUNCATE strategy, involving initial treatment with an intensive two-month (eight-week) antibiotic regimen, extended for a further two to four weeks if needed for persistent clinical disease at week eight, monitoring after completion of treatment, with a second course for anyone whose TB was not cured or later returned.
What difference did this study make?
The TRUNCATE strategy using an initial two-month bedaquiline-linezolid treatment regimen was as effective as standard six-month, rifampicin-based treatment with no additional safety concerns. By shortening the total treatment length, this alternative regimen could improve patients’ motivation to stick to their prescribed treatment and make treatment programmes more efficient.
Future cost-effectiveness analyses will explore whether the added costs of monitoring and retreatment are offset by the costs saved with a shorter treatment duration.
Type of study
Who funded the study?
When did it take place?
TRUNCATE-TB was funded in September 2013 and the first patient enrolled in March 2018. Follow-up is ongoing.
Where did it take place?
South-east Asia and Uganda.
Who was included?
Adult patients with drug-sensitive pulmonary TB confirmed by GeneXpert.