When STREAM began, the standard of care for MDR-TB lasted up to 24 months, included an injectable agent and had an average success rate of just over 50%. Stage 1 aimed to generate evidence to support the use of an effective new regimen that would significantly reduce treatment time for MDR-TB. The regimen evaluated in Stage 1 contains injectable agents, which are associated with significant side effects, including hearing loss and renal impairment. Stage 2 of the trial aims to generate evidence regarding the efficacy and safety of a shorter, all-oral regimen that could further reduce the burden of MDR-TB treatment.
STREAM Stage 1 compared a 9–11-month MDR-TB regimen to the 20-month regimen previously recommended by the World Health Organization (WHO). The final results of Stage 1 showed that the 9–11-month regimen is non-inferior to, or at least as good as, the 20-month regimen. The 9–11-month regimen reduces treatment time significantly, which also means the overall pill burden for patients decreases by approximately 60 percent.
STREAM Stage 2 is now evaluating an all oral, bedaquiline-containing regimen that is potentially as effective and more tolerable than the injectable-containing regimens currently in use. It is also evaluating the comparative cost of the two regimens, for both the patient and the health system.