5.6 Using modified all-oral shorter MDR-TB regimens under operational research

At present, there is little evidence to support modified all-oral shorter MDR-TB regimens that are designed using the hierarchy of TB medicines (Table 6.1). NTPs that intend to pilot such types of shorter MDR-TB regimens are advised to do so under operational research conditions. To facilitate such research, the Special Programme for Research and Training in Tropical Diseases (TDR), in close collaboration with the WHO Global TB Programme (WHO/GTB) and with technical partners, has developed ShORRT (Short, all-Oral Regimens for Rifampicin-resistant Tuberculosis8). ShORRT is an operational research package that is designed to assess the effectiveness, safety, feasibility, acceptability, cost and impact (including on quality of life) of the use of all-oral shorter drug regimens for patients with DR-TB (61).

All-oral shorter MDR-TB regimens are usually designed as a four-drug or five-drug standardized regimen. There is some advantage to using the all-oral shorter MDR-TB regimens that are currently being tested in randomized clinical trials, because these regimens have been endorsed by scientific committees for testing, and their use under operational research conditions will contribute to the evidence base on these regimens. The ShORRT research package describes some proposed modified regimens for testing under operational research conditions (61). The all-oral shorter MDR-TB regimens that contain all Group A drugs in combination with clofazimine (sometimes including Group C medicines such as pyrazinamide or delamanid) are possible combinations for countries to implement under operational research conditions.

When choosing an all-oral shorter MDR-TB regimen, an important consideration is that the programme must be able to follow patients for 1 year post-treatment for recurrent TB, to ensure that there is documentation that the all-oral shorter MDR-TB regimen is not resulting in a high relapse rate.

8 See https://tdr.who.int/activities/shorrt-research-package.

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