Table 2.

Characteristics of the Target Regimen profile for rifampicin-resistant TB

	Attribute	Minimum The minimal target should be considered as a potential go/no go decision point	Optimum The optimistic target should reflect what is needed to achieve broader, deeper, quicker global health impact
1	Indication	The rifampicin-resistant TB regimen is indicated for patients infected with rifampicin-resistant strains (including MDR-TB). Indication may be contingent upon additional resistance to existing first or second line drugs, and supported by appropriate DST.	The rifampicin-resistant TB regimen is indicated for all patients infected with rifampicin-resistant TB strains, with usage consistent with principles of good antibiotic stewardship.
2	Efficacy and duration of treatment	A 6–12 months treatment regimen. Efficacy (bacteriologic cure without relapse in at least one-year follow up, among patients who are not lost to follow up) should be not inferior to the WHO recommended standard of care for MDR-TB.	Less than or equal to 6 months treatment regimen. Efficacy should be greater than 90%.
3	Target population in respect to age.	At least adolescent (age 12–19) and adults	All age groups irrespective of severity of disease, pulmonary or extrapulmonary, or HIV status.
4	Safety and Tolerability	Serious adverse events (SAEs) no more than 5%, and treatment discontinuation due to treatment emergent adverse events (TEAEs) no more than 2.5%. The QT prolongation and proarrhythmic effects of the regimen would not put the patient at a moderate or high risk of arrhythmias or sudden death.	SAEs are no more than 2%, and treatment discontinuation due to TEAEs no more than 2%. The regimen would have no or insignificant QT prolongation or proarrhythmic effects.
5	Drug-drug interactions and metabolism	Ability to adjust dosing or perform safe monitoring for DDIs with: At least one first-line ART regimen Drugs that induce or inhibit P450 liver enzymes Pro-arrhythmic QT prolonging drugs	No dose adjustment with other medications and ability to safely use without active laboratory tests monitoring with: ART regimens and cotrimoxizole Drugs that induce or inhibit P450 liver enzymes Pro-arrhythmic QT prolonging drugs
6	Formulation dosage, route of administration, and dosing (including schedule)	Formulation to be oral for all drugs in regimen. Ability to deliver paediatric dosing of the regimen. Twice daily dosing and manageable food restrictions.	Formulation to be oral. FDC formulations available (desirable to have no weight adjustment for adults) Paediatric (oral), and IV formulations must also be available. One daily or intermittent dosing. (Preference for once weekly or only monthly as the intermittency)
7	Stability/Shelf-Life	3 years for all drugs in the regimen. No cold chain requirements.	5 years for all drugs in the regimen. No cold chain requirements.
8	Special populations	Adults and women of childbearing potential. Increased acceptable risk (benefits outweigh the risk in most cases) for pregnancy women, paediatrics, and those with significant renal or hepatic disease. Inclusions of patients with co-morbidities including: HIV Diabetes Alcoholism Viral hepatitis	Adults, paediatrics, women of childbearing potential, pregnant women. Ability to use the regimen with patients with significant renal disease. Inclusions of patients with comorbidities including: HIV Diabetes Alcoholism Viral hepatitis Opiate addiction
9	Barrier to emergence of drug resistance (propensity to develop resistance, generation of cross-resistance)	New resistance to one or more drugs in the regimen emerges in fewer than 2% of treatment courses when taken as prescribed and when no pre-existing resistance to the drugs in the regimen exists.	Essentially no acquired resistance (<0.1%) when regimen is taken as prescribed and no pre-existing resistance to the drugs in the regimen exists.