Standardized / Conventional Treatment of RR/MDR-TB patients

Clinical description

Drug resistance survey data from representative patient populations are used to base regimen design in the absence of individual DST in which all patients in a defined group or category receive the same regimen as per national guidance. Conventional regimen will be phased out.

Advantages of choosing standardised regimen  Simpler implementation  Simpler drug supply management  Easy to train health care workers  Reduces chance of error in regimen construction  Minimizes the need for sophisticated culture and DST laboratories Empiric Treatment standardised regimen Initiation of treatment prior to determination of a firm diagnosis of drug-resistance TB based patient’s risk for drug resistance. Empiric regimen is mainly reserved for children in whom DST confirmation is unlikely or pending. And need to be considered in HIV patients or EPTB patients where confirmation is not possible or difficult.

Standardised Treatment regimen followed by individualised treatment This approach requires that all patients initiated on standardised regimen will be individualised based on the result of full DST while on treatment. Hence, samples should be sent for full DST upon treatment initiation for all confirmed MDR-TB patients.

Individualising a standardised regimen should be:

• History of previous exposure to the first-line and second-line drugs. (Detailed history

National Tuberculosis Control Programme 79 and review of previous treatment records).

• Previous exposure for more than one month in a failing regimen suggests the drugs

are not effective even if DST results reports susceptibility.

• A sound knowledge of cross-resistance among anti-TB drugs is required.
• Unnecessary changes that will cause lack of options for possible future use of drugs.

Standardized regimen for RR/MDR-TB management The recommended treatment for MDR-TB is standardised and comprises of Cm, Lfx, Z, Eto and Cs in a regimen which will be given for at least 20 months. All newly diagnosed MDR-TB patients should receive a standardised regimen. (See table 10.4.5 for dosage)

Intensive phase: 8 Cm-Lfx-Cs-Eto-Z Continuation phase: 12 Lfx-Cs-Eto-Z MDR-TB regimen consists of two phases Intensive phase: refers to the initial period of treatment when maximal bacillary load reduction is aimed. This period is noted by the presence of an injectable drug.

Continuation phase: refers to the period where the injectable drug is discontinued and patient continues to take oral drugs. The duration continuation phase of treatment is guided by culture conversion.

• The two phases are separated by a forward slash in the regimen format.
• The number shown before each phase stands for phase duration in months and is the

minimum amount of time that phase should last.

• The drugs in the higher groups are written first followed in descending order of

potency.

• The drug dosage is determined by body weight.
• An injectable agent is used for a period of not less than 8 months. Treatment in the

continuation phase is for a minimum duration of 12 months.

• The current standardized longer MDR-TB regimen will be phased out once Malawi

adopted the newly recommend shorter MDR-TB regimen.

80 National Tuberculosis Control Programme