Standards of TB Care In India related to Treatment of TB

Standards for TB Care in India - Pillar 2

A total of five standards related to tuberculosis treatment have been mentioned in the Standard for TB Care in India guidelines. Each of these standards is described below:

Standard 7: Treatment with first-line regimen

The salient features of this standard are:

• All new patients should receive an internationally accepted first-line treatment regimen for 6 months minimum. The duration can be extended in special situations.

• The treatment duration is divided into an initial intensive phase of two months followed by a continuation phase of at least 4 months. The initial phase should consist of 4 drugs (Isoniazid (H), Rifampicin (R), Pyrazinamide (Z) and Ethambutol (E)) and the continuation phase should consist of three drugs (H, R and E).

• These drugs in the form of Fixed Drug Combinations (FDCs) should be given daily to the patients in dosages depending upon their body weight.

• Previously treated TB patients may receive the retreatment regimen containing first-line drugs: 2HREZS/ 1HREZ/ 5HRE.

Standard 8: Monitoring treatment response

The salient features of this standard are:

• Sputum samples from patients should be collected for microscopy/ culture at the end of the intensive phase and at the end of treatment to monitor the success of therapy.

• The extension of the intensive phase is not recommended.

• In the event of a positive sputum report, Drug Resistance Test (DRT)/ Drug Sensitivity Test (DST) should be performed to detect any acquired resistance and to guide the further selection of therapy.

• The treatment response to extrapulmonary and bacteriologically negative TB should be done clinically.

• After completion of treatment, the patients should be followed up with clinical and/or sputum examination at the end of six months and 12 months.

Standard 9: Drug-resistant TB management

The salient features of this standard are:

• The regimen for Multidrug-resistant TB (MDR-TB)  should consist of at least four drugs (second line) to which the organisms are susceptible or presumed susceptible.

• The regimen should include at least a later-generation fluoroquinolone and a parenteral agent.

• Regimen for MDR patients with fluoroquinolone and second-line injectables resistance detected early should be suitably modified at the initiation of treatment or during the early intensive phase, preferably not later than four to six weeks.

• Total treatment should be given for at least 24 months in patients newly diagnosed with MDR-TB with recommended intensive phase of treatment being six to nine months.

• All patients with MDR-TB and Extensively Drug-resistant TB (XDR-TB) should be evaluated for surgery at the initiation of treatment and/or during follow-up.

• Regimen for MDR patients with fluoroquinolone and second-line injectables resistance detected during the later stage of treatment must be treated with a suitable regimen for XDR-TB.

• Monitoring response to therapy among MDR/RR-TB patients should be done using culture at monthly intervals during the first 6 months and quarterly after that. If culture is positive during treatment, follow-up after 6 months and repeat DST.

• New drugs need to be considered for inclusion in regimens whenever scientific evidence for their efficacy and safety becomes available.

Standard 10: Addressing TB with HIV infection and other comorbid conditions

The salient features of this standard are:

• TB patients living with HIV should receive the same duration of TB treatment with a daily regimen as HIV-negative TB patients.

• Antiretroviral therapy must be offered to all patients with HIV and TB as well as DR-TB, irrespective of CD4 cell count, as early as possible.

• For all asymptomatic HIV patients in whom active TB is ruled out, Isoniazid Preventive Therapy (IPT) should be offered for six months or longer.

Standard 11: Treatment adherence

The salient features of this standard are:

• A patient-centred approach should be followed to ensure treatment adherence.

• Treatment supporters should be given the necessary training to ensure adherence.

• Optimal use of Information Communication Technology (ICT) should be done to promote treatment literacy and adherence.

Resources

• Standards for TB Care in India, World Health Organisation, 2014.

Assessment