Table 3

Guidelines for implementing a national tuberculosis preventive treatment programme in India

A recent review identified a number of further research needed to improve our understanding of tuberculosis infection from clinical and programmatic perspectives.93 Several priority activities may be adopted for India by thematic areas:
1.Accurate estimates of the tuberculosis infection burden in India. Rational, targeted testing and treatment of tuberculosis infection shall be guided by local epidemiological trends. This includes local and regional estimates for infection and also rates of antituberculosis drug resistance, diabetes mellitus, HIV coprevalence and undernutrition
2.Development and programmatic assessment of accurate diagnostic tests for predicting progression from infection to active tuberculosis disease. Tests should be sensitive and specific, convenient to the patient, inexpensive and highly reproducible. Ideally, tests should be able to distinguish between latency and active disease and recognise drug-resistant forms of tuberculosis.
3.Improved selection of candidates for tuberculosis preventive treatment (TPT). We need to improve our understanding of the host-pathogen interaction in India, immunological response and biomarkers to predict which persons benefit most from TPT. We need further studies to understand how M. tuberculosis evades the immune system, which persons it infects, how it lays dormant for years and what mechanisms trigger progression to active disease. These studies will inform the development of vaccines and also which persons to treat.
4.Development and programmatic assessment of a variety of efficacious treatment options. Short, well-tolerated, therapeutic regimens are needed. Randomised clinical trials conducted in the Indian context to assess efficacy, tolerability and drug-interaction profile are required. In high prevalent areas, the risk of reinfection increases. In such communities, the optimal duration of treatment remains unclear. There is no evidence (through randomised clinical trial) of specific treatment regimens for persons exposed to drug-resistant forms of tuberculosis. We need further research to define the composition, posology and duration of preventive regimens for such persons.
5.Simple, easy-to-use algorithms for determining TPT eligibility, appropriate regimen and length of treatment should be developed based on individual risk, local epidemiology and programmatic performance.
6.Optimising tuberculosis infection treatment to the Indian context. Context-specific interventions need development to enhance adherence to treatment through the optimisation of local Indian resources
7.Monitoring and evaluation of programme performance in implementing tuberculosis infection treatment. Surveillance systems for tuberculosis infection and treatment-associated adverse events need to be developed and used to monitor programme implementation and performance. Preventive treatment cascades should be considered to objectively assess progress and make direct quantitative measurements of patient retention at each step of tuberculosis service delivery (figure 1).
8.Cost-effectiveness analysis. Targeted cost-effectiveness studies are required for the rational scale-up of tuberculosis infection treatment among various populations throughout India (eg, diabetics, undernourished and other vulnerable populations).