Abstract:

Background: India accounts to one fifth of the global TB burden. It is implementing all the components of WHO STOP TB strategy for TB control through the Revised National TB Control program (RNTCP) since 1997. However, RNTCP neither has a policy to monitor TB treatment based on body weight of the patients nor provisions for nutritional support to TB patients with low body weight. Recent evidences also show that relapse and MDR rates are high in India compared to other High TB Burden Countries (HBCs). Karnataka (population 63 million) is a southern State in India implementing RNTCP with overall annual TB case notification of ~ 103 per 100,000 population and success rate of ~ 83% for new smear positive (NSP) cases below the global benchmark of >85%. Our hypothesis is that unfavorable treatment outcomes were more common among patients with lower body weight at initiation of treatment. We studied the relapse and MDR rates in India in 2011 from the published data, in comparison to other HBCs and the outcomes of TB patients treated under RNTCP in 2012, in two districts of Karnataka with the specific objective to examine the effect of initial body weight on treatment outcomes.

Methodology: In this record based cohort study, we reviewed two separate data set. In first, we examined the published data on all TB patients treated nationally (covering 1.25 billion population) in 2011 for published relapse and MDR rates. In second, we examined treatment cards of all adult TB patients weighing more than 30 kgs, registered for treatment in the year 2012 from two districts (Gadag and Uttara Kannada) of Karnataka covering ~ 2.6 million populations.

Results: Part 1: National level: Of the total 754,829 incident TB cases (NSP plus Reinfection/Reactivation) treated in India, 112,508 (15%) had relapse. MDR TB among retreatment cases was 15%.

Part 2: Study districts: Of the 2147 adult patients (with initial body weight more than 30 kgs) enrolled for treatment, the mean body weight was 43 kgs (IQR 38-48 kgs), with p5 at 32 kgs and p95 at 58 kgs. Outcome “died” was highest among patients weighing between 30-39.9 kgs across all the types of TB (Chi square=13.82, df=2, P<0.001); failure was also highest in this weight band among retreatment cases (Chi square=6.72 df = 2, P<0.05).

Conclusion: Standardized treatment regimen in India had high relapse and MDR rates. Lower body weight at initiation of treatment is associated with higher risk of death across all types of TB and with failure among retreatment cases. While further study is indicated to explore the reasons for these findings, clearly, National TB Programs should have strategies to monitor treatment based on initial body weight and consider nutritional support to TB patients with low body weight at diagnosis to improve survival.

Keywords: Tuberculosis, Body-weight, TB-Treatment, Nutrition, RNTCP.

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