Recurrence of tuberculosis among newly diagnosed sputum positive pulmonary tuberculosis patients treated under the Revised National Tuberculosis Control Programme, India: A multi-centric prospective study

• DOI: 10.1371/journal.pone.0200150
• Publication Date: 2018-07-06T13:44:32Z
• Authors: Banurekha Velayutham; Vineet Kumar Chadha; Neeta Singla; Pratibha Narang; Vikas Gangadhar Rao; Sanjeev Nair; Srinivasan Ramali...; Gomathi Narayanan...; Bency Joseph; Sriram Selvaraju; Shivakumar Shanmugam; Rahul Narang; Praseeja Pachikkaran; Jyothi Bhat; Chinnaiyan Ponnuraja; Bhoomika Bajaj Bh...; Bhadravathi Amarn...; George Sebastian; Rajiv Yadav; Ravendra Kumar Sh...; Rohit Sarin; Vithal Prasad Myn...; Rupak Singla; Khalidumer Khayyam; Sunil Kumar Mrith...; Subramonia Pillai...; Praveen Sanker; Krishnaveni Viswa...; Rajeevan Viswambh...; Kapil Mathuria; Manpreet Bhalla; Nitu Singh; Kondeshvar Balaji...; Ajay Dawale; Chandra Prakash T...; Radhelal Bansod; Lavanya Jayabal; Lakshmi Murali; Sunil D. Khaparde; Raghuram Rao; Mohideen S. Jawahar; Mohan Natrajan
• Keywords: Adult; Male; 0301 basic medicine; Adolescent; National Health Programs; Science; Antitubercular Agents; India; Minisatellite Repeats; Young Adult; 03 medical and health sciences; Clinical Research; Recurrence; Risk Factors; Humans; Prospective Studies; Tuberculosis, Pulmonary; Aged; Aged, 80 and over; Q; R; Sputum; Mycobacterium tuberculosis; Middle Aged; 3. Good health; Medicine; Female; Research Article

There is lack of information on the proportion of new smear-positive pulmonary tuberculosis (PTB) patients treated with a 6-month thrice-weekly regimen under Revised National Tuberculosis Control Programme (RNTCP) who develop recurrent TB after successful treatment outcome.To estimate TB recurrence among newly diagnosed PTB patients who have successfully completed treatment and to document endogenous reactivation or re-infection. Risk factors for unfavourable outcomes to treatment and TB recurrence were determined.Adult (aged ≥ 18 yrs) new smear positive PTB patients initiated on treatment under RNTCP were enrolled from sites in Tamil Nadu, Karnataka, Delhi, Maharashtra, Madhya Pradesh and Kerala. Those declared "treatment success" at the end of treatment were followed up with 2 sputum examinations each at 3, 6 and 12 months after treatment completion. MIRU-VNTR genotyping was done to identify endogenous re-activation or exogenous re-infection at TB recurrence. TB recurrence was expressed as rate per 100 person-years (with 95% confidence interval [95%CI]). Regression models were used to identify the risk factors for unfavourable response to treatment and TB recurrence.Of the1577 new smear positive PTB patients enrolled, 1565 were analysed. The overall cure rate was 77% (1207/1565) and treatment success was 77% (1210 /1565). The cure rate varied from 65% to 86%. There were 158 of 1210 patients who had TB recurrence after treatment success. The pooled TB recurrence estimate was 10.9% [95%CI: 0.2-21.6] and TB recurrence rate per 100 person-years was 12.7 [95% CI: 0.4-25]. TB recurrence per 100 person-years varied from 5.4 to 30.5. Endogenous reactivation was observed in 56 (93%) of 60 patients for whom genotyping was done. Male gender was associated with TB recurrence.A substantial proportion of new smear positive PTB patients successfully treated with 6 -month thrice-weekly regimen have TB recurrence under program settings.