Abstract

IntroductionThere 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.ObjectiveTo 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.MethodologyAdult (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.ResultsOf 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.ConclusionA substantial proportion of new smear positive PTB patients successfully treated with 6 –month thrice-weekly regimen have TB recurrence under program settings.

Highlights

  • 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

  • Under RNTCP, newly diagnosed smear-positive pulmonary TB patients were treated with a 6-month thrice-weekly regimen, consisting of an initial intensive phase (IP) of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) for two months followed by a continuation phase (CP) of H and R for four months (2 H3R3Z3E3 / 4H3R3)

  • Each dose during IP was to be given under direct observation; during CP, the first weekly dose was given under direct observation and the remaining two doses of the week were self-administered [2]

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Summary

Methods

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. 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. Supervision: Banurekha Velayutham, Vineet Kumar Chadha, Neeta Singla, Pratibha Narang, Vikas Gangadhar Rao, Sanjeev Nair, Srinivasan Ramalingam, Gomathi Narayanan Sivaramakrishnan, Bency Joseph, Sriram Selvaraju, Rahul Narang, Praseeja Pachikkaran, Jyothi Bhat, Rajiv Yadav, Ravendra Kumar Sharma, Rohit Sarin, Vithal Prasad Myneedu, Khalidumer Khayyam, Sunil Kumar Mrithunjayan, Subramonia Pillai Jayasankar, Praveen Sanker, Krishnaveni Viswanathan, Rajeevan Viswambharan, Kapil Mathuria, Manpreet Bhalla, Nitu Singh, Kondeshvar Balaji Tumane, Ajay Dawale, Chandra Prakash Tiwari, Radhelal Bansod, Lavanya Jayabal, Lakshmi Murali, Sunil D.

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