Initial experience of bedaquiline implementation under the National TB Programme at NITRD, Delhi, India.

BACKGROUND: Bedaquiline (BDQ) was approved for treatment of drug resistant TB (DR-TB) under Conditional Access Programme (CAP) of Revised National Tuberculosis Control Programme (RNTCP) and was also implemented in the National Institute of TB and Respiratory Diseases (NITRD). We present early efficacy and safety of BDQ containing regimens for DR-TB. OBJECTIVE: To ascertain the early efficacy and safety of Bedaquline containing regimens in treatment of DR-TB. METHODS: BDQ containing regimens along with other drugs were designed as per WHO recommendations for DR-TB patients. They were followed up for sputum smear and culture conversion, adverse events during the treatment. RESULTS: A cohort of 290 DR-TB patients (Median age-29.77) were initiated on BDQ containing regimens. Of the available Sputum results, smear conversion was seen in 51% and 91% patients at the end of 1st week and 3rd month respectively. Similarly, 93% and 98% patients had culture conversion at the end of 3rd and 6th month respectively. 201 adverse events (AE) including 47 deaths were reported among 109 patients. QTc prolongation was seen in 29% patients but only 4 required discontinuation of BDQ. Lost to follow up of treatment was about 6%. CONCLUSION: Bedaquiline along with an optimized background regimen has shown early sputum conversion in larger number of difficult to treat patients having additional resistance of second line drugs along with INH and Rifampicin. The regimen is feasible in programmatic conditions and is relatively safe.

Clinical profile and treatment outcome of tuberculous lymphadenitis in children using DOTS strategy.

BACKGROUND: Extra pulmonary TB (EPTB) including tuberculous lymphadenitis is becoming more common probably due to human immuno deficiency virus (HIV) co-infection. While children do experience a high TB related morbidity and mortality, management of TB in children is challenging. The present study was designed to study the treatment outcome of DOTS strategy for pediatric tuberculous lymphadenitis. OBJECTIVE: To study the efficacy of DOTS strategy for pediatric lymphhnode tuberculosis. METHODS: Retrospective analysis of 669 children of lymphnode tuberculosis treated with DOTS strategy over 9 1/2 years. RESULTS: Mean age was 9.8 years with significantly more girls (61.3%) than boys (38.7%) {chi2=34.08, P<0.001 (S)}. Most of the patients were in the age group of 11-14 years (48.0%) followed by 6-10 years (34.5%) and 0-5 years (17.5%) respectively. Cervical tuberculous lymphadenitis (88.2%) was the commonest form for all ages followed by axillary lymphadenitis in 3.3%. TB of other sites was seen in only 57 (8.5%) cases. Out of total 622 (93%) cases of lymphnode TB where fine needle aspiration and/or excisional biopsy was done, it was positive (84.2%) and negative (15.6%) respectively for AFB/cytology, while it could not be done in 47 patients due to inaccessible sites. Category I, II and III was started on 15.4%, 7.5% and 77.1% patients respectively. Overall, treatment completion rate was 94.9% and the default rate was 2.2% with a failure rate of 2.5%. Death rate was 0.3%. CONCLUSION: The study confirms the efficacy of DOTS strategy for pediatric TB lymphadenitis.

Clinical profile and treatment outcome of tubercular pleurisy in pediatric age group using DOTS strategy.

BACKGROUND: A significant proportion of global tuberculosis (TB) caseload is contributed by children. Management of pediatric TB especially EPTB is challenging. The present study was designed to study demographic, clinical profile and treatment outcome of DOTS strategy for pediatric tubercular pleurisy. AIM: To study the efficacy of DOTS strategy. METHODS: Retrospective analysis of 106 TB pleurisy children treated with DOTS. RESULTS: Mean age was 10.8 years (median age 12.2 years) with more females (51.9%) than males (48.1%) chi1(2) = 0.15; P = 0.698 (NS). In the age group of 0-5, 6-10 and 11-14 years, there were 15.1%, 30.2% and 54.7% patients respectively. Fever was the commonest symptom (98.1%) followed by cough (77.4%) and chest pain (55.7%). History of contact could be elicited only in 2/3rd of cases unilateral effusion (61.3%) was commonest, followed by empyema (22.6%), massive effusion and broncho-pleural fistula each in 13.2% cases respectively. Bilateral effusion was seen in 3.8% cases only. Conventional methods (mantoux, radiograph, ultrasound, pleural aspiration) and minimal invasive surgical techniques, percutaneous pleural biopsy were done to arrive at the diagnosis. Diagnosis was made by X-ray Chest in 92.5%, exudative pleural fluid (100%) predominantly lymphocytic in 85.8%, positive AFB smear and culture in 4.7 and 5.7% cases respectively. Category I, II and III was started on 35.9%, 2.8% and 61.3% patients respectively. Overall treatment completion rate was 94.3%, 4.7% default rate, 0.9% failure rate and no deaths. CONCLUSION: The study confirms early detection by simple tests and ensuring complete treatment using DOTS strategy.

The DOTS strategy for treatment of paediatric pulmonary tuberculosis in South Delhi, India.

SETTING: Paediatric Pulmonology Department, TB Institute, New Delhi, India. OBJECTIVE: To evaluate the outcome of the DOTS strategy for paediatric pulmonary tuberculosis (TB). DESIGN: Retrospective analysis of 1098 children. RESULTS: The mean age of the children included in the study was 11.2 years, with more females (61.7%) than males (38.3%). In the 0-5, 6-10 and 11-14 year age groups, the percentage of patients was respectively 18.3%, 26.6% and 55.1%. Patients were registered as new cases (87.7%), relapses (1.9%), failures (1.0%), defaulters (5.0%), transferred in (0.9%) and others (3.5%). Of the total number of cases, 414 were smear-positive and 404 smear-negative, while sputum status was not known for 280 patients. Sputum positivity increased with age. Category I, II and III regimens were started by respectively 50.6%, 10.5% and 38.9% patients. The cure rate was 92.4% (302/327) for new and 92% (80/87) for retreatment cases (chi(2)(1) = 0.02, P = 0.901), but the treatment completion rate was significantly higher for new cases (97%, 636/656) than retreatment cases (53.6%, 15/28) (chi(2)(1) = 100.8, P < 0.001). The overall success rate was 95.4% and 82.6% for new and retreatment cases, respectively (chi(2)(1) = 30.35, P < 0.001). Overall, the rates for default, failure and death in the study were respectively 3%, 1.9% and 1%. CONCLUSION: DOTS appears to be a highly efficacious treatment strategy.