Level of adherence to anti‐tubercular treatment among drug‐sensitive tuberculosis patients on a newly introduced daily dose regimen in South India: A cross‐sectional study

Thamineni, Rajavardhana; Peraman, Ramalingam; Chenniah, Jayakumar; Meka, Geethavani; Munagala, Ashok Kumar; Mahalingam, Vijayakumar Thangavel; Ganesan, R

doi:10.1111/tmi.13824

Cited by 6 publications

(3 citation statements)

References 29 publications

(31 reference statements)

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“…However, measuring adherence in routine care is difficult [ 171 , 172 ]. Use of novel and accurate approaches for detecting nonadherence, like urine drug metabolite testing [ 87 , 173 ], may facilitate early identification of people at risk for poor outcomes, so they can be given additional support. Medication adverse effects contributed to loss to follow-up across numerous studies for people with drug-susceptible TB (with up to 42% to 47% of people who stopped therapy doing so due to adverse effects [ 92 , 113 , 115 ]) and drug-resistant TB (with up to 75% of patients who stopped therapy doing so due to adverse effects [ 143 ]).…”

Section: Discussionmentioning

confidence: 99%

Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies

Jhaveri,

Galivanche

et al. 2024

PLoS Med

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Background India accounts for about one-quarter of people contracting tuberculosis (TB) disease annually and nearly one-third of TB deaths globally. Many Indians do not navigate all care cascade stages to receive TB treatment and achieve recurrence-free survival. Guided by a population/exposure/comparison/outcomes (PECO) framework, we report findings of a systematic review to identify factors contributing to unfavorable outcomes across each care cascade gap for TB disease in India. Methods and findings We defined care cascade gaps as comprising people with confirmed or presumptive TB who did not: start the TB diagnostic workup (Gap 1), complete the workup (Gap 2), start treatment (Gap 3), achieve treatment success (Gap 4), or achieve TB recurrence-free survival (Gap 5). Three systematic searches of PubMed, Embase, and Web of Science from January 1, 2000 to August 14, 2023 were conducted. We identified articles evaluating factors associated with unfavorable outcomes for each gap (reported as adjusted odds, relative risk, or hazard ratios) and, among people experiencing unfavorable outcomes, reasons for these outcomes (reported as proportions), with specific quality or risk of bias criteria for each gap. Findings were organized into person-, family-, and society-, or health system-related factors, using a social-ecological framework. Factors associated with unfavorable outcomes across multiple cascade stages included: male sex, older age, poverty-related factors, lower symptom severity or duration, undernutrition, alcohol use, smoking, and distrust of (or dissatisfaction with) health services. People previously treated for TB were more likely to seek care and engage in the diagnostic workup (Gaps 1 and 2) but more likely to suffer pretreatment loss to follow-up (Gap 3) and unfavorable treatment outcomes (Gap 4), especially those who were lost to follow-up during their prior treatment. For individual care cascade gaps, multiple studies highlighted lack of TB knowledge and structural barriers (e.g., transportation challenges) as contributing to lack of care-seeking for TB symptoms (Gap 1, 14 studies); lack of access to diagnostics (e.g., X-ray), non-identification of eligible people for testing, and failure of providers to communicate concern for TB as contributing to non-completion of the diagnostic workup (Gap 2, 17 studies); stigma, poor recording of patient contact information by providers, and early death from diagnostic delays as contributing to pretreatment loss to follow-up (Gap 3, 15 studies); and lack of TB knowledge, stigma, depression, and medication adverse effects as contributing to unfavorable treatment outcomes (Gap 4, 86 studies). Medication nonadherence contributed to unfavorable treatment outcomes (Gap 4) and TB recurrence (Gap 5, 14 studies). Limitations include lack of meta-analyses due to the heterogeneity of findings and limited generalizability to some Indian regions, given the country’s diverse population. Conclusions This systematic review illuminates common patterns of risk that shape outcomes for Indians with TB, while highlighting knowledge gaps—particularly regarding TB care for children or in the private sector—to guide future research. Findings may inform targeting of support services to people with TB who have higher risk of poor outcomes and inform multicomponent interventions to close gaps in the care cascade.

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Section: Discussionmentioning

confidence: 99%

Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies

Jhaveri,

Galivanche

et al. 2024

PLoS Med

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“…However, measuring TB medication adherence in routine care is challenging, with recent studies from India showing that 99DOTS (a digital adherence technology used in the NTEP) and patient self-report have suboptimal accuracy [182][183][184]. Use of novel approaches for detecting nonadherence, such as urine isoniazid testing [29,185], may facilitate early identification of patients at risk for poor outcomes, so that they can be provided with additional support. A recent study in India found that negative urine isoniazid test results…”

Section: Findings Specific To Each Care Cascade Gapmentioning

confidence: 99%

Barriers to engagement by people with active tuberculosis in the care cascade in India: a systematic review of two decades of quantitative research

Jhaveri,

Galivanche

et al. 2023

Preprint

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Background. India has the highest burden of tuberculosis (TB), accounting for more than one-quarter of people with active TB and nearly one-third of TB deaths globally. Most people contracting active TB in India do not successfully navigate all stages of the care cascade to receive treatment and achieve TB recurrence-free survival. Understanding reasons for losses across the care cascade is critical to improve outcomes. In this paper, guided by a PECO (population/exposure/comparison/outcome) framework, we describe quantitative findings of a systematic review aimed at identifying factors contributing to unfavorable outcomes experienced by people with TB at each care cascade gap in India. Methods and findings. We defined care cascade gaps as comprising people with confirmed or presumptive TB who did not: start the TB diagnostic workup (Gap 1), complete the diagnostic workup (Gap 2), start treatment (Gap 3), achieve treatment success (Gap 4), or achieve TB recurrence-free survival (Gap 5). Three systematic searches were conducted to identify 147 unique articles published from 2000 to 2021 that evaluated factors associated with unfavorable outcomes for each gap (reported as odds, relative risk, or hazard ratios) and, among people experiencing unfavorable outcomes, reasons reported for these outcomes (reported as proportions). Findings were organized into patient-, family-, society-, or health system-related factors, using a social-ecological framework. Some factors were common and associated with unfavorable outcomes across multiple care cascade stages. These included male sex, older age (variably defined across studies), a broad array of poverty-related factors, lower symptom severity or duration, undernutrition, alcohol use, smoking, and distrust of (or dissatisfaction with) local government health services. People who had been previously treated for TB were more likely to seek care and engage in the TB diagnostic workup (Gaps 1 and 2) but were also more likely to suffer pretreatment loss to follow-up (Gap 3) and unfavorable outcomes during TB treatment (Gap 4), especially those who had been lost to follow-up during their prior treatment episode. For individual care cascade gaps, multiple studies highlighted the importance of lack of TB knowledge and structural barriers to care (e.g., transport or financial challenges in reaching clinics) in contributing to lack of care-seeking for TB symptoms (Gap 1, 15 studies or analyses); lack of access to diagnostics (e.g., chest X-ray), non-identification of eligible patients for testing, and failure of providers to communicate concern for TB to patients in contributing to non-completion of the diagnostic workup (Gap 2, 20 studies or analyses); TB stigma, poor recording of patient contact information by providers, and early death due to diagnostic delays in contributing to pretreatment loss to follow-up (Gap 3, 25 studies); and medication adverse effects, TB stigma, and lack of TB knowledge in contributing to unfavorable treatment outcomes (Gap 4, 104 studies). Medication nonadherence contributed to unfavorable treatment outcomes (Gap 4) and post-treatment TB recurrence (Gap 5, 15 studies). Conclusions. This extensive systematic review illuminates common patterns of risk that shape outcomes for people with TB in India, while also highlighting gaps in knowledge, particularly with regard to TB care for children or in the private sector, that can help to guide future research. These findings may help inform targeting of additional support services to people with TB who are at higher risk of poor outcomes and inform development of multi-component interventions to close gaps in India′s TB care cascade.

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“…The standard antitubercular treatment (ATT) regimen for pulmonary tuberculosis (PTB) in India includes isoniazid, rifampicin (R), ethambutol, and pyrazinamide for the first 2 months, followed by isoniazid, rifampicin, and ethambutol for the next 4 months. Lengthy duration and adverse effects that affect drug compliance may contribute to unfavorable outcomes [ 1 ] and delay in achieving World Health Organization End TB Strategy targets. Hence, there is need for modification of existing drug regimens to achieve early bacteriologic conversion and to reduce ATT-induced toxicity.…”

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confidence: 99%

Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial

Perumal Kannabiran,

Palaniappan,

Manoharan

et al. 2024

Open Forum Infectious Diseases

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Background Globally no trial data available on head-to-head comparison between 10 and 25/35 mg/kg rifampicin in treating pulmonary tuberculosis (PTB) during study initiation. Methods A multi-centric, phase-IIb randomized trial recruited 333 new culture-positive, drug-sensitive adult PTB patients, to compare safety and efficacy of high-dose rifampicin (R25/R35), against conventional dose (R10) given daily for 8-weeks followed by standard doses for 16-weeks. Main outcomes were treatment-emergent grade 3/4 adverse events (AE) and time-to-culture conversion in liquid media, assessed by DAIDS criteria and Kaplan-Meier methods. Results In modified intention-to-treat population of 323 (R10-105/R25-112/R35-106), grade 3/4 AEs were reported in 34 patients [R10-9.5% (10/105), R25-9.8% (11/112), R35-12.3% (13/106)] during intensive phase. Among 23 patients [R10-3.8% (4/105), R25-6.3% (7/112), R35-11.3% (12/106)] with grade 3/4 hepatotoxicity, 15 [R10-1.9% (2/105), R25-3.6% (4/112), R35-8.5% (9/106)] had grade 3/4 hyperbilirubinemia and 9 patients [R10-1.0% (1/105), R25-0.9% (1/112), R35-6.6% (7/106)] developed clinical jaundice. Significant differences observed only between R10 and R35 with hepatotoxicity (p = 0.039), hyperbilirubinemia (p = 0.031), clinical jaundice (p = 0.032), and treatment interruption (p = 0.039). Eighteen serious AEs and six deaths (R10-3/R25-1/R35-2) occurred during study period. Time-to-stable culture conversion in liquid media was faster in R25 [adjusted hazard ratio 1.71, 95% confidence interval (CI) 1.26-2.31; (solid: 1.97, 95%CI, 1.46-2.67)] and R35 [1.81, 95%CI, 1.33-2.48; (solid: 2.24, 95%CI, 1.64-3.06)], than R10 [34 vs 44 days]. R25 had no failure/relapse. Conclusions Hepatotoxicity, clinical jaundice and treatment interruptions occurred significantly higher with R35 than R10. Since R25 was comparably safe as R10 and also highly efficacious than R10, it may be considered for implementation. Clinical Trials Registration CTRI/2017/12/010951

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Level of adherence to anti‐tubercular treatment among drug‐sensitive tuberculosis patients on a newly introduced daily dose regimen in South India: A cross‐sectional study

Cited by 6 publications

References 29 publications

Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies

Barriers to engagement in the care cascade for tuberculosis disease in India: A systematic review of quantitative studies

Barriers to engagement by people with active tuberculosis in the care cascade in India: a systematic review of two decades of quantitative research

Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial

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