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Figure no. 1. Reasons for default of anti-TB treatment under RNTCP
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Introduction: India is the highest Tuberculosis (TB) burden country accounting for 1/5th (21%) i.e. 2 million cases of the global annual incidence of 9.4 million. Poor adherence to anti-tubercular treatment is a major barrier to disease control leading to defaulters.This study aimed to know the reasons of treatment interruption among the tuberculos...
Citations
... The multifaceted nature of this unfortunate outcome unveiled a diverse array of contributing factors, including the perils of migration, the vice of alcoholism, the disheartening presence of unwillingness, the burden of side effects, the pursuit of alternative therapies, the complexities of pregnancy, and the demands of occupational responsibilities. 3 Among these factors, we must underscore the considerable challenges faced by patients ensnared in the clutches of alcoholism, for their steadfast adherence to treatment regimens proves excessively elusive, thereby unpropitiously compromising the desired therapeutic outcomes associated with any programmatic TB protocol. Consequently, these disconcerting statistics converge to illuminate the complex challenges that pervade the quest to secure unwavering patient adherence, thereby magnifying the significance of a careful examination of the applicability and feasibility of implementing the TRUNCATE-TB trial regime within specific field settings, especially within the intricate tapestry of a nation like India. ...
The recently published results of TRUNCATE TB trial do advocate a shorter anti TB treatment regime of 2 months but with strict follow up schedule for 2 years. There are potential concerns regarding the implementation of such a regime in Indian scenario where such a rigorous post treatment follow may not always be possible. This editorial article discusses this aspect of the TRUNCATE TB trial.
Introduction: In India, the daily weight-based, Fixed Dose
Combination (FDC) Antituberculosis Treatment (ATT) regime under
the National Tuberculosis Elimination Programme (NTEP) was
introduced, replacing the previous intermittent regime with the
aim of improving compliance, decreasing Adverse Drug Reactions
(ADRs) and thus ultimately translating to improved treatment
outcomes. The ADRs are an important factor that can adversely
impact the treatment compliance and outcomes of an ATT regime.
There is currently a paucity of studies reflecting the development
of ADRs in the Indian population to the new ATT regime.
Aim: To study the ADRs of daily FDC-based first-line ATT regime
under NTEP.
Materials and Methods: A prospective cohort analysis was
conducted in the Department of Respiratory Medicine at Indira
Gandhi Government Medical College (tertiary care centre), Nagpur,
Maharashtra, India, from January 2019 to September 2020. Total
750 People With Tuberculosis (PWTB) were enrolled in the study.
They were administered a standardised daily FDC first-line ATT
regime under NTEP comprising of initial two months of intensive
phase with Isoniazid (INH or H), Rifampicin (R), Ethambutol (E),
and Pyrazinamide (Z) followed by a continuation phase of four
months with INH, rifampicin, and ethambutol (2EHRZ/4HRE).
Clinical evaluation and/or laboratory investigations were used at
baseline and when clinically indicated during therapy to identify
treatment-related adverse events.
Results: Among the 750 PWTB, 402 (53.60%) were females,
and 348 (46.40%) were males. The mean age of PWTB was
36.46±15.6 years. The ADR to ATT was present in 271 (36.13%)
PWTB, 217 (80.07%) were managed on an Outpatient Department
(OPD) basis and 54 (19.93%) patients required hospitalisation.
Causality assessment revealed that most ADRs were probable
(81.18%), followed by possible (18.82%). Regarding the severity
of ADRs, 87.08% were mild, 11.44% were moderate, 1.48% were
severe, and none of the ADRs was life-threatening. In 67.9%
of PWTB, gastrointestinal ADRs were seen, followed by joint
pain (37.64%) and cutaneous drug reactions (16.60%). Female
PWTB, People Living with Human Immunodeficiency Virus and
Tuberculosis (PLHIV-TB), and PWTB with systemic co-morbidities,
especially diabetes and systemic hypertension, were at a higher
risk of developing ADRs. The risk of ADRs was unaltered with
age distribution, body mass index distribution, type of diet, the
type of tuberculosis, or the pill burden. Addiction to alcohol and
tobacco did not significantly alter the risk of ADRs.
Conclusion: This is the largest Indian study on ADRs of first line FDC-ATT under programmatic conditions. The ADRs caused by daily FDC-based ATT are
common, but most are mild and can be managed on an OPD
basis. Gastrointestinal ADRs, arthralgia, and cutaneous drug
reactions are the most common ADRs of the daily FDC-based
ATT regime. Female PWTB, PLHIV-TB, and PWTB with systemic
co-morbidities, especially diabetes and systemic hypertension,
being at a high risk of developing ADRs, need to be actively
screened for ADRs during treatment.
