To Tuberculosis Treatment Research Articles

Estimation of potential social support requirement for tuberculosis patients in India.

Providing social support to tuberculosis (TB) patients is a recommended strategy as households having TB patients find themselves in a spiral of poverty because of high cost, huge income loss and several other economic consequences associated with TB treatment. However, there are few examples of social support globally. The Indian government introduced the 'Nikshay Poshan Yojana' scheme in 2018 to provide nutritional support for all registered TB patients. A financial incentive of 500 Indian Rupee (6 United States Dollars) per month was proposed to be transferred directly to the registered beneficiaries' validated bank accounts. We examined the reach, timing, amount of benefit receipt and the extent to which the benefit alleviated catastrophic costs (used as a proxy to measure the impact on permanent economic welfare as catastrophic cost is the level of cost that is likely to result in a permanent negative economic impact on households) by interviewing 1482 adult drug-susceptible TB patients from 16 districts of four states during 2019 to 2023, using the methods recommended by the World Health Organization for estimating household costs of TB nationally. We also estimated the potential amount of social support required to achieve a zero catastrophic cost target. At the end of treatment, 31-54% of study participants received the benefit. In all, 34-60% of TB patients experienced catastrophic costs using different estimation methods and the benefit helped 2% of study participants to remain below the catastrophic cost threshold. A uniform benefit amount of Indian Rupee 10 000 (127 United States Dollars) for 6 months of treatment could reduce the incidence of catastrophic costs by 43%. To improve the economic welfare of TB patients, levels of benefit need to be substantially increased, which will have considerable budgetary impact on the TB programme. Hence, a targeted rather than universal approach may be considered. To maximize impact, at least half of the revised amount should be given immediately after treatment registration.

Immune Responses to Mycobacterium tuberculosis Infection in the Liver of Diabetic Mice.

Individuals with uncontrolled diabetes are highly susceptible to tuberculosis (TB) caused by Mycobacterium tuberculosis (M. tb) infection. Novel treatments for TB are needed to address the increased antibiotic resistance and hepatoxicity. Previous studies showed that the administration of liposomal glutathione (L-GSH) can mitigate oxidative stress, bolster a granulomatous response, and diminish the M. tb burden in the lungs of M. tb-infected mice. Nonetheless, the impact of combining L-GSH with conventional TB treatment (RIF) on the cytokine levels and granuloma formation in the livers of diabetic mice remains unexplored. In this study, we evaluated hepatic cytokine profiles, GSH, and tissue pathologies in untreated and L-GSH, RIF, and L-GSH+RIF treated diabetic (db/db) M. tb-infected mice. Our results indicate that treatment of M. tb-infected db/db mice with L-GSH+RIF caused modulation in the levels of pro-inflammatory cytokines and GSH in the liver and mitigation in the granuloma size in hepatic tissue. Supplementation with L-GSH+RIF led to a decrease in the M. tb burden by mitigating oxidative stress, promoting the production of pro-inflammatory cytokines, and restoring the cytokine balance. These findings highlight the potential of L-GSH+RIF combination therapy for addressing active EPTB, offering valuable insights into innovative treatments for M. tb infections.

Usability testing of a mobile health application to support individuals with active tuberculosis: a mixed methods study

ABSTRACT Poor adherence to tuberculosis (TB) treatment leads to further disease transmission, worsened outcomes, and the development of drug resistance. Digital adherence technologies may facilitate a more patient-centered approach for improving TB treatment outcomes than current strategies. The objective of this study was to evaluate and explore improving usability of the TB Treatment Support Tools (TB-TST) mobile application. We used an iterative convergent mixed-method design consisting of two quantitative surveys and a qualitative think-aloud interview. Testing was conducted in three testing cycles consisting of a total of 16 interviews and 26 surveys. Results were thematically analyzed and reported to the development team during weekly team meetings. Participants rated the TB-TSTs application as having high usability and the iterative approach resulted in several refinements to the application in response to participant feedback. These refinements were well received during qualitative interviews but did not result in a statistically significant improvement in usability testing scores between cycles. Using an iterative convergent mixed-method design was an effective method for refining our mHealth application. Data collected from think-aloud interviews, the MAUQ, and the Health-ITUES identified key areas of application design that needed refinement.

Nutritional status and treatment outcomes of tuberculosis in Mizan Tepi University Teaching Hospital, a five -year retrospective study.

Public health problems related to tuberculosis (TB) remain substantial globally, particularly in resource-limited countries. Determining TB treatment outcomes and identifying contributing factors are the basic components of the TB control strategy. In Ethiopia, different studies have been done on treatment outcomes and multiple associated factors, and there is also a little information on the effect of nutritional status on TB treatment outcomes. So there is a need for comprehensive research that examines the combined effects of multiple factors along with nutritional status. A five-year institution-based retrospective cross-sectional study was conducted at Mizan Tepi University Teaching Hospital, South West Ethiopia. This study included all tuberculosis patients who were documented in the TB registration and had known treatment outcomes at the treatment facility between January 1, 2016, and December 31, 2020. Data was collected through a pretested structured data extraction checklist. Data were entered into Epidata version 3.1 and analyzed through SPSS version 22. Multiple logistic regression was employed to assess the association between dependent and independent variables. A p-value of less than 0.05 was considered statistically significant. Of the total 625 TB patients, 283 (45.3%), 175 (28%), and 167 (26.7%) had smear-positive, extra-pulmonary, and smear-negative tuberculosis, respectively. The majority of study participants had normal weight (62.2%), were in the age group of 15-44 (67.4%), were new cases (73.8%), and were from urban areas (69.4%). About 32.2% of cases were HIV-positive. The overall unsuccessful treatment rate was 25%. From the total unsuccessful treatment rates, the highest proportion was a death rate of 90 (14.4%), followed by a treatment failure of 56 (9%). Being female (AOR = 1.7, 95% CI: 1.2-2.5), HIV positive (AOR = 2.7, 95% CI: 1.9-4.1), undernutrition (BMI<18.5kg/m2) (AOR = 1.9, 95% CI: 1.3-2.9), and smear-negative pulmonary TB (AOR = 1.6, 95% CI: 1-2.5) were independent predictors of unsuccessful treatment outcomes. The treatment success rate in the study area is very poor. Poor treatment outcomes were associated with undernutrition, female gender, HIV positivity and smear-negative pulmonary TB. So, continuous and serious supervision and monitoring of directly observed treatment short course (DOTS) program accomplishment, early detection of HIV and TB, prompt anti TB and antiretroviral treatment initiation and adherence, enhanced nutritional assessment, and counseling services need to be strengthened to improve treatment outcomes.

Cost-effectiveness of improving patients’ adherence to tuberculosis treatment in South Korea using discrete event simulation

BackgroundPoor adherence to tuberculosis (TB) treatment is an obstacle to controlling the disease. The Korean government’s national TB control plan includes a program on adherence to TB treatment to manage patients with TB. This study aimed to assess the cost-effectiveness of a national TB program for improving patient adherence. MethodsA discrete event simulation (DES) model was developed to estimate the costs and quality-adjusted life-years (QALYs) of adherent and non-adherent patients. In this model, we considered treatment completion, loss to follow-up, recurrence, death, and treatment changes from drug-susceptible to multidrug-resistant TB as clinical events. We obtained input parameters such as costs, probability of events, and time distributions for each event from the Korean National Health Insurance claims data. We estimated the costs and QALYs before implementation of the program (adherence rate = 79%) and at present (current adherence rate = 94%). The incremental cost-effectiveness ratio (ICER) was used to evaluate whether the program was cost-effective given the willingness-to-pay threshold. ResultsIn the simulation, the program increasing the proportion of adherent patients gained 0.018 QALY/patient while spending $162/patient. The ICER of the TB program was $8790/QALY. Given a willingness-to-pay threshold of $20,000, the national TB program was considered cost-effective. ConclusionImprovements in adherence to TB treatment through the current TB program were cost-effective. The DES model accurately reflected the real world. Commitment programs to improve patient adherence may help manage TB nationwide.

Impact of a pharmacist-led patient-centred care intervention along with textmessage reminders, on the management of newly diagnosed tubercular patients: A protocol for a randomized controlled trial.

Non-adherence to tuberculosis (TB) treatment is the leading cause of the increase in drug resistance cases. This study will determine the effectiveness of pharmaceutical-care-based interventions coupled with short messages delivered by a pharmacist on treatment outcomes and adherence among TB patients. The study will be conducted in TB Control Center of Pakistan Institute of Medical Sciences Hospital, Islamabad and District Bannu TB Control Center time period will be from August 2019 to September 2021. The patients will be included into the control group (usual care) or the intervention group pharmaceutical care and SMS reminder. The primary outcome includes a change in mean score from baseline in treatment outcomes and adherence, measured by Morisky Medication Adherence Scale, and clinic appointment attendance registration. Secondary outcomes include health-related quality of life of patients, disease knowledge, and patient satisfaction with the intervention. The major issues in patients with TB are cure rate and medication adherence. The method anticipated in this manuscript could set the foundation of pharmaceutical care and mobile SMS for the future provision of care to improve TB treatment outcomes. The study will make available fundamental information about the influence of the patient centered program on the adherence and clinical outcomes of patients with TB.Trial status and registration: Clinical Trials.gov assigned Identifier NCT04645836.

“It’s about time they taught us”: a qualitative study evaluating the barriers to finding and screening child contacts under five at risk for TB in Gauteng Province, South Africa from the provider and caregiver perspectives

BackgroundInadequate numbers of children under five years of age who are exposed to tuberculosis (TB) in the home (child contact) are initiated on TB preventive treatment (TPT) in South Africa. We assessed barriers of initiating isoniazid preventive therapy (IPT) in this age group.MethodsWe conducted a qualitative study at two primary health clinics in the Ekurhuleni district in Gauteng Province. Between April and July 2019, we enrolled facility managers, TB staff and parents or legal guardians of child contacts (caregivers) attending for care, at the two facilities. Semi-structured questionnaires, facility observations and in-depth interviews using a semi-structured interview guide were used to collect data. Findings from the semi-structured questionnaires with facility staff and facility observations were summarized. Thematic analysis with a deductive approach was used to analyse the data from the in-depth interviews with caregivers.ResultsTwo facility managers took part in the study and were assisted to complete the semi-structured questionnaires by TB staff. Fifteen caregivers aged between 18 and 43 years were interviewed of which 13 (87%) were female. Facility managers and TB staff (facility staff) felt that even though caregivers knew of family members who were on TB treatment, they delayed bringing their children for TB screening and TPT. Facility staff perceived caregivers as not understanding the purpose and benefits of TB prevention strategies such as TPT. Caregivers expressed the desire for their children to be screened for TB. However, caregivers lacked knowledge on TB transmission and the value of TB prevention in children at high risk of infection.ConclusionWhile facility staff perceived caregivers to lack responsibility, caregivers expressed limited knowledge on the value of screening their children for TB as reasons for not accessing TB preventive services. Health education on TB transmission, screening, and TB prevention strategies at a community level, clinics, creches, schools and via media are important to achieve the global end TB goal of early detection and prevention of TB.

Using the Baidu index to predict trends in the incidence of tuberculosis in Jiangsu Province, China.

To analyze the time series in the correlation between search terms related to tuberculosis (TB) and actual incidence data in China. To screen out the "leading" terms and construct a timely and efficient TB prediction model that can predict the next wave of TB epidemic trend in advance. Monthly incidence data of tuberculosis in Jiangsu Province, China, were collected from January 2011 to December 2020. A scoping approach was used to identify TB search terms around common TB terms, prevention, symptoms and treatment. Search terms for Jiangsu Province, China, from January 2011 to December 2020 were collected from the Baidu index database. Correlation coefficients between search terms and actual incidence were calculated using Python 3.6 software. The multiple linear regression model was constructed using SPSS 26.0 software, which also calculated the goodness of fit and prediction error of the model predictions. A total of 16 keywords with correlation coefficients greater than 0.6 were screened, of which 11 were the leading terms. The R2 of the prediction model was 0.67 and the MAPE was 10.23%. The TB prediction model based on Baidu Index data was able to predict the next wave of TB epidemic trends and intensity 2 months in advance. This forecasting model is currently only available for Jiangsu Province.

The more the better? How social support predicted perceived barriers to tuberculosis treatment across groups of different socioeconomic statuses

ObjectiveSocial support can lower perceived barriers to medical treatment, but this relationship may vary in groups of different socioeconomic statuses (SES). This study examined whether different types of social support predicted different types of perceived barriers to tuberculosis (TB) treatment and whether these relationships varied across different levels of SES. MethodA paper-pencil survey covering 12 cities in Guangdong, China (N = 1386) was conducted in December 2020, which measured demographics, three types of perceived social support (informational, instrumental, and emotional) and barriers to TB treatment (cognitive, instrumental, and psychological). ResultsInformational support and instrumental support were negatively related to cognitive barriers and instrumental barriers. These relationships were stronger among more educated individuals and urban residents. However, emotional support predicted psychological barrier positively, and this relationship was stronger among less educated individuals and rural residents. ConclusionHigh SES groups benefit more from individual-level support. Thus, there is a gap of social support, which reveals the power nature of social support exchanges. Practice ImplicationsTB campaigns need provide support for low SES groups to compensate for their insufficient support. Campaigns need provide information about disease management and the legal and financial support for TB patients, and change tuberculosis-related norms.

Evaluating the impact of cash transfers on tuberculosis (ExaCT TB): a stepped wedge cluster randomised controlled trial.

Mitigating financial barriers to tuberculosis (TB) diagnosis and treatment is a core priority of the global TB agenda. We evaluated the impact of a cash transfer intervention on completion of TB testing and treatment initiation in Uganda. We conducted a pragmatic complete stepped wedge randomised trial of a one-time unconditional cash transfer at 10 health centres between September 2019 and March 2020. People referred for sputum-based TB testing were enrolled to receive UGX 20 000 (∼USD 5.39) upon sputum submission. The primary outcome was the number initiating treatment for micro-bacteriologically confirmed TB within 2 weeks of initial evaluation. The primary analysis included cluster-level intent-to-treat and per-protocol analyses using negative binomial regression. 4288 people were eligible. The number diagnosed with TB initiating treatment was higher in the intervention period versus the pre-intervention period (adjusted rate ratio (aRR)=1.34) with a 95% CI of 0.62-2.91 (p=0.46), indicating a wide range of plausible true intervention effects. More were referred for TB testing (aRR=2.60, 95% CI 1.86-3.62; p<0.001) and completed TB testing (aRR=3.22, 95% CI 1.37-7.60; p=0.007) per National Guidelines. Results were similar but attenuated in per-protocol analyses. Surveys revealed that while the cash transfer supported testing completion, it was insufficient to address long-term underlying social/economic barriers. While it is uncertain whether a single unconditional cash transfer increased the number of people diagnosed and treated for TB, it did support higher completion of diagnostic evaluation in a programmatic setting. A one-time cash transfer may offset some but not all of the social/economic barriers to improving TB diagnosis outcomes.

Adolescent, caregiver and provider perspectives on tuberculosis treatment adherence: a qualitative study from Lima, Peru

ObjectivesTo understand the perspectives of adolescents (10–19 years old), their caregivers and healthcare providers regarding factors that impact adherence to tuberculosis (TB) treatment among adolescents.DesignWe conducted in-depth interviews using semistructured...

Molecular typing and drug sensitivity profiles of M. Tuberculosis isolated from refugees residing in Ethiopia

BackgroundRefugees in developing countries have poor access to Tuberculosis (TB) care and control services. The understanding of genetic diversity and drug sensitivity patterns of M. tuberculosis (MTB) is important for the TB control program. However, there is no evidence that shows the drug sensitivity profiles and genetic diversity of MTB circulating among refugees residing in Ethiopia. This study aimed to investigate the genetic diversity of MTB strains and lineages, and to identify the drug sensitivity profiles of MTB isolated from refugees residing in Ethiopia. MethodsA cross-sectional study was conducted among 68 MTB positive cases isolated from presumptive TB refugees from February to August 2021. Data and samples were collected in the refugee camp clinics and both rapid TB Ag detection and region of difference (RD)-9 deletion typing were used to confirm the MTBs. Drug susceptibility test (DST) and molecular typing were done using Mycobacterium Growth Indicator Tube (MGIT) method and spoligotyping respectively. ResultsDST and spoligotyping results were available for all 68 isolates. The isolates were grouped into 25 spoligotype patterns, which consisted of 1–31 isolates with 36.8% strain diversity. The international shared type (SIT)25 was predominant spoligotype pattern consisting of 31 (45.6%) isolates, followed by SIT24 comprising 5 (7.4%) isolates. Further investigation showed that 64.7% (44/68) of the isolates were belonged to CAS1-Delhi family and 75% (51/68) of the isolates were belonged to lineage(L)-3. Multi-drug resistance (MDR)-TB was observed only in one isolate (1.5%) for first-line anti-TB drugs and the highest level of mono-resistance, 5.9% (4/68), was observed for PZA(Pyrazinamide). Mono-resistance was observed in 2.9 % (2/68) and while 97.0% (66/68) of the MTB positive cases were susceptible to the second-line anti-TB drugs. ConclusionThe findings are useful evidence for the TB screening, treatment and control in refugee populations and surrounding communities in Ethiopia.

Digitizing tuberculosis treatment monitoring in Wuhan city, China, 2020-2021: Impact on medication adherence.

Digital technologies can improve adherence to tuberculosis (TB) treatment. We studied the impact of digitizing TB treatment monitoring on adherence among TB patients in Wuhan, China, during 2020-2021. We compared an electronic system introduced to monitor TB medication adherence (e-Patient Service System; e-PSS) with the p paper-based standard of care (TB Control Information System; TCIS) in terms of prescribed TB treatment doses taken by patients and patient outcome after six months of follow up. We designed a cross sectional study using retrospective data for all drug susceptible pulmonary TB patients recorded on both systems. The main indicators were: compliant first follow up visit (within 3 days of start of treatment); medication adherence (80% or more of monthly doses taken); and end of treatment success ratio. A total of 1,576 TB patients were recorded in TCIS in July September, 2020 and 1,145 TB cases were included in e-PSS in January March, 2021. The distribution of patient demographic and clinical features was similar between the two groups. A larger proportion from the e-PSS group visited the community doctor in the first three days compared with the TCIS group (48.91 versus 29. 76 % respectively). Medication adherence was also higher in the e-PSS group during the 6 months of treatment than in the TCIS group (84. 28 versus 80.3 3 % respectively). Treatment success was 92.52% in the e-PSS group and 92.07% in the TCIS group. Multivariate logistic regress ion analysis demonstrated that adjusted odds ratios for compliant first follow up visit, medication adherence and favorable treatment outcome in the e-PSS versus TCIS groups were 2.94 (95% 2.47 3.50), 1.33 (95% 1.08 1.63), and 1. 12 (95% CL: 0.79 1.57) respectively. This study revealed improvements in TB care following an intervention to monitor treatment digitally in patients in Wuhan, China.

The effect of internal displacement due to armed conflict on tuberculosis treatment outcomes in northwest Syria, 2019–2020

BackgroundNorthwest Syria accounts for over 4 million people of whom more than half are internally displaced persons (IDPs). More than 1 million IDPs reside in camps and many more live in settings which are overcrowded and poorly ventilated. Suboptimal social living conditions leave these populations susceptible to tuberculosis (TB) morbidity and mortality. This study aimed to assess the effect of internal displacement due to armed conflict on the risk of unsuccessful treatment outcomes among TB patients in northwest Syria. MethodsAll patients registered to start TB treatment at three centres in northwest Syria between the 1st June 2019 to the 31st December 2020 were included. Unsuccessful TB treatment outcome was defined as a composite outcome combining the WHO TB treatment outcomes of treatment failure, loss to follow-up, and death. We assessed the association between internal displacement and unsuccessful TB treatment outcomes using multivariable logistic regression. We also explored the risk of an unsuccessful treatment outcome by internal displacement setting (camp, village or city). ResultsOf the total 737 registered patients included in the analysis, 400 (54%) were documented as internally displaced. The median age of IDPs was 30 (IQR: 21.5–48) and the median age of residents was 34 (IQR:22–50). A significantly higher percentage of those who were IDPs had an unsuccessful treatment outcome compared to residents (40% vs 18%, p<0.001). After adjustment for confounders, the relative risk of having unsuccessful TB treatment was two-fold higher in internally displaced TB patients compared to residents (95% CI: 1.5–2.6). IDPs living in villages had a 30% lower risk of an unsuccessful treatment outcome compared to IDPs living in camps (RR 95% CI: 0.50–0.91), and IDPs living in cities had a 13% lower risk of an unsuccessful treatment outcome (RR 95% CI: 0.57–1.18). ConclusionThis is one of few studies which aims to quantify the effect of internal displacement on TB treatment outcomes during times of conflict. Our findings starkly highlight how social determinants contribute to poor TB outcomes and act as a starting point for much needed research on how best to manage TB in humanitarian crisis settings.

OTOTOXICITY OF ANTIMYCOBACTERIAL THERAPY: MANIFESTATIONS, MECHANISMS OF MANAGEMENT AND CONTROL.

The aim: To study the nature and incidence of hearing loss related to tuberculosis (TB) or resulting from antimycobacterial therapy, and its impact on treatment outcomes in patients with multidrug-resistant TB (MDR-TB). Materials and methods: An analysis of reports on adverse reactions, medical records and electronic database of the register of TB patients was made. The pathogen was microbiologically verified in all the patients. Patients underwent clinical and laboratory, instrumental, microbiological (BACTEC), molecular genetic (Xpert® MTB/RIF® Ultra, Xpert® MTB/XDR, GenoType® MTBDRplus/sl) examinations. To prevent the development of complications and to control adverse effects, alongside with the determination of the corrected QT interval, visual acuity, and color vision, brief peripheral neuropathy screen and audiometry were performed. Results: During MDR-TB treatment with aminoglycosides, therapy was more commonly interrupted during the second episode of therapy (p=0,051), while treatment failure, longer treatment duration, and hearing impairment were almost equally observed in both groups (р=0,431, р=0,432, р=0,69). Treatment success was more commonly observed among patients receiving the first course of therapy. Some patients undergoing repeated antimycobacterial therapy were transferred to palliative care (p=0,13). The short-term treatment regimen effectively prevented ototoxicity. Conclusions: Novel antimycobacterial agents and short-term TB treatment regimens increased patient compliance with treatment and reduced the incidence of certain adverse effects due to their monitoring and prevention. Due to the transition to mainly drug therapy, adverse effects such as ototoxicity were completely eliminated. This was due to personalized treatment selection, its monitoring, and assessing the outcomes.

Tuberculosis treatment without rifampin in kidney/kidney-pancreas transplantation: A case series report.

The best approach to tuberculosis (TB) treatment in transplanted patients is still unknown. Current guidelines are based on evidence either extrapolated from other populations or observational. Rifampin-containing regimens have strong pharmacokinetic interactions with immunosuppressive regimens, with high rates of organ dysfunction and ∼20% mortality. This report describes the results obtained using non-rifampin-containing regimens to treat confirmed TB in adult patients with kidney/kidney-pancreas transplantation. Retrospective data analysis from confirmed TB cases in adult kidney/kidney-pancreas transplant recipients (2006-2019), treated "de novo" with non-rifampin-containing regimens. Fifty-seven patients had confirmed TB. Thirty patients were treated "de novo" with non-rifampin-containing regimens. These patients' mean age was 49.24 (±11.50) years. Induction immunosuppression was used in 22 patients. Maintenance immunosuppression was tacrolimus-mycophenolate-steroids in 13 (43%), sirolimus-mycophenolate-steroids in 6 (20%), and other immunosuppressive regimens in 11 (36%). Belatacept was used in four patients. TB localizations: pulmonary 43%; disseminated 23%; extrapulmonary 33%. Twenty-seven (90%) patients completed treatment with isoniazid, ethambutol, and levofloxacin (12 months, 23; 9 months, 3; 6 months, 1); 12 of these patients also received pyrazinamide for the first 2months and were cured with functioning grafts. One patient (3%) lost the graft while on treatment. Two patients (7%) died while on TB treatment. Median (range) follow-up after completion of TB treatment was 32 (8-150) months. No TB relapses were observed. Results with non-rifampin-containing TB treatments in this case series were better (in terms of mortality and graft dysfunction) than those previously described with rifampin-containing regimens in transplanted patients.

Isoniazid Adherence Reduces Mortality and Incident Tuberculosis at 96 Weeks Among Adults Initiating Antiretroviral Therapy With Advanced Human Immunodeficiency Virus in Multiple High-Burden Settings.

BackgroundPeople with human immunodeficiency virus (HIV) and advanced immunosuppression initiating antiretroviral therapy (ART) remain vulnerable to tuberculosis (TB) and early mortality. To improve early survival, isoniazid preventive therapy (IPT) or empiric TB treatment have been evaluated; however, their benefit on longer-term outcomes warrants investigation.MethodsWe present a 96-week preplanned secondary analysis among 850 ART-naive outpatients (≥13 years) enrolled in a multicountry, randomized trial of efavirenz-containing ART plus either 6-month IPT (n = 426) or empiric 4-drug TB treatment (n = 424). Inclusion criteria were CD4 count <50 cells/mm3 and no confirmed or probable TB. Death and incident TB were compared by strategy arm using the Kaplan-Meier method. The impact of self-reported adherence (calculated as the proportion of 100% adherence) was assessed using Cox-proportional hazards models.ResultsBy 96 weeks, 85 deaths and 63 TB events occurred. Kaplan-Meier estimated mortality (10.1% vs 10.5%; P = .86) and time-to-death (P = .77) did not differ by arm. Empiric had higher TB risk (6.1% vs 2.7%; risk difference, −3.4% [95% confidence interval, −6.2% to −0.6%]; P = .02) and shorter time to TB (P = .02) than IPT. Tuberculosis medication adherence lowered the hazards of death by ≥23% (P < .0001) in empiric and ≥20% (P < .035) in IPT and incident TB by ≥17% (P ≤ .0324) only in IPT.ConclusionsEmpiric TB treatment offered no longer-term advantage over IPT in our population with advanced immunosuppression initiating ART. High IPT adherence significantly lowered death and TB incidence through 96 weeks, emphasizing the benefit of ART plus IPT initiation and completion, in persons with advanced HIV living in high TB-burden, resource-limited settings.

Time Trend Analysis of Tuberculosis Treatment While Using Digital Adherence Technologies-An Individual Patient Data Meta-Analysis of Eleven Projects across Ten High Tuberculosis-Burden Countries.

Worldwide, non-adherence to tuberculosis (TB) treatment is problematic. Digital adherence technologies (DATs) offer a person-centered approach to support and monitor treatment. We explored adherence over time while using DATs. We conducted a meta-analysis on anonymized longitudinal adherence data for drug-susceptible (DS) TB (n = 4515) and drug-resistant (DR) TB (n = 473) populations from 11 DAT projects. Using Tobit regression, we assessed adherence for six months of treatment across sex, age, project enrolment phase, DAT-type, health care facility (HCF), and project. We found that DATs recorded high levels of adherence throughout treatment: 80% to 71% of DS-TB patients had ≥90% adherence in month 1 and 6, respectively, and 73% to 75% for DR-TB patients. Adherence increased between month 1 and 2 (DS-TB and DR-TB populations), then decreased (DS-TB). Males displayed lower adherence and steeper decreases than females (DS-TB). DS-TB patients aged 15–34 years compared to those >50 years displayed steeper decreases. Adherence was correlated within HCFs and differed between projects. TB treatment adherence decreased over time and differed between subgroups, suggesting that over time, some patients are at risk for non-adherence. The real-time monitoring of medication adherence using DATs provides opportunities for health care workers to identify patients who need greater levels of adherence support.

Pharmacovigilance of Antitubercular Therapy in Tuberculosis.

BackgroundAdverse drug reactions (ADRs) to tuberculosis (TB) drugs are a significant concern for medical professionals and health authorities. Adverse events due to drug-resistant TB (DRTB) treatment are among the most important reasons for treatment interruption.MethodsThis study was an observational study conducted among patients diagnosed with TB (pulmonary/extrapulmonary) receiving antitubercular therapy (ATT) (first line/second-line drugs) irrespective of their age and gender. The patients who consented to participate, registered under National Tuberculosis Elimination Program (NTEP), Puducherry, during the study period from March 2020 to December 2020, were included in the study. The demographic details were recorded from the treatment card, and the participants were provided a diary to note down the adverse events. They were asked to report over the phone or during their visits to treatment centers for the first two months. During the follow-up (irrespective of their treatment phase [intensive/continuation]), the patients were assessed for symptoms and signs of common adverse events. Any adverse events reported by the patient were also recorded and analyzed for causality and severity.ResultsDuring the study period, 219 patients were included, of which 92 patients (42%) presented with adverse events. Among the patients with ADRs, 56.5% were males and 43.5% were females. The females were found to be at more risk than males for adverse events with the OR 1.871 (95% CI: 1.066-3.284). GI system was the most common body system involved (39%), followed by musculoskeletal system and skin disorders (24% and 21%), respectively. Most of the adverse events were latent in nature (60.9%), followed by sub-acute onset (28.3%) and acute events (6.5%). Maximum adverse events reported were mild to moderate (71.8%), followed by severe (18.5%). Most of the events were probable in nature (41.3%), and the definite category was 25% as per Naranjo’s probability scale.ConclusionThe current study shows the frequency of adverse events in patients receiving antitubercular drug therapy. The females were found to be at more risk than males for adverse events. It was found that the GI system was most affected as a known reaction to TB therapy followed by the musculoskeletal system. With more effective pharmacovigilance measures implementation, the adverse events being one of the factors for treatment interruption can be overcome.

POSA416 Treatment Adherence As a Cost Determinant in Patients with Tuberculosis

Poor adherence to anti-tuberculosis treatment is an essential obstacle to tuberculosis (TB) control. It aims to observe all-cause/TB-related costs by TB treatment adherence and explore the association between medication adherence and medical cost in patients with TB in South Korea.