Prevalence and factors associated with reported adverse-events among patients on multi-drug-resistant tuberculosis treatment in two referral hospitals in Uganda – BMC Infectious Diseases

Multi-drug-resistant tuberculosis (MDR-TB) treatment involves toxic drugs that cause adverse events (AEs), which are life-threatening and may lead to death if not well managed. In Uganda, the prevalence of MDR-TB is increasingly high, and about 95% of the patients are on treatment. However, little is known about the prevalence of AEs among patients on MDR-TB medicines. We therefore estimated the prevalence of reported adverse events (AEs) of MDR-TB drugs and factors associated with AEs in two health facilities in Uganda.

Methods

A retrospective cohort study of MDR-TB was conducted among patients enrolled at Mulago National Referral and Mbarara Regional Referral hospitals in Uganda. Medical records of MDR-TB patients enrolled between January 2015 and December 2020 were reviewed. Data on AEs, which were defined as irritative reactions to MDR-TB drugs, were extracted and analyzed. To describe reported AEs, descriptive statistics were computed. A modified Poisson regression analysis was used to determine factors associated with reported AEs.

Results

Overall, 369 (43.1%) of 856 patients had AEs, and 145 (17%) of 856 had more than one. Joint pain (244/369, or 66%), hearing loss (75/369, or 20%), and vomiting (58/369, or 16%) were the most frequently reported effects. Patients started on the 24-month regimen (adj. PR = 1.4, 95%; 1.07, 1.76) and individualized regimens (adj. PR = 1.5, 95%; 1.11, 1.93) were more likely to suffer from AEs. Lack of transport for clinical monitoring (adj. PR = 1.9, 95%; 1.21, 3.11); alcohol consumption (adj. PR = 1.2, 95%; 1.05, 1.43); and receipt of directly observed therapy from peripheral health facilities (adj. PR = 1.6, 95%; 1.10, 2.41) were significantly associated with experiencing AEs. However, patients who received food supplies (adj. PR = 0.61, 95%; 0.51, 0.71) were less likely to suffer from AEs.

Conclusion

The frequency of adverse events reported by MDR-TB patients is considerably high, with joint pain being the most common. Interventions such as the provision of food supplies, transportation, and consistent counseling on alcohol consumption to patients at initiation treatment facilities may contribute to a reduction in the rate of occurrence of AEs.

Background

in result permanent disabilities like hearing loss. It is important to understand and know the number of people affected by AEs of second-line anti – TB treatment. However, there is relatively limited research about prevalence and incidence of AEs related to MDR – TB treatment, and most of the studies have focused on the factors associated with the AEs. As a result, the purpose of this study was to determine and describe the prevalence of reported AEs of second-line drugs, as well as the factors associated with them.

Methods

Study design

The study was a retrospective cohort study that employed quantitative research methods among MDR-TB patients receiving or who received second line anti-TB drugs. This involved reviewing the records of MDR-TB patients enrolled on second line TB drugs. Such records included the drug-resistant management information system (DR-TB MIS) that has most of the patient information, and the patients’ files which are kept at the initiation facilities in locked cabinets.

Study setting

The study was conducted in Mulago national referral hospital (NRH) (TB ward, that is, wards 5 and 6) and Mbarara regional referral hospital (RRH) (TB ward) in Uganda. Mulago NRH is the largest public hospital in Uganda. It’s located on Mulago Hill in the northern part of Kampala, less than five kilometers (km) from Kampala’s central business district. The MDR-TB site in Mulago NRH serves the central region that includes districts such as Mpigi, Luwero, Kayunga, Buikwe, Kampala divisions, and Wakiso. It leads the national MDR-TB panel and has the greatest number of patients initiated on treatment. Mbarara RRH is located in Mbarara district, Ankole sub-region within the central business district by road, it is approximately 268 km south-west of Kampala, Uganda’s capital city. The hospital has an MDR-TB site that serves districts such as Mbarara, Isingiro, Bushenyi, Kiruhura, Ibanda, Ntugamo, Sheema, and Mitooma. The hospital serves a population of over four million people and has a bed capacity of over 350 beds. Both facilities are responsible for coordinating and training follow up facilities (FUFs) in administering DOTs to MDR-TB patients in their respective regions. Both Mulago NRH and Mbarara RRH were selected because of the great numbers of MDR-TB patients that are seen at these two facilities. The facilities had updated records of their MDR-TB patients compared to other MDR-TB facilities.

Study Population

Most of the MDR-TB patients were new cases 454 (53%) and mostly co-infected with HIV 489 (57.1%). The majority of the patients (457/53.4%) were started on a long-term regimen (LTR), and the majority of them (744/86.1%) received their treatment from follow-up facilities (FUFs). The majority of them 505 (59%) had attended their clinical visits, 690 (80.6%) had received food supplies, and 767 (89.6%) had received transportation. The majority of them 565 (66%) stayed on treatment, and only 287 (33.5%) drank alcohol while on treatment. As seen in Table 1.

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