Patient Determinants and Effects on Adherence of Adverse Drug Reactions to Tuberculosis Treatment: A Prospective Cohort Analysis.

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

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Affiliated Institutions:  Department of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts, USA. Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA. Mental Health, Alcohol, Substance Use & Tobacco Research Unit, South African Medical Research Council, Cape Town, South Africa. Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA. Section of Infectious Diseases, Boston University Chobanian and Avedisian School of Medicine and Boston Medical Center, Boston, Massachusetts, USA. Brewelskloof Hospital, Worcester, South Africa. SAMRC Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Stellenbosch University, Cape Town, South Africa. Departments of Epidemiology, Biostatistics, Global Health and Medicine, Boston University, Boston, Massachusetts, USA.

Abstract summary 

Adverse drug reactions (ADRs) to tuberculosis (TB) medications make treatment completion challenging. We investigated the impact of alcohol, human immunodeficiency virus (HIV), and other patient determinants on ADRs and treatment adherence.We administered monthly ADR questionnaires to participants with TB in Worcester, South Africa. Adherence was defined as the proportion of observed doses on days when directly observed therapy was attempted. We used regression modeling to identify associations between age, sex, HIV status, alcohol, and smoked substance use with ADRs and adherence.Of 286 participants, 70 (24.5%) had moderate alcohol use (phosphatidylethanol [PEth], 20-200 ng/mL), 81 (28.3%) had heavy alcohol use (PEth, >200 ng/mL), and 81 (28.3%) had HIV. A total of 156 (54.5%) reported ≥1 ADR, with maximum severity of moderate (75.6%) or mild (22.4%). Alcohol use and HIV were not associated with ADRs. The presence of ≥1 comorbidity compared with none was associated with a 46% increase in the risk of ADRs (P = .01). Nearly 70% of participants had ≥80% adherence. Among participants with moderate or severe ADRs, HIV with CD4 count <200 cells/µL compared with no HIV (rate ratio = 1.71, P = .01), moderate or severe alcohol use compared with low (rate ratio = 1.55, P = .01 and rate ratio = 1.69, P = .01), and smoked substance use compared with none (rate ratio = 1.37, P = .04) were associated with increased missed doses.Half of participants on TB treatment experienced ADRs, but most remained adherent to treatment. Among participants with moderate or severe ADRs, those with poorly controlled HIV, alcohol use, or smoked substance use had lower adherence.

Authors & Co-authors:  Tzelios Christine A CA Malatesta Samantha S Carney Tara T White Laura F LF Weber Sarah E SE Thomson Sarah S Theron Danie D Myers Bronwyn B Parry Charles D H CDH Warren Robin M RM Horsburgh C Robert CR Farhat Maha R MR Jacobson Karen R KR

Study Outcome 

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Statistics
Citations : 
Authors :  13
Identifiers
Doi : ciae642
SSN : 1537-6591
Study Population
Male,Female
Mesh Terms
Other Terms
Adverse drug reactions;Alcohol;HIV;Treatment adherence;Tuberculosis
Study Design
Cohort Study
Study Approach
Country of Study
South Africa
Publication Country
United States