LAUSR

BACKGROUND HIV is one of the most important risk factors for TB-related morbidity and mortality. Isoniazid preventive therapy (IPT) is recommended to prevent latent TB reactivation in HIV patients. However, due to multiple therapies and comorbidities these patients are predisposed to adverse drug reactions (ADRs) which lead to increased morbidity and mortality. The aim of this study was to determine the prevalence and associated factors of suspected IPT-linked ADRs in HIV-positive patients using IPT. METHODS A cross-sectional study was conducted between February and March 2020 at three regional referral hospitals (RRHs) in central Uganda. We sampled 660 HIV-positive patients aged 10 years and older who received IPT between July and December 2019 inclusive. Patients were interviewed using a pre-tested structured questionnaire and their treatment records were reviewed. A modified poisson regression model with clustered robust standard errors was used to identify factors associated with suspected IPT-linked ADRs. RESULTS The prevalence of the suspected ADRs was 51 % (334/660; 95% CI: 18% - 83%). Patients' self-reported 7-fold more suspected ADRs than were documented by the Health Care Workers (HCWs). Musculoskeletal symptoms were the most frequently experienced reaction (14%) followed by dizziness (13%) and peripheral neuropathy (11%). Serious suspected ADRs were experienced by 12 % of the study participants; the most common were hepatotoxicity (26%), dizziness (23%) and neuropathy (17%). Female sex (aPR: 0.92, 95% CI = 0.88-0.95), study site (aPR: 1.09, 95% CI = 1.09-1.18), level of education (aPR: 0.94, 95% CI = 0.94-0.99) and history of TB (aPR: 0.93, 95% CI = 0.87-0.99), good IPT adherence (aPR: 1.16, 95% CI = 1.05-1.29) and use of protease inhibitor (PI)-based ART (aPR: 1.01, 95% CI = 1.00-1.02) were significantly associated with suspected IPT-linked ADRs. CONCLUSION The prevalence of suspected IPT-linked ADRs is high and hepatotoxicity is the most commonly reported serious suspected ADR. Patients self-reported more suspected ADRs than were documented by HCWs. Patient engagement could improve ADR detection and potentially strengthen the pharmacovigilance system. High ADR-risk patients ought to be monitored regularly to enable early detection and management.