Adverse effects profile of multidrug-resistant tuberculosis treatment in a South African outpatient clinic

Background: Highly active antiretroviral therapy (HAART) and drugs that are used to treat multidrug-resistant tuberculosis have potentially overlapping adverse effects. Few South African studies have documented adverse effects in the multidrugresistant tuberculosis population. This study examined the adverse effects profile in a sample of the outpatient population at the King George V Hospital Multidrug-Resistant Tuberculosis Clinic in Durban, KwaZulu-Natal. Method: The method was an anonymous, retrospective record review of 350 patients with multidrug-resistant tuberculosis, who were attending the King George V Hospital Multidrug-Resistant Tuberculosis Clinic (2010-2011). Adverse effect profiles in patients with multidrug-resistant tuberculosis only, and those who were co-infected with the human immunodeficiency virus (HIV) who were on and not on HAART, were documented and analysed. Results: Adverse events were recorded for 80.6% of patients. These included hearing loss (28.7%); peripheral neuropathy (23.2%); diarrhoea, nausea and vomiting (20.5%); arthralgia (15.9%); rashes and dermatological effects (excluding Stevens-Johnson syndrome) (14%); abdominal pain and dyspepsia (10.3%); and psychoses and confusion (8.3%). In this study population, 72.6% of patients were HIV positive, and 85% were concomitantly on HAART and multidrug-resistant tuberculosis treatment. Adverse events were significantly more common in patients who were HIV positive than in patients who were HIV negative with regard to peripheral neuropathy (p-value 0.001), psychosis and confusion (p-value = 0.04), hearing loss (p-value = 0.047), and thyroid disease (p-value 0.001). The use of HAART in patients who were HIV positive and on multidrug-resistant tuberculosis treatment was not significantly associated with the overall incidence of adverse events (p-value = 0.432). However, the calculated likelihood ratios of several individual adverse events occurring in these patients was greater. Patients who were HIV negative experienced the least adverse ...