Serious Treatment Related Adverse Drug Reactions amongst Anti-Retroviral Naïve MDR-TB Patients

Martha Van Der Walt,Jason Farley,Johanna Lancaster,Ronel Odendaal,Jeanne Garcia Davis,Karen Shean,Madhukar Pai

doi:10.1371/journal.pone.0058817

Martha Van Der Walt, Jason Farley + Show 5 more

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https://doi.org/10.1371/journal.pone.0058817

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Abstract

BackgroundGlobally treatment outcomes for multidrug-resistant Mycobacterium tuberculosis (MDR-TB) remain poor and this is compounded by high drug toxicity. Little is known about the influence of adverse drug reactions (ADRs) on treatment outcomes in South Africa.MethodsWe evaluated the impact of severe ADRs among a prospective cohort of MDR-TB patients in South Africa (2000–2004). The HIV-infected study participants were anti-retroviral naïve.ResultsOf 2,079 patients enrolled, 1,390 (66.8%) were included in this analysis based on known HIV test results (39.1% HIV-infected). At least one severe ADR was reported in 83 (6.9%) patients with ototoxicity being the most frequent ADR experienced (38.9%).ConclusionsWe found that being HIV-infected but antiretroviral naïve did not increase occurrence of SADRs in patients on second-line anti-tuberculosis drugs. Early screening and proactive management of ADRs in this patient population is essential, especially given the rollout of decentralized care and the potential for overlapping toxicity of concomitant MDR-TB and HIV treatment.

Highlights

One of the challenges facing patients treated with second-line drugs (SLD) is the toxic nature of these drugs [1]
The number of SADRs experienced by patients was higher in human immunodeficiency virus (HIV)-uninfected patients 53.7% (58/108) compared to 46.3% (50/108) in the HIVinfected sub-group
There were higher rates (91.4% vs. 84.0%) of bilateral disease recorded for patients with SADRs compared to those with no reported SADRs (p = 0.189)

Summary

Introduction

One of the challenges facing patients treated with second-line drugs (SLD) is the toxic nature of these drugs [1]. This is exacerbated in settings with high co-infection with the human immunodeficiency virus (HIV) due to the potential overlap and additive drug toxicity of anti-retroviral treatment (ART) [2,3,4]. Adverse drug reactions (ADRs) are described in many MDR-TB cohort studies with varying profiles between different settings [5,6,7,8] These studies provide limited insight into the severity of ADRs experienced and include relatively small numbers of patients with HIV co-infection. Little is known about the influence of adverse drug reactions (ADRs) on treatment outcomes in South Africa

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Results

Conclusion