Serious treatment related adverse drug reactions amongst anti-retroviral naïve MDR-TB patients

PLoS One. 2013;8(4):e58817. doi: 10.1371/journal.pone.0058817. Epub 2013 Apr 3.

Abstract

Background: Globally 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.

Methods: We 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.

Results: Of 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%).

Conclusions: We 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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antitubercular Agents / adverse effects*
  • Antitubercular Agents / therapeutic use
  • Coinfection
  • Cycloserine / adverse effects*
  • Cycloserine / therapeutic use
  • Drug Resistance, Multiple, Bacterial
  • Female
  • HIV Infections / complications*
  • HIV Infections / drug therapy
  • Hearing Loss / chemically induced
  • Humans
  • Isoxazoles / adverse effects*
  • Isoxazoles / therapeutic use
  • Male
  • Middle Aged
  • Mycobacterium tuberculosis
  • Ofloxacin / adverse effects*
  • Ofloxacin / therapeutic use
  • Oxazolidinones / adverse effects*
  • Oxazolidinones / therapeutic use
  • Prospective Studies
  • Psychoses, Substance-Induced / etiology
  • South Africa
  • Treatment Outcome
  • Tuberculosis, Multidrug-Resistant / complications
  • Tuberculosis, Multidrug-Resistant / drug therapy*
  • Tuberculosis, Pulmonary / complications
  • Tuberculosis, Pulmonary / drug therapy*

Substances

  • Antitubercular Agents
  • Isoxazoles
  • Oxazolidinones
  • terizidone
  • Cycloserine
  • Ofloxacin

Grants and funding

National pilot, DOTS-Plus project supported by the TB directorate, Department of Health in South Africa. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.