Screening for Possible Nevirapine Induced Ototoxicity in Neonates, when Administered as Part of the Prevention of Motherto-Child Transmission at Dr. George Mukhari Academic Hospital, Gauteng, South Africa Programme: A Pilot Study - Abstract
Background: Drugs that are included in treatment regimens, including prevention programmes for the Human Immunodeficiency Virus (HIV), may place patients at risk of ototoxicity due to their side-effect profiles. Ototoxicity is part of this side-effect profile but is comparatively understudied in HIV-positive patients receiving antiretroviral (ARVs) agents. Patient safety has been identified as a part of the National Core Standards from the National Department of Health. As part of this strategy and due to the limited information available on the possible ototoxicity of nevirapine (NVP) as part of the prevention of mother-to-child transmission (PMTCT) in neonates, the study was conducted.
Method: The study aimed to determine if there was a possible association between neonates receiving NVP as part of PMTCT and ototoxicity at Dr George Mukhari Academic Hospital (DGMAH). A descriptive, quantitative cohort study was conducted prospectively. Participants were allocated purposively to either an experimental (received NVP) or control (NVP not received) group. The research team consisted of pharmacists, who performed the screening for eligible participants, and audiologists, who conducted all audiological assessments.
Results: A total of 165 participants were enrolled over a period of ten months; however, only 40 participants (24%) completed the study. The two study arms were comparable in terms of demographic variables. All of the participants that received NVP (n=20) were adherent. Both study arms (n=40) failed to pass the distortion product otoacoustic emission (DPOAE) assessments at baseline (day 0). There were no statistically significant differences between the two study arms in terms of the DPOAE results (p>0.05) tested at both two and six weeks.
Conclusion: Contrary to available literature, the results from this study showed that NVP administered as part of PMTCT was not associated with hearing loss in neonates who participated in this study. Future monitoring is strongly suggested as possible insults to the cochlea cannot be excluded at such an early age.