Association of hearing loss in the patients with treated with lamivudine: a systematic review protocol
Background: Hearing loss has been reported with lamivudine therapy. The World Health Organization (WHO) international database of suspected adverse drug reactions (Vigibase) prioritised clinical review of lamivudine and hearing loss in 2015. This manuscript provides the details of research protocol for a systematic review of association of lamivudine with hearing loss.
Methods: English-language publications that assess hearing loss within patients who are receiving lamivudine therapy will be included. All study types like clinical trial designs, case-control study, cohort study, retrospective study, case-series or a case report will be included. Preclinical studies, studies enrolling patients with known differential diagnosis such as presbycusis etc will be excluded. Electronic databases (PubMed, Cochrane reviews, Embase and Google scholar), international clinical trials registry, clinicaltrials.gov and pharmaceutical company clinical study registries will be searched for key words related to lamivudine and hearing loss. After a thorough electronic/manual search of manuscript they will undergo a screening process and selected articles will be assessed for risk of bias using online ROBINS-I tool. We will explore outcomes as an observational systematic review.
Conclusions: This review will provide detailed benefit-risk analysis of lamivudine with respect to hearing loss in patients with chronic conditions such as Human immunodeficiency virus (HIV) and Hepatitis B virus (HBV) infection.
Trial Registration: PROSPERO registration number is CRD42018112205.0.001.
Lamivudine (Epivir) US FDA label. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020564s37_020596s036lbl.pdf. Accessed on 24 April, 2020.
Lamivudine (Epivir HBV) US FDA label. Available at: https://www.accessdata.fda.gov/drugsatfda_ docs/label/2013/021003s015,021004s015lbl.pdf. Accessed on 24 April, 2020.
Bankaitis AE, Schountz T. HIV-related ototoxicity. In: Seminars in Hearing. Thieme Medical Publishers, Inc. 1998;19(2):155-63.
Kohan D, Rothstein SG, Cohen N. Otologic disease in patients with acquired immunodeficiency syndrome. Ann Otol Rhinol Laryngol. 1988; 97(6):636-40.
Michaels L, Soucek S, Liang J. The ear in the acquired immunodeficiency syndrome: I. Temporal bone histopathologic study. Am J Otol. 1994; 15(4):515-22.
Thein P, Kalinec PM, Park C, Kalinec F. In vitro assessment of antiretroviral drugs demonstrates potential for ototoxicity. Hear Res. 2014;310:27-35.
Araújo ES, Zucki F, Corteletti LC, Lopes AC, Feniman MR, Alvarenga KF et al Reversible bilateral ototoxicity in a patient with chronic hepatitis B during peginterferon alpha-2a treatment. Indian J Pharmacol. 2015;47(1):121-2.
Campanini A, Marani M, Mastroianni A, Cancellieri C, Vicini C. Human immunodeficiency virus infection: personal experience in changes in head and neck manifestations due to recent antiretroviral therapies. Acta Otorhinolaryngol Ital. 2005;25:30-5.
Eda AS, Zucki F, Corteletti LC, Lopes AC, Feniman MR, Alvarenga Kde F. Hearing loss and acquired immune deficiency syndrome: systematic review. J Soc Bras Fonoaudiol. 2012;24(2):188-92.
WHO Pharmaceuticals newsletter. 2018;(3). http://apps.who.int/medicinedocs/documents/s23169en/s23169en.pdf. Accessed on 12 April, 2020.
Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A (deceased), Petticrew M, et al. On the behalf of PRISMA-P Group. Preferred reporting items for systematic review andmeta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.
Moher D, Shamseer L, Clarke M, Ghersi D, Liberti A (deceased), Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 4. 2015;1.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009;6(7):e1000100.
Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group: Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. BMJ. 2009;339:b2535.
Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000;283:2008-12.
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary?. Controlled Clinical Trials. 2017;(1):1-12.
Sterne JAC, Hernán MA, McAleenan A, Reeves BC, Higgins JPT. Assessing risk of bias in a non-randomized study. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0. Cochrane. 2019. Available at: www.training.cochrane.org/ handbook. Accessed on 10 March, 2020.
Sterne JAC, Hernan M, Reeves BC, Savovic J, Berkman ND, Viswanathan M et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
ROBINS-1 tool. 2016. Available at: https://www. riskofbias.info/welcome/home/current-version-of-robins-i/robins-i-tool-2016. Accessed on 21 April, 2020.
No authors listed. Halpern HS, Douglas MJ (editors). Appendix: Jadad Scale for Reporting Randomized Controlled Trials Blackwell Publishing Ltd; 2005: 237-238.