Dolutegravir Reported Adverse Drug Reactions: A Systematic Review Protocol

Abstract Background: Until recently, the first-line regimen for the management of Human Immunodeficiency Virus (HIV) was Tenofovir (TDF)-Emtricitabine (FTC) and Efavirenz (EFV). However, the use of EFV has now been limited due to adverse neurosensory effects and a low genetic barrier to resistance. This regimen has been replaced by the Dolutegravir (DTG)-based regimen since DTG has a high genetic barrier to resistance. Studies have reported a higher risk of Immune Reconstitution Inflammatory Syndrome (IRIS), weight gain, insomnia, and neural tube defects amongst people who received DTG. This review aims to assess the adverse drug reaction (ADR) profile of Dolutegravir by identifying and classifying Dolutegravir-associated adverse drug reactions.Methods: Studies will be identified from an electronic database search. Studies that are potentially eligible will be selected through screening. Two team members will independently screen all citations, full-text articles, and abstract data; conflicts will be resolved through discussion. The (PRISMA-P) flow diagram that outlines all phases of screening and reasons for exclusion will be used during the selection process. After the selection of the final study sample, a data extraction form will be used as a collection tool. The data will be entered into Cochrane Collaboration Review Manager (RevMan 5.2) for storage and management. All the evidence gathered will be assessed for bias through the use of the Risk of Bias tool RoB 2.0 of Cochrane Collaboration. Reported ADRs will then be classified. We will also provide data for the effect of different demographic factors on ADRs as well as the effects of co-administration of DTG with other drugs on ADRs. We will additionally provide information on how Dolutegravir use in different regimens affects the ADRs. Results from the review will be summarized quantitatively through meta-analysis. A forest plot will be used to present results from the meta-analysis. Conclusion: A review of existing studies will aid in establishing the safety profile of this drug. This review will make significant contributions to healthcare practice. It will aid in improving prescribers' and dispensers’ knowledge of the drug. Additionally, it will also aid in patient education of the potential ADRs to DTG.Systematic review registration DOI: doi.org/10.17605/OSF.IO/Z9YAF