Abstract
Background: Anti-retroviral therapy (ART) is of great value for the survival of patients living with human immunodeficiency virus (HIV). Like most chronically administered drugs, ART has documented adverse effect and toxicities. These effects range from mild to fatal, from short to long term, but little is known about adverse drug reactions (ADRs) in women living with HIV / AIDS. Objective: To identify and compare the occurrence of antiretroviral adverse reactions in women living with HIV / AIDS. Identify strategies to minimize and manage short-term and long-term antiretroviral adverse reactions in women living with HIV / AIDS in health systems contexts. Method: For the systematic review of prevalence and comparative assessment of ADR, studies that examine the effects of six classes of antiretroviral drugs (contained in the protocols and therapeutic guidelines of the Brazilian Ministry of Health) administered to HIV-infected women will be included. Primary safety outcomes include: number of severe ADR, non-adherence or cessation of ART due to ADR, number of hospitalizations, number of ADR, congenital malformation (general or specific). Secondary include: cardiovascular events, neurological events, lipodystrophies, dyslipidemias, allergies and skin, musculoskeletal, gastrointestinal, hepatic, renal and death disorders. We will include randomized controlled trials. No limitations will be imposed on publication status, length of follow-up, study driving time, and language. Comprehensive bibliographic searches will be conducted in major electronic databases, including MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL). Portals for ECR records will also be consulted (Clinicaltrials.gov, Rebec and WHO). The gray literature will be identified through research dissertation databases, Upsala Monitoring registries, and conference abstracts. Two team members will independently select all citations, full text articles, and abstracts; conflicts will be resolved through discussion. The risk of bias and methodological quality will be assessed using appropriate tools (for example, the Cochrane Collaboration tool for assessing bias risk, the Newcastle-Ottawa Scale and the McMaster Damage Quality Scale). If possible and appropriate, we will conduct meta-analyzes meta-analysis models for the synthesis of prevalence results, such as the double-arcosene-adjusted weighting, provided their limitations are safeguarded. The network meta-analysis will be considered for the results with the largest number of available treatment comparisons that meet the assumptions of the network meta-analysis (eg., consistency of evidence between direct and indirect data and low statistical heterogeneity among included studies). The overall quality of evidence for each outcome will be determined using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) recommendations hierarchy system. Expected results: We anticipate that the reviews will clarify the current scope and quality of evidence regarding the prevalence of ADR in women living with HIV / AIDS. In addition, comparative evidence of ADR risks compared to ART will be produced through a network meta-analysis. (AU)