Marco Lorío1, Jonathan Colasanti2, Sumaya Moreira3, Gamaliel Gutierrez4, Carlos Quant3. 1. Internal Medicine, University of Miami, Miami, FL, USA Division of Infectious Diseases, Hospital Dr. Roberto Calderón Gutiérrez, Managua, Nicaragua mloriodr@gmail.com. 2. Division of Infectious Diseases, Emory University, Atlanta, GA, USA. 3. Division of Infectious Diseases, Hospital Dr. Roberto Calderón Gutiérrez, Managua, Nicaragua. 4. Sustainable Sciences Institute of Nicaragua, Managua, Nicaragua.
Abstract
OBJECTIVE: Adverse drug reactions (ADRs) to antiretroviral therapy (ART) are an important cause of hospitalization, treatment discontinuation, and regimen changes in both developed and developing countries. This study is the first to examine and understand ADRs in HIV-infected patients in Nicaragua. METHODS: A retrospective descriptive study was conducted from May 2010 to March 2011, in a cohort of HIV-infected patients receiving ART at the largest public hospital in Managua, Nicaragua. Patients were identified based on ADRs reporting on a standardized antiretroviral pharmacotherapy form. Subsequently, chart reviews of these patients were performed in order to document the specific ADRs. RESULTS: Six hundred ninety-two patients on ART were included. The incidence of ADRs was 6.4% (95% confidence interval [CI] 4.5-8.2). Females demonstrated a higher incidence, that is, 10.2% (95% CI 5.3-15.1, P = .020). Patients treated with combinations of zidovudine (ZDV)/lamivudine (3TC) and emtricitabine (FTC)/tenofovir (TDF) had fewer ADRs (P < .01) than those using other combinations. Five patients were hospitalized or had a prolonged hospitalization secondary to ADRs, with no mortality attributed to ADR. The most common manifestations of ADRs were central nervous system (20 of 44), gastrointestinal (12 of 44), and dermatologic (8 of 44) reactions. Adverse drug reactions were classified as "likely ADRs" (25 of 44) and "possible ADRs" (19 of 44). No ADRs were preventable. CONCLUSION: Adverse drug reactions most frequently affected the central nervous system. No ADR was life threatening. The frequency of ADRs in this Nicaraguan patient population was less than that reported from other studies in resource-limited settings.
OBJECTIVE: Adverse drug reactions (ADRs) to antiretroviral therapy (ART) are an important cause of hospitalization, treatment discontinuation, and regimen changes in both developed and developing countries. This study is the first to examine and understand ADRs in HIV-infectedpatients in Nicaragua. METHODS: A retrospective descriptive study was conducted from May 2010 to March 2011, in a cohort of HIV-infectedpatients receiving ART at the largest public hospital in Managua, Nicaragua. Patients were identified based on ADRs reporting on a standardized antiretroviral pharmacotherapy form. Subsequently, chart reviews of these patients were performed in order to document the specific ADRs. RESULTS: Six hundred ninety-two patients on ART were included. The incidence of ADRs was 6.4% (95% confidence interval [CI] 4.5-8.2). Females demonstrated a higher incidence, that is, 10.2% (95% CI 5.3-15.1, P = .020). Patients treated with combinations of zidovudine (ZDV)/lamivudine (3TC) and emtricitabine (FTC)/tenofovir (TDF) had fewer ADRs (P < .01) than those using other combinations. Five patients were hospitalized or had a prolonged hospitalization secondary to ADRs, with no mortality attributed to ADR. The most common manifestations of ADRs were central nervous system (20 of 44), gastrointestinal (12 of 44), and dermatologic (8 of 44) reactions. Adverse drug reactions were classified as "likely ADRs" (25 of 44) and "possible ADRs" (19 of 44). No ADRs were preventable. CONCLUSION: Adverse drug reactions most frequently affected the central nervous system. No ADR was life threatening. The frequency of ADRs in this Nicaraguan patient population was less than that reported from other studies in resource-limited settings.
Authors: Santiago Avila-Ríos; Claudia García-Morales; Margarita Matías-Florentino; Daniela Tapia-Trejo; Bismarck F Hernández-Álvarez; Sumaya E Moreira-López; Carlos J Quant-Durán; Guillermo Porras-Cortés; Gustavo Reyes-Terán Journal: PLoS One Date: 2016-10-13 Impact factor: 3.240