ABSTRACT
A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , HIV Infections , Humans , Brazil , Pharmacovigilance , Adverse Drug Reaction Reporting SystemsABSTRACT
Combination Antiretroviral Therapy (cART) in single-tablet regimens (STR) is a simplificationâ¯strategy that can potentially improve medication adherence andâ¯clinicalâ¯outcomes. We conducted a retrospective cohort study of 1206 patients using efavirenz, tenofovir and lamivudine in multiple-tablet regimen who switched to the STR containing the same active ingredients in a southeast metropolis in Brazil. We measured adherence using the proportion of days covered (PDC≥95%) and evaluated this outcome before and after the switch using paired non-parametric statistics. Additionally, we used group-based trajectory modeling to identify adherence patterns to cART for each period and evaluate the migration behavior of patients between the trajectory groups. We observed a 14% increase in the proportion of adherent patients after switching to STR and a 6.2% increase in the proportion of patients with CD4 count>500 cells/µl (p < 0.001), without changes in viral load outcomes. We identified four adherence trajectories in each period. Most patients (60%, n = 722) migrated towards a group with better adherence trajectory or remained in the trajectory group with the highest probability of adherence after the switch. Our findings suggest that the implementation of the STR had a positive impact on adherence and CD4 count. This may potentially improve virologic outcomes later on treatment.
