Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná

The aim of this study was to investigate adverse reactions to Dolutegravir, a drug recently made available by the Unified Health System (SUS) for treating HIV infections. The frequency, severity and sex distribution of adverse reactions to Dolutegravir were identified over the first 18 months of its availability in users in the state of Paraná. Information was obtained through the pharmacovigilance questionnaire prepared by the Ministry of Health, accessed through the Logistics Control System for Medicines(SICLOM). During the study period, dolutegravirwas dispensed to 9,865 patients in the state. However, 9,207 users (93.3%) answered the pharmacovigilance questionnaire. Among them, 1.75% reported 279 adverse reactions. This population was composed mainly of male people (69.57%), in the ratio of 2.29 men for each woman, white (67.08%), aged between 20 and 29 years (26.71%), single (45.34%) and with education between 8 and 11 years of study (41.61%). Gastrointestinal (36.92%) and nervous system (14.34%) disorders were the most prevalent. 77.78% adverse reactions were considered non-serious by users. It can be concluded that dolutegravirhad a low prevalence of adverse reactions in users in the state of Paraná, demonstrating to be safe for use by the population in therapy against HIV, in accordance with clinical trials.

Estimativa de adesão ao medicamento antirretroviral coformulado 3 em 1 / Estimation of adhesion to antiretroviral coformulated 3 in 1

INTRODUÇÃO: Com o propósito de estimular a adesão aos antirretrovirais e minimizar os riscos de resistência a estes medicamentos, o Ministério da Saúde (MS) passou a disponibilizar o medicamento 3 em 1, uma coformulação de tenofovir (300 mg), lamivudina (300 mg) e efavirenz (600 mg), o qual inova com uso de um único comprimido diário. OBJETIVO: Estimar a adesão aos medicamentos antirretrovirais da primeira linha de tratamento contra o HIV. MÉTODOS: Verificação da frequência dos retornos mensais de pacientes a um dispensário dos medicamentos antirretrovirais fornecidos pelo MS. RESULTADOS: Os pacientes em tratamento com o medicamento 3 em 1 foram mais assíduos e retornaram com frequência 65% maior ao dispensário. CONCLUSÃO: Com a introdução do 3 em 1 confirma-se que a simplificação de esquemas terapêuticos é uma medida que facilita a adesão ao tratamento. Isso gera a expectativa de manter por mais tempo os indivíduos em uso da primeira linha de tratamento, retardando a necessidade de recorrer a outras linhas terapêuticas mais onerosas, com maior número de medicamentos e riscos associados.

INTRODUCTION: In order to stimulate adherence to antiretrovirals and minimize the risks of viral mutations and resistance to these drugs, the Ministry of Health (MS) started providing the 3-in-1 drug, a co-formulation of tenofovir (300 mg), lamivudine (300 mg) and efavirenz (600 mg), which innovates by the use of a single daily tablet. OBJECTIVE: Estimating the adherence to antiretroviral drugs in the first line of HIV treatment. METHODS: Verification of the frequency of monthly patient returns to a dispensary of antiretroviral drugs provided by MS. RESULTS: Patients treated with the 3-in-1 medication were more assiduous and returned 65% higher at the dispensary. CONCLUSION: The introduction of 3-in-1 confirms that the simplification of therapeutic schemes is a measure that facilitates adherence to treatment. This generates the expectation of keeping individuals in the first line of treatment longer, delaying the need to resort to other more expensive therapeutic lines, with a higher number of drugs and associated risks.