RESUMO
PURPOSE: To evaluate the real-world rates of non-adherence and non-persistence to antiretroviral therapy (ART) among treatment-naïve adult patients with HIV after a 12-month follow-up period in Belgium. METHODS: A retrospective analysis of longitudinal pharmacy claims was conducted using the Pharmanet database from January 1, 2018, to December 31, 2021. Non-adherence was assessed over 12 months and reported as the proportion of days covered below the 80% threshold. Non-persistence was defined as the first 90-day gap in treatment between the two types of ART dispensed. Poisson regression with robust standard error and Cox proportional hazard models were used to assess the factors associated with non-adherence and non-persistence, respectively. RESULTS: Overall, 2999 patients were initiated on ART between 2018 and 2021. After a 12-month follow-up, the proportions of non-adherence and non-persistence were 35.6% and 15.9%, respectively in 2018, and decreased to 18.7% and 6.8%, respectively in 2021. Non-adherence was higher among women, Brussels residents, and those receiving multiple-tablet regimens (MTRs). Similarly, the prevalence of non-persistence was higher among women and MTR recipients. CONCLUSION: Among treatment-naïve adults with HIV in Belgium, non-adherence, and non-persistence to ART showed improvement over the study period but remained at high levels. Disparities were observed by sex and between geographical regions. Prioritizing strategies targeting women in Brussels and facilitating the transition from MTRs to single-tablet regimens should be emphasized optimize adherence to ART in Belgium.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Adesão à Medicação , Humanos , Bélgica/epidemiologia , Feminino , Masculino , Adesão à Medicação/estatística & dados numéricos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Adulto , Estudos Retrospectivos , Pessoa de Meia-Idade , Fármacos Anti-HIV/uso terapêutico , Fármacos Anti-HIV/administração & dosagem , Bases de Dados Factuais , Adulto Jovem , Bases de Dados de Produtos Farmacêuticos/estatística & dados numéricos , Seguimentos , Adolescente , Estudos LongitudinaisRESUMO
The Objective of this study was to examine change over time of prevalence of chronic diseases medications (CDM) prescriptions among People living with HIV (PLWH) in Belgium, using Pharmanet database from 2018 to 2021. We identified 13,570, 14,175, 14,588 and 14,813 PLWH in 2018, 2019, 2020 and 2021, respectively. Prescriptions of cardiovascular diseases (CVD) medications (31.7-37.2%) and antidiabetics (7.4-9.0%), increased significantly (p for trend < 0.001 for all), while the prescription of neurological and mental disorders medications (18.0-19.3%) remained stable (p for trend = 0.11) and the prescription of chronic respiratory diseases (CRD) medications decreased from 12.2 to 10.6% (p for trend < 0.001), between 2018 and 2021. It is imperative to ensure that these medications are used appropriately.
Assuntos
Prescrições de Medicamentos , Infecções por HIV , Humanos , Bélgica/epidemiologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Masculino , Feminino , Doença Crônica/tratamento farmacológico , Pessoa de Meia-Idade , Adulto , Prescrições de Medicamentos/estatística & dados numéricos , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/epidemiologia , Bases de Dados Factuais , Idoso , PrevalênciaRESUMO
The rapid deployment of COVID-19 vaccines to a large proportion of the population requires a focus on safety. However, few studies have assessed the safety of COVID-19 vaccines in Africa. In Burkina Faso, this issue has not yet been addressed. The objective of this study was to contribute to the description of the characteristics of adverse events following immunization (AEFIs) related to COVID-19 vaccines in Burkina Faso. This was a cross-sectional descriptive retrospective study of spontaneous reports of COVID-19 vaccine-related AEFIs recorded in VigiBase® between June 2021 and November 2022 in Burkina Faso. Individual case safety reports (ICSRs) were extracted from VigiBase® using the Anatomical Therapeutic Chemical level 2 (ATC2) code. The proportion of ICSRs according to the reporter's qualification, the reporting rate, the time taken to submit and record ICSRs, and the completeness score were calculated. A total of 973 ICSRs concerned COVID-19 vaccines and represented 32.6% of all 2,988 reports in VigiBase®. Overall, 82.0% of the reporters were nurses/midwives, 7.8% were physicians, 6.7% were pharmacists, and 3.4% were patients. The median time between the onset of AEFIs and the submission of the report to the Pharmacovigilance Center was 180 days (IQR: 136; 281). The median registration time was 188 days (IQR: 149; 286). The mean ICSR completeness score was 0.8 (standard deviation = 0.1). The overall AEFI reporting rate was 27.8 per 100,000 vaccine doses. The AEFI reporting rates for the ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran, and HB02 vaccines were 454.2, 17.4, 11.0, 10.2, and 0.4 per 100,000 vaccine doses, respectively. The majority of AEFIs were systemic in nature (90.1%). Headache (21.2%), fever (19.4%), and myalgia (11.0%) were the most frequently reported AEFIs. Eighteen cases (1.8%) of serious AEFIs (9 hospitalizations, 4 life threatening, 3 temporary disabilities, and 2 others unspecified) were reported. The majority of AEFIs reported were systemic in nature and mild. However, there have been reports of serious AEFIs. The overall AEFI reporting rate was low. There is a need to strengthen the monitoring of these vaccines to better organize strategies to optimize the adherence of the population of Burkina Faso.
Le déploiement rapide des vaccins anti COVID-19 sur une grande partie de la population nécessite de mettre l'accent sur la sécurité. Cependant, peu d'études ont évalué la sécurité des vaccins anti COVID-19 en Afrique. Au Burkina Faso, cette question n'a pas encore été abordée. La présente étude avait pour objectif de contribuer à la description des caractéristiques des manifestations post-vaccinales indésirables (MAPI) liées aux vaccins anti COVID-19 au Burkina Faso. Il s'est agi d'une étude transversale rétrospective ayant porté sur les notifications de MAPI liées aux vaccins anti COVID-19 enregistrées dans VigiBase® entre juin 2021 et novembre 2022 au Burkina Faso. Les cas individuels de rapports de sécurité (CIRS) ont été extraits de VigiBase® à l'aide du code Anatomical Therapeutic Chemical niveau 2 (ATC2). La proportion de CIRS selon la qualification du notificateur, le taux de notification, le délai de transmission et d'enregistrement des CIRS et le score d'exhaustivité ont été calculés. Au total 973 CIRS concernaient les vaccins anti COVID-19 et représentaient 32,6 % des 2 988 rapports enregistrés dans VigiBase®. La répartition des notifications en fonction de la qualification du notificateur a montré que 82,0 % étaient des infirmiers/sage femmes, 7,8 % des médecins, 6,7 % des pharmaciens et 3,4 % des patients. Le délai médian entre l'apparition des MAPI et la transmission du rapport au Centre de pharmacovigilance était de 180 jours (IQR : 136 ; 281). Le délai médian d'enregistrement était de 188 jours (IQR : 149 ; 286). Le score d'exhaustivité moyen des CIRS était de 0,8 (écart type = 0,1). Le taux global de notifications des MAPI était de 27,8 pour 100 000 doses de vaccins. Les taux de notification des MAPI pour les vaccins ChAdOx1-nCoV-19, JNJ 78436735, Elasomeran, Tozinameran et HB02 étaient de 454,2 ; 17,4 ; 11,0 ; 10,2 et 0,4 pour 100 000 doses, respectivement. La majorité des MAPI était de manifestation systémique (90,1 %). Les céphalées (21,2 %), la fièvre (19,4 %) et les myalgies (11,0 %) étaient les MAPI les plus fréquemment notifiés. Dix-huit cas (1,8 %) de MAPI graves (9 hospitalisations, 4 mises en jeu du pronostic vital, 3 incapacités temporaires et 2 autres non précisés) ont été rapportés. La majorité des cas notifiés dans le cadre de la surveillance des MAPI était de manifestation systémique et de nature bénigne. Néanmoins, des cas de MAPI graves ont été notifiés. Le taux global de notification des MAPI était faible. Il est nécessaire de renforcer la surveillance de ces vaccins pour mieux organiser les stratégies visant à optimiser l'adhésion de la population burkinabé.
Assuntos
Vacinas contra COVID-19 , COVID-19 , Vacinas , Humanos , Ad26COVS1 , Sistemas de Notificação de Reações Adversas a Medicamentos , Burkina Faso/epidemiologia , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos Transversais , Imunização/efeitos adversos , Estudos Retrospectivos , Vacinas/efeitos adversosRESUMO
Hepatitis B e antigen (HBeAg) is a marker of wild-type hepatitis B virus replication. In resource-limited countries where access to enzyme-linked immunosorbent assay (ELISA) remains a challenge, rapid diagnostic tests (RDT) constitute a good alternative. The HBeAg status is employed to evaluate eligibility for antiviral therapy and to prevent the transmission of hepatitis B from mother to child (PMTCT). The objective of this study was to assess the diagnostic performance of the SD-Bioline®HBeAg RDT commonly used for detecting HBeAg in laboratories in Burkina Faso. The sample panel used was collected from HBsAg-positive patients received in the laboratory for the detection of HBeAg with the rapid test. The samples were retested for HBeAg using the VIDAS HBe/Anti-HBe enzyme-linked fluorescent assay (ELFA) (Gold standard). Then, the viral load (VL) of HBV DNA was determined using the GENERIC HBV CHARGE VIRLAE kit (GHBV-CV). The diagnostic performances of the SD-Bioline®HBeAg and its agreement with the gold standard were calculated with their 95% confidence intervals. Overall, 340 sera obtained from HBsAg-positive patients were included in this evaluation Compared to the VIDAS HBe/Anti-HBe ELFA test, the sensitivity (Se) and specificity (Sp) of the SD-Bioline®HBeAg test were 33.3% and 97.9%, respectively. The concordance between the two tests was 0.42. Depending on the viral load, the Se and Sp varied from 8.8% and 98.3% for a VL < 2000 IU/mL to 35.5% and 98.4% for a VL > 2,000,000 IU/mL. The results showed a low sensibility of the SD-Bioline®HBeAg RDT test, indicating that its use is inappropriate for the clinical management of HBV-infected patients. They also highlight the urgent need to develop HBeAg rapid tests with better sensitivities.
RESUMO
Pharmacovigilance is the science and activities related to the detection, evaluation, understanding and prevention of adverse drug reactions or any other possible drug-related problems. In our tropics, this discipline is in an embryonic state. The availability of a management system capable of responding to pharmacovigilance activities is the main objective of our study. The coding was done on the DJANGO Framework. Signal detection was done using the ROR method. We designed three modules which are the notification module, the analysis module and the statistics module. This study has allowed us to launch the basis for a computerization of the pharmacovigilance information system and partly meets our objective. However, it could lead to the integration of the dictionary of adverse effects such as MedDRA as well as the International Classification of Medicines (ATC, EphMRA).