ABSTRACT
PURPOSE: To design a randomized clinical trial to assess the efficacy and safety of favipiravir in patients with COVID-19 disease with pneumonia. METHODS: A randomized, double blind, placebo-controlled clinical trial of favipiravir in patients with COVID-19 pneumonia was conducted in three Spanish sites. Randomization 1:1 to favipiravir or placebo (in both groups added to the Standard of Care) was performed to treat the patients with COVID-19 pneumonia. The primary endpoint was "time to clinical improvement," measured as an improvement for ≥ two categories on a 7-point WHO ordinal scale in an up to 28 days' time frame. RESULTS: Forty-four patients were randomized (23 in the favipiravir group and 21 in the placebo group). The median time to clinical improvement was not different between the favipiravir and the placebo arms (10 days for both groups) and none of the secondary endpoints showed significant differences between arms. The proportion of adverse events (both serious and non-serious) was statistically different between the favipiravir group (68.29%) and the placebo group (31.7%) (p = 0.019), but there was insufficient statistical evidence to correlate the degree of severity of the events with the treatment group. CONCLUSIONS: Favipiravir administered for ten days to patients with COVID-19 and pneumonia did not improve outcomes compared with placebo. Although this is an underpowered negative study, efficacy results align with other randomized trials. However, in the present study, the non-serious adverse events were more frequent in the favipiravir group.
ABSTRACT
Background. The health crisis due to the COVID-19 pandemic is a challenge in the dispensing of outpatient hospital medication (OHM). Models of Antiretroviral Therapy (ART) based on community pharmacy support (ARTCP) have proven to be successful. The aim was to evaluate the degree of satisfaction, acceptability and limitations of the implementation of ARTCP, in the context of a pandemic, in our environment. Methods. Descriptive cross-sectional study carried out in a Barcelona hospital, during the months of July-November 2020. A telephone survey was carried out via a questionnaire on the quality dimensions of the model (degree of satisfaction, acceptability) and associated inconveniences. Data collected: demographics, antiretroviral treatment (ART), concomitant medication, drug interactions (DDIs), CD4 lymphocyte count and plasma viraemia. Data analysis included descriptive statistics. Results. A total of 533 (78.0%) HIV patients receiving ART were included. 71.9% (383/533) of these patients were very satisfied and 76.2% preferred attending the community pharmacy rather than the hospital. The mean satisfaction rating was 9.3 (DS: 1.4). The benefits reported were: 1) proximity to home (406: 76.1%); 2) lower risk of contagion of COVID-19 (318: 59.7%); 3) shorter waiting time (201: 37.1%); 4) time flexibility (104: 19.5%); 5) reduction of financial expenses (35: 6.57%). A total of 11 (2%) patients reported no benefit. Only 22.9% reported disadvantages associated with ARTCP: 1) lack of privacy (65: 12.2%); 2) lack of coordinationorganization (57: 10.7%). Conclusion. The COVID-19 pandemic has had an impact on the provision of pharmaceutical care for HIV patients. The ARTPC model has proved efficient, with patients reporting a high degree of satisfaction. (AU)
Introducción. La crisis sanitaria por la pandemia COVID-19 plantea un desafío en la dispensación de la medicación hospitalaria de dispensación ambulatoria (MHDA). Los modelos de terapia antirretroviral basados en el apoyo de la farmacia comunitaria (TARFC) han demostrado tener éxito. El objetivo del estudio fue evaluar el grado de satisfacción, aceptabilidad y limitaciones de la implementación del TARFC, en contexto de pandemia, en nuestro entorno. Métodos. Estudio descriptivo transversal realizado en un hospital de Barcelona, durante los meses de julio-noviembre del 2020. Se realizó una encuesta telefónica, mediante un cuestionario sobre dimensiones de calidad del modelo (grado de satisfacción, aceptabilidad) e inconvenientes asociados. Se recogieron datos: demográficos, tratamiento antirretroviral (TAR), medicación concomitante, interacciones farmacológicas (DDIs), recuento de linfocitos CD4 y viremia plasmática. El análisis de datos incluyó estadística descriptiva. Resultados. Se incluyeron 533 pacientes VIH adherentes al TAR. El 71,9% (383/533) de pacientes estaban muy satisfechos y el 76,2% preferían acudir a la farmacia comunitaria frente a la hospitalaria. La calificación de satisfacción media fue de 9,3 (DS: 1,4). Los beneficios reportados fueron: 1) cercanía al domicilio (406: 76,1%); 2) menor riesgo de contagio de COVID-19 (318: 59,7%) 3) menor tiempo de espera (201: 37,1%); 4) flexibilidad horaria (104: 19,5%); 5) reducción de gastos económicos (35: 6,57%). Un total de 11 (2%) pacientes no reportaron ningún beneficio. Únicamente el 22,9% reportaron desventajas asociadas al TARFC: 1) falta de privacidad (65:12,2%); 2) falta de coordinación-organización (57: 10,7%) Conclusión. La pandemia de COVID-19 tiene un impacto en la prestación de atención farmacéutica al VIH. El modelo TARFC ha resultado eficiente con un elevado grado de satisfacción por parte de los pacientes. (AU)
