Sustained virological response to treatment of chronic hepatitis C with peginterferon alfa and ribavirin

This study aimed to evaluate the rate of sustained virological response (SVR) and the clinical and treatment characteristics of patients with chronic hepatitis C (CHC). A retrospective uncontrolled cohort study was conducted among patients who received treatment for CHC between 2005 and 2008 attended at the Center for the Application and Monitoring of Injectable Medications, in Florianopolis, SC, Brazil. The inclusion criteria were: patients over 18 years of age, with a confirmed diagnosis of chronic hepatitis C according to Brazilian guidelines, treated with PEG-IFN alfa-2a or 2b associated with RBV. A total of 188 patients were included in the study: 70% men, 59% genotype 1, 27% coinfected with HIV, 31% with cirrhosis. The SVR rate, calculated by probability theory, was determined as 26% (max=57.4% and min=12.8%) and the intention to treat was 12.8%. Associations between Sustained Virological Response (SVR) and the variables sex (p=0.017), age (p=0.003), genotype (p=0.648) and cirrhosis (p=0.275), were determined in the bivariate analysis and only sex and age were significantly associated with SVR. The SVR rate was considered low, which can be partially explained by patients' unfavorable pretreatment characteristics.

O objetivo do estudo foi avaliar a taxa de resposta viral sustentada (RVS) e as características clínicas e do tratamento dos pacientes portadores de hepatite C crônica. Realizou-se uma coorte retrospectiva não controlada com recorte temporal dos anos de 2005 a 2008, dos pacientes atendidos no Polo de Aplicação e Monitoramento de Medicamentos Injetáveis, em Florianópolis, SC. Os critérios de inclusão foram: pacientes maiores de 18 anos, com diagnóstico confirmado de hepatite C crônica de acordo com o protocolo brasileiro, tratados com PEG-IFN alfa-2a ou 2b associado a ribavirina. Total de 188 pacientes foi incluído no estudo, 70% homens, 59% genótipo 1, 27% co-infectados com o HIV e 31% apresentando cirrose. A taxa de RVS calculada através da teoria das probabilidades foi de 26% (max=57,4% and min=12,8%) e por intenção de tratamento de 12,8%. Verificou-se a associação da RVS com as variáveis: sexo (p=0,017), idade (p=0,003), genótipo (p=0,648) e presença de cirrose (p=0,275). Somente sexo e idade foram associados significativamente com a RVS. A taxa de RVS foi considerada baixa e, em parte, pode ser explicada pelas características desfavoráveis dos pacientes para a obtenção de RVS.

Desarrollo tecnológico de un antiviral de amplio espectro para administración parenteral: ribavirina 100 mg/mL / Technological development of a wide spectrum antiviral agent to parenteral administration: 100 mg/mL Ribavirin

Se describe el desarrollo de una formulación que contiene ribavirina como principio activo, a una concentración de 100 mg/mL que mantiene sus propiedades estables desde el punto de vista físico, químico y microbiológico. Se realizaron los estudios de formulación correspondientes con el objetivo de determinar la formulación idónea, el procedimiento tecnológico y el envase adecuado para garantizar la estabilidad del producto terminado. Se elaboraron 3 lotes del medicamento, los cuales se envasaron en bulbos incoloros de vidrio, con calidad hidrolítica I y se almacenaron a temperatura ambiente de 30 ± 2 ºC durante 12 meses; se estudió su estabilidad física y química por el método acelerado y de vida de estante. Se comprobó su estabilidad microbiológica a través de un ensayo de esterilidad, a cada uno de los lotes elaborados, al inicio y final del estudio, según la Farmacopea de los Estados Unidos 30 y la regulación establecida por el Centro Estatal de Control de Medicamentos de Cuba; se obtuvieron resultados satisfactorios. Se realizó un estudio toxicológico del inyectable que mostró un amplio margen de seguridad para ser usado en humanos. Todos los resultados obtenidos cumplieron con los límites de calidad establecidos en la literatura oficial para este tipo de forma farmacéutica, por lo que se llegó a la conclusión que el medicamento desarrollado está correctamente formulado desde el punto de vista galénico con un tiempo de vida útil de 12 meses, almacenado bajo las condiciones estudiadas. Finalmente el medicamento fue introducido al nivel industrial sin que se presentaran problemas tecnológicos

Development of a formula containing Ribavirin as active principle at a 100 mg/mL concentration maintaining its stable properties from the physical, chemical and microbiological point of view is described. The aim of present formula studies was to determine the suitable formula, the technological procedure and the appropriate package to guarantee stability of end product. Three drugs batches were manufactured, which were packing in colourless glass bulbs with a hydrolytic I quality and stored at room temperature of 30 ± 2 ºC for 12 months; its physical and chemical was studied by accelerated method and shelf life. Its microbiological stability was verified by sterility trial in each of processed batches at study onset and at the end according to USA Pharmacopeia-30 and the regulation established by Cuban State Center for Drug Control with satisfactory results. A toxicology study was conducted of injectable agent showing a wide safety margin to human use. All results obtained fulfilled the quality limits established in official literature for this type of pharmaceutical way thus concluded that the developed drug is properly formulated from the medical point of view with a useful life time of 12 months, stored under study conditions. Finally, the drug was introduced at industrial level without technological problems