Non-pharmacologic direct cost of a simplified strategy with glecaprevir/pibrentasvir for 8 weeks in naïve non-cirrhotic patients with hepatitis C implemented in clinical practice. The Just SIMPLE Study / Costes directos no farmacológicos de una estrategia simplificada con glecaprevir/pibrentasvir durante 8 semanas en pacientes naïve, no cirróticos, con hepatitis C, implementada en la práctica clínica. Estudio Just SIMPLE

Background and objective: The emergence of highly tolerable, effective, and shorter duration direct-acting antivirals (DAAs) regimens offers the opportunity to simplify hepatitis C virus management but medical costs are unknown. Thus, we aimed to determine the direct medical costs associated with a combo-simplified strategy (one-step diagnosis and low monitoring) to manage HCV infection within an 8-week glecaprevir/pibrentasvir (GLE/PIB) regimen in clinical practice in Spain. Patients and methods: Healthcare resources and clinical data were collected retrospectively from medical charts of 101 eligible patients at 11 hospitals. Participants were adult, treatment naïve subjects with HCV infection without cirrhosis in whom a combo-simplified strategy with GLE/PIB for 8 weeks were programmed between Apr-2018 and Nov-2018. Results: The GLE/PIB effectiveness was 100% (CI95%: 96.2–100%) in the mITT population and 94.1% (CI95%: 87.5–97.8%) in the ITT population. Three subjects discontinued the combo-simplified strategy prematurely, none of them due to safety reasons. Five subjects reported 8 adverse events, all of mild-moderate intensity. Combo-simplified strategy mean direct costs were 754.35±103.60€ compared to 1689.42€ and 2007.89€ of a theoretical 12-week treatment with 4 or 5 monitoring visits, respectively; and 1370.95€ and 1689.42€ of a theoretical 8-week with 3 or 4 monitoring visits, respectively. Only 4.9% of the subjects used unexpected health care resources. Conclusions: 8-week treatment with GLE/PIB combined with a combo simplified strategy in real-life offers substantial cost savings without affecting the effectiveness and safety compared to traditional approaches.(AU)

Antecedentes y objetivo: La aparición de regímenes antivirales de acción directa altamente tolerables, eficaces y de corta duración permite simplificar el manejo de la hepatitis C, pero los costes médicos se desconocen. Así, se pretende determinar los costes médicos directos asociados a una estrategia simplificada (diagnóstico en un solo paso y monitorización reducida) para controlar la infección por VHC con un régimen de 8 semanas de glecaprevir/pibrentasvir (GLE/PIB) en la práctica clínica en España. Pacientes y métodos: Los recursos sanitarios y los datos clínicos se recopilaron retrospectivamente de las historias médicas de 101 pacientes elegibles en 11 hospitales. Los participantes fueron sujetos adultos, sin tratamiento previo de la infección por VHC y sin cirrosis, en los que se programó una estrategia combinada simplificada con GLE/PIB durante 8 semanas entre abril y noviembre de 2018. Resultados: La eficacia de GLE/PIB fue del 100% (IC 95% 96,2-100) en la población mITT y del 94,1% (IC 95% 87,5-97,8) en la población ITT. Tres sujetos suspendieron prematuramente la estrategia combinada simplificada, ninguno de ellos por razones de seguridad. Cinco sujetos reportaron 8 acontecimientos adversos de intensidad leve-moderada. Los costes directos fueron de 754,35±103,60€ frente a 1.689,42€ y 2.007,89€ de un tratamiento teórico de 12 semanas con 4 o 5 visitas de monitorización, respectivamente; y 1.370,95€ y 1.689,42€ de un tratamiento teórico de 8 semanas con 3 o 4 visitas de monitorización, respectivamente. El 4,9% de los sujetos utilizaron recursos de atención médica inesperados. Conclusiones: En la vida real, el tratamiento de 8 semanas con GLE/PIB junto con una estrategia simplificada ofrece ahorros sustanciales de costos, sin afectar la eficacia y seguridad, en comparación con abordajes tradicionales.(AU)

Non-pharmacologic direct cost of a simplified strategy with glecaprevir/pibrentasvir for 8 weeks in naïve non-cirrhotic patients with hepatitis C implemented in clinical practice. The Just SIMPLE Study.

BACKGROUND AND OBJECTIVE: The emergence of highly tolerable, effective, and shorter duration direct-acting antivirals (DAAs) regimens offers the opportunity to simplify hepatitis C virus management but medical costs are unknown. Thus, we aimed to determine the direct medical costs associated with a combo-simplified strategy (one-step diagnosis and low monitoring) to manage HCV infection within an 8-week glecaprevir/pibrentasvir (GLE/PIB) regimen in clinical practice in Spain. PATIENTS AND METHODS: Healthcare resources and clinical data were collected retrospectively from medical charts of 101 eligible patients at 11 hospitals. Participants were adult, treatment naïve subjects with HCV infection without cirrhosis in whom a combo-simplified strategy with GLE/PIB for 8 weeks were programmed between Apr-2018 and Nov-2018. RESULTS: The GLE/PIB effectiveness was 100% (CI95%: 96.2-100%) in the mITT population and 94.1% (CI95%: 87.5-97.8%) in the ITT population. Three subjects discontinued the combo-simplified strategy prematurely, none of them due to safety reasons. Five subjects reported 8 adverse events, all of mild-moderate intensity. Combo-simplified strategy mean direct costs were 754.35±103.60€ compared to 1689.42€ and 2007.89€ of a theoretical 12-week treatment with 4 or 5 monitoring visits, respectively; and 1370.95€ and 1689.42€ of a theoretical 8-week with 3 or 4 monitoring visits, respectively. Only 4.9% of the subjects used unexpected health care resources. CONCLUSIONS: 8-week treatment with GLE/PIB combined with a combo simplified strategy in real-life offers substantial cost savings without affecting the effectiveness and safety compared to traditional approaches.

Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection: Results from the Spanish HEPA-C real-world cohort.

In randomized controlled trials of patients with chronic HCV infection, elbasvir/grazoprevir (EBR/GZR) demonstrated high cure rates and a good safety profile. This study assessed the effectiveness and safety of EBR/GZR, with and without ribavirin, in a real-world HCV patient cohort. HEPA-C is a collaborative, monitored national registry of HCV patients directed by the Spanish Association for the Study of the Liver and the Networked Biomedical Research Centre for Hepatic and Digestive Diseases. Patients entered into HEPA-C between December 2016 and May 2017, and treated with EBR/GZR with at least end-of-treatment response data, were included. Demographic, clinical and virologic data were analysed, and adverse events (AEs) recorded. A total of 804 patients were included in the study. The majority were male (57.9%), with a mean age of 60 (range, 19-92) years. Genotype (GT) distribution was GT 1, 86.8% (1a, 14.3%; 1b, 72.5%); GT 4, 13.2% and 176 patients (21.9%) were cirrhotic. Overall, among 588 patients with available data, 570 (96.9%) achieved sustained virologic response at 12 weeks post-treatment (SVR12). SVR12 rates by genotype were GT 1a, 97.7%; GT 1b, 98.6%; and GT 4, 98.1%. No significant differences in SVR12 according to fibrosis stage were observed. Eighty patients experienced an AE, resulting in treatment discontinuation in three. In this large cohort of patients with chronic HCV managed in a real-world setting in Spain, EBR/GZR achieved high rates of SVR12, comparable to those observed in randomized controlled trials, with a similarly good safety profile.