OBJECTIVE: Direct-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain. METHODS: An economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied. RESULTS: SOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197M. CONCLUSION: SOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain.
Microelimination strategies for the hepatitis C virus (HCV) in vulnerable populations, such as users of Addiction Centres (AC), are key for the elimination of hepatitis C. The aim of the HepCelentes project was to design a certification program for AC from the generation of a guide with the criteria to favour the prevention, diagnosis, control, and treatment of HCV in Spain. The project was structured in 4 phases: normalisation, implementation, certification, and communication. In the first phase, developed between July and December 2020, a Steering Committee was created (formed by representatives of scientific societies, healthcare professionals from AC, primary care centres and hospital units, and patient associations) that, from of an exhaustive bibliographic review, generated by consensus an accreditation guide for AC. The guide consists of 22 criteria (15 mandatory and 7 recommended) structured based on the requirements to be met by AC, justification for the selection, level of action (management, prevention, diagnosis and treatment/follow-up), measurement of the indicator, objective level to be achieved, evidence of compliance, clarifications to improve understanding, and mandatory / recommendation (depending on their relevance to achieve HCV elimination and its feasibility for implementation in real practice). The development of a certification system for the AC, based on consensus and coordination of multidisciplinary teams, is intended to favour the management of hepatitis C and its elimination in AC users, supporting the international, national, and regional elimination strategies.
Las estrategias de microeliminación del virus de la hepatitis C (VHC) en poblaciones vulnerables, como los usuarios de los centros de adicciones (CA), son fundamentales para lograr la eliminación de la hepatitis C. El objetivo del proyecto HepCelentes fue diseñar un programa de certificación para los CA, a partir de la generación de una guía con los criterios para favorecer la prevención, diagnóstico, control y tratamiento del VHC en España. El proyecto se estructuró en 4 fases: normalización, implementación, certificación y comunicación. En la primera fase, desarrollada entre julio y diciembre de 2020, se creó un Comité de Normalización (formado por representantes de sociedades científicas, profesionales sanitarios de CA, centros de atención primaria, unidades hospitalarias, y asociaciones de pacientes) que, a partir de una revisión bibliográfica exhaustiva, generó por consenso una guía de certificación de los CA. La guía consta de 22 criterios (15 obligatorios y 7 recomendados) estructurados en base a la definición del criterio, justificación de su selección, nivel de actuación (gestión, prevención, diagnóstico y tratamiento/seguimiento), fórmula de medición, nivel objetivo a alcanzar, evidencias de su cumplimiento, aclaraciones para mejorar su comprensión y obligatoriedad/recomendación (en función de la relevancia en la eliminación y capacidad de implementación). El desarrollo de un sistema de certificación para los CA, a partir del consenso y la coordinación de equipos multidisciplinares, pretende favorecer el manejo de la hepatitis C y su eliminación en los usuarios de los CA, apoyando las estrategias de eliminación internacionales, nacionales y autonómicas.
La tecnología MRgFUS (magnetic resonance guided focused ultrasound surgery) es una técnica de cirugía no invasiva basada en la necrosis coagulativa térmica del tejido mediante la concentración focalización de ultrasonidos guiados por resonancia magnética. Es una novedosa tecnología aprobada por la Food and Drug Administration norteamericana en 2004 y por la Unión Europea (marca CE) en 2006 para el tratamiento de los miomas uterinos. En 2010 recibió la aprobación CE para el tratamiento de la adenomiosis y se está desarrollando para el tratamiento no invasivo de otras patologías tumorales, principalmente en oncología. Presentamos los primeros 3 casos de gestaciones tras tratamiento de miomas conseguidos en Instituto Cartuja, único centro en España con la tecnología MRgFUS, concluyendo que se trata de una técnica fiable, segura y efectiva para el tratamiento de fibromas uterinos incluso en mujeres con deseo genésico (AU)
Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a non-invasive surgical technique based on thermal coagulative necrosis of tissue by focused ultrasound guided by magnetic resonance. This fairly recent technique was approved by the American Food and Drug Administration in 2004 and by the European Union in 2006 for the treatment of uterine fibroids. In 2010 MRgFUS was approved by the European Union (CE label) for the treatment of adenomyosis and is being developed for the non-invasive treatment of other tumoral diseases, mainly in oncology. We present the first three cases of pregnancy achieved at the Instituto Cartuja, the only site in Spain with MRgFUS technology. We conclude that MRgFUS is a safe, reliable and effective technique for the treatment of uterine fibroids, even in women with a desire to preserve fertility (AU)
Humans , Female , Pregnancy , Adult , Myoma/complications , Myoma/diagnosis , Fibroma/diagnosis , Fibroma/surgery , Magnetic Resonance Imaging/methods , Myoma/physiopathology , Myoma , Fibroma/physiopathology , Fibroma , Endometriosis/diagnosis
Los tumores de ovario se diagnostican en su mayoría mediante hallazgos casuales en pruebas diagnósticas realizadas por otro motivo. La endometriosis sintomática es un motivo de consulta frecuente en mujeres jóvenes. Los tumores de Sertoli-Leydig son tumores de origen embrionario muy poco habituales. En este caso, el diagnóstico del tumor embrionario se produce en una intervención quirúrgica por endometriosis y como hallazgo de una biopsia del ovario contralateral en una mujer con deseo reproductivo y sin sospecha previa (AU)
Ovarian tumours are mostly casual findings in imaging tests performed for another reason. Symptomatic endometriosis is a common reason in young women attending clinics. Sertoli-Leydig tumours have an embryological origin and are very rare. In this case the diagnosis was made during surgery for an endometriosis and as a finding in the contralateral ovarian biopsy (AU)
Humans , Female , Adult , Sertoli-Leydig Cell Tumor/complications , Sertoli-Leydig Cell Tumor/diagnosis , Sertoli-Leydig Cell Tumor/surgery , Endometriosis/diagnosis , Endometriosis/therapy , Ovarian Cysts/diagnosis , Ovarian Cysts/surgery , Sertoli-Leydig Cell Tumor/physiopathology , Ovarian Cysts , Biomarkers
Presentamos el caso de una mujer de 57 años concistoadenoma mucinoso en un ovario y tumor dela granulosa como hallazgo casual en el anejocontralateral. Clínicamente, la paciente, que referíauna amenorrea primaria, debutó con metrorragia ytumoración abdominal.Los tumores de la granulosa del adulto, quepertenecen a las neoplasias del estroma gonadaldel ovario, son más frecuentes en mujeresposmenopáusicas. En la clínica suelen debutar consíntomas secundarios a la secreción estrogénica,aunque la proporción de tumores de la granulosasecretores de hormonas es difícil de establecer (AU)
We present the case of a 57-year-old womanwith mucinous cystoadenoma in one ovary andgranulosa tumor as an incidental finding in theother. The patient reported primary amenorrhea,and clinical presentation consisted of metrorrhagiaand an abdominal mass.Adult granulosa tumors, which belong to thegroup of gonadal stroma neoplasms of the ovary,are more common in postmenopausal women.Clinically, these tumors usually manifest withsymptoms secondary to estrogen secretion, althoughthe proportion of tumors of this kind that secretehormones is difficult to establish (AU)
Humans , Female , Middle Aged , Granulosa Cell Tumor/complications , Cystadenocarcinoma, Mucinous/complications , Ovarian Neoplasms/complications , Granulosa Cell Tumor/diagnosis , Cystadenocarcinoma, Mucinous/diagnosis , Ovarian Neoplasms/diagnosis
La coexistencia de un teratoma quístico maduro con un adenocarcinoma de células claras en el mismo ovario es rara. No hemos encontrado ninguna referencia sobre esta asociación en la literatura médica.Presentamos el caso de una paciente de 56 años, asintomática, intervenida de masa anexial compleja con elevación de los marcadores tumorales ováricos, en estadio quirúrgico IIc. El resultado anatomopatológico fue teratoma quístico maduro asociado a carcinoma de células claras en el mismo ovario.Los teratomas pueden malignizar (1-2%), pero generalmente a carcinoma epidermoide. No está descrita la transformación a carcinoma de células claras. Existen referencias de degeneración en este sentido de lesiones histológicamente benignas, como la endometriosis. La rareza del caso nos hace plantearnos si se trata de una simple coincidencia o de una malignización del teratoma
The coexistence of mature cystic teratoma and clear cell adenocarcinoma in the same ovary is extremely infrequent. We found no reports of this association in the literature.We report the case of a 56-year-old asymptomatic patient who underwent surgery for a complex annexal mass with elevated ovarian tumoral markers. Surgical stage was IIc. Pathological diagnosis was mature cystic teratoma associated with clear cell carcinoma in the same ovary.Teratomas can become malignant (1-2%) but transformation is usually to epidermoid carcinoma. Transformation to clear cell carcinoma has not previously been described. There have been reports of this type of degeneration inhistologically benign lesions such as endometriosis. The rarity of this case prompted us to question whether the association was coincidental or was due to malignanttransformation of the teratoma
Humans , Female , Middle Aged , Adenocarcinoma, Clear Cell/pathology , Adenocarcinoma, Clear Cell/surgery , Ovarian Neoplasms/pathology , Ovarian Neoplasms/surgery , Teratoma/pathology , Teratoma/surgery
