RESUMEN
BACKGROUND: In clinical trials, hepatitis C virus (HCV) salvage treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) achieved an SVR12 rate of >95% in NS5A-experienced participants. Lower SVR12 rates have been reported in real-world studies, particularly for genotype (GT)3 infection and cirrhosis. We determined the efficacy and safety of SOF/VEL/VOX in a large real-world cohort. METHODS: We assessed the efficacy of salvage SOF/VEL/VOX for HCV infection in NS5A-inhibitor experienced participants with cirrhosis and portal hypertension, prior liver transplantation (LT) or severe extra-hepatic manifestations. SOF/VEL/VOX was available via an early access program. The primary outcome was SVR12. Secondary outcome was frequency of adverse events (AE). FINDINGS: Ninety-seven participants were included. Median age was 58, 82% were male, 78% had cirrhosis, most with portal hypertension (61%, nâ =â 46/76), and 18% had prior-LT. Of the cirrhotic participants, 96% were Child-Turcotte-Pugh class A, and 4% were class B. Of the 72% with GT3, 76% were also cirrhotic. By intention-to-treat analysis, SVR12 rate was 85% (nâ =â 82/97). Per protocol, the SVR12 rate was 90%, including 91% in GT1 (GT1a nâ =â 18/18, GT1b nâ =â 2/4), 89% in GT3 (nâ =â 59/66) and 100% in GT6 (nâ =â 3/3). SVR12 in participants with GT3 and cirrhosis was 90%. No predictors of non-SVR12 were identified. There were 4 serious AEs including 1 death and 3 hepatic decompensation events. NS5A resistance-associated substitutions detected at baseline did not affect SVR12. CONCLUSIONS: This real-world study confirms high efficacy of SOF/VEL/VOX for the treatment of difficult-to-cure NS5A-inhibitor experienced patients, including those with GT3 and cirrhosis. Treatment was well tolerated in most; however, serious AEs can occur in those with advanced liver disease.
Asunto(s)
Hepatitis C Crónica , Hepatitis C , Ácidos Aminoisobutíricos , Antivirales/efectos adversos , Carbamatos , Ciclopropanos , Genotipo , Hepacivirus/genética , Hepatitis C/tratamiento farmacológico , Hepatitis C Crónica/complicaciones , Hepatitis C Crónica/tratamiento farmacológico , Compuestos Heterocíclicos de 4 o más Anillos , Humanos , Lactamas Macrocíclicas , Leucina/análogos & derivados , Masculino , Persona de Mediana Edad , Prolina/análogos & derivados , Quinoxalinas , Sofosbuvir/efectos adversos , Sulfonamidas , Respuesta Virológica Sostenida , Resultado del TratamientoRESUMEN
BACKGROUND: There are limited prospective population-based data on the health care cost of IBD in the post-biologicals era. A prospective registry that included all incident cases of inflammatory bowel disease [IBD] was established to study disease progress and health cost. AIM: To prospectively assess health care costs in the first year of diagnosis among a well-characterised cohort of newly diagnosed IBD patients. METHOD: Incident cases of IBD were prospectively identified in 2007-2008 and 2010-2013 from multiple health care providers, and enrolled into the population-based registry. Health care resource utilisation for each patient was collected through active surveillance of case notes and investigations including specialist visits, diagnostic tests, medications, medical hospitalisation, and surgery. RESULTS: Off 276 incident cases of IBD, 252 [91%] were recruited to the registry, and health care cost was calculated for 242 (146 Crohn's disease [CD] and 96 ulcerative colitis [UC] patients). The median cost in CD was higher at A$5905 per patient (interquartile range [IQR]: A$1571-$91,324) than in UC at A$4752 [IQR: A$1488-A$58,072]. In CD, outpatient resources made up 55% of all cost, with medications accounting for 32% of total cost [15% aminosalicylates, 15% biological therapy], followed by surgery [31%], and diagnostic testing [21%]. In UC, medications accounted for 39% of total cost [of which 37% was due to 5-aminosalicylates, and diagnostics 29%; outpatient cost contributed 71% to total cost. CONCLUSION: In the first year of diagnosis, outpatient resources account for the majority of cost in both CD and UC. Medications are the main cost driver in IBD.
Asunto(s)
Costos de la Atención en Salud/estadística & datos numéricos , Enfermedades Inflamatorias del Intestino/economía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Atención Ambulatoria/economía , Antiinflamatorios/economía , Antiinflamatorios/uso terapéutico , Niño , Terapia Combinada , Femenino , Estudios de Seguimiento , Fármacos Gastrointestinales/economía , Fármacos Gastrointestinales/uso terapéutico , Humanos , Inmunosupresores/economía , Inmunosupresores/uso terapéutico , Enfermedades Inflamatorias del Intestino/diagnóstico , Enfermedades Inflamatorias del Intestino/terapia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Victoria , Adulto JovenRESUMEN
BACKGROUND AND AIM: We have previously found high incidence of inflammatory bowel disease (IBD) in Australia. A population-based registry was established to assess disease severity, frequency of complications, and prognostic factors. METHODS: Incident cases were prospectively identified over 4 years. Early disease severity was assessed according to need for hospitalization and resective surgery and medication use. RESULTS: We report on the early outcomes (median 18 months, range 12-60 months) for 252 patients comprising 146 with Crohn's disease (CD), 96 with ulcerative colitis (UC), and 10 IBD undifferentiated. Eighty-seven percent of CD patients had inflammatory disease at diagnosis, and this reduced to 73% at 5 years (n = 38). Immunomodulators were prescribed in 57% of CD patients and 19% with UC. A third of all CD patients were hospitalized, the majority (77%) in the first 12 months. Risk factors for hospitalization included penetrating, perianal, and ileocolonic disease (P < 0.05). Twenty-four percent of UC patients were hospitalized, most within the first 12 months. Intestinal resection rates were 13% at 1 year in CD and 26% at 5 years. Risk factors include penetrating and stricturing disease (P < 0.001) and ileal involvement (P < 0.05). Colectomy rates in UC were 2% and 13% at 1 and 5 years. High C-reactive protein (CRP) at diagnosis was associated with colectomy. CONCLUSIONS: A high rate of inflammatory disease, frequent immunomodulator use in CD, and a low rate of surgery in both CD and UC were identified. In CD, ileal involvement and complex disease behavior are associated with a more severe disease course, while in UC a high CRP predicted this outcome.