Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Abstract

Summary Background Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre‐registration studies. Aim To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real‐world conditions. Methods Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. Results A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b‐infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti‐viral therapies and 84 (40.2%) were null‐responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child–Pugh B and post‐orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On‐treatment decompensation was experienced by seven (3.3%) patients. Conclusions The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1‐infected patients treated in the real‐world setting.

Real-Life Use of 3 Direct-Acting Antiviral Regimen in a Large Cohort of Patients with Genotype-1b HCV Compensated Cirrhosis

“…Our study is in accordance with previous real-life studies investigating the efficacy of OBV/PTV/r+DSV±RBV in chronic hepatitis C patients [9][10][11][12][17][18][19] with SVR rates between 86% and 100%. In real-life cohorts, patients who failed to achieve SVR were mainly cirrhotics [9][10][17][18]. In the study of Fox et al [17], SVR rates were lower for patients <65years, with cirrhosis, HCC, or a GT-non-1 infection.…”

“…All AEs were present only in 36.4% compared to 91.7% in the Spanish study [10] or 72.2% in the Polish study [9]. This was observed despite the fact that our patients were all cirrhotics, so the number of expected side effects should have been higher.…”

“…Also, the discontinuation rate due to serious adverse events occurred only in 0-2% in clinical trials [4][5][6][7][8]. Recent studies from clinical daily experience showed similar excellent SVR rates (93-100%) and good tolerability and safety (discontinuation rate 0-5%) [9][10][11][12]. Achieving SVR in patients with F3-F4 METAVIR fibrosis leads to a lower incidence of cirrhosis-related complications, J Gastrointestin Liver Dis, September 2017 Vol.…”

Effectiveness of second-generation direct-acting antivirals in chronic hepatitis C

“…Este aspecto no parece atribuible a la existencia de factores favorables a la respuesta al tratamiento en la población del estudio, ya que el 40% era pretratada y el 46% tenía cirrosis (subgrupo que no llega a suponer el 20% de la población en la mayoría de ensayos clínicos y que obtenía peores tasas de RVS) 17,20 . Los resultados obtenidos muestran una alta efectividad en estas poblaciones difíciles de tratar: más del 95% de los pacientes que habían fracasado a terapias previas consiguieron RVS con AAD de segunda generación, así como el 94% de los pacientes cirróticos (tanto en monoinfectados como coinfectados por VIH), cifras similares a las observadas en otras cohortes de "vida real" 21,22 . A pesar de que la mayoría de los pacientes cirróticos tenían una enfermedad compensada, un 10% presentaban cifras superiores a 40 kPa en Fibroscan®, indicando un riesgo inminente de descompensación 23 .…”

A hepatitis C-vírus-fertőzés szűrése, diagnosztikája, antivirális terápiája, kezelés utáni gondozása. Magyar konszenzusajánlás. Érvényes: 2016. október 15-től

“…• HCV-G1b genotípussal fertőzött korábban peg-IFN + RBV + PI kezelésben részesült cirrhosisos vagy nem cirrhosisos betegek: 12 hetes ABT3D + RBV kezelés [35][36][37].…”