RESUMO
Despite the high sustained virologic response (SVR) rates of direct-acting antiviral (DAAs) therapy, a small number of patients does not eradicate the virus, and these patients represent a challenge. This study aims to compare the outcomes of three second-line regimens for DAAs-experienced patients with chronic hepatitis C (CHC). This prospective observational study was conducted at the Damanhur Viral Hepatitis Center from January 2017 to February 2020. We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV). The primary endpoint was SVR-12 after re-treatment. This study included 360 patients (with a mean age of 51.53±11.38 years). Approximately 51.1% of the patients were males, and 65.5% had liver cirrhosis. All patients of group 1 (45 patients) received SOF/VEL/VOX over 12-weeks; SVR-12 was achieved in 44 patients (97.8%). Group 2 (28 patients) received SOF/DAC/RBV over 24-weeks; (one patient was lost during follow-ups and one patient discontinued treatment due to hepatic decompensation). SVR-12 was achieved in 25 patients (96.2%). Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks. Eight patients were lost during follow-ups, and one patient discontinued treatment due to grade 4 adverse events. SVR-12 was achieved in 276 patients (99.3%). There was no difference between the groups regarding their age, gender distribution, baseline viral load or comorbidities. Adverse events (thrombocytopenia, anemia, hyperbilirubinaemia and prolonged INR) were significantly higher in group 3, while group 1 did not experience any. The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events.
Assuntos
Hepatite C Crônica , Sofosbuvir , Adulto , Antivirais/efeitos adversos , Estudos de Coortes , Quimioterapia Combinada , Feminino , Genótipo , Hepacivirus/genética , Hepatite C Crônica/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Ribavirina/uso terapêutico , Falha de Tratamento , Resultado do TratamentoRESUMO
ABSTRACT Despite the high sustained virologic response (SVR) rates of direct-acting antiviral (DAAs) therapy, a small number of patients does not eradicate the virus, and these patients represent a challenge. This study aims to compare the outcomes of three second-line regimens for DAAs-experienced patients with chronic hepatitis C (CHC). This prospective observational study was conducted at the Damanhur Viral Hepatitis Center from January 2017 to February 2020. We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV). The primary endpoint was SVR-12 after re-treatment. This study included 360 patients (with a mean age of 51.53±11.38 years). Approximately 51.1% of the patients were males, and 65.5% had liver cirrhosis. All patients of group 1 (45 patients) received SOF/VEL/VOX over 12-weeks; SVR-12 was achieved in 44 patients (97.8%). Group 2 (28 patients) received SOF/DAC/RBV over 24-weeks; (one patient was lost during follow-ups and one patient discontinued treatment due to hepatic decompensation). SVR-12 was achieved in 25 patients (96.2%). Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks. Eight patients were lost during follow-ups, and one patient discontinued treatment due to grade 4 adverse events. SVR-12 was achieved in 276 patients (99.3%). There was no difference between the groups regarding their age, gender distribution, baseline viral load or comorbidities. Adverse events (thrombocytopenia, anemia, hyperbilirubinaemia and prolonged INR) were significantly higher in group 3, while group 1 did not experience any. The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events.
RESUMO
Renal function has a significant impact on early mortality in patients with cirrhosis. However, creatinine and creatinine-based equations are inaccurate markers of renal function in cirrhosis. The aim of this study was to reassess correlations between creatinine-based equations and measured glomerular filtration rate (GFR) and to investigate the impact of inaccuracies on the Model for End-Stage Liver Disease (MELD) score. GFR was measured using iohexol clearance and calculated with creatinine-based equations in 157 patients with cirrhosis during pretransplant evaluation. We compared the accuracy of creatinine to that of true GFR in a prognostic score also including bilirubin and the international normalized ratio. In patients with creatinine below 1 mg/dL, true GFR ranged from 34-163 mL/minute/1.73 m(2). Cockcroft and Modification of Diet in Renal Disease (MDRD) significantly overestimated true GFR. On multivariate analysis, younger age and ascites were significantly correlated with the overestimation of true GFR by 20% or more. Body mass index was an independent risk factor of overestimation of GFR with Cockcroft but not with MDRD. The accuracy of a prognostic score combining bilirubin, international normalized ratio, and true GFR was superior to that of MELD, whether creatinine was rounded to 1 mg/dL when lower than 1 mg/dL or not (c-statistic of 0.8 versus 0.75 and 0.73, respectively). Creatinine-based formulas overestimate true GFR, especially in patients younger than 50 years or with ascites. In patients with serum creatinine below 1 mg/dL, the spectrum of true GFR is large. True GFR seems to have a better prognostic value than creatinine and creatinine-based equations. Specific equations are needed in patients with cirrhosis to improve prognostic scores.