Results of interferon-free treatment for HCV-infected patients with decompensated cirrhosis from a Brazilian real-life cohort

Abstract

Real-life data on the HCV treatment with direct-acting agents in patients with decompensated cirrhosis are scarce. Study to investigate the effectiveness and safety of sofosbuvir-containing regimens in a prospective cohort of patients with HCV decompensated cirrhosis. A total of 150 patients were enrolled (64% male, 84% genotype 1 with a mean age of 61 ± 9 years). The median MELD was 12, and 79% were Child-PughB. Most patients were treated with sofosbuvir and daclatasvir (98%) with ribavirin in 27%. The overall intention to treat SVR12 was 91% (137/150). The most frequent adverse event was anemia (17%), 73% associated with ribavirin. Twenty-one (14%) patients experienced renal dysfunction, 81% AKI I, and 1 discontinued treatment. Thirty-five (23%) patients presented at least 1 infectious episode, mainly respiratory tract infection (29%). Thirty-three patients (22%) had at least 1 episode of cirrhosis decompensation throughout treatment, particularly worsening of previous ascites in 19%. Nine patients died, and among those, 7 patients died from sepsis. The probability of decompensation in 28, 90 and 180 days was 4%, 19% and 25%. During treatment, infection (OR 2.24; 95 CI 1.09-4.61; P = .03) was a predictor of cirrhosis decompensation, and baseline MELD and CHILD ≥ B8 were both associated with infection. In decompensated cirrhosis, the overall virological response was high with mild adverse events. However, this population had a high frequency of liver-associated decompensation and infections. Abbreviations: AKI = acute kidney injury, CI = confidence interval, DAA = direct-acting agents, DCV = daclatasvir, Hb = hemoglobin, HBV = hepatitis B virus, HCC = hepatocellular carcinoma, HCV = hepatitis C virus, HE = hepatic encephalopathy, HIV = human immunodeficiency virus, INR = international normalized ratio, IRB = institutional review board, LDV = ledipasvir, MELD = model of end-stage liver disease, OR = odds ratio, RBV = ribavirin, RCT = randomized clinical trial, SOF = sofosbuvir, SVR = sustained virological response, VEL = velpatasvir.