Real‐world effectiveness and safety of direct‐acting antivirals in patients with cirrhosis and history of hepatic decompensation: Epi‐Ter2 Study

Abstract

Background and Aims The aim of this study was to assess the real‐life effectiveness and safety of direct acting antivirals (DAAs) in patients with cirrhosis and history of hepatic decompensation compared to those with compensated cirrhosis. Method Data of patients treated with DAAs and included in the EpiTer‐2 database (N = 10 152) were collected retrospectively. The primary endpoint was sustained viral response (SVR) at 12 weeks posttreatment. Patients were also evaluated in terms of liver‐related adverse events and treatment modification/discontinuation. Results The overall SVR rate was 91.4% in the intent to treat (ITT) analysis and 95.2% in the per‐protocol (PP) analysis (P < .001). Patients with decompensated cirrhosis had lower SVR rates compared to those with compensated cirrhosis in ITT analysis (86.4% vs 92.0%, P < .001), while not in PP analysis (92.9% vs 95.5%, P > .05). Adverse events (AE) occurred 45.6% and 29.3% of patients with decompensated and compensated cirrhosis (P < .001). Patients with decompensated cirrhosis were at higher risk of death (5.4% vs 0.9%; P < .0001) or liver decompensation (21.5% vs 1.3%; P < .0001). Treatment with protease inhibitors was not associated with hepatic decompensation (P = .3). Only 82.6% of patients with decompensated cirrhosis completed DAA treatment (vs 92.8% in compensated cirrhotics; P < .0001). Conclusion Despite higher frequency of AE and treatment modifications, once completed, DAAs yield comparable results for patients with decompensated and compensated cirrhosis. High rate of serious adverse events in patients with advanced liver disease treated with PI may not be related to the detrimental effect of the medications, but rather to the disease itself.

HCV Cure With Direct-Acting Antivirals Improves Liver and Immunological Markers in HIV/HCV-Coinfected Patients

“…Direct-acting antivirals (DAA) have transformed HCV therapy because almost all treated patients achieve a sustained virological response (SVR) (32)(33)(34)(35). HCV eradication after DAA therapy decreases the risk of LRE in HCV-monoinfected patients with compensated cirrhosis, although this decrease has not been observed among those with decompensated cirrhosis (36)(37)(38). HIV/HCV-coinfected patients have a similar risk of LRE after successful DAA therapy as HCV-monoinfected individuals; however, the former group has a higher chance of non-liverrelated death (39,40).…”

Clinical characteristics and antiviral therapy in patients infected with hepatitis C virus in the interferon-free era

“…Further observations are necessary to determine whether this trend will continue. It is a worrying phenomenon given that DAA therapy in patients with liver cirrhosis is effective and safe, and HCV eradication reduces the risk of serious complications, including decompensation and HCC [26,27].…”

Therapy of Chronic Viral Hepatitis: The Light at the End of the Tunnel?

“…Patients with decompensated cirrhosis may benefit from antiviral treatment with DAAs, even though most clinical trials [67][68][69][70][71][72] showed a significant decrease in SVR rates among decompensated cirrhotics. However, liver function improves as confirmed by amelioration both in Child-Turcotte-Pugh (CPT) classification and Model for End-Stage Liver Disease (MELD) scores in a significant proportion of patients [73][74][75][76][77]. Whether such benefit is durable over the long-term is still matter of debate [78][79][80][81].…”