Experience with Direct Acting Agents for the Treatment of Hepatitis C in Flanders.

Abstract

Introduction: Hepatitis C (HCV) remains one of the main causes of chronic liver disease worldwide. The impact of chronic HCV on the long-term ranges widely, from minimal histologic changes to decompensated cirrhosis or hepatocellular carcinoma. These last years, the development of direct acting antivirals have revolutionized HCV care. We present the experience in the KU Leuven affiliated hospitals with the latest generation of direct acting antivirals. These are therapies without concomitant use of interferon, such as simeprevir, sofosbuvir, daclatasvir, and ombitasvir/paritaprevir ritonavir – dasabuvir. Aim Goal of this abstract is to demonstrate the safety and efficacy of the newest generation of direct acting antivirals in the general population in Belgium (the KU Leuven affiliated hospitals). Methods A national retrospective, interventional cohort study conducted between December 2013 and November 2015 in 6 Belgian centers during which patients infected with HCV were treated with the new regimes of DAA. All centers were experienced in treating HCV. In case antiviral treatment was started data were collected in a central database, with main focus on treatment outcome and side effects. Results and discussion In total, 134 patients (age 58 ± 12 years) were treated with one of the newest generation DAAs. All patients had multiple comorbidities, with an average rate of 1.55 ± 1.6. These were highest in the simeprevir/sofosbuvir group. HCV genotype 1b was most prevalent. 45.9% of the patients were treatment naïve, and 38.7% % was once treated before. 59 patients were treated with daclatasvir/sofosbuvir ± ribavirin, 48 with simeprevir/sofosbuvir ± ribavirin, and 27 with ombitasvir/ paritaprevir, ritonavir – dasabuvir ± ribavirin. Treatment is completed in only 60.4% of all patients. Moreover, only 42.5% were treated long enough so they could achieve SVR. From this group, almost everyone obtained SVR (96.5%). Subanalysis showed an SVR-rate of 100% (10/10) in the daclatasvir/sofosbuvir ± ribavirin group, 92.6% (25/27) in the simeprevir/sofosbuvir ± ribavirin group, and 100% (20/20) in the ombitasvir/ paritaprevir, ritonavir – dasabuvir ± ribavirin group. Side effects were present in 49.3 % of the total population, most frequent were an increase in fatigue and skin eruptions. Only in 9.7 %, this required a change in therapy. Ribavirin was lowered in dose or stopped in these cases. These are preliminary results, we will present larger data at the time of the congress.

Conclusion Real-life experience with DAAs in Belgium shows comparable excellent results in achieving SVR for the treatment of HCV. Side effects were frequent, but rarely cause a need for therapy change.