Sofosbuvir in combination with simeprevir +/- ribavirin in genotype 4 hepatitis C patients with advanced fibrosis or cirrhosis: a real-life experience from Belgium

Background: All-oral, interferon-free regimens that combine
direct-acting antiviral drugs have significantly advanced the
treatment of hepatitis C (HCV), especially for genotype 1(G1)
patients. However, efficacy and safety data of interferon-free
regimens in HCV genotype 4 (G4) patients are scarce. In Belgium,
Sofosbuvir (SOF) and Simeprevir (SMV) treatment is
available since January 2015 for G4 patients with advanced
fibrosis (F3-F4 METAVIR) for 12 weeks. Methods: analysis of
HCV G4 patients receiving SOF and SMV treatment in Belgium.
The aim of the study was to evaluate the safety and efficacy
of the treatment. Results: 73 G4 patients were enrolled in
this data collection including 32 (43.8%) patients with severe
fibrosis F3 and 41(56.2%) cirrhotic patients. The study population
comprised 58.9% male, 77.8% treatment experienced
patients. Median age was 59 [51-66] years and 5 patients
were HCV/HIV co-infected. 24 patients received the treatment
associated with ribavirin, 11/32 (34.37%) of patients with
advanced fibrosis and 13/41 (31.71%) of cirrhotic patients. In
cirrhotic patients, median MELD and Child-Pugh score were 9
[7-12.5] and 5 [5-6], 46.2% had platelet below 100.000/mm
and 28.6% had albumin below 35 g/L. W4 HCV RNA was
undetectable in 31.25% (15/48). 9 of the 15 patients with
undetectable W4 HCV RNA received RBV. At W12, 100%
(23/23) had HCV RNA below the limit of quantification, with
6/23 still detectable. All SVR12 data will be available at the
time of presentation. No patient experienced serious adverse
event. Conclusions: these preliminary results in difficult-to-treat
G4 HCV patients show that SOF/SIM +/- RBV treatment is safe
and seems promising, in line with that was observed in G1
HCV patients.