Patients with hepatitis C and Child-Pugh A cirrhosis had similar rates of treatment-related adverse events and lower rates of hepatic decompensation after treatment with Viekira Pak (Holkira Pak in Canada) compared with untreated patients, according to recently published data. However, those with a history of advanced cirrhosis were more likely to experience treatment-related adverse events.
“Importantly, many of the events consistent with hepatic decompensation were self-limiting and improved without treatment interruption, or occurred at time points not typically associated with drug toxicity,” Fred Poordad, MD, from the Texas Liver Institute and University of Texas Health Science Center, San Antonio, and colleagues wrote.
The researchers pooled safety data from 12 phase 2 and phase 3 studies that included patients with HCV and compensated cirrhosis who received Viekira Pak(ombitasvir/paritaprevir/ritonavir, AbbVie) or ombitasvir/paritaprevir/ritonavir with dasabuvir, with or without ribavirin in either case.
Thirteen patients experienced a treatment-related adverse event that the researchers considered consistent with hepatic decompensation. Eleven of those 13 received ribavirin with treatment.