Effectiveness and safety of ombitasvir, paritaprevir, ritonavir ± dasabuvir ± ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection
Perelló C (1,2), Carrión JA (3,4, Ruiz-Antorán B (1), Crespo J (5,6), Turnes J (7), Llaneras J (8), Lens S (2,9), Delgado M (10), García-Samaniego J (2,11), García-Paredes F (12), Fernández I (13), Morillas RM (2,14), Rincón D (2,15), Porres JC (16), Prieto M (2,17), Lázaro Ríos M (18), Fernández-Rodríguez C (19), Hermo JA (20), Rodríguez M (21), Herrero JI (2,22), Ruiz P (23), Fernández JR (24), Macías M (25), Pascasio JM (2,26), Moreno JM (27), Serra MÁ (28,29), Arenas J (30), Real Y (31), Jorquera F (2,32), Calleja JL 1,2,33; Spanish Collaborative Group for the Study of the Use of Hepatitis C Direct-Acting Drugs.
Over the last 5 years, therapies for hepatitis C virus (HCV) infection have improved significantly, achieving sustained virologic response (SVR) rates of up to 100% in clinical trials in patients with HCV genotype 1.
We investigated the effectiveness and safety of ombitasvir/paritaprevir/ritonavir±dasabuvir in an early access programme.
This was a retrospective, multicentre, national study that included 291 treatment-naïve and treatment-experienced patients with genotype 1 or 4 HCV infection. Most patients (65.3%) were male, and the mean age was 57.5 years.
The mean baseline viral load was 6.1 log, 69.8% had HCV 1b genotype, 72.9% had cirrhosis and 34.7% were treatment-naïve. SVR at 12 weeks posttreatment was 96.2%. Four patients had virological failure (1.4%), one leading to discontinuation. There were no statistical differences in virological response according to genotype or liver fibrosis.
Thirty patients experienced serious adverse events (SAEs) (10.3%), leading to discontinuation in six cases. Hepatic decompensation was observed in five patients. Four patients died during treatment or follow-up, three of them directly related to liver failure.
Multivariate analyses showed a decreased probability of achieving SVR associated with baseline albumin, bilirubin and Child-Pugh score B, and a greater probability of developing SAEs related to age and albumin.
This combined therapy was highly effective in clinical practice with an acceptable safety profile and low rates of treatment discontinuation.