Efficacy and safety of pegylated interferon α and ribavirin in patients monoinfected with HCV genotype 4.

Introduction: Dual therapy (PegIFN and ribavirin) (DT) was the standard of care in patients infected with HCV genotype 4 (HCV-4) until 2014. Nowadays, new treatment options are available including interferon (IFN)-based and other IFN-free regimens.

Aim: To assess the efficacy (SVR24) and safety of DT and the selected predictor factors of SVR in HCV-4 infected patients.

Material and methods: One hundred and twelve patients (62 men) of median age 23 years were treated with DT for 48/72 weeks (107/5) in the years 2006-2014. Most of them were treatment naïve (80.4%) and with fibrosis F ≤ 2 (83.1%). To select a subset of independent predictors of SVR Logistic Regression Analysis was applied.

Results: SVR24 was achieved in 46/112 (41.1%) patients. The mean viral load was 5.55 log10 IU/ml. Lack of therapy experience increases the odds of achieving SVR (OR = 4.17; 1.04-16.67), whereas more advanced fibrosis and higher baseline viral load tend to decrease the probability of SVR (OR = 0.05; 0.01-0.52 and OR = 0.44; 0.17-1.13, respectively). In contrast, the weight loss is associated with higher probability of virological response (OR = 4.31; 1.37-13.60). Two hundred and seventy-nine adverse events (AEs) were reported in 96 individuals. The rates and types of AEs were similar in patients treated with PegIFN-α2a/RBV and PegIFN-α2b/RBV. Overall, 3 (2.7%) patients discontinued therapy prematurely because of serious AEs.

Conclusions: SVR24 was low. Loss of weight was a new positive predictive factor of SVR found in our study. Most of the AEs were typical of those previously reported for DT.