Background: Direct acting antiviral agents (DAAs) revolutionized chronic hepatitis C (CHC) treatment. However, the limited DAAs failure is still challenging.
Objective: Assessment of efficacy and tolerability of the combination of sofosbuvir (SOF), ritonavir boosted paritaprevir, ombitasvir (OBV/PTV/r) and ribavirin (RBV), or SOF, simeprevir (SMV), daclatasvir (DCV) and RBV in re-treatment of CHC patients who failed response to SOF/DCV-based therapy.
Patients and methods: This prospective study included 104 Egyptian CHC patients who failed response to SOF/DCV-based therapy. Patients were allocated to 2 groups; group A (n=54) received SOF plus OBV/PTV/r+RBV and group B (n=50) received SOF/SMV/DCV+RBV. Efficacy was assessed by achievement of sustained virological response (SVR), defined as undetectable HCV RNA 12 weeks after treatment completion. Tolerability was assessed through monitoring of treatment related adverse events (AEs) and laboratory abnormalities.
Results: The SVR12 rates were 94.4% (51/54) in group A and 96% (48/50) in group B, with no significant difference (p=1.000). Only one patient in group B discontinued treatment due to development of hepatic decompensation. Most reported AEs were mild to moderate in severity according to Common Terminology Criteria for Adverse Events (CTCAEv5.0) with no deaths during the study. Dermatological AEs (photosensitivity and pruritis) were significantly predominant in group B (p=0.005), while headache was more significant in group A (p=0.032). Fatigue was the commonest AE in both groups (29.6% and 28% in group A and B respectively), followed by headache and abdominal pain in group A (20.4% and 18.5% respectively), compared to photosensitivity and itching (both 14%) in group B.
Conclusion: Multi-target DAAs combinations are efficient in re-treatment of Egyptian CHC relapsers after failure of SOF/DCV-based therapy in real world management.