Abstract
Purpose: To evaluate the efficacy and safety of ombitasvir (OMV), paritaprevir (PTV), ritonavir (r), ribavirin (RBV) (OMV/PTVr + RBV), ledipasvir (LDV) and sofosbuvir (SOF) therapies in genotype 4 (GT4) patients, and to determine if the rapid virological response (RVR) observed at 4th week of therapy has a role in predicting sustainability of the response at week 12 (SVR12) post-therapy. Methods: The investigation included 71 subjects with diagnosis of Hepatitis C (HCV) GT4. Some of the patients (40/71) were treated using combination of OMV (25 mg/day), PTV (150 mg/day), ritonavir (r) (100 mg/day), while the others (31/71) were treated using combination of LDV (90 mg/day) and SOF (400 mg/day). Body weight-based RBV was added to both treatment regimens, and the treatments given for a total of 84 days. Viral levels in the patients were evaluated after the 4th and 12th week of drug administration, and at 12 weeks post-administration. Results: The SVR12 responses of the patients on the basis of sub-groups, were 97.5 % for OMV/PTVr + RBV, 96.8 % for LDV/SOF + RBV (p = 0.6); 91.3 % for cirrhotic, 100 % for non-cirrhotic (p = 0.1); 100 % in untreated, and 95.5 % for treated (p = 0.33). While there were numerical differences, these were not statistically significant. The SVR12 response was 100 % in patients with RVR response, and 87.5 % for patients without RVR response (p < 0.05). When the patients' aspartate transaminase (AST), alanine transaminase (ALT), platelet (PLT), albumin, creatinine, prothrombin time (PT) and fib4 values before and after treatment were compared, significant difference were observed for all variables (p < 0.01), except for PT (p = 0.3). there were no dangerous adverse events such as decompensation or death, aside from mild fatigue, with incidence of 19 %. Conclusion: RVR response after OMV/PTVr + RBV and LDV/SOF + RBV treatments show that the treatments can be used safely and effectively in patients with HCV genotype 4. Moreover, RVR might be a suitable determinant of SVR12 response.