Background and study aim: In Egypt, the prevalence of hepatitis C virus (HCV) antibodies is the highest worldwide by 7.6%. Applying efficient treatment protocol on large scale could decrease HCV prevalence as well as disease burden.The aim of this study isto compare the efficacy of Sofosbuvir plus ledipasvir versus Sofosbuvir plus daclatasvir in management of chronic hepatitis C Egyptian patients with either easy to treat (naive patients with Child score A5)or difficult to treat (interferon experienced).
Patients and Methods: the study was performed on 200 chronic hepatitis C patients and they were classified into Group I: Included 100 patients fulfill criteria of [easy to treat] and were subdivided into two subgroups; Group Ia: 50 patients were treated with daily Sofosbuvir (400 mg) plus Daclatasvir (60 mg) for 12 weeks. Group Ib: 50 patients were treated with daily Sofosbuvir (400 mg) plus Ledipasvir (90 mg) for 12 weeks. Group II: Included 100 patients fulfill criteria of (difficult to treat) and were subdivided into two subgroups; Group IIa: 50 patients were treated with daily Sofosbuvir (400 mg) and Daclatasvir (60 mg) plus daily weight-based Ribavirin for 12 weeks; Group IIb: 50 patients were treated with daily Sofosbuvir (400 mg) ) plus Ledipasvir (90 mg) plus daily weight-based Ribavirin for 12 weeks.
Results: GIa: 50 patients treated with Sof-Dac showed 100% cure (-ve PCR) at wk12 and wk 24. GIb: 50 patients treated with Sof-Led showed 98% cure (-ve PCR) at wk12 and wk 24. GIIa: 50 patients treated with Sof-Dac-Riba showed 100% cure (-ve PCR) at wk12 and 98% at wk 24. GIIb: 50 patients treated with Sof-Led-Riba showed 98% cure (-ve PCR) at wk12 and 96% at wk 24.The difference between treatment regimens (Sof + Dac or Sof + Lid with or without Riba), regarding the cure rate and adverse events in all the studied groups was not significant which indicates the safety and effectiveness of both medication regimens. The decrease in FIB4 calculation at week 24 was highly significant in comparison to the baseline in GIa (2.23 to 0.67) and GIb (2.1 to 1.12) (easy to treat, while the difference in FIB4 calculation was not statistically significant at week 24 in GIIa and GIIb (difficult to treat).
Conclusion: Both regimens are effective, well tolerated and showed excellent rate of sustained virological response (SVR).