Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4

Abstract

The findings from the present study suggested that SOF/DCV (with or without RBV) regimen exhibited high effectiveness, was well tolerated in the treatment of chronic HCV GT 4, and revealed itself as a better option for patients with advanced liver disease, making the eradication of HCV a more realistic target to achieve.

Hepatitis C virus genotype 4-infection and interferon-free treatment in Egypt

“…The main adverse events during and after 12 weeks of treatments were fatigues, asthenia, headache, gastrointestinal trouble, nausea and dyspnea. Serious adverse events were reported in seven patients (hospitalized due to four abdominal troubles and three anemia), and no cases of death or discontinuation were reported due to serious adverse events [3].…”

“…The estimated rates of HCV infection in Egypt is around 14.7%, and the predominant HCV GT is GT4, where GT4a, GT4b, GT1 and GT3 represent 63, 30, 6 and 1% of cases, respectively [1]. Recently, the results of treatment with combinations of direct-acting antivirals (DAAs) for HCV GT4 Egyptian patients have been reported [2][3][4][5][6]. Almost all of these regimens could lead to more than 95% or more than 90% SVR rates, respectively, in the following patients: ''easy-to-treat'' patients who were treatment-naïve and did not have cirrhosis but had compensated liver biochemical parameters or ''difficult-to-treat'' patients who had previously failed interferon therapy with or without DAAs or an interferon-free combination, regardless of fibrosis stage, and had cirrhosis.…”

“…Abdel-Moneim et al [3] also analyzed data from a large cohort of 946 HCV GT4 Egyptian patients treated with a 12-week combination of SOF/DCV with or without ribavirin. HCV GT4a, GT4 m, GT4n, and GT4o showed rates of 76, 5, 7 and 12%, and IL28B GTs CC, CT and TT of 19, 54 and 27%, respectively.…”

“…According to the FIB-4 score, the authors defined a FIB-4 score\ 1.45 and a FIB-4 score [ 3.25 as F0-F1 (none or mild fibrosis) and F3-F4 (advanced fibrosis or cirrhosis), respectively. A total of 111 patients (12%) had advanced fibrosis or cirrhosis [3]. The patients were classified into two groups: the ''easy-to-treat'' 758 patients and the ''difficult-to-treat'' 188 patients.…”

“…The patients were classified into two groups: the ''easy-to-treat'' 758 patients and the ''difficult-to-treat'' 188 patients. The ''difficult-to-treat'' group included all 111 patients with advanced fibrosis or cirrhosis, as well as all 99 treatmentexperienced patients (including 77 non-cirrhotic patients): interferon-a/ribavirin, 16; SOF/interferon-a/ribavirin, 32; or SOF/simeprevir (SMV), 51 [3]. The ''difficult-to-treat'' or ''easy-to-treat'' group, respectively, was treated with a dual therapy of SOF/DCV with or without ribavirin daily for 12 weeks.…”