Background and study aim: Hepatitis C virus (HCV) is a major cause of liver diseases including
chronic hepatitis‚ liver cirrhosis and hepatocellular carcinoma. Egypt has the highest worldwide prevalence of HCV
with more than 90% of HCV isolates are genotype 4 variants. To avoid progression of the disease and its
complications, antiviral treatment is needed. Genotype-1 infected patients achieved a SVR ranging from 41-52%
after 48 weeks of peginterferon-ribavirin with slight higher rates in genotype 4. This study was designed to evaluate
the efficacy and safety of adding sofosbuvir to this standard combination therapy in naive patients with chronic
hepatitis c and those previously experienced. Patients and methods: Ninety patients with chronic hepatitis c were
included in this study. Forty five patients were treatment- naïve while the other 45 patients was failed previous
course of pegylated IFN and ribavirin. All patients were evaluated by history, clinical examination, imaging and
laboratory investigations. Sofosbuvir was added to the standard combination therapy. Side effects during therapy
were observed in patients of both groups to assess safety. Real time quantitative PCR was repeated after 12 weeks
from the end of treatment to evaluate sustained virological response (SVR) of patients in both groups to assess
efficacy. Results: The overall SVR in all patients was 72.2%. It was achieved in (35/45) patients in the treatment-
naïve group (77.8%) while in the experienced one, it was achieved in (30/45) patients (66.7%) with non-significant
difference between both groups (p=0.239). In the treatment-experienced group, patients with breakthrough on old
regimen (27/45) patients achieved SVR in a significantly lower rate than those in patients with history of relapse
(51.9% vs 88.9 % respectively) (p=0.010). The main side effects developed were headache (84.4 & 55.6%), fever
(64.4 & 51.1%), bone aches (57.8 & 40%) and asthenia (53.3 & 37.8%) in naïve and experienced groups
respectively. headache was significantly more frequent in the treatment-naïve group (p=0.003). Conclusion: Adding
sofosbuvir to standard combination therapy (peginterferon-ribavirin) is associated with increased SVR in both
treatment-naïve and those experienced with high safety profile in both groups |
