Abstract
BackgroundThe combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a (peg-IFN-alfa-2a) as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials. However, there is only limited data concerning the efficacy and safety in a “real-life” cohort.MethodsWe analyzed a cohort of 119 patients with chronic HCV infection treated at four investigational sites in Germany. All patients received either a combination treatment of SOF, RBV and peg-IFN-alfa-2a or SOF and RBV.ResultsThe rates of SVR at 12 weeks after end of treatment (SVR 12) were as follows: Among 76 patients with genotype 1 infection the SVR 12 rate was 74 % (n = 56), among 14 patients with genotype 2 infection the SVR 12 rate was 79 % (n = 11), among 24 patients with genotype 3 infection the SVR 12 rate was 92 % (n = 22) and among 5 patients with genotype 4 infection the SVR 12 rate was 80 % (n = 4). Of all 26 patients with a relapse in our cohort, 69 % (n = 18) of these patients presented with liver cirrhosis and 58 % (n = 15) were treatment experienced. Notably, the level of HCV-RNA after 4 weeks of treatment was a significant predictor of treatment response in genotype 1 patients. Patients with HCV-RNA levels ≥ 12 IU ml-1 after 4 weeks of treatment achieved SVR 12 only in 30 % (n = 17/56, p < 0.0001) of cases and treatment response was even lower with SVR 12 of 25 % (n = 5/20, p = 0.0016) in the subgroup of patients with cirrhosis.ConclusionWe observed a high rate of SVR 12 with SOF-based treatment regimes, however probably due to the high number of patients with liver cirrhosis and prior treatment experience, treatment response rates were lower than in previously published trials. In genotype 1 patients the analysis of early virological response may predict treatment response in SOF-based combination therapies.
Highlights
The combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials
As HCV patients are at risk for developing end-stage liver disease with a variety of complications including hepatocellular carcinoma and decompensated liver cirrhosis with the need for liver transplantation, chronic HCV infection is associated with an elevated risk for liver-related mortality [3,4,5]
The study population consisted of a large proportion of patients with liver cirrhosis 46 % (n = 55)
Summary
The combination of sofosbuvir (SOF), ribavirin (RBV) and peg-interferon-alfa-2a (peg-IFN-alfa-2a) as well as the combination of SOF and RBV for the treatment of patients infected with hepatitis c virus (HCV) has improved rates of sustained virological response (SVR) considerably in recent trials. The generation direct acting antiviral (DAA) sofosbuvir (SOF), which has been recently approved by national health authorities, represents the milestone in the development of new therapeutic options and opens up potent treatment regimes for chronic HCV patients. Due to preselected patient populations and underrepresentation of difficult-to-treat patients, such as treatment experienced cirrhotics, these data may differ in a real-life setting and the validation of these results in a diverse patient population with less favorable conditions towards an SVR regarding concomitant diseases or constitutional factors may yield additional aspects and knowledge valuable for the future management of affected patients [11, 12]
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