Since 2014, several directly acting agents (DAA) have been approved for therapy of chronic hepatitis C virus (HCV) infection in Europe. Henceforward, interferon–free regimens have become standard-of-care in Germany. Recently shortening therapy to 8 weeks was introduced for sofosbuvir (SOF) and ledipasvir (LDV). Here, we report data from the German hepatitis C cohort (GECCO).
The GECCO cohort is a multicenter cohort from 8 sites in Germany. All patients starting on the following DAAs were included in the analysis: SOF/pegylated interferon (PegIFN)/ribavirin (RBV); SOF/RBV; SOF/simeprevir (SMV); SOF/daclatasvir (DCV) +/- RBV; SOF/ledipasvir (LDV) +/-RBV; paritaprevir/ritonavir)/ombitasvir/dasabuvir (3D)+/-RBV. A particular interest was given to patients treated for 8 weeks with SOF/LDV. All GECCO patients are part of the German hepatitis C registry.
Up to now, 1157 patients were included into the cohort, 65% were male, and the mean age was 53 years. 282 (24.4%) were HIV-HCV coinfected with a median CD4 cell count of 608/mm3 (IQR 403-765). The HCV genotype (GT) distribution was as follows: 841 (73%) GT 1, 49 (4.4%) GT 2, 188 (16%) GT 3, 74 (6.3%) GT4.
The SVR12 (ITT) rates were: GT1: 89%, GT2: 87%, GT3: 81%, GT4: 79%, but only 6% of failures were related to relapse. HIVHCV-coinfected patients responded as well as HCV monoinfected patients (83% vs 81%, p=ns).
In patients with genotype 1 and 4, SVR12 rates were significantly lower in patients with liver cirrhosis than without cirrhosis (75% vs 89%, p=0.02). 3 hepatic decompensations and 3 deaths occurred. 3 reinfections after SVR were documented within the observational period.
132 (127 GT 1 and 5 GT 4) patients were treated with SOF/LDV for 8 weeks: 19% of the patients had been unsuccessfully treated before, mainly with dual therapy consisting of pegylated interferon and ribavirin. 17% were HIV coinfected. Post-treatment week 12 has been reached by 92 patients so far, only 2 patients relapsed (SVR =98%).
DAA-based treatments are highly effective in real-life in HCV-mono- and HIV-HCV-coinfected patients. Relapse occurs only in 6%, and more often in patients with liver cirrhosis. All DAA combinations were generally well tolerated. In particular SOF/LDV for 8 weeks seems highly effective in selected patients in this population.