Z Gastroenterol 2015; 53 - KG162
DOI: 10.1055/s-0035-1559188

Real-world effectiveness of Ledipasvir/Sofosbuvir 8 weeks chronic hepatitis C treatment

P Buggisch 1, J Petersen 1, K Wursthorn 1, A Gauthier 2, P Atanasov 2
  • 1Asklepios Klinik St. Georg Haus L, IFI Institut für Interdisziplinäre Medizin, Hamburg, Deutschland
  • 2Amaris, London, Vereinigtes Königreich

Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) single tablet regimen (STR) is approved in Europe for chronic hepatitis C (CHC) patients with genotypes (GT) 1, 3 and 4. In the ION-3 study 8 weeks (8w) of LDV/SOF was non-inferior to 12 w in previously untreated GT1 patients without cirrhosis with no benefit for the addition of Ribavirin. According to the SPC 8w may be considered in this population. The aim of the present analysis is to characterise the population receiving 8w LDV/SOF and to describe outcomes in clinical practice.

Methods: The first CHC patients treated with 8w LDV/SOF in a single centre in Germany, and for whom SVR12will be available in June, were included. Baseline characteristics, prior treatment history, safety and effectiveness were investigated. Analysis was performed using descriptive statistics.

Results: 46 patients met the inclusion criteria and initiated 8w treatment with LDV/SOF between 24/11/2014 to 27/01/2015. No patient had ribavirin added to the STR. The mean (SD) age was 50.9 (12.4) years and 56.5% were males. Genotype distribution was 52%, 44% and 4% for GT1a, GT1b and GT4.. At entry, 98% of patients had no cirrhosis, one patient had compensated disease. The METAVIR stage distribution of non-cirrhotic patients at baseline was 39.1%, 32.6%, 19.6% and 8.7% for F0, F1, F2 and F3.. Median (range) HCV RNA at baseline was 5.86 (Q1-Q3 5.38 – 6.22; Min-Max 3.74 – 6.67) log10 IU/ml, no patient had HCV RNA ≥6 million IU/mL. No patient was HIV co-infected and one patient was HBV co-infected. Overall, 98% of the patients were treatment-naïve. One patient had relapsed after previous IFN/RBV therapy. At baseline, co-morbidities were reported in 93% of patients, with depression (16%) and arterial hypertension (16%) being most common. Up to date, no discontinuations or relevant Adverse Drug Reactions have been observed. Complete results for SVR12, adverse events and discontinuations will be available at the time of presentation.

Conclusion: 8w LDV/SOF is predominantly prescribed according to the SPC for treatment-naïve non-cirrhotic CHC patients with HCV RNA < 6 million IU/mL at baseline. Preliminary results indicate that LDV/SOF is a safe, well tolerated treatment option with no adverse drug reactions or discontinuations reported so far.