Rral-life data of telaprevir-based triple-therapy in patients with chronic hepatitis C GT1 in Germany – an interim analysis
Background/aims: Telaprevir (TVR)-based triple therapy in patients (pts) with chronic Hepatitis C (HCV) in daily practice in Germany is investigated in this non-interventional study to evaluate the implementation of futility rules, response-guided therapy, safety and efficiency.
Methods: Prospective study, investigating TVR-based therapy in therapy-naive and pretreated pts with chronic HCV GT 1. Data from the first 400 pts starting treatment (50% of the planned total) at 67 sites, followed up for a maximum of 24 weeks (W) of treatment.
Results: 70.3% of pts were pretreated (41.3% prior relapser, 32.7% non-responder) and 16% of pts reported cirrhosis at baseline (BL). 42.0% of pts had HCV RNA levels < 800.000 IU/ml (BL). 78.9%* of pts (79.4% therapy-naïve; 78.3% pretreated) showed rapid virological response (RVR). Adherence to futility rules (stop if HCV-RNA > 1000 IU/ml at W4) was found in 5 of 7 pts; two pts continued treatment until W12. At W12, 90.6%* of pts had undetectable HCV RNA. 73.3%* of therapy-naive pts and 76.0%* of pretreated pts were HCV-RNA negative at both W4 and W12. 12 pts (3.0%) with RVR at W4 suffered a breakthrough. Most pts (86.8%) had adverse events (AE) during the first 12W, 11.5% serious adverse events (SAE). AEs were mostly mild (62.0%) or moderate (35.1%), including rash (32.2%, mostly rated as mild or moderate) and anemia (30.1%). Hb decrease < 12 g/dl ♀ or < 13 g/dl ♂ was reported in 88.5% of pts. Mean Hb levels decreased from 14.3 g/dl at BL to 10.4 g/dl at W12; Hb levels < 8.5 g/dl within the first 24W of treatment were present in 19.6% of anemia cases and 8.4% required transfusion. 14 pts (3.5%) received erythropoeitin. 14 (3.8%) anemia cases and 13 (15.3%) rash cases were considered as SAE.
Conclusions: This interim analysis confirms the antiviral efficiency of TVR-based triple-therapy in GT1 HCV in a real life setting showing eRVR rates of more than 70% in treatment naïve and pre-treated patients. Adherence to futility rules was confirmed in most patients. As observed in clinical trials, adverse events were reported frequently.