Boehringer Ingelheim announced new data from its Phase 3 clinical trial program, STARTVerso evaluating the investigational protease inhibitor faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV) in genotype 1 (GT1) patients with hepatitis C (HCV). Faldaprevir is an investigational, oral protease inhibitor specifically designed to target viral replication in the liver.
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The Phase 3 clinical program includes trials in treatment-naive (STARTVerso 1&2), treatment-experienced (STARTVerso 3), and HIV/HCV coinfected (STARTVerso 4) patients with genotype-1 (GT1) hepatitis C (HCV). The primary efficacy endpoint of all trials is viral cure 12 weeks after the conclusion of treatment (SVR12).
In a pooled analysis of treatment-naive, genotype 1 patients (STARTVerso 1&2):
- 73% (382/521) and 72% (378/524) of all patients treated with faldaprevir 120mg or 240mg once daily, both in combination with PegIFN/RBV, respectively, achieved SVR12.
- 50% (131/264) of patients treated with PegIFN/RBV alone achieved SVR12.
- 84% (436/521) of patients who received a regimen including faldaprevir 120mg once daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. 83% (362/436) of these patients achieved SVR12.
In treatment-experienced patients (STARTVerso 3):
- 12 weeks of faldaprevir-based treatment (240mg once daily), in combination with PegIFN/RBV, demonstrated SVR12 of 70% (69/99) in patients who relapsed on previous HCV treatment, compared to 14% (7/49) of patients taking PegIFN/RBV alone.
- In patients who partially responded to previous treatment, 58% (33/57) achieved SVR12, compared to 3% (1/29) of patients taking PegIFN/RBV alone.
- In patients who showed no response to previous treatment, 33% (48/145) achieved SVR12.
Early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso 4) demonstrated that 74% (229/308) of patients treated with a faldaprevir-based regimen (120mg or 240mg once daily), in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). This study includes patients coinfected with HCV and HIV who were treatment-naive or had relapsed after previous HCV therapy with PegIFN/RBV, and were either HIV treatment-naive or being treated with ART.
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