Provided by Formulary
NOV 08, 2013
By: Formulary staff
New data evaluating the investigational protease inhibitor faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV), studied in genotype 1 (GT1) patients with hepatitis C (HCV), were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting, in Washington, DC.
Data from four phase 3 trials (STARTVeso) with varying study designs (NCT01343888, NCT01297270, NCT01358864, NCT01399619) were presented at AASLD by representatives of Boehringer Ingelheim. The primary efficacy end point of all of the STARTVerso trials was sustained virologic response 12 weeks post-treatment (SVR12). The STARTVerso clinical trial program included a wide range of difficult-to-cure patient populations, such as those with a non-CC IL28B genotype, HIV/HCV coinfection, those with advanced liver fibrosis, and African-American patients.
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 120 mg or 240 mg faldaprevir once daily, both in combination with PegIFN/RBV, respectively, achieved SVR12. In comparison, 50% (131/264) of patients treated with PegIFN/RBV alone achieved SVR12.
Also in the pooled analysis, 84% (436/521) of patients who received a regimen that included 120 mg of faldaprevir once daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. Of these patients, 83% (362/436) achieved SVR12.
In treatment-experienced patients (STARTVerso 3), 12 weeks of faldaprevir-based treatment (240 mg 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.
In addition, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso 4) showed that 74% (229/308) of patients treated with a faldaprevir-based regimen (120 mg or 240 mg once daily), in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). The study includes patients coinfected with HCV and HIV who were treatment-naïve or had relapsed after previous HCV therapy with PegIFN/RBV, and were either HIV treatment-naïve or being treated with ART.
“Patients with HCV may benefit from an individualized treatment approach as factors that influence treatment response vary from patient to patient,” said Peter Piliero, vice president, clinical development and medical affairs, Boehringer Ingelheim. “Overall, our HCV clinical trial program includes both interferon-free and interferon-based regimens, and we are working toward our goal of offering patients appropriate treatment options for their individual needs.”