Interim Results Presented at EASL from PROVE 1 Clinical Trial of Investigational Drug Telaprevir in Patients with Genotype 1 Hepatitis C. PROVE 1 data support potential to shorten treatment duration in treatment-na?ve, genotype 1 HCV patients.
In a late-breaker presentation at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL), researchers presented data from a planned interim analysis of the PROVE 1 clinical trial, which is the first trial to evaluate short-duration therapy with the investigational hepatitis C protease inhibitor telaprevir (TVR, VX-950) in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) in treatment-na?ve, genotype 1-infected hepatitis C patients.
The data from PROVE 1 demonstrated a high rate of rapid viral response (RVR) in the telaprevir groups and a low rate of on-treatment viral breakthrough, and suggested that 12 weeks of telaprevir-based therapy enabled some patients to clear the virus.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) is developing telaprevir in collaboration with Tibotec.
?The high rates of RVR observed in the telaprevir groups in PROVE 1, and the fact that some patients have remained persistently viral negative 20 weeks after stopping the 12 weeks of telaprevir-based therapy, suggest that we may be able to shorten the treatment duration in genotype 1 HCV patients,? said John McHutchison, M.D., Principal Investigator for the PROVE 1 study and Director of Gastroenterology and Hepatology Research at Duke Clinical Research Institute.
?These interim results are encouraging and suggest that high sustained viral response (SVR) rates may be achieved with regimens that are 24 weeks in total duration. We look forward to 24 week follow-up data from the initial group of patients who stopped treatment at 12 weeks, and follow-up data from patients in the study who received 24 weeks of treatment.?