Vertex Hepatitis C Drug Works in More than 80% of Patients
Vertex has announced the results of their Phase 2 Study C208 which explored the use of telaprevir-based regimen in hepatitis C patients. The study which showed more than 80% of patients responded is to be represented at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which began yesterday in Boston.
Telaprevir (VX-950) is an investigational oral hepatitis C virus (HCV) protease inhibitor being developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec and Mitsubishi Tanabe Pharma. Telaprevir is being evaluated as part of a global Phase 3 registration program in more than 2,200 treatment-naïve and treatment-failure patients.
Study C208, an exploratory, four-arm, randomized, open label, Phase 2 clinical trial, was conducted by Tibotec in Europe in 161 treatment-naïve patients with genotype 1 HCV infection. The study evaluated the safety and efficacy of telaprevir administered every 12 hours (1125mg) or every eight hours (750mg). Each dosing regimen of telaprevir was studied in combination with either peg-IFN-alfa-2a (PEGASYS) or peg-IFN-alfa-2b (PEGINTRON) and ribavirin (RBV), the currently approved therapies for chronic HCV infection.
Across the four arms, sustained viral response (SVR) rates were 82% and 83% in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively). SVR was 81% and 85% in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen.
The study protocol stipulated that patients who achieved a rapid viral response (RVR) at week 4 and who maintained undetectable HCV RNA (<25 IU/mL, undetectable Roche COBAS TaqMan HCV test)through to week 20, were able to stop all treatment at the 24-week time point and were followed six-months post-treatment to evaluate whether they achieved an SVR. Patients who did not meet the response-guided criterion were assigned to receive a total of 48 weeks of peg-IFN and RBV therapy. Eighteen percent of patients across the treatment arms were required to continue treatment up to week 48.
Low rates of viral relapse (defined as patients who achieved undetectable HCV RNA at the completion of treatment, but relapsed during post-treatment follow up) were observed in patients who completed their assigned regimen (3%).
The frequency and severity of adverse events (AEs) and the rate of treatment discontinuations were similar to those reported in prior telaprevir trials. The most common adverse events reported were pruritis, nausea, rash, anemia, flu-like illness, fatigue and headache, and were similar overall between the patient groups receiving every 8 hour dosing and those receiving every 12 hour dosing. Serious AEs leading to permanent treatment discontinuation of all drugs occurred in 8 out 161 patients (5%) and were mainly related to rash (3%, 4/161) and anemia (2%, 3/161).
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), affecting 3.2 million individuals in the United States. Hepatitis C is spread through direct contact with the blood of infected people. Many people with HCV infection may not experience symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue and fever. Chronic HCV significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death.
Vertex Pharmaceuticals Press Release