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Telaprevir –A drug promise for HCV treatment-failed patients?

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Monday, April 27, 2009, 11:35 This news item was posted in Pharma category and has 0 Comments so far.

 

Telaprevir, a protease inhibitor drug is found to be a potential treatment against hepatitis C virus. 

Telaprevir has shown unprecedented sustained viral response or SVR rates in hepatitis C-infected treatment-failure patients, including those with cirrhosis, according to data from Vertex Pharmaceuticals.

Telaprevir has proved superior efficacy across all HCV genotype 1 non-responders and up to 76% in prior relapsers and patients with cirrhosis.

Telaprevir showed 51% and 52% SVR rates in telaprevir-based regimens compared to 14% in the 48-week control arm,   Treatment-failure patient population represents the greatest unmet medical need in HCV,  data Presented at 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark shows.

Telaprevir is being developed by Vertex Pharmaceuticals Inc in collaboration with Tibotec and Mitsubishi Tanabe Pharma.

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease. HCV protease is an enzyme essential for viral replication. Telaprevir is in Phase 3 clinical trials in treatment-naive and treatment-failure patients.

In comparison, SVR rates were achieved by 14% of patients randomized to receive 48 weeks of peg-IFN and RBV alone. Adverse events were generally consistent with those reported in prior telaprevir Phase 2 trials.

“Previously treated patients who didn’t achieve SVR represent the hardest to treat patient population in physicians’ practices,” said Michael P. Manns, M.D., Principal Investigator for the PROVE 3 Study and Director of the Department of Gastroenterology, Hepatology and Endocrinology at Medical School of Hannover, Germany.

The SVR rates achieved in this difficult-to-treat population, with safety results consistent with prior telaprevir studies, add to the growing body of data supporting further development of telaprevir across the broad HCV patient population, researchers said.

Telaprevir using PROVE 3 was a randomized, double-blind, placebo-controlled Phase 2b study. The study enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders, prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The results included 453 patients who were enrolled and received at least one dose of study drug.

Sixty-nine and 76% of prior relapsers in the 24- and 48-week telaprevir-based treatment arms, respectively, achieved SVR as compared to 20% in the control arm, and 39%.

38% of prior non-responders in the 24- and 48-week telaprevir-based treatment arms, respectively, achieved SVR as compared to 9% in the control arm.

For cirrhosis patients,  53% and 45% of success rate was achieved in the 24- and 48-week telaprevir-based treatment arms compared to 8% in the control arm – these results were similar to those obtained for patients without cirrhosis.

Telapavir’s adverse events reported were fatigue, nausea, headache, rash, pruritus, diarrhea, insomnia, pyrexia, alopecia, and chills. Erythropoiesis stimulating agents (ESA) were not recommended for the PROVE 3 study and were rarely used (in less than 1% (2 of 339) of patients) in the telaprevir-based treatment arms.

Vertex retains commercial rights to telaprevir in North America. Vertex and Tibotec are collaborating to develop and commercialize telaprevir in Europe, South America, Australia, the Middle East and other countries. Vertex is collaborating with Mitsubishi Tanabe Pharma to develop and commercialize telaprevir in Japan and certain Far East countries.

About Hepatitis C

Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people. Though 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.

Current therapies for HCV provide sustained benefit in less than half of patients with genotype 1 HCV, the most common strain of the virus. As many as 250,000 patients in the United States have received at least one course of treatment with pegylated interferon and ribavirin but have not achieved sustained virologic response (SVR). Patients who have failed interferon-based treatment typically have few or no available treatment options, and are at risk for progressive liver disease. In a recent study, the risk of liver failure, cancer or death following unsuccessful HCV treatment was 23% after 4 years, and 43% after 8 years.

Vertex Pharmaceuticals Incorporated is a global biotechnology company developing small molecule drugs for serious diseases.. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

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