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Tibotec BVBA today announced results of an open label study, which showed that overall 59 percent of patients with chronic genotype 1 hepatitis C virus (HCV) who failed prior treatment with the standard of care were able to achieve sustained virologic response (SVR) when telaprevir was added to their regimen during a new course of treatment.
Telaprevir, an investigational DAA (Direct Acting Antiviral), is being co-developed by Tibotec and Vertex Pharmaceuticals. Data from Study 107 were presented today at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
Chronic infection with HCV can cause severe liver problems, including liver cancer and cirrhosis, and is the most common cause of liver transplant in Europe. The goal of HCV treatment is to achieve SVR, which means the virus remains undetectable in patients blood six months after they have finished treatment. The current standard of care for HCV, pegylated interferon combined with ribavirin, may cause debilitating side effects and cures approximately half of patients starting therapy for the first time. For those that fail therapy, there are currently no effective therapeutic options.
“This study is encouraging for patients who have failed standard HCV treatment and have limited options remaining to achieve SVR,” said Thomas Berg, M.D., Professor, Hepatology, University Clinic, Leipzig, Germany. “The addition of telaprevir to standard therapy can help a significant amount of hard-to-treat patients achieve SVR, and do so in a relatively short amount of time.”
Patients in this open-label study were null responders, partial responders, relapsers, or had viral breakthrough in the control arms of the PROVE1/2/3 studies, in which they were treated with peginterferon and ribavirin (PR). In Study 107, 117 patients were treated with 12 weeks of telaprevir (750 mg) combined with PR, followed by either 12 or 36 weeks of PR alone depending on HCV RNA levels at week 4 and week 12.
Initially, all patients were to receive a total of 24 weeks of therapy. The protocol was later amended and total treatment duration was decided as follows: partial responders, viral breakthroughs, and relapsers with undetectable HCV RNA at week 4 and/or week 12 received 12 additional weeks of PR.4 Patients with detectable HCV RNA at week 4 and/or week 12 and all null responders received an additional 36 weeks of PR.
Of the 81 patients who received 24 weeks of treatment, 60 percent achieved SVR, including 17 percent of prior null responders (n=24), 60 percent of prior partial responders (n=25), 96 percent of prior relapsers (n=25), and 86 percent of those with prior viral breakthrough (n=7). Of the 34 patients who received 48 weeks of treatment, 53 percent achieved SVR, including 56 percent of prior null responders (n=27), and 100 percent of prior relapsers (n=3). No prior partial responders (n=3) or viral breakthrough patients (n=1) in the group receiving 48 weeks of treatment achieved SVR.
“This study is an important milestone in our company’s entry into the hepatitis C arena and an expression of our commitment to improving cure rates for this highly prevalent disease for which many unmet needs remain,” said Maria Beumont-Mauviel, Medical Director, Clinical Development, Tibotec.
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