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28 April 2013

Boehringer Ingelheim announces results from one of its HCV Phase III trials: Investigational compound faldaprevir+shows high viral cure and early treatment success in treatment-naïve patients with genotype-1 hepatitis C




Results from the pivotal Phase III STARTVerso TM1 trial for the investigational once-daily protease inhibitor faldaprevir+ (BI 201335), combined with pegylated interferon ?2a and ribavirin (PegIFN/RBV), in treatment-naïve patients with chronic genotype-1 hepatitis C infection, will be presented at the International Liver CongressTM (ILC) in Amsterdam this week. The primary endpoint of the trial was sustained virological response 12 weeks after completion of treatment (SVR12).1
In STARTVersoTM1, patients who received faldaprevir+plus PegIFN/RBV were able to stop all treatment early if their virus level was low enough at week 4 and week 8 of treatment (Early Treatment Success (ETS) as defined in the protocol*).1 ETS was achieved by 88 percent of patients treated with the faldaprevir+-based regimen.1These patients were eligible to stop all treatment at week 24 and 88 percent of them achieved viral cure (SVR12). In the whole study, up to 80 percent of faldaprevir+ treated patients achieved the primary end point of viral cure when measured 12 weeks after treatment was stopped (SVR12).1 In comparison, only 52 percent of patients who received placebo plus PegIFN/RBV achieved SVR12.1 No dose effect on efficacy was observed for faldaprevir in the study. With the lower 120mg once-daily dosing of faldaprevir+ 79 percent achieved viral cure (SVR12). Side-effect related treatment discontinuation was similar to placebo.1
"These results are encouraging as STARTVersoTM1 included a significant proportion of patients with advanced liver disease and still demonstrated an SVR12 rate up to 80 percent in patients treated with the faldaprevir+ containing regimen," Principal Investigator Professor Peter Ferenci of the Medical University Vienna pointed out. "The fact that the vast majority of patients were able to stop treatment early (after 24 weeks) and achieve viral cure along with the favourable tolerability of faldaprevir+ is very promising."
In addition, faldaprevir+ was well tolerated and adverse events that led to discontinuation of all study medications were similar to placebo (5% for 120mg faldaprevir+ treated patients vs. 4 % for placebo treated patients).1 Elevations in unconjugated bilirubin were observed in all faldaprevir+ dose groups, but these were reversible and not accompanied by increases in liver enzymes. Other changes in laboratory parameters, including those relating to haemoglobin, neutrophil counts and white blood cells, were also similar across all treatment arms. Anaemia (11%, 13%, 12%), rash (6%, 8%, 9%) and gastrointestinal issues (3%, 7%, 12%) were the most common Grade 2-4 adverse events in the placebo, faldaprevir 120mg and faldaprevir 240mg arms, respectively.
"These Phase III results for the faldaprevir interferon-based regimen represent an important milestone as we continue to strive towards our ambition to develop a well-tolerated treatment option that considerably improves cure rates in difficult to cure genotype-1 patients. At the same time, nearly 90 percent of patients qualified for 24 weeks total treatment," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "Reducing the duration of interferon-based treatment means a considerable benefit in terms of quality of life "´ as well as providing a therapy regimen that relieves the patient from a high-pill burden and the necessity of a high fat diet intake."
The STARTVersoTM1 results are due to be presented tomorrow at the International Liver Conference TM (ILC) as part of the official press conference. In depth data will be provided by Professor Peter Ferenci during the oral presentation session Free Presentations "´ 

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