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Boehringer Ingelheim’s BI 201335 plus BI 207127

Terms used in these reports:

  • RVR (Rapid virological response)= No virus detected at week 4
  • eRVR(Extended rapid virological response) = No virus detected at week 4 and week 12
  • EVR (Early Virological Response) — 2 log drop of HCV RNA after 12 weeks.
  • cEVR = Complete Early Virological Response — No virus detected after 12 Weeks.
  • SVR12 (Sustained virological response) = No virus detected at 12 weeks after completion of treatment.
  • SVR24 = No virus detected at 24 weeks after completion of treatment.

Boehringer Ingelheim are developing a combination therapy that consists of a polymerase inhibitor BI 207127 and a protease inhibitor BI 201335 taken together with or without Ribavirin. Current research is showing good results for patients with the most difficult to treat genotype-1.

Like many of the other DAA’s (Direct Acting Antivirals) in development, these studies are being conducted without the use of Interferon and will be an all oral (in the form of pills) treatment.

A copy of the Press release containing the latest research into BI 207127 and BI 201335 that was unveiled at the American Association for the Study of Liver Diseases Liver Meeting (AASLD 2012) is below.

BI 201335 plus BI 207127

INGELHEIM, 10 November 2012 – Final results from the Phase IIb study, SOUND-C2, confirmed that up to 85 percent of hepatitis C (HCV) patients infected with the most prevalent type of HCV globally, genotype-1b (GT-1b), achieved and subsequently sustained viral cure with Boehringer Ingelheim’s interferon-free regimen, when measured 12 and 24 weeks (SVR12 & SVR24) after treatment. This high cure rate was achieved following just 28 weeks of treatment with the highly effective polymodal* therapy, faldaprevir (BI 201335)+, a potent next wave once daily protease inhibitor, and BI 207127+, a potent non-nucleoside polymerase inhibitor, plus ribavirin.1

These full results from the largest interferon-free trial of its kind to be concluded to date, include patients with advanced liver disease that are more challenging to cure. Boehringer Ingelheim’s rigorous HCV development programme aims to include a diverse population that reflects the type of patients that physicians see in clinical practice. Through its comprehensive study programme, Boehringer Ingelheim aims to deliver an all-oral interferon-free therapy that would enable more patients to achieve a viral cure with shorter treatment duration and an improved side-effect profile, compared to current-interferon based treatments.

Results are being presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), 9 – 13 November in Boston, MA. Building on this success, the pivotal Phase III clinical trial programme for this all-oral interferon-free HCV regimen will be initiated shortly.

"Eliminating interferon-alfa is a critical goal in hepatitis C. These Phase IIb results bring us a step closer to an interferon-free anti-HCV treatment for many patients," said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Goethe University Hospital in Frankfurt, Germany. "We included a broad spectrum of patients in SOUND-C2, reflecting those that we see day-to-day in our clinics, including patients with cirrhosis, who desperately need an effective alternative treatment option to interferon-based therapies."

The Phase IIb study included 362 treatment-naïve patients with genotype-1 HCV (both GT-1a and GT-1b infection). When looking at all patients collectively, inclusive of the most challenging to cure, a viral cure was achieved for 69 percent, compared with 85 percent seen in the prevalent GT-1b patient subgroup. 9 percent of the total population had liver cirrhosis (severe scarring of the liver), an advanced form of liver disease and achieved viral cure rates of up to 67 percent.2 This represents a population with high unmet need, urgently requiring more effective and better tolerated treatment.3 Interferon is a central component of existing treatment, however, it can be difficult for patients to take due to long treatment duration and often severe side-effects.4,5 Interferon containing regimens are not an option for up to 50 percent of patients.6

"Based on the high viral cure rates seen in the Phase IIb studies for our novel hepatitis C compounds faldaprevir and BI 207127, we are optimistic in being able to deliver new treatment options in response to the high unmet medical need in HCV," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "We are proud to announce the initiation of our robust Phase III interferon-free trial programme in HCV. We continue to pursue our goal of delivering an all-oral, highly effective polymodal therapy without interferon, to provide more hepatitis C patients with a viral cure, following a shorter treatment, and reduce harsh side-effects."

The most common adverse events (AEs) in SOUND-C2 were mild skin changes (itchy skin, rash or photosensitivity) or gastrointestinal (GI) disorders and transient indirect hyperbilirubinemia which sometimes presented as jaundice.1 36 percent of patients experienced some form of side-effect, 12 percent of these were considered severe and eight percent led to discontinuation of treatment.1 This compares with approximately 25 percent discontinuation due to adverse events associated with interferon and ribavirin treatment.7