iconstar paper   Hepatitis C Articles (HCV)  
Back grey arrow rt.gif
BI HCV Protease & Other New HCV Drugs
  from Jules: studies from many new drugs support that for a significant number of patients, particularly for those who achieve an early good response at weeks 4 and 12, 12 weeks therapy may be adequate. New oral HCV drugs in combinations of 2, 3 or 4 with or without Peg/Rbv will cure very close 100% of patients in studies, we are moving very quickly to this point, but the studies are still ongoing & so these drugs & combination therapies are not yet available in the pharmacy but now only in clinical studies. But we will I say be there in several years. At this AASLD in San Francisco just completed yesterday many new study presentations support this. Here are links to the studies:

62th Annual Meeting of the American Association for the Study of Liver Diseases
San Francisco
2011 Nov 6-9

BI 201335 Shortens HCV Treatment Duration While Achieving High-sustained Virological Response Rates

AASLD: Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD - press release - (11/08/11)

AASLD: Treatment with the 2nd generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates - results from SILEN-C1 in treatment-naïve patients across different baseline factors - (11/08/11)

AASLD: High SVR following IFN-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI 201335, polymerase inhibitor BI 207127 and ribavirin, followed by BI 201335 and PegIFN/ribavirin - the SOUND-C1 study - (11/08/11)

AASLD: SILEN-C3: treatment for 12 or 24 weeks with BI 201335 combined with peginterferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype-1 HCV infection - (11/07/11)

AASLD: Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study - (11/08/11)

At the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, Boehringer Ingelheim presented results from two Phase IIb studies that assessed the combination of the company's next generation protease inhibitor, BI 201335, with pegylated interferon (PegIFN) and ribavirin (RBV) in treatment-naïve genotype 1 (GT1) hepatitis C (HCV) patients.

Findings from the SILEN-C3 study demonstrated that BI 201335 can potentially shorten the period of treatment to 12 weeks and improve the likelihood of viral cure (sustained viral response; SVR) compared with shorten patients' treatment duration to 12 weeks and improve the likelihood of viral cure (sustained viral response; SVR) compared with traditional standard of care of 48 weeks of PegIFN/RBV therapy alone. The SILEN-C1 study also showed BI 201335's ability to improve SVR in commonly difficult to treat populations.

Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim commented:

"Reducing the length of treatment time for HCV patients is one of several important goals for Boehringer Ingelheim as we seek to innovate a better cure for this chronic disease. The SILEN-C3 study results are very encouraging and suggest that treatment with BI 201335 may not be required beyond 12 weeks in the majority of treatment-naïve HCV patients. Results from the SILEN-C1 study in difficult to treat virus types are also encouraging and we are keen to see the outcomes of our BI 201335 Phase III studies in 2013."

According to SILEN-C3 study findings, 12 weeks of treatment with BI 201335 was sufficient to attain SVR for patients to reach an extended rapid viral response (eRVR), whilst those with undetectable HCV RNA in the blood before week 12 showed similar SVR rates, irrespective of whether BI 201335 treatment was administered for 12 (82%) or 24 (81%) weeks.

The overall analysis of the SILEN-C1 study also demonstrates that in addition to the SILEN-C3 study, 83.1% of patients treated with BI201335 240 mg QD achieved SVR, compared with 56.3% of patients on PegIFN/RBV alone (p<0.0001).

Most patients with difficult to treat HCV subtypes, such as those with the viral GT1a or the IL-28B non-CC gene variant (polymorphism), achieved SVR. Particularly in 32 patients with GT1a HCV, a virus type that tends to be more treatment resistant than GT1b, 82% achieved SVR compared with 38 GT1b HCV patients who achieved 84% SVR. 29 Patients with the non-CC polymorphism of the IL-28B gene also achieved SVR of 71%, and whilst 11 patients with the CC polymorphism reached an SVR of 100%, 31 of patients with missing IL-28B genotyping reached 86%. The findings also showed that patients exhibiting the non-CC polymorphism are less likely to achieve SVR with PegIFN/RBV treatment.

GT1 HCV represents the biggest challenge for treating the genotype HCV and those carrying the IL-28B non-CC polymorphism tend to achieve less SVR compared with those with the CC polymorphism. Some studies demonstrate a difference in treatment response, which is almost seven fold.

Written by Petra Rattue
Copyright: Medical News Today

  iconpaperstack View Older Articles   Back to Top   www.natap.org