2007 4 Week Therapy With the Non-Nucleosidic Polymerase Inhibitor Bi207127 in Combination With Peginterferon-Alfa2a and Ribavirin in Treatment Naive and Treatment Experienced Chronic HCV Gt1 Patients

Larrey, Dominique; Lohse, AW; Lédinghen, Victor de; Trépo, Christian; Gerlach, Tilman; Zarski, Jean–Pierre; Tran, Albert; Mathurin, Philippe; Thimme, Robert; Arastéh, Keikawus; Cerny, Andreas; Dikopoulos, Nektarios; Schuchmann, Marcus; Heim, Markus H.; Gerken, Guido; Stern, Jerry O.; Wu, Kou Juey; Abdallah, Nahed; Girlich, Birgit; Josepf, S.; Wulf, Bradley G.; Berger, F; Steffgen, Jürgen

doi:10.1016/s0168-8278(10)61198-1

Cited by 15 publications

(13 citation statements)

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“…BI 207127 is currently in phase 2 of development. 10 Drug resistance stud-ies in cell culture show that BI 201335 and BI 207127 have different resistance profiles, and previous observations using NS3/4A protease inhibitors and NS5B thumb pocket 1 NNI compounds have shown that 2-drug combinations profoundly reduce the selection of drug-resistant variants. 11 Here we report the results of a clinical phase 1b trial (SOUND-C1: Safety and antiviral effect of Oral combinations withoUt iNterferon in patients Diagnosed with chronic hepatitis C) investigating the safety, antiviral effect, and pharmacokinetics of BI 207127 in combination with BI 201335 and RBV for 4 weeks in treatment-naïve patients with chronic HCV GT-1 infection.…”

Section: Watch This Article's Video Abstract and Others At Http:// Timentioning

confidence: 95%

Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection

et al. 2011

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Section: Watch This Article's Video Abstract and Others At Http:// Timentioning

confidence: 95%

Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection

et al. 2011

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“…Four weeks of BI 207127 (600 mg three times daily) in combination with PEG-IFN alfa-2a/RBV has resulted in a median reduction of 5.6 log 10 HCV RNA in treatment-naïve genotype 1 patients and no viral breakthrough was observed [58]. Results of further studies have to be awaited.…”

Section: Antivirals Targeting the Hcv Rna Polymerasementioning

confidence: 99%

New hepatitis C therapies in clinical development

Vermehren

Sarrazin

2011

Eur J Med Res

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With the current standard of care for the treatment of chronic hepatitis C, a combination of pegylated interferon alfa and ribavirin, sustained virologic response rates can be achieved in approximately 50% of patients only.Improved understanding of the viral life cycle has led to the identification of numerous potential targets for novel, direct-acting antiviral compounds. Inhibitors of the NS3/4A protease are currently the most advanced in clinical development. Recently completed phase 3 studies of the two protease inhibitors telaprevir and boceprevir, each given in combination with standard of care, yielded sustained virologic response rates in the range of 66-75% in treatment-naive patients and 59-66% in treatment-experienced patients with HCV genotype 1 infection. Studies of second-generation protease inhibitors, with the potential advantage of improved potency, drug metabolism and pharmacokinetics profile, are already underway.Inhibitors of the HCV NS5A protein and NS5B polymerase are potentially active across different HCV genotypes and have shown promising antiviral efficacy in early clinical studies. Other emerging mechanisms include silymarin components and inhibitors of cell proteins required for HCV replication.While improved formulations of current HCV therapies are also being developed, future hopes lie on the combination of direct-acting antivirals with the eventual possibility of interferon-free treatment regimens.

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“…BI207127 (77), Filibuvir (78), ANA598 (79), ABT‐072 and ABT‐333 have good antiviral properties. When used with PEG/RIB, BI207127 increased rates of RVR (80), ABT‐072, ABT‐333 (81) and filibuvir achieved high rates of EVR. However, ANA598 treatment with PEG/RIB did not have any advantage over PEG/RIB (82).…”

Section: Resultsmentioning

confidence: 99%

New therapies for chronic hepatitis C infection: a systematic review of evidence from clinical trials

Lee¹,

Tong²,

Wong³

et al. 2012

International Journal of Clinical Practice

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Summary Introduction: Hepatitis C virus (HCV) affects approximately 3% of the world population. The current standard of care for treatment of HCV is a combination of pegylated interferon and ribavirin. Approximately 10% of patients will stop treatment and 30% of patients require dose reduction because of side effects. For genotype 1 HCV‐infected patients, only 40% of patients will achieve undetectable viral load 26 weeks posttreatment. Aims: The objectives of this review were to identify new treatments that are in clinical trials. These include boceprevir and telaprevir which are in routine clinical use and form part of the American Association for the Study of Liver Diseases (AASLD) 2011 guidelines as well as drugs based on observational studies, improving/modifying ribavirin or interferon‐based therapies, modifying the host response and finally the use of direct‐acting antiviral agents (DAA). Materials and methods: MEDLINE and EMBASE databases were searched from 2008 to 2011 for treatments for hepatitis C. Furthermore, abstracts and poster presentations for the annual European Association Study of the Liver, AASLD, Digestive Disease Week and Asian Pacific Association for the study of the Liver were searched for relevant material. Results: All four classes of DAA; NS3/NS4a serine protease inhibitors, cyclophilin inhibitors, NS5b polymerase inhibitors and NS5a inhibitors, show good success rates. Trials have been performed without ribavirin or interferon and demonstrate good antiviral activity with a decreased side effect profile. Combinations of DAA are a promising area of research with a high success rate. Conclusions: Clinical trials show that future HCV therapy could be personalised, achieve higher success rates with decreased adverse incidents.

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2007 4 Week Therapy With the Non-Nucleosidic Polymerase Inhibitor Bi207127 in Combination With Peginterferon-Alfa2a and Ribavirin in Treatment Naive and Treatment Experienced Chronic HCV Gt1 Patients

Cited by 15 publications

References 0 publications

Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection

Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection

New hepatitis C therapies in clinical development

New therapies for chronic hepatitis C infection: a systematic review of evidence from clinical trials

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