Achieved a sustained viral response in 83% of patients with hepatitis C protease inhibitor for HCV New Boehringer Ingelheim
‘The final results of the Silen-C1 and two studies have demonstrated the potential for an excellent performance of this protease inhibitor once daily in a wide range of HCV patients,’ said Prof. ‘The current standard of care for HCV is not effective for many patients. The cure rate achieved viral protease inhibitors, such as IB 201 335 highlights the potential to improve treatment outcomes and the possibility of shortening the overall treatment of most HCV patients. ‘Silen-C2 in the study, patients in the non-response, the dosage of 240mg once a day 201 335 BI has also achieved impressive results in a population that has not responded to the SOC, and reached such a lead-in therapy.
The most common adverse events related to the dose in BI-201335 treatment groups were mild gastrointestinal disturbances, rash, and mild photosensitivity resulting from an isolated unconjugated hyperbilirubinaemia. Mean alanine aminotransferase (ALT) improved in all groups compared to placebo BI 201,335. Interestingly, there was no excess of anemia reported in the active group compared to SOC. In Phase III BI 201 335 are in preparation.
Phase II-C2 Silen study evaluated the virologic response and safety of different doses of BI 201335 in treatment-experienced patients who have not responded to at least 12 weeks prior to peginterferon / RBV. The results demonstrate that treatment with BI 201,335 times a day to 240 mg, COS offers the most efficient and well tolerated in this very difficult to treat patient population, with 41percent achieved SVR. As shown in Silen-C1, an advance of three days with COS was associated with reduced viral response. In Phase III BI 201 335 are in preparation.
The most common adverse events related to the dose of BI 201335 treatment groups were similar to those observed in C1-Silen. Severe or serious adverse events were reported more frequently in the BI 201335 240mg bid with lead (LI) group.
(Oral presentation at EASL Parallel Session: HCV drug development, 17:30 am-17: 45 hours, Abstract 66) SILEN-C 2: SVR and safety of BI 201,335 combined with peginterferon alfa-2a and ribavirin in hepatitis chronic HCV genotype-1 patients with non-response to peginterferon / RBV
The new data presented today at the International Liver CongressTM 2011, the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin, stressed the effectiveness of the Boehringer Ingelheim times a day orally protease inhibitor BI 201335, in both treatment-na ve and-experienced patients with genotype-1 chronic hepatitis C virus (HCV). HCV genotype, HCV genotype-1 is the most difficult to treat.
The results of Silen-C1 show trial of high rates of sustained virologic response (SVR, which is considered a cure viral) in patients without prior treatment, who received 120 mg or 240mg BI 201,335 times a day compared to standard current treatment (SOC ) or pegylated interferon (peginterferon) and ribavirin (RBV). Up to 87percent of patients were able to reduce the overall treatment of 48 to 24 weeks.
