cnl_21

Studi scientifici principali



    1. EPAR European Public Assessment Report Daklinza 2014 - Product Information http://www.ema.europa.eu/ema/index. jsp?curl=pages/medicines/human/medicines/003768/human_med_001792.jsp&mid=WC0b01ac058001d124

    2. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T et al., AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N EnglJ Med. 2014 Jan 16;370(3):211-21.

    3. AI444010 Clinical Study Report: A Phase 2b study of BMS-790052 in combination with peg-interferon alfa-2a and ribavirin in treatment naïve subjects with chronic hepatitis C genotype 1 and 4 infection. Bristol-Myers Squibb Company; 2013. Document Control No. 930068336.

    4. Initial Data Assesment Study AI444042-Primary Analysis: Follow-up Week 12 (SVR12).

    5. AI444011 Clinical Study Report: A Phase 2B Study of BMS-790052 in Combination with Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who are Null or Partial Responders to Prior Treatment with Peginterferon Alfa plus Ribavirin Therapy. Bristol-Myers Squibb Company; 2013. Document Control No. 930068338.

    6. AI444014 Clinical Study Report: A Phase 2a study of BMS-790052 in combination with peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in treatment naïve subjects with chronic hepatitis C virus genotype 1 infection. Bristol-Myers Squibb Company; 2010. Document Control No. 930046340.

    7. AI444021 Clinical Study Report: A Phase 2a study of BMS-790052 in combination with peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®) in Japanese subjects with genotype 1 chronic hepatitis C virus (HCV) infection. Bristol-Myers Squibb Company; 2012. Document Control No. 930062734.

    8. AI444022 Clinical Study Report: A Phase 2a study of BMS-790052 in combination with peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in Japanese subjects with genotype 1 chronic hepatitis C virus (HCV) infection. Bristol-Myers Squibb Company; 2012. Document Control No. 930064826.

    9. AI444031 Clinical Study Report: A Phase 2b pilot study of short-term treatment of BMS-790052 in combination with peg-interferon alfa-2a and ribavirin in treatment naïve subjects with chronic hepatitis C genotype 2 or 3 infection. Bristol-Myers Squibb Company; 2013. Document Control No. 930070641.

    10. Studio di fase 3 Daclatasvir, Sofosbuvir e ribavirina in soggetti cirrotici e soggetti post-trapiantati (ALLY-1). Codice identificativo Clinical Trial.gov: NCT02032875.

    11. Poordad F. et al, Daclatasvir, Sofosbuvir, and Ribavirin Combination for HCV Patients with Advanced Cirrhosis or Post-transplant Recurrence: ALLY-1 Phase 3 Study. Oral Presentation EASL 2015, Vienna, 22-26 Aprile 2015.

    12. Daclatasvir in Combination With Sofosbuvir for HIV/HCV Coinfection: ALLY-2 Study - Wyles DL, Ruane P, Sulkowski M, Dieterich D, Luetkemeyer AF, Morgan TR, Sherman KE, Liu Z, Noviello S, Ackerman P. Oral Presentation CROI 2015 Seattle, WA, February 23-26.

    13. Studio di fase 3 Daclatasvir e Sofosbuvir per i pazienti affetti da HCV genotipo 3 (ALLY-3). Codice identificativo Clinical Trial.gov: NCT02032901.

    14. Nelson, et al. All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 Study. Hepatology. 2015 Jan 23.

    15. Hezode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med 2009; 360(18):1839-50.

    16. ICH Harmonised Tripartite Guideline. Ethnic Factors in the Acceptability of Foreign Clinical Data. Topic E5 (R1), 1998.

    17. European Medicines Agency. Reflection paper on the extrapolation of results from clinical studies conducted outside the EU to the EU population. EMEA/CHMP/EWP/692702/2008.

    18. Osinusi A, Meissner EG, Lee YJ et al., Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA. 2013; 28;310(8):804-11.

    19. Genotypic and Phenotypic Analysis of Daclatasvir in Hepatitis C Virus Genotype-4 NS5A Sequences and Comparison with Genotype 1. Bristol-Myers Squibb Company 2013, Document Control Number 930073428.

    20. Nonclinical Report Addendum: In vitro efficacy of the NS5A inhibitor, BMS-790052, Bristol-Myers Squibb Company, 2013, Document Control Number 930023288.

    21. Hézode C. et al, Daclatasvir plus peg-interferon alfa-2a and ribavirin for treatment naïve chronic hepatitis C genotype 1 or 4 infection: a randomized study. Gut 2014 Jul 30.

    22. Hézode c. et al daclatasvir plus sofosbuvir with or without ribavirin in patients with hcv genotype 3 infection: interim analysis of a french multicenter compassionate use program, oral presentation easl 2015, vienna, 22-26 aprile 2015.

    23. Gr foster, treatment of decompensated hcv cirrhosis in patients with diverse genotypes: 12 weeks sofosbuvir and ns5a inhibitors with/without ribavirin is effective in hcv genotypes 1 and 3, uk cohort, oral presentation easl 2015, vienna, 22-26 aprile 2015


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