Studi scientifici principali
- 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
- 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.
- 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.
- Initial Data Assesment Study AI444042-Primary Analysis: Follow-up Week 12 (SVR12).
- 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.
- 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.
- 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.
- 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.
- 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.
- Studio di fase 3 Daclatasvir, Sofosbuvir e ribavirina in soggetti cirrotici e soggetti post-trapiantati (ALLY-1). Codice identificativo Clinical Trial.gov: NCT02032875.
- 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.
- 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.
- Studio di fase 3 Daclatasvir e Sofosbuvir per i pazienti affetti da HCV genotipo 3 (ALLY-3). Codice identificativo Clinical Trial.gov: NCT02032901.
- 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.
- 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.
- ICH Harmonised Tripartite Guideline. Ethnic Factors in the Acceptability of Foreign Clinical Data. Topic E5 (R1), 1998.
- 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.
- 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.
- 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.
- Nonclinical Report Addendum: In vitro efficacy of the NS5A inhibitor, BMS-790052, Bristol-Myers Squibb Company, 2013, Document Control Number 930023288.
- 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.
- 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.
- 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
