De noterade företagens konvertering till IAS/IFRS

Syfte: Syftet är att redogöra för hur långt de noterade företagen har kommit med sitt arbete att konvertera till IAS/IFRS och att identifiera de standarder samt de affärsmässiga konsekvenser som skapar störst omställningsproblem i konverteringsarbetet. Metod: Induktivt tillvägagångssätt med deskriptivt syfte. Kvalitativa intervjuer, kvantitativ enkätundersökning och kvantitativ innehållsanalys. Teoretiska perspektiv: De noterade företagen befinner sig i en ständig förändringsprocess då redovisningen harmoniseras inom EU. Den 1 januari 2005 ska företagen ha anpassat sig till IAS/IFRS. Empiri: Den empiriska delen består av intervjuer samt en enkätundersökning på de svenska börserna. I en innehållsanalys granskas vad de mest omsatta företagen (på Stockholmsbörsens A-lista) skrivit om konverteringen i sina koncernredovisningar för räkenskapsåret 2003. Slutsatser: Många företag har mycket kvar att arbeta med, inga varningsflaggor hängs dock i dagsläget upp för att företagen inte skulle ha kommit tillräckligt långt. Det största problemet för företagen vid konverterings-arbetet är osäkerheten kring vilka standarder som ska implementeras samt vilket utseende dessa kommer att anta. De individuella standarder som bedöms medföra störst omställningsproblem är IAS 39, IAS 19/RR 29 och IAS 22/IFRS 3

C-BREEZE 1: Efficacy and safety of ruzasvir 60 mg plus uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis c virus (HCV) genotype (GT)1, 2, 3, 4, or 6 infection.

Background: Ruzasvir (RZR, MK‐8408, an NS5A inhibitor) plus uprifosbuvir (UPR, MK‐3682, an NS5B uridine nucleotide polymerase inhibitor) in combination with grazo‐ previr (GZR, an NS3/4A inhibitor) as a three‐drug regimen has demonstrated promising efficacy in people with HCV GT1, 2, 3, 4, or 6 infection. Given the high efficacy of the three‐drug regimen, the aim of this trial was to evaluate the safety and efficacy of a two‐drug regimen of RZR 60 mg + UPR 450 mg without ribavirin for 12 weeks. Methods: A Phase 2, open‐label, multi‐arm clinical trial was conducted in adults with GT1‐6 chronic HCV infection who were treatment‐naive or treatment‐experienced with interferon ± RBV and either had no cirrhosis or compensated cirrhosis (NCT02759315). All participants received RZR 60 mg + UPR 450 mg once daily for 12 weeks. The primary objectives were the assessment of efficacy (sustained virologic response at 12 weeks after the end of study therapy [HCV RNA \u3c15 IU/mL]), and safety and tolerability. Resistance‐associated substitutions (RASs) were assessed using next‐generation sequencing (15% sensitivity threshold). Results: One hundred sixty participants were enrolled (GT1a, n=54; GT1b, n=15; GT2, n=29; GT3, n=39; GT4, n=20; GT5, n=0; GT6 n=3), 50 (31%) of whom had cirrhosis. All participants had HCV RNA \u3c15 IU/mL at the end of treatment. Results to date are based on 149 participants who received 12 weeks of therapy and have at least 8 weeks of post‐therapy follow‐up (Table) One cirrhotic treatment naïve participant with GT1a infection and baseline NS5A Q30H and Y93H RASs relapsed with detectable treatment‐emergent Q30L and M28G. Nine treatment naïve participants with GT3 infection relapsed, two of whom had baseline NS5A S62T and/or A30L RASs; all nine developed treatment‐emergent Y93H. Treatment was generally well tolerated. The most frequent drug‐related adverse events in all participants were fatigue (6.3%), diarrhea (5.6%), nausea (4.3%), and headache (3.8%). Conclusions: The two‐drug combination of RZR 60 mg + UPR 450 mg for 12 weeks was well tolerated and has promising efficacy in GT1, 2, and 4 infection. However, the efficacy in GT3 infection was lower, particularly in cirrhotic participants (6/9 GT3 failures had cirrhosis). Viro‐ logic failure in participants with GT3 infection was not clearly associated with presence of baseline RASs, but was associated with treatment‐emergent NS5A RASs. Higher doses of RZR in a two‐drug combination with UPR may be needed to optimize efficacy against some HCV genotypes. Complete SVR12 results will be presented

Efficacy and safety of ruzasvir 60 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection.

In clinical trials, the three-drug regimen of ruzasvir (RZR) 60 mg, uprifosbuvir (UPR) 450 mg and grazoprevir 100 mg, with or without ribavirin, has demonstrated promising efficacy and excellent tolerability across a wide range of hepatitis C virus (HCV)-infected individuals. The present study assessed the efficacy and safety of the two-drug combination of RZR 60 mg plus UPR 450 mg administered for 12 weeks in participants with HCV genotype (GT) 1-6 infection. In this open-label clinical trial, treatment-naive or -experienced and cirrhotic or noncirrhotic participants with chronic HCV GT1-6 infection received RZR 60 mg plus UPR 450 mg orally once daily for 12 weeks (NCT02759315/protocol PN035). The primary efficacy endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). One hundred and sixty participants were enrolled. SVR12 rates were 96% (52 of 54) in participants with GT1a infection; 100% (15 of 15) in those with GT1b infection; 97% (28 of 29) in those with GT2 infection; 77% (30 of 39) in those with GT3 infection; 90% (18 of 20) in those with GT4 infection; and 67% (2 of 3) in those with GT6 infection. Drug-related adverse events (AEs) reported by \u3e5% of participants were fatigue (n = 10, 6.3%) and diarrhoea (n = 9, 5.6%). Five participants reported a total of 11 serious AEs, none considered drug-related. One participant experienced on-treatment alanine aminotransferase/aspartate aminotransferase elevations that resolved without intervention. Data from the present study indicate that the combination of RZR 60 mg plus UPR 450 mg once daily for 12 weeks was well tolerated overall but was effective only for certain genotypes

Efficacy and Safety of Ruzasvir 60 mg and Uprifosbuvir 450 mg for 12 Weeks in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, or 6 Infection

In clinical trials, the three-drug regimen of ruzasvir (RZR) 60 mg, uprifosbuvir (UPR) 450 mg, and grazoprevir 100 mg, with or without ribavirin has demonstrated promising efficacy and excellent tolerability across a wide range of hepatitis C virus (HCV)-infected individuals. The present study assessed the efficacy and safety of the two-drug combination of RZR 60 mg plus UPR 450 mg administered for 12 weeks in participants with HCV genotype (GT) 1-6 infection. In this open-label clinical trial, treatment-naive or -experienced and cirrhotic or noncirrhotic participants with chronic HCV GT1-6 infection received RZR 60 mg plus UPR 450 mg orally once daily for 12 weeks (NCT02759315/protocol PN035). The primary efficacy endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). One hundred and sixty participants were enrolled. SVR12 rates were 96% (52/54) in participants with GT1a infection; 100% (15/15) in those with GT1b infection; 97% (28/29) in those with GT2 infection; 77% (30/39) in those with GT3 infection; 90% (18/20) in those with GT4 infection; and 67% (2/3) in those with GT6 infection. Drug-related adverse events (AEs) reported by \u3e5% of participants were fatigue (n=10, 6.3%) and diarrhea (n=9, 5.6%). Five participants reported a total of 11 serious AEs, none considered drug-related. One participant experienced on-treatment alanine aminotransferase/aspartate aminotransferase elevations that resolved without intervention. Data from the present study indicate that the combination of RZR 60 mg plus UPR 450 mg once daily for 12 weeks was well-tolerated overall but was effective only for certain genotypes. This article is protected by copyright. All rights reserved