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EASL Coverage: 6 phase 3 studies; Simeprevir+Sofosbuvir Update; HIV Coinfection: 2 studies reported
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EASL: Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype-1 prior null responders with METAVIR F0-2: COSMOS study subgroup analysis - (04/14/14)
EASL: Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype-1 prior null-responder / treatment-naïve patients (COSMOS study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2) - (04/14/14)
Janssen Initiates Phase 3 OPTIMIST Trials of Once-Daily Simeprevir in Combination with Once-Daily Sofosbuvir for the Treatment of Genotype 1 Chronic Hepatitis C - (04/03/14)
from Jules: Over 10,000 attended this EASL conference organizers reported, in London at the ExCel Center in the Canary Wharf section of London. I have been attending EASL every year since 1998 when the peginterferons were in development and NATAP.org has been providing HIV & hepatitis conference coverage since 1996, the advent of HIV protease inhibitors. This 2014 EASL ended Sunday March 13, all the new key study results for the new DAA IFN-free therapies in later stage development and the data has been reported by NATAP and can be viewed by clicking the link below, simultaneous publications included. Gilead & Abbvie reported Phase 3 data from large studies, with expected high SVR results, that will be submitted to the FDA & EMA european authorities to review for approval. Gilead reported three phase 3 studies for their fixed dose combination of sofosbuvir+ledipasvir: ION-1(naives 12 vs 24 weeks with & without RBV), ION-2 (treat-exp including a PI with & without Rbv for 12 & 24 weeks) and ION-3 (8 vs 12 weeks with & without Rbv) all of which I have reported through the NATAP listserve in real-time from the EASL meeting in London. Abbvie reported phase 3 studies TURQUOISE-II in patients with cirrhosis, SAPPHIRE-II in treatment-experienced patients, and SAPPHIRE-I in treatment-naive patients, all of which NATAP reported as well in real-time from London. And of course several other studies have been reported here by both companies including in liver transplant patients and GT4. Gilead reported results with Sofosbuvir+GS5816 (2nd generation NS5A) in Gt1-6 (
http://www.natap.org/2014/EASL/EASL_29.htm). Merck reported phase 2 C-WORTHY study results with MK5172+MK8742 +/- rbi in patients with cirrhosis & in previous null-responders where they looked at 12-18 weeks treatment (
http://www.natap.org/2014/EASL/EASL_21.htm), and Merck reported SVR4 results of 12 weeks of treatment in HIV coinfected patients (http://www.natap.org/2014/EASL/EASL_22.htm) and announced formerly here phase 3 has started. As well, the NIH group results with Sofosbuvir/Ledipasvir FDC in 50 coinfected mostly African-Americans Gt1, 22-38% with HAI fibrosis stage 3 with interim SRV4/SVR12 100% Rates (http://www.natap.org/2014/EASL/EASL_05.htm). BMS has previously started a number of phase 3 studies that are ongoing including three phase 3 studies of daclatasvir+sofosbuvir and phase 3 for their DAA therapy of daclatasvir+asunaprevir+BMS325, and at EASL reported large phase 3 study results for daclatasvir+asunaprevir in Gt1b (
http://www.natap.org/2014/EASL/EASL_45.htm) (
http://www.natap.org/2014/EASL/EASL_25.htm); globally outside USA Gt1b is a large segment of patients vs Gt1a which predominates in the USA . Janssen announced just before EASL the start of a large phase 3 study program for Simeprevir+Sofosbuvir, and at EASL reported updated results for Simeprevir+Sofosbuvir from COSMOS, cohorts 1 & 2, in null-responders, cirrhotics, and naives (COSMOS-1: http://www.natap.org/2014/EASL/EASL_46.htm) (COSMOS-2:
http://www.natap.org/2014/EASL/EASL_26.htm). Idenix reported several studies including for their nuke, similar to sofosbuvir, which they are developing now starting clinical studies in combination with their NS5A. Achillion reported their latest data at APASL. Later this year we can expect the FDA to approve the 2 new all-oral HCV regimens from both Gilead & Abbvie, where SVR rates go as high as 100% depending on the patient group, from the easiest to treat to the most difficult to treat who would be prior null responders with cirrhosis, and of course treatment in the setting of liver transplant, but look through the data and all the results are very encouraging. I have been working in HCV since 1998, reporting data, advocating with NYC, NYS, nationally and in Wash DC getting HCV into the Ryan White Care Act, and this is the beginning of the new treatment era, we have been waiting for this for a long time.
EASL - The International Liver Congress 2014 49th Annual Meeting of the European
Association for the Study of the Liver
London, United Kingdom
April 9-13
Phase 3 Studies:
EASL: All Oral Fixed-Dose Combination Ledipasvir/Sofosbuvir With Or Without Ribavirin for 12 or 24 Weeks in Treatment-Naive Genotype 1 HCV-Infected Patients: the Phase 3 ION-1 Study - (04/14/14)
EASL: All Oral Fixed-Dose Combination Ledipasvir/Sofosbuvir With or Without Ribavirin for 12 or 24 Weeks in Treatment-Experienced Genotype 1 HCV-Infected Patients: The Phase 3 ION-2 Study - (04/14/14)
EASL: Ledipasvir/Sofosbuvir With and Without Ribavirin for 8 Weeks Compared to Ledipasvir/Sofosbuvir for 12 Weeks in Treatment-Naïve Noncirrhotic Genotype-1 HCV-Infected Patients: The Phase 3 ION-3 Study - (04/11/14)
EASL: TURQUOISE-II: SVR12 RATE OF 92-96% IN 380 HEPATITIS C VIRUS GENOTYPE 1-INFECTED ADULTS WITH COMPENSATED CIRRHOSIS TREATED WITH ABT-450/r/ABT-267 AND ABT-333 PLUS RIBAVIRIN - (04/14/14)
EASL: SAPPHIRE-I: PHASE 3 PLACEBO-CONTROLLED STUDY OF INTERFERON-FREE, 12-WEEK REGIMEN OF ABT-450/r/ABT-267, ABT-333, AND RIBAVIRIN IN 631 TREATMENT-NAïVE ADULTS WITH HEPATITIS C VIRUS GENOTYPE 1 - (04/11/14)
EASL: SAPPHIRE-II: PHASE 3 PLACEBO-CONTROLLED STUDY OF INTERFERON-FREE, 12-WEEK REGIMEN OF ABT-450/r/ABT-267, ABT-333, AND RIBAVIRIN IN 394 TREATMENT-EXPERIENCED ADULTS WITH HEPATITIS C VIRUS GENOTYPE 1 - (04/10/14)
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