Watch Pr. Jean-Michel Pawlotsky review the highlights of EASL’s recommendations on treatment of Hepatitis C 2016
EASLEurope
Showing posts with label 2016-EASL/AASLD. Show all posts
Showing posts with label 2016-EASL/AASLD. Show all posts
Thursday, October 6, 2016
Friday, September 23, 2016
Watch Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
EASL- AASLD Special ConferenceNew perspectives in hepatitis C virus infection - The roadmap for cure
Source - EASLEurope
Online now - EASL Recommendations on Treatment of Hepatitis C
Download 2016 - Update of the HCV EASL recommendations
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
If video will not play please click here.....
Source - EASLEurope
Online now - EASL Recommendations on Treatment of Hepatitis C
Download 2016 - Update of the HCV EASL recommendations
Watch the livestreamed EASL updated HCV recommendations with a follow-up Q&A session.
If video will not play please click here.....
AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® for Genotype 1b
AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C
- 98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1
- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1
- GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4
- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'
NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
"VIEKIRAX + EXVIERA has already achieved high cure rates with 12 weeks of treatment," said Stefan Zeuzem, M.D., study author and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These results now show the potential for cure in just eight weeks with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients without liver cirrhosis. The efficacy in this population is particularly important as GT1b is the most common subtype of hepatitis C virus globally."
Approximately 160 million people worldwide are infected with HCV.5 Genotype 1 is the most prevalent of the six major HCV genotypes, affecting an estimated 83 million people worldwide.6 In Europe, GT1b is the most predominant subtype accounting for 47 percent of the nine million people infected with chronic HCV.3,4,6
"AbbVie remains focused on continuing to explore and understand the expectations of HCV care, including a shorter treatment duration with VIEKIRAX + EXVIERA in GT1b patients," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie.
In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1
About the GARNET Study1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.
Additional information about the GARNET study can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
- 98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1
- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1
- GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4
- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'
NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
"VIEKIRAX + EXVIERA has already achieved high cure rates with 12 weeks of treatment," said Stefan Zeuzem, M.D., study author and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These results now show the potential for cure in just eight weeks with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients without liver cirrhosis. The efficacy in this population is particularly important as GT1b is the most common subtype of hepatitis C virus globally."
Approximately 160 million people worldwide are infected with HCV.5 Genotype 1 is the most prevalent of the six major HCV genotypes, affecting an estimated 83 million people worldwide.6 In Europe, GT1b is the most predominant subtype accounting for 47 percent of the nine million people infected with chronic HCV.3,4,6
"AbbVie remains focused on continuing to explore and understand the expectations of HCV care, including a shorter treatment duration with VIEKIRAX + EXVIERA in GT1b patients," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie.
In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1
About the GARNET Study1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).
Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.
Additional information about the GARNET study can be found on www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks with RBV.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Friday, September 9, 2016
EASL/AASLD2016 - Achillion Reports 100% SVR In Phase2a Trial:Odalasvir, AL-335, and Simeprevir for Geno 1 Treatment-Naive
Achillion Announces 100% SVR Reported in Janssen’s Phase 2a Trial Evaluating Triple Combination of Odalasvir, AL-335, and Simeprevir for Genotype 1 Treatment-Naive HCV
New data released today in abstract for upcoming EASL / AASLD Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap For Cure -
New data released today in abstract for upcoming EASL / AASLD Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap For Cure -
- Janssen advancing triple combination into Phase 2b clinical trial -
NEW HAVEN, Conn., Sept. 09, 2016 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that new interim results from a phase 2a study being conducted by Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies (Janssen), were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, September 23 - 24, 2016, in Paris, France.
This ongoing phase 2a study was designed to confirm the required dose and treatment duration for an all-oral combination regimen containing odalasvir (ODV) and AL-335 with or without simeprevir (SMV) for durations of eight or six weeks of treatment in treatment-naïve patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.
“We are delighted by the significant progress Janssen has made in advancing the all-oral, short-duration treatment regimen of odalasvir, AL-335 and simeprevir and are impressed with the Phase 2a study results being presented. Based on these interim results, Janssen plans to advance a phase 2b program for the triple combination to further understand the potential of this 3DAA drug combination to shorten the duration of treatment for patients suffering from HCV,” commented Dr. Milind Deshpande, President and Chief Executive Officer of Achillion. “Despite recent therapeutic advances, we believe there remains a significant unmet need in addressing the global burden of hepatitis C virus in those living with the disease.”
Data included in the abstract were as of the time of submission in July 2016. Updated results, including sustained viral response 12 weeks after completion of therapy (SVR12) for all cohorts, are scheduled to be presented on Friday, September 23, 2016, in an ePoster entitled "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." Interim results from cohorts 1-4, summarized in the table below, showed that the triple combination regimen was highly effective and well tolerated in non-cirrhotic patients with GT1 HCV.
Table 1: Interim Phase 2a Results for Cohorts 1 – 4
| Cohort # | Dose | Dosing Duration (weeks) | Number (%) withundetectable* HCV RNA (EOT or SVR) | ||
| AL-335 (mg QD) | ODV (mg) | SMV (mg QD) | |||
| 1 | 400 | 50 QD | 100 | 8 | 20/20 (100%), SVR24 |
| 2 | 800 | 50 QOD | -- | 8 | 18/20 (90%), SVR12 |
| 3 | 800 | 50 QOD | 75 | 8 | 20/20 (100%), SVR4 |
| 4 | 800 | 50 QOD | 75 | 6 | 20/20 (100%), EOT |
*Or below the limit of quantitation (N=2; Cohort 4 only)
EOT: end of treatment; QD: every day; QOD: every other day; RNA: ribonucleic acid
EOT: end of treatment; QD: every day; QOD: every other day; RNA: ribonucleic acid
Summary of Phase 2a Study Design and Interim Results
This phase 2a study was designed to determine the pharmacokinetics, efficacy and safety of ODV and AL-335 with or without SMV, in treatment naïve patients with GT1 or 3 HCV infection for treatment durations of eight weeks or less.
Of the 20 patients treated in cohort 1, who received the triple combination of odalasvir (50mg QD), AL-335 (400mg QD) and simeprevir (100mg QD) for eight weeks (triplet, 8 weeks), 100 percent remained HCV RNA undetectable 24 weeks after completing therapy (SVR24). Additional patients were subsequently enrolled into two further cohorts (3 & 4), where they received adjusted doses of the same triplet combination for either eight or six weeks. In cohort 3 all were HCV RNA negative and remained HCV RNA undetectable 4 weeks after completing therapy (SVR4) and in cohort 4 all were HCV RNA negative (N=18) or below the limit of quantitation (N=2) at end of treatment. Of the 20 patients treated in cohort 2, who received the dual combination of odalasvir (50mg QOD) and AL-335 (800mg QD) for eight weeks (doublet, 8 weeks), 90 percent remained HCV RNA undetectable twelve weeks after completing therapy (SVR12).
All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The majority of adverse events (AEs) were mild, most commonly headache, fatigue, and upper respiratory tract infection. In cohort 1, there was a single serious adverse event (Mobitz Type 1 2nd degree atrioventricular block), which was attributed to treatment. This ECG abnormality was not associated with clinical or echocardiographic abnormalities, and resolved following treatment discontinuation. No clinically significant laboratory abnormalities were observed.
Ongoing Phase 2 Development Program
Based upon the interim results from the phase 2a study, which confirmed the required dose for each component and the treatment duration, the triple combination is being advanced into a phase 2b program consisting of once daily odalasvir 25mg, AL-335 800mg, and simeprevir 75mg. The development program will include two multi-center, randomized, open-label studies that will enroll treatment-naive and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and 6. These studies will be complemented by an expansion of the ongoing phase 2a study focusing on patients with or without compensated cirrhosis and on patients with HCV genotype 2 and 3 infection. The results from the phase 2 program will guide further development.
Further information on this study can be found at www.clinicaltrials.gov. Study identifier: CT02765490.
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