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Weekend Reading - When Should Patients on the Liver Transplant Waitlist Receive HCV Therapy?
Today we have a few EASL updates, but first up an article published at Clinical Care Opitions this past Friday; "When Should Patients on the Liver Transplant Waitlist Receive HCV Therapy?" by John Roberts, MD.
The good doctor offers us his expert opinion on which patients should receive HCV treatment before transplantation.
An excerpt;
Now that highly tolerable, highly effective HCV treatments are available, treatment in the pretransplant setting is a viable approach for many patients currently on the waitlist. Does this approach have a downside?
For transplantation candidates, the introduction of effective and tolerable HCV direct-acting antivirals has led to a challenging question: Who on the liver transplant waitlist should receive HCV therapy prior to transplantation and how can appropriate timing be achieved?
Read more, here
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What an exciting weekend, tons of research on hepatitis C is coming out of the 50th Annual Meeting of the European Association for the Study of the Liver (EASL 2015)
Over the next few weeks we can expect to find numerous media highlights of the meeting, but anyone living with HCV or considering therapy may want to dig a little deeper by reading in-depth coverage offered in an array of formats available online at "Clinical Care Options."
Where To Start
If you're in search of something self-explanatory, CCO has downloable slide-sets, easy to follow capsule summaries, and expert analysis. Coverage at CCO is ongoing, to get you started check out CCO's latest content.
Latest Content
SVR12 in 71% of GT1 Patients Receiving 24 Weeks of Ledipasvir/Sofosbuvir Following Previous Treatment Failure With 8 or 12 Weeks of Ledipasvir/Sofosbuvir-Based Therapy
In this open-label trial, SVR12 rates were numerically lower in patients with vs without baseline NS5A RAVs and in patients who received 12 vs 8 weeks of previous ledipasvir/sofosbuvir-based therapy.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
C-EDGE: Grazoprevir/Elbasvir Highly Effective in Treatment-Naive Patients With Genotype 1, 4, or 6 HCV Infection
High efficacy observed regardless of presence of cirrhosis, although patients with high baseline HCV RNA level were more likely to experience virologic failure.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
C-SCAPE: 12-Week Grazoprevir/Elbasvir Plus RBV Demonstrates Efficacy in Patients With Genotype 2 HCV Infection in Phase II Study
Efficacy also observed in genotype 4 HCV–infected patients receiving grazoprevir/elbasvir with or without ribavirin; evaluation of efficacy in genotypes 5 and 6 require additional patient numbers.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
Sofosbuvir Plus Ledipasvir or Daclatasvir With or Without Ribavirin Effective in Patients With HCV Genotypes 1 and 3 and Decompensated Cirrhosis
In this observational cohort study, higher SVR12 rates with 12 weeks of sofosbuvir plus daclatasvir than sofosbuvir/ledipasvir among patients with genotype 3 HCV infection.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/24/2015
C-SALVAGE: High SVR12 Rate Following 12 Weeks of Grazoprevir, Elbasvir, and Ribavirin in GT1 PI-Experienced Patients
The SVR12 rate in this PI-experienced population was 96% overall and 95% among patients with previous virologic failure; 3 patients relapsed with treatment-emergent NS3 and NS5A RAVs.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/24/2015
Complete coverage is also available at the following websites.
In this open-label trial, SVR12 rates were numerically lower in patients with vs without baseline NS5A RAVs and in patients who received 12 vs 8 weeks of previous ledipasvir/sofosbuvir-based therapy.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
C-EDGE: Grazoprevir/Elbasvir Highly Effective in Treatment-Naive Patients With Genotype 1, 4, or 6 HCV Infection
High efficacy observed regardless of presence of cirrhosis, although patients with high baseline HCV RNA level were more likely to experience virologic failure.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
C-SCAPE: 12-Week Grazoprevir/Elbasvir Plus RBV Demonstrates Efficacy in Patients With Genotype 2 HCV Infection in Phase II Study
Efficacy also observed in genotype 4 HCV–infected patients receiving grazoprevir/elbasvir with or without ribavirin; evaluation of efficacy in genotypes 5 and 6 require additional patient numbers.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/25/2015
Sofosbuvir Plus Ledipasvir or Daclatasvir With or Without Ribavirin Effective in Patients With HCV Genotypes 1 and 3 and Decompensated Cirrhosis
In this observational cohort study, higher SVR12 rates with 12 weeks of sofosbuvir plus daclatasvir than sofosbuvir/ledipasvir among patients with genotype 3 HCV infection.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/24/2015
C-SALVAGE: High SVR12 Rate Following 12 Weeks of Grazoprevir, Elbasvir, and Ribavirin in GT1 PI-Experienced Patients
The SVR12 rate in this PI-experienced population was 96% overall and 95% among patients with previous virologic failure; 3 patients relapsed with treatment-emergent NS3 and NS5A RAVs.
Source: 2015 Annual Meeting of the European Association for the Study of the Liver
Date Posted: 4/24/2015
Complete coverage is also available at the following websites.
Slide presentations and commentary
Healio
Live Coverage
Medscape
Read clinically focused news coverage of key developments from EASL 2015.
HIV and Hepatitis
Look for breaking news coverage from HIV and Hepatitis and our partners at Aidsmap.com
Coming Soon
EASL In The News
Single Pill Combination Therapy For Some Hepatitis C Subtypes
Single Pill Combination Therapy For Some Hepatitis C Subtypes
Interferon- and ribavirin-free regimens are needed to treat HCV infection. The objective of the study was to evaluate the safety and efficacy of grazoprevir (NS3/4A-protease-inhibitor) and elbasvir (NS5A-inhibitor) in previously untreated patients with chronic hepatitis C(without and with liver cirrhosis).
Interferon Tx Scores in Tough-to-Treat HCV
Demonized drug performs well in genotype 3 of hepatitis C.
Hepatitis C screening essential to help catch patients with advanced liver fibrosis
Cancer rates among patients with hepatitis C are increased compared to those not infected
The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin's lymphoma, renal and prostate cancers, as well as liver cancer.
The aim of the study was to describe the rates of all cancers in the cohort of HCV patients compared to the non-HCV population. Known cancer types associated with hepatitis C include non-Hodgkin's lymphoma, renal and prostate cancers, as well as liver cancer.
April 25
BOSON: Sovaldi plus PEG-RBV improved SVR12 in genotype 3 HCV
Twelve weeks of therapy with Sovaldi plus peginterferon and ribavirin was associated with 12-week sustained virologic response rates…
ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B)
97% of post-transplant patients with HCV genotype 1a achieved cure
91% of post-transplant patients with HCV genotype 3 achieved cure
No need seen to alter existing transplantation medication regimens
Gilead Announces Results From Studies Evaluating Sofosbuvir-Based Regimens in Chronic Hepatitis C Patients With Genotypes 2-5
-- High Cure Rates Observed Across a Range of Genotypes --
VIENNA, Austria--(BUSINESS WIRE)--Apr. 25, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two studies evaluating the safety and efficacy of investigational uses of sofosbuvir-based regimens in chronic hepatitis C virus (HCV)-infected patients with genotypes 2, 3, 4 and 5. Results from the BOSON study of Sovaldi® (sofosbuvir 400 mg) in combination with ribavirin (RBV) or with pegylated interferon (PEG)/RBV demonstrated high cure rates across all patients with genotypes 2 and 3. Separately, results from a Phase 2 study demonstrate the safety and efficacy of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in patients with genotypes 4 or 5 infection. Data from both studies will be presented in oral sessions at the 50th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress™ 2015) in Vienna, Austria.
ABBVIE PRESENTS LATE-BREAKING, PRELIMINARY PHASE 3B DATA WITH VIEKIRAX® + EXVIERA® IN HCV PATIENTS W-RENAL IMPAIRMENT
- RUBY-I EVALUATES TREATMENT-NAÏVE, NON-CIRRHOTIC, GENOTYPE 1 CHRONIC HEPATITIS C PATIENTS WITH SEVERE RENAL IMPAIRMENT
- IN PRELIMINARY DATA FROM RUBY-I, PATIENTS RECEIVING VIEKIRAX + EXVIERA WITH OR WITHOUT RIBAVIRIN WHO REACHED POST-TREATMENT WEEK FOUR (N=10 OF 20 ENROLLED) ACHIEVED 100 PERCENT SUSTAINED VIROLOGIC RESPONSE AT FOUR WEEKS POST-TREATMENT (SVR4)1
- ABBVIE'S PHASE 3B STUDIES EXPLORE VIEKIRAX + EXVIERA IN ADDITIONAL PATIENT POPULATIONS SEEN IN CLINICAL PRACTICE AND ACROSS MULTIPLE COUNTRIES AROUND THE WORLD
Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver Congress™ 2015
Results of C-SALVAGE Study Showed High Sustained Virologic Response Rates in Patients Who Failed Prior Combination Therapy with Certain Direct Acting Antiviral (DAA) Agents
Results of C-SWIFT Study Provide Proof-of-Concept for Shorter Than Twelve Weeks Duration of Treatment with Triple-DAA Regimen in Patients with Chronic Hepatitis C Virus (HCV) Genotypes 1 and 3 Infection
Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection
Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015
Interferon Tx Scores in Tough-to-Treat HCVDemonized drug performs well in genotype 3 of hepatitis C.
VIENNA -- Rumors of the death of pegylated interferon may have been exaggerated.
In a surprising result, the widely demonized immune system booster came up trumps as therapy for patients with the difficult-to-treat genotype 3 hepatitis C (HCV), according to Kosh Agarwal, MD, of Kings College Hospital in London.
Once-Daily Oral Combination Clears Hepatitis C in 95%
Medscape Medical News, April 24, 2015
April 24
Merck oral hepatitis C regimen shows 95 pct cure rate
(Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.
Press Release
Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1
Patients feel stigma, discrimination when living with hepatitis
Merck’s Hepatitis C Medicines May Challenge Gilead and AbbVie
Two Diabetes Drugs May Ease Fatty Liver Disease
Cancer rates among patients with hepatitis C are increased compared to those not infected
April 23
Merck and Gilead square off in battle of the next-next-gen hep C combos
By John Carroll
Early today both Gilead and Merck issued new data on their next-next-gen hepatitis C combos, demonstrating just how brutal the competition for market share is becoming while highlighting some of the boundaries that are emerging in shortening treatment regimens.
Watch the body defend against attack from the hepatitis B virus
EASL Young Investigator, Matteo Iannacone, discusses the impact of a new pioneering technique – intravital microscopy, which allows scientists to observe real-time cell behaviour in a liver infected with hepatitis B.
Read full article and watch videos at www.lastampa.it
Liver
April 25
Lifestyle-induced weight loss produces improvement in NASH, fibrosis
VIENNA — Weight loss induced through year-long lifestyle intervention independently predicted improvement in non-alcoholic steatohepatitis, non-alcoholic steatosis and fibrosis, according to a study presented at the 2015 International Liver Congress.
“Weight loss induced by a comprehensive lifestyle program during 12 months produces important changes in most of the histological NASH-related features,” Eduardo Vilar-Gomez, MD, from the National Institute of Gastroenterology, Havana, Cuba, said during his presentation. “Our findings support the current recommendation for weight loss lifestyle modification as the first-line therapy for patients with NASH.”
Statins Show Benefit in Hepatitis C Compensated Cirrhosis
Medscape Medical News, April 25, 2015
Fatty Liver Disease Surging as Liver Cancer Cause
Medscape Medical News, April 25, 2015
April 24
VIDEO: 2DMRE accurately predicts advanced fibrosis in patients with NAFLD
April 24, 2015VIENNA — Jeffrey Y. Cui, fourth year medical student in the NAFLD Translational Research Unit at University of California San Diego School of…
BOSON: Sovaldi plus PEG-RBV improved SVR12 in genotype 3 HCV
Twelve weeks of therapy with Sovaldi plus peginterferon and ribavirin was associated with 12-week sustained virologic response rates…
ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B)
97% of post-transplant patients with HCV genotype 1a achieved cure
91% of post-transplant patients with HCV genotype 3 achieved cure
No need seen to alter existing transplantation medication regimens
Gilead Announces Results From Studies Evaluating Sofosbuvir-Based Regimens in Chronic Hepatitis C Patients With Genotypes 2-5
-- High Cure Rates Observed Across a Range of Genotypes --
VIENNA, Austria--(BUSINESS WIRE)--Apr. 25, 2015-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from two studies evaluating the safety and efficacy of investigational uses of sofosbuvir-based regimens in chronic hepatitis C virus (HCV)-infected patients with genotypes 2, 3, 4 and 5. Results from the BOSON study of Sovaldi® (sofosbuvir 400 mg) in combination with ribavirin (RBV) or with pegylated interferon (PEG)/RBV demonstrated high cure rates across all patients with genotypes 2 and 3. Separately, results from a Phase 2 study demonstrate the safety and efficacy of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in patients with genotypes 4 or 5 infection. Data from both studies will be presented in oral sessions at the 50th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress™ 2015) in Vienna, Austria.
ABBVIE PRESENTS LATE-BREAKING, PRELIMINARY PHASE 3B DATA WITH VIEKIRAX® + EXVIERA® IN HCV PATIENTS W-RENAL IMPAIRMENT
- RUBY-I EVALUATES TREATMENT-NAÏVE, NON-CIRRHOTIC, GENOTYPE 1 CHRONIC HEPATITIS C PATIENTS WITH SEVERE RENAL IMPAIRMENT
- IN PRELIMINARY DATA FROM RUBY-I, PATIENTS RECEIVING VIEKIRAX + EXVIERA WITH OR WITHOUT RIBAVIRIN WHO REACHED POST-TREATMENT WEEK FOUR (N=10 OF 20 ENROLLED) ACHIEVED 100 PERCENT SUSTAINED VIROLOGIC RESPONSE AT FOUR WEEKS POST-TREATMENT (SVR4)1
- ABBVIE'S PHASE 3B STUDIES EXPLORE VIEKIRAX + EXVIERA IN ADDITIONAL PATIENT POPULATIONS SEEN IN CLINICAL PRACTICE AND ACROSS MULTIPLE COUNTRIES AROUND THE WORLD
Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver Congress™ 2015
Results of C-SALVAGE Study Showed High Sustained Virologic Response Rates in Patients Who Failed Prior Combination Therapy with Certain Direct Acting Antiviral (DAA) Agents
Results of C-SWIFT Study Provide Proof-of-Concept for Shorter Than Twelve Weeks Duration of Treatment with Triple-DAA Regimen in Patients with Chronic Hepatitis C Virus (HCV) Genotypes 1 and 3 Infection
Merck’s Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection
Data Sets Include Treatment-Naïve, Treatment-Experienced and HIV Co-Infected Patients with Chronic Hepatitis C Virus Genotypes 1, 4 or 6 Infection
Merck Remains on Track to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in First Half of 2015
Interferon Tx Scores in Tough-to-Treat HCVDemonized drug performs well in genotype 3 of hepatitis C.
VIENNA -- Rumors of the death of pegylated interferon may have been exaggerated.
In a surprising result, the widely demonized immune system booster came up trumps as therapy for patients with the difficult-to-treat genotype 3 hepatitis C (HCV), according to Kosh Agarwal, MD, of Kings College Hospital in London.
Once-Daily Oral Combination Clears Hepatitis C in 95%
Medscape Medical News, April 24, 2015
April 24
Merck oral hepatitis C regimen shows 95 pct cure rate
(Reuters) - Merck and Co Inc presented trial results on Friday showing that a once-daily combination of two experimental pills cured 95 percent of previously untreated hepatitis C patients after 12 weeks.
Press Release
Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
C-SURFER Trial is First to Investigate an All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in Treatment-Naïve and Treatment-Experienced Patients with Advanced Chronic Kidney Disease Infected with Hepatitis C Virus Genotype 1
Patients feel stigma, discrimination when living with hepatitis
Merck’s Hepatitis C Medicines May Challenge Gilead and AbbVie
Two Diabetes Drugs May Ease Fatty Liver Disease
Cancer rates among patients with hepatitis C are increased compared to those not infected
April 23
Merck and Gilead square off in battle of the next-next-gen hep C combos
By John Carroll
Early today both Gilead and Merck issued new data on their next-next-gen hepatitis C combos, demonstrating just how brutal the competition for market share is becoming while highlighting some of the boundaries that are emerging in shortening treatment regimens.
Watch the body defend against attack from the hepatitis B virus
EASL Young Investigator, Matteo Iannacone, discusses the impact of a new pioneering technique – intravital microscopy, which allows scientists to observe real-time cell behaviour in a liver infected with hepatitis B.
Read full article and watch videos at www.lastampa.it
April 25
Lifestyle-induced weight loss produces improvement in NASH, fibrosis
VIENNA — Weight loss induced through year-long lifestyle intervention independently predicted improvement in non-alcoholic steatohepatitis, non-alcoholic steatosis and fibrosis, according to a study presented at the 2015 International Liver Congress.
“Weight loss induced by a comprehensive lifestyle program during 12 months produces important changes in most of the histological NASH-related features,” Eduardo Vilar-Gomez, MD, from the National Institute of Gastroenterology, Havana, Cuba, said during his presentation. “Our findings support the current recommendation for weight loss lifestyle modification as the first-line therapy for patients with NASH.”
Statins Show Benefit in Hepatitis C Compensated Cirrhosis
Medscape Medical News, April 25, 2015
Fatty Liver Disease Surging as Liver Cancer Cause
Medscape Medical News, April 25, 2015
April 24
VIDEO: 2DMRE accurately predicts advanced fibrosis in patients with NAFLD
April 24, 2015VIENNA — Jeffrey Y. Cui, fourth year medical student in the NAFLD Translational Research Unit at University of California San Diego School of…
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