Saturday, November 15, 2014

Weekend Reading - AASLD 2014: Overview with expert commentary on key studies presented at the meeting

AASLD 2014: Overview with expert commentary on key studies presented at the meeting

*Updated Nov 16 to include HCV Advocate's Mid-Month Publication 

Good day folks, welcome to another edition of Weekend Reading.

Is everyone thinking about celebrating Thanksgiving? If only I had time to ready my new abode for the upcoming holiday, but Nana has been diverted by a clever 30 pound Zombie hunting mutant ninja turtle!

Every morning while I attempt to plan the families menu,  I hear a gentle tap, tap at my door, waiting on the other side is my three year old grandson ready for the hunt. Off we go racing through Nana's complex in search of Zombies. To date we saved three ladybugs, two spiders and one plastic cat without a tail. Although we did find a ladder leading up to the roof, wow, imagine our excitement as we climbed to the top only to realize the hatch was firmly locked, my complex is secure!

Anyhow, if you too are searching for Zombies on this fine Saturday, please do carry on. However, if you came by for a bit of weekend reading, we begin with HCV Advocates Mid-Month Newsletter:

HCV Advocate's Mid-Month Edition

In This Issue:
Genotype 3
Alan Franciscus, Editor-in-Chief
In the past, HCV genotype 3 was thought to be one of the easiest to cure. As a result there was little incentive to develop newer therapies especially since there were fewer people with genotype 3 in developed countries. Now we know that of all HCV genotypes 1 through 4, genotype 3 is the hardest to treat and cure with HCV inhibitor therapy.

Hepatitis C in Canada
—Cheryl Reitz, MA & CD Mazoff, PhD
Canada has a large population with hepatitis C, but there is no national strategy in place for testing or treatment. While the new HCV inhibitors are slowly being approved, access to them and whether they will be covered under "Pharmacare" plans differs widely from province to province. 

Alan Franciscus, Editor-in-Chief
Read about whether there is a relationship between HCV and diabetes, the use of Sovaldi for post-transplant infection, shorter treatment times and the continuum of HCV testing and care. 

Preparing Your Medical Record for Disability
Jacques Chambers, CLU
Transitioning from work to disability is a major life event with all the confusion, frustration, and emotional upheaval such events can bring. Now is the time to start getting your medical record into a shape that will support disability, if and when it is needed. 

What's New
Alan Franciscus, Editor-in-Chief
Hepatitis C Vaccine Shows Promise
FDA Approves Olysio/Sovaldi Combo

New & Updated Spanish Easy C Facts
Alan Franciscus, Editor-in-Chief
Ayuda con Medicamentos (Help with Medicines)
Tratamiento para Genotipo 1: Harvoni (Sofosbuvir & Ledipasvir).

Over at ViralEd check out a review of this months liver meeting. The Live eSymposium took place on November 11, the replay is available here, or click here to view the EU edition featuring Europe-based clinicians reporting on the meeting.

Don't forget to watch for an On-Demand Program reviewing the meeting - coming soon at  ViralEd.

Independent reporting from AASLD 

Commentary by 
Mark Sulkowski, MD
Nezam H. Afdhal, MD
K. Rajender Reddy, MD
Fred Poordad, MD
Program Overview
While an increasing number of options are available or in development for effectively treating patients with HCV infection, many clinicians find it challenging to keep abreast of important developments in HCV therapeutics. This 1.5-hour Internet symposium will feature independent reporting on, review and discussion of the key studies on chronic hepatitis C presented at the 65th American Association for the Study of Liver Diseases Annual Meeting (AASLD 2014).

The expected result is that participants will not only gain an increased understanding of key data presented at AASLD 2014, they will also be better prepared to address their HCV patients' health needs and provide optimal care, which should improve adherence, increase individualized care, reduce adverse effects and drug-drug interactions, and improve quality of life.
Begin Here.......

For additional coverage check out Clinical Care Options CCO for an in-depth program overview with capsule summaries and expert commentary covering key studies presented at the meeting, updated November 14.

CORAL-1: High SVR Rates With 24 Weeks of All-Oral Paritaprevir/Ritonavir/Ombitasvir + Dasabuvir and Ribavirin in Patients With Recurrent Genotype 1 HCV After Liver Transplantation
97% of patients in this historically challenging patient population achieved SVR12, with no episodes of acute or chronic liver graft rejection.
Date Posted: 11/14/2014

High SVR12 Rates in Pooled Analysis of Phase III Trials of Paritaprevir/RTV/Ombitasvir + Dasabuvir ± Ribavirin in Cirrhotic and Noncirrhotic Patients With Genotype 1a HCV Infection
The addition of ribavirin resulted in higher SVR rates, and extension of therapy to 24 weeks beneficial for cirrhotic patients with a previous null response to peginterferon/ribavirin.

TURQUOISE-II Subanalysis: Most Baseline Characteristics Not Associated With SVR12 to Paritaprevir/RTV/Ombitasvir Plus Dasabuvir and Ribavirin in Patients With Genotype 1 HCV Infection and Cirrhosis
In logistic regression analysis, IL28B TT genotype, previous null response to peginterferon/ribavirin, and genotype 1a HCV only factors significantly associated with not achieving SVR12.

Retreatment With Ledipasvir/Sofosbuvir + RBV Highly Efficacious, Safe in Patients With Genotype 1 HCV Infection Who Failed Previous Sofosbuvir-Based Therapy
Among the 50 patients with genotype 1 HCV infection in this study, 100% achieved SVR12 after 12 weeks of retreatment; single relapse was misclassified patient later found to have genotype 3a HCV infection.

UNITY-1: High SVR12 Rates Following 12 Weeks of Daclatasvir/Asunaprevir/Beclabuvir in Treatment-Naive and Previously Treated Noncirrhotic Patients With Genotype 1 HCV
SVR12 rate of approximately 90% for both treatment-naive and treatment-experienced patients.

Ledipasvir/Sofosbuvir + Ribavirin Safe and Effective for Treatment of HCV in Patients With Decompensated Cirrhosis
High SVR12 rates and improved liver function with low rates of treatment-emergent adverse events.

C-SWIFT: Initial Results Show All-Oral Regimen of Grazoprevir/Elbasvir + Sofosbuvir for 6-8 Weeks Effective and Safe in Treatment-Naive Noncirrhotic and Cirrhotic Patients With Genotype 1 HCV Infection
SVR4/8 rates higher in patients with genotype 1b HCV infection, IL28B CC genotype, or lower baseline HCV RNA level.

8-Week Regimen of Sofosbuvir + GS-5816 With or Without Ribavirin Effective but Resulted in SVR Rates Lower Than Previously Seen With 12 Weeks in Treatment-Naive Noncirrhotic Patients With Genotype 1 or 2 HCV Infection
In this phase II trial, sofosbuvir plus GS-5816 with or without ribavirin was generally safe and well tolerated with only 1 patient discontinuing treatment because of adverse events.

Final C-WORTHY Results: Grazoprevir + Elbasvir ± RBV Yields High SVR12 Rates in Genotype 1 Treatment-Naive Cirrhotic Patients and Previous Null Responders
SVR12 rates ≥ 90% were attained regardless of RBV use or treatment duration.

ALLY-3: High SVR12 Rates With 12 Weeks of Daclatasvir + Sofosbuvir in Treatment-Naive or Treatment-Experienced Patients With Genotype 3 HCV Infection
SVR12 rates substantially lower for both treatment-naive and treatment-experienced cirrhotics vs noncirrhotics.

ELECTRON-2: High SVR12 Rates With Sofosbuvir + NS5A Inhibitor GS-5816 With or Without Ribavirin in Treatment-Naive, Noncirrhotic Genotype 3 HCV–Infected Patients in Phase II Trial
Low levels of discontinuation due to adverse events; no virologic failure with 100-mg dose of GS-5816. Inclusion of ribavirin associated with more frequent adverse events with no efficacy benefit.

HCV-TARGET: Real-World Use of Sofosbuvir-Containing Regimens Yields Overall SVR4 Rates ≥ 85% in Patients With Genotype 1 or 2 HCV Infection
To date, regimens allowing removal of peginterferon most commonly selected: sofosbuvir plus ribavirin in patients with genotype 2/3 infection and sofosbuvir plus simeprevir with or without ribavirin in genotype 1 HCV infection.

Ledipasvir/Sofosbuvir Regimens Highly Effective, Safe, and Well Tolerated in Patients With Genotype 1 HCV and Compensated Cirrhosis
Similar SVR12 rates with 24-week ribavirin-free regimen vs 12-week ribavirin-containing regimen in treatment-experienced cirrhotics.

HCV Management (Coming soon)

HCV Management (Coming soon)

HCV Management (Coming soon)

Traditionally Hard-to-Treat HCV (Coming soon)

Traditionally Hard-to-Treat HCV (Coming soon)

Traditionally Hard-to-Treat HCV (Coming soon)

All-Oral Fixed-Dose Combination Therapy With Daclatasvir/Asunaprevir/BMS-791325 ± Ribavirin for Patients With Chronic HCV Genotype 1 Infection and Compensated Cirrhosis: UNITY-2 Phase III SVR12 Results (Coming soon)

Source: Official Conference Coverage
2014 Annual Meeting of the American Association for the Study of Liver Diseases

Coverage on hepatitis B is available at Hepatitis B Foundation, reported by Christine Kukka.

Comprehensive data investigating HCV interferon-free, ribavirin-free regimens presented at the liver meeting is now available on this blogs website.

Updated daily, categorized by genotype and pharmaceutical company, with links to breaking news, clinical data, commentary and slide-sets from premier Hepatitis C websites.

Hepatitis C New Drug Research: Conference Reports

Of Interest
Media-Investment Commentary 
The Post AASLD Annual Meeting Hepatitis C Landscape

See you all soon, enjoy the weekend.

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