AASLD / IDSA Guidance - Treat All Patients with Chronic Hepatitis C

WHEN AND IN WHOM TO INITIATE HCV THERAPY

Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. When the US Food and Drug Administration (FDA) approved the first IFN-sparing treatment for HCV infection, many patients who had previously been “warehoused” sought treatment, and the infrastructure (experienced practitioners, budgeted health-care dollars, etc) did not yet exist to treat all patients immediately. Thus, the panel offered guidance for prioritizing treatment first to those with the greatest need. Since that time, there have been opportunities to treat many of the highest-risk patients and to accumulate real-world experience of the tolerability and safety of newer HCV medications. More importantly, from a medical standpoint, data continue to accumulate that demonstrate the many benefits, within the liver and extrahepatic, that accompany HCV eradication. Therefore, the panel continues to recommend treatment for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy. Accordingly, prioritization tables are now less useful and have been removed from this section.

Despite the strong recommendation for treatment for nearly all HCV-infected patients, pretreatment assessment of a patient’s understanding of treatment goals and provision of education on adherence and follow-up are essential. A well-established therapeutic relationship between practitioner and patient remains crucial for optimal outcomes with new direct-acting antiviral (DAA) therapies. Additionally, in certain settings there remain factors that impact access to medications and the ability to deliver them to patients. In these settings, practitioners may still need to decide which patients should be treated first. The descriptions below of unique populations may help physicians make more informed treatment decisions for these groups. (See sections on HIV/HCV coinfection, cirrhosis, liver transplantation, and renal impairment).

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AASLD/IDSA release updated HCV treatment guidelines

The AASLD and IDSA HCV Guidance Panel has released updated guidelines for the treatment of hepatitis C virus infection, according to newly published data in Hepatology.
AASLD/IDSA HCV Guidance Panel. Hepatology. 2015;doi:10.1002/hep.27950.
 
“The goal of the hepatitis C guidance is to provide up-to-date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence,” the researchers wrote. “This review provides a condensed summary of recommendations from the guidance.”

The panel, which included HCV Next Editorial board members Arthur Y. Kim, MD, and Michael R. Charlton, MD, and HCV Next Co-Chief Editor Michael S. Saag, MD, used an evidence-based approach to review available information for the HCV guidance. Sources of information included peer-reviewed research; FDA research and safety information on products; manufacturer information; drug interaction data; prescribing information from FDA-approved products; and more.

Key recommendations were outlined in various topics: HCV testing and linkage to care, when and in whom to begin HCV therapy, the initial treatment of HCV, treating unique patient populations, HIV/HCV coinfection and acute HCV.

Download the Practice Guidance here (PDF)

Source:  http://www.healio.com/hepatology/hepatitis-c/news/online/%7Bb26d77d8-268d-49de-b524-e5e01d669a71%7D/aasldidsa-release-updated-hcv-treatment-guidelines

AASLD Updates Guidance for Use of Hepatitis C Drugs

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AASLD Updates Guidance for Use of Hepatitis C Drugs

The American Association for the Study of Liver Diseases (AASLD), in partnership with the Infectious Diseases Society of America (IDSA) and in collaboration with the International Antiviral Society-USA (IAS-USA), created online Recommendations for Testing, Managing, and Treating Hepatitis C in 2014 to aid practitioners treating patients infected with hepatitis C virus (HCV). Now an update to the Guidance, with a summary of recommendations regarding treatment with direct-acting antiviral drugs, is published in the AASLD journal, Hepatology.

HCV is a blood-borne virus that infects the liver and may lead to cirrhosis or liver cancer (hepatocellular carcinoma). In the past 25 years HCV has gone from an undiagnosed disease to an epidemic level, with the World Health Organization (WHO) estimating that up to 150 million people worldwide live with chronic disease.

In the U.S., close to 30,000 new acute cases were reported in 2013 and 2.7 million Americans have chronic HCV according to the Centers for Disease Control and Prevention (CDC). “The good news is that HCV is now on the cusp of being a curable disease for the millions of Americans, many of whom are undiagnosed,” says Dr. Gary Davis, President of MedLogician Consulting and co-chair of the AASLD/IDSA HCV Guidance writing panel. “The web-based Guidance document is an easy-to-use resource for practitioners treating HCV patients with novel antivirals.”

A panel of 26 hepatologists and infectious diseases specialists and a patient advocate developed the original consensus recommendations that include:

• HCV testing details and linkage to care
• Recommendations for initial treatment of HCV infection in patients starting treatment
• Retreatment information in persons in whom prior therapy has failed
• Unique patient populations data

 
“The Guidance is a living document that will continually be updated with evidence-based advice about how to best use the next generation of direct-acting antivirals and other treatment options,” comments Dr. Keith Lindor from the Arizona State University and President-elect of AASLD. “Our role as associations of researchers and clinicians is to provide key information in the appropriate format to patients and those who care for them.”
 
Practitioners involved with treating patients with liver disease may access the Guidance, including new updates, at www.HCVGuidelines.org.

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Access the full study on the Wiley Press Room here. (To access PDFs and embargoed stories you must be logged in to the Press Room before clicking the link. Request a login here.) Full citation:"Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected with Hepatitis C Virus." Authors on behalf of the Hepatitis C Guidance Panel (see AASLD/IDSA HCV Guidance panel members and authors). Hepatology; Published Online: June 25, 2015, (DOI: 10.1002/hep.27950).

URL: http://doi.wiley.com/10.1002/hep.27950

About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published by Wiley on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://wileyonlinelibrary.com/journal/hep.

About Wiley
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Pharmalot, Pharmalittle: We’re Reading About Gilead, Hepatitis C Drug Prices and More!!

A 30-member panel of doctors and health experts will, for the first time, address the cost effectiveness of hepatitis C drugs in updated guidelines that may change prescribing and coverage for the medicines, Bloomberg News reports. The panel is a joint effort by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which together represent more than 10,000 physicians, health workers and scientists. ”The panel will explicitly consider cost and cost- effectiveness,” says Benjamin Linas, a panel member and physician.

Meanwhile, the U.K.’s National Institute for Health and Care Excellence endorsed Harvoni, the newest Gilead Sciences GILD -1.00% treatment for hepatitis C, for use on the state health service in the U.K., where it costs significantly less than in the U.S., according to Reuters. Harvoni, which combines Gilead’s drug Sovaldi with another of its anti-viral medicines into a daily pill, is priced at $58,400 for a 12-week treatment course – a third less than in the U.S. And PMLive notes that, unlike Sovaldi, Harvoni will not face a funding delay in the U.K.

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HCV Drugs —Alan Franciscus, Editor-in-Chief

AbbVie's VIEKIRA PAK Approval & AASLD 2014

In this month’s HCV Drugs we have news on AbbVie’s drug approval of their HCV drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD).  In Lucinda’s Snapshots column this month, information on Janssen’s AASLD presentations is included.

AbbVie
On December 19, 2014 the Food and Drug Administration (FDA) approved AbbVie’s 3D combination—VIEKIRA PAK—to treat HCV genotype 1 patients.   On December 23, 2014, the 3D combination was approved by Health Canada as HOLKIRA PAK. AbbVie conducted phase 3 trials in about 2,300 patients and the cure rates were over 90%.  Included in the FDA label was information about HIV/HCV coinfection and liver transplantation treatment results.  For more information, visit our website for new VIEKIRA PAK fact sheets, FDA Approved Prescribing Information and detailed information from their phase 3 studies included in past issues of our HCV Advocate monthly and mid-monthly newsletters. 

        VIEKIRA PAK

Gilead
GS-5816 is a new investigational NS5A inhibitor being developed by Gilead.  It has activity across all genotypes (pan-genotypic).  In the current studies, it is being combined with sofosbuvir (polymerase inhibitor) with and without ribavirin.

Safety and Efficacy of Treatment with Sofosbuvir plus GS-5816 With and Without Ribavirin for 8 or 12 Weeks in Treatment-Naïve Patients with Genotype 1-6 HCV Infection—T Tran et al.

Summary:  The combination of sofosbuvir plus GS-5816 without ribavirin produced high cure rates in all genotypes. 

Gilead continues to study sofosbuvir in combination with other investigational compounds—in this case with GS-5816, an NS5A inhibitor. 

Part A of the current study comprised 8 arms—all arms received sofosbuvir plus GS-5816 at either 25 mg or 100 mg without ribavirin for 12 weeks. Included in the study were treatment-naïve patients without cirrhosis.  There were two parts (A and B) of the study.  Part A had six treatment arms that included genotypes 1 through 6.  Listed below are the number of patients and cure rates. 

• Genotype 1:  55 patients:  96% to 100%
• Genotype 2:  21 patients: 91% to 100%
• Genotype 3:  54 patients 93%
• Genotype 4:  14 patients 86% to 100%
• Genotype 5:  1 patient 100%
• Genotype 6:  9 patients 100%

Part B of the study included only genotype 1 and 2 patients.  There were also 8 arms in Part B, but the genotype 1 non-cirrhotic patients received only 8 weeks of treatment at the same doses.  Half of the patients in the study received ribavirin.   Genotype, number of patients and cure rates are listed below:

• Genotype 1:  59 patients no ribavirin 83% to 87%; 61 patients (81% - 83%) with ribavirin
• Genotype 2:  52 patients no ribavirin 87% to 90%; 51 patients (88%) with ribavirin

The combination of sofosbuvir and GS-5816 with and without ribavirin was safe and well-tolerated.  The most common side effects were fatigue, headache, and nausea.

The combination of sofosbuvir (400 mg) and GS-5816 (100 mg) has been co-formulated into one pill taken once daily.  It is currently in phase 3 clinical trials to be studied with and without ribavirin for the treatment of HCV genotype 1, 2, 3, 4, 5, and 6.  

Comments:  Sofosbuvir and GS-5816 has been co-formulated into 1 pill taken once-a-day and is in phase 3 clinical trials with and without ribavirin for a treatment duration of 12 weeks for genotype 1 through 6.  Another study being conducted in genotype 3 patients is comparing the treatment duration of 12 vs. 24 weeks.

AASLD/ IDSA/IAS-USA Recommendations
Check out the updated HCV Guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America that include Harvoni and VIEKERA PAK. Seven sections of the HCV Guidance have been extensively revised based on newly available therapies and data: Initial, Retreatment, Monitoring, and Unique Populations (HIV/HCV Coinfection, Cirrhosis, Post-Liver Transplantation, and Renal Impairment).
www.hcvguidelines.org


http://hcvadvocate.org/news/newsLetter/2015/advocate0115.html#2