Thursday, December 29, 2016

Hepatitis C Hot Topics - Research and News of 2016

Hepatitis C Hot Topics - Research and News of 2016

Today we take a look back at the top HCV news stories of 2016. Sit back and review a collection of hepatitis C research articles, guideline updates, conference reports, learning activities, and news from around the web.

Recent News
AbbVie Awaits NDA Approval For Hepatitis C Treatment
Dec. 19, 2016
AbbVie (ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). In Phase 3 clinical studies, eight weeks of therapy with G/P achieved high sustained virologic response (SVR) rates across all major genotypes (GT 1-6) in patients without cirrhosis, which represents the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). In historically difficult to treat populations, including those not cured* by prior direct-acting antiviral (DAA) treatment regimens, high SVR rates were achieved with durations as short as 12 weeks.

Of Interest
Press Release
Nov 11, 2016
Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C
NORTH CHICAGO, Ill., Nov. 11, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12 rates with 8 weeks of treatment with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) across all major chronic hepatitis C virus (HCV) genotypes. In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711).

November 13, 2016
Glecaprevir/Pibrentasvir: High SVR Rates in HCV GT 2, 4, 5, 6 Without Cirrhosis

Dec 8, 2016
Gilead Submits New Drug Application to U.S. Food and Drug Administration for the Investigational Single Tablet Regimen Sofosbuvir/Velpatasvir/Voxilaprevir
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.

Of Interest
October 2016
Gilead Announces SVR12 Rates From Four Phase 3 Studies of a Once-Daily, Fixed-Dose Combination of Sofosbuvir, Velpatasvir and Voxilaprevir in Treatment-Naïve and Treatment-Experienced Genotype 1-6 Chronic HCV-Infected Patients
Gilead Sciences, Inc. (NASDAQ: GILD) today announced topline results from four international Phase 3 clinical studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4) evaluating an investigational, once-daily, fixed-dose combination of sofosbuvir (SOF), a nucleotide analog NS5B polymerase inhibitor; velpatasvir (VEL), a pangenotypic NS5A inhibitor; and voxilaprevir (VOX; GS-9857), an investigational pangenotypic NS3/4A protease inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.                      

From The Journals

Journal of Hepatology 2017 Issue
Summary @ MD
Dec 16, 2016
Hepatitis C Still Increases Mortality Rate After Being Cured

NATAP - Full Text Article
Mortality in hepatitis C patients who achieve a sustained viral response compared to the general population

Of Interest
Correspondence: Prof. Dr. J.K. Rockstroh
2016/2017 - New HCV two and three drug regimens on their way: what do they promise?
Topic Summary
Risk of HBV reactivation after starting DAA therapy
Surveillance for hepatocellular carcinoma (HCC) and risk for HCC after achieving SVR following DAA therapy.
Intravenous drug users and patients on opioid substitution therapy
Patients in the prison setting
HIV/HCV coinfected patients
Patients with renal insufficiency or on hemodialysis
Patients older than 70 years
Patients receiving short treatment durations of 8 week
HCV three drug rescue combinations with licensed drugs
New dual DAA combinations
New three drug combinations

The Lancet Gastroenterology & Hepatology
Dec 12, 2016
Editorial Access to HCV treatments: hurdles not barriers

Infectious Diseases and Therapy
Evidence shows value of treating all stages of chronic HCV
November 1, 2016
Available evidence suggests that HCV treatment with the new direct-acting antivirals (DAAs) should not be limited to patients with advanced liver disease.

Liver Cancer After Treatment For Hepatitis C
November 23, 2016
A collection of 2016 articles retrieved online from press releases, conferences (The Liver Meeting® 2016 and the International Liver Congress 2016) and peer-reviewed journals featuring long-term risk for liver cancer in those who were cured of Hepatitis C.

December 2016
The following article appeared in the December print edition of HCV NEXT, published online at Healio; Screening for HCC in the Post-SVR12 Setting

Gastroenterology & Hepatology
December 2016
Interview
The Possible Association Between DAA Treatment for HCV Infection and HCC Recurrence
Download the PDF
G&H  How common is the coexistence of hepatocellular carcinoma and hepatitis C virus infection in a patient?


RB  Among patients with hepatitis C virus (HCV) infection and cirrhosis, the risk of hepatocellular carcinoma (HCC) is estimated to be 1% to 3% per year. Thus, in any given year, the risk is relatively low, but over a decade, the risk is considerable. More importantly, with the rise in the number of baby boomers who have had HCV infection for more than 2 decades, we are seeing an increasing prevalence of HCC. Although the rate of new cases of HCV infection is falling, the prevalence of HCV infection with cirrhosis is still rising, as is the number of patients who have HCV infection and HCC.
Continue reading...

Research Article
November 25, 2016
What’s Important to the Patient? Informational Needs of Patients Making Decisions About Hepatitis C Treatment
Patients contemplating hepatitis C virus treatment want a great deal of information to make informed treatment decisions.

Journal Of Gastroenterology and Hepatology
November 2016
Comparative Treatment Effectiveness of Direct Acting Antiviral Regimens for Hepatitis C:  Data from the Veterans Administration
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/jgh.13652

Journal Of Hepatology
New Perspectives in HCV Infection
October 2016 Issue
Second generation direct-acting antivirals – Do we expect major improvements?
Future landscape of hepatitis C research – Basic, translational and clinical perspectives

Liver International
October 2016
The value of cure associated with treating treatment- naïve chronic hepatitis C genotype 1: Are the new all- oral regimens good value to society?

Gastroenterology
October 1, 2016
Hepatitis C Therapy: Game Over!
Alessio Aghemo, Maria Buti
DOI: http://dx.doi.org/10.1053/j.gastro.2016.09.034
Publication stage: In Press Accepted Manuscript
NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir, and the new protease inhibitor GS-9857 (voxilaprevir)
Download PDF

Hepatology
Emerging complexities with HCV DAA regimens: Less is still way more.
September 2016
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/hep.28832

Clinical Gastroenterology and Hepatology
SVR Linked to Long-Term Reduction in Fibrosis, Cirrhosis
July Issue 2016
The Changing HCV Landscape:
October 26, 2016
Hepatitis C virus (HCV) continues to be a significant global burden, with more than 170 million people...

Conferences, Learning Activities and Guidelines

International Congress on Drug Therapy in HIV Infection
Generic hepatitis C drugs purchased online achieve high cure rates
October 27, 2016
Use of generic versions of direct-acting antivirals resulted in very high cure rates for people who obtained the products through three buyers’ clubs, indicating that the generic products are effective, according to three presentations at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) this week.

Of Interest
AASLD 2016: Generic Sofosbuvir Underperforms in Real World, May Be Due to Suboptimal Regimens
Dec 15, 2016
Generic sofosbuvir-based combinations for hepatitis C may not perform as well as branded sofosbuvir-containing regimens, according to a study conducted in Qatar and presented at the recent 2016 AASLD Liver Meeting. People treated with generics were less likely to be cured and more likely to experience adverse events compared to people who received branded drugs. But the investigators speculate that the generics may have underperformed because many people treated were with suboptimal regimens, and believe this deserves further research.

Watch - An Introduction to Access to Generic Hepatitis C Medicines
November 8, 2016
Following the success of the first two webinars in the Knowledge for Change series covering access to diagnostics and medicines, we were pleased to deliver the next in the series, ‘An Introduction to Accessing Generic Hepatitis C Medicines’ on 1 November. The webinar explored the generics landscape for hepatitis C with discussions on legalities, quality and performance of generics medicines as well as providing examples of how people across the globe are accessing them.

EASL- AASLD Special Conference New perspectives in hepatitis C virus infection - The roadmap for cure
September 23, 2016
Watch Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016

EASL Recommendations on Treatment of Hepatitis C
Download 2016 - Update of the HCV EASL recommendations

American Association for the Study of Liver Diseases 67th Annual Meeting 2016
November 18, 2016
After each conference this blog links to a series of education-related information on important findings related to ongoing challenges of managing and treating viral hepatitis. Review three programs offering a review of key studies presented at the American Association for the Study of Liver Diseases 67th Annual Meeting 2016.

New at Healio
December 26, 2016

Related
Healio - Highlights from The Liver Meeting

AASLD Coverage @ HIV and Hepatitis

ALL CONFERENCE COVERAGE
HIV and Hepatitis

VIDEO: Cost to treat HCV could be as low as $80 in the US
November 19, 2016
In this exclusive video at The Liver Meeting, Andrew M. Hill, PhD, discusses data from a new study that show the price of a direct-acting antiviral generic regimen could be as low as $80 in the U.S. to cure hepatitis C virus infection in one patient.

American College of Gastroenterology (ACG) 2016 Annual Scientific Meeting
November 22, 2016
LAS VEGAS — Rapid advances in the treatment of hepatitis C have clinicians seeing outcomes they never thought possible, and experts are optimistic that more complex and challenging patients will respond to therapy.

Healio
See more from American College of Gastroenterology Annual Meeting

National AIDS Treatment Advocacy Project (NATAP)
View All 2016 HCV and HIV conference reports at NATAP

 2016 Updates

HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C

HCV Guidelines Update: People with HCV Should Be Tested for HBV Before Starting Antiviral Therapies
September 16, 2016
All patients beginning hepatitis C (HCV) treatment using direct acting antiviral (DAA) therapies should be assessed for hepatitis B (HBV), according the American Association for the Study of Liver Diseases/Infectious Diseases Society of America Guidance Panel, which provides up-to-date guidance on the treatment of hepatitis C on its website, HCVguidelines.org.

AASLD Offers Two New Practice Guidelines
New Practice Guidelines covering the treatment of hepatocellular carcinoma and portal hypertensive bleeding in cirrhosis have been released by AASLD.

These evidence-based guidelines are developed and updated regularly by a committee of experts and include recommendations of preferred approaches to the diagnostic, therapeutic, and preventative aspects of care.

Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management was published in December. Treatment of Hepatocellular Carcinoma has a January 2017 publication date.

For details about AASLD’s practice guidelines, click here.

FDA MedWatch/Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating
October 4, 2016
The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.

July 6, 2016
This version of the Guidance has been updated to reflect several important developments, including the recent approval of sofosbuvir/velpatasvir, together with new information regarding the use of testing for HCV resistance associated variants....
Read more 

February 24, 2016
This version of the Guidance has been updated to reflect several important developments, including the recent approval of elbasvir/grazoprevir, together with new information regarding the use of testing for HCV resistance associated variants....
Read more 

 Emerging Hepatitis C Treatment Strategies For Difficult‐to‐Cure Patients
November 12, 2016
Sit back and watch a panel of HCV experts discuss the recent updates and changes to AASLD-IDSA recommendations for testing, managing, and treating hepatitis C. Other topics include: efficacy of various DAA regimens in patients who have failed prior DAA therapies and efficacy and safety of different DAA regimens in the new difficult-to-cure patients.

Top Hepatitis Stories From Around The Web

Healio
HCV Next Cover Story - 2017 A Year in Transition
2017: A Year in Transition
"HCV Next" features cutting edge news on the latest HCV research developments. With in-depth articles on a range of topics; diagnosis, hepatitis c treatment regimens, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.
Begin here.....

 HIVandHepatitis.com
Top 10 HIV and Hepatitis Stories of 2016
Simplification and optimization of antiretroviral therapy for HIV, wider use of pre-exposure prophylaxis (PrEP), a growing appreciation that people with undetectable viral load do not transmit HIV, and an expanded armamentarium of treatments for hepatitis C were among the top HIV and viral hepatitis headlines this year. Here's a look back at some of our biggest news from 2016.

Hepatitis B Foundation
Ten Things You Should Know About Hepatitis B and Do in 2017
It’s 2017, and experts around the world continue to study the complex life cycle of the hepatitis B virus in order to find a chink in its armor that will lead to a cure. In 2016, there were successes and disappointments in the research and healthcare arena. Here is what you need to know about hepatitis B in 2017.

Healio: Top Ten Most Read Articles In 2016
ILC coverage, HCV guidelines, FDA approvals among 2016 hot topics in hepatology
New data presented at the 2016 International Liver Congress, new guidelines on the management of hepatitis C virus infection from EASL and the WHO, and several new FDA approvals were among the most popular news topics covered by Healio.com/Hepatology this year.

HEP Your Guide To Hepatitis
Here are the stories and blogs with the most shares across social media this year;
2016 Top Shared Stories

1. FDA Approves Gilead’s Hepatitis C Regimen Epclusa (Sofosbuvir/Velpatasvir)
Posted: June 28

2. Epclusa: The Newest Hepatitis C Treatment
Posted: June 28

3. Looks Like Boomers Didn’t Get Hepatitis C From Youthful Drug Use After All
Posted: April 13

4. Hepatitis C Is Now the Biggest Killer Among All Infectious Diseases
Posted: May 4

5. Success for 8 Weeks of Gilead’s All-Genotype Hepatitis C Regimen
Posted: April 25

6. Zepatier: The Newest Hepatitis C Drug
Posted: February 1

7. After Curing Hepatitis C, Risk of Liver Cancer Remains Elevated
Posted: June 15

8. All Veterans With Hepatitis C, Without Restrictions, to Get Treatment
Posted: March 15

9. Near Perfect Hepatitis C Cure Rate For Ravidasvir and Sovaldi Among Those With Genotype 4
Posted: March 6

10. Hepatitis C is Killing Americans in Record Numbers While Patients Cannot Access Life Saving Medicine
Posted: May 16

11. Harvoni is Safe and Effective in Seniors With Hepatitis C
Posted: March 30

12. Hep C Relapses Are Uncommon Among Those Proclaimed Cured, But Reinfection is a Concern
Posted: March 7

13. Tattoos and Hepatitis C: What Are the Risks?
Posted: July 14

14. How Long Does Recovery From Hep C Treatment Take?
Posted: July 13

15. Hepatitis C Treatment Side Effects
Posted: May 31

Specialty Pharmacy Times
Lauren Santye, Assistant Editor
Publish Date: Wednesday, December 28, 2016
AbbVie Hepatitis C Drug Granted Breakthrough Therapy Designation
Experimental hepatitis C medication treats genotypes 1 through 6.

A Patient's Long, Difficult Journey to a Cure for Hepatitis C
Burdened by the symptoms of hepatitis C, an Australian man faced an uncertain future before new antiviral drugs offered hope.

Zepatier Tops Other Hepatitis C Drugs in Safety Comparison
Researchers compare top selling hep C medications Zepatier, Sovaldi, Harvoni, and Viekira Pak.

Merck Wins Nearly $2.5 Billion from Gilead in Hepatitis C Drug Royalties Verdict
Jury declares Merck’s acquired HCV drug patent valid.

First Drug for All Major Hepatitis C Genotypes Approved by FDA
Epclusa showed up to 99% viral suppression after 12 weeks across major hepatitis C genotypes.

Experts Call for End of Restricted Access to Hepatitis C Antivirals for Drug Users
Achieving global elimination of the virus starts with illicit drug users accessing curative hepatitis C virus treatments.

Is Prior Authorization Creating a Barrier to Eradicating Hepatitis C?
Nearly 1 of 4 initial requests for Harvoni were denied in a recent study of hepatitis C drug coverage.

Pharmacist Pleads Guilty in Hepatitis C Drug Fraud Case
Tennessee pharmacist admits to falsifying prior authorizations, medical lab reports, and drug test results for at least 51 hepatitis C patients prescribed Sovaldi, Harvoni, Viekira Pak, and Daklinza.

Black Plague Left Clues for Fighting Hepatitis C, HIV
Aberrant protein mutation associated with the black plague may lead to treatments for HIV and hepatitis C.

Improved Hepatitis C Screening Still Needed for Baby Boomers
Baby boomer generation are five times more likely to be diagnosed with hepatitis C virus.

Most Physicians Believe High-Cost Hepatitis C Drugs Are Worth the Price Tag
Debate continues surrounding cost versus cure in hepatitis C treatment.

Express Scripts Adds Hepatitis C Drug Harvoni to 2017 National Formulary
After 2 years of exclusion, Harvoni has been added to the Express Scripts national formulary for the treatment of hepatitis C.

New Hepatitis C Drug Expected to Challenge Dominance of Gilead in HCV Market
Zepatier is priced considerably lower with similar efficacy to Harvoni and Sovaldi.

As Out-of-Pocket Costs Rise, Hepatitis C Drug Adherence Drops
Manufacturer coupons found to show significant benefits reducing Sovaldi cost share.

GoodRx
2016 Year in Review: Good News, Bad News, and Looking Ahead to 2017
The two largest prescription insurance companies, Express Scripts and Caremark, dropped coverage for 40 popular drugs in 2016. Most notably, medications like the popular insulin Lantus, and venlafaxine ER (Effexor XR) for depression have been dropped by Caremark. Express Scripts dropped Taltz for psoriasis, and Orencia for rheumatoid arthritis, among others, and Viekira Pak now has only limited coverage. Insurers are also restricting coverage for many of the expensive (but effective) hepatitis C drugs like Zepatier and Olysio, leaving only Sovaldi and Harvoni as options.
                          
Wishing you all a safe and healthy 2017!
Tina
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