Friday, July 15, 2016

TGIF Rewind - HCV Medications Blog; Genotype, cure rates, side effects, and drug interactions

To The People Of France
My family and I wish to convey our solidarity and sorrow to the citizens of France today. May we offer our sincere condolences to the victims families who were injured and killed by the barbaric event that took place in France last night.

I have been to Europe many times over the last two years, last summer our family celebrated Bastille Day with 3 lovely French students. We all share bittersweet memories of that day.

Our hearts remain full with unbearable sadness for all who have suffered and are suffering as a result of yet another cowardly attack on France.

TGIF Rewind
Hello everyone, welcome to this issue of  "HCV Rewind" with a look back at this weeks headlines and publications. We begin with HCV Advocate and a link to their newest blog.

The HCV Advocate -  HCV Medications Blog
Alan and the staff of the HCV Advocate;
We are happy to announce a new feature of our Website – the HCV Advocate HCV Medications Blog.  In the Blog, I have summarized information about all of the direct-acting antiviral medications that have been approved by the Food and Drug Administration (FDA) to treat chronic hepatitis C. 

The summaries are taken from the FDA Prescribing Information.  I have listed the genotype, treatment, and duration of treatment.  I have matched this information to the cure rates listed in the FDA Prescribing Information.  The side effects, common drug interactions, patient assistance programs, and additional information is also summarized. There are also tabs for that define commonly used terms (Terms) in the Blog and patient assistance programs (PAP) that may help with the co-payments or coverage of the drugs.    

You can find a link to this new blog when you are on under our Top menu under the Treatments then Current Treatments button.

Begin, here...

Stay Current
Stay current by reading all about living with or treating hepatitis C over at HCV Advocate. Each month HCV Advocate puts out a newsletter with a quick overview of newly approved drugs and drugs still in the pipeline, click here to view updates in June, and here for July.

FDA Approved: Epclusa® (Sofosbuvir/Velpatasvir
At the end of June the FDA Approved Gilead's Epclusa® (Sofosbuvir/Velpatasvir) to treat Genotype 1-6, for news and updates click here, for prescribing information click here, in addition on July 8th the European Commission granted marketing authorization for Epclusa, followed yesterday by approval in Canada.

HCV Guidelines
A great source for learning all about treatment can be found in the HCV Guidelines, this ever changing document is updated when new HCV drugs are approved, and new real world data is established. Last week it was updated to include Epclusan ®.

Blog Updates
Over at HIV and ID Observations a New England Journal Of Medicine (NEJM) blog,  Dr. Paul Sax writes about Epclusa in patients with HCV genotypes 2 and 3; Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3.

Hepatitis C Treatment: Are You Taking the Right Amount of Ribavirin?
By Lucinda K. Porter, RN
Fortunately, new hepatitis C treatments using direct-acting antiviral drugs (DAAs) are often ribavirin-free. However, ribavirin is still being used, and when it is necessary to take it, it is best to take the right dose. Sounds simple, right? Sadly, simple doesn’t match reality; presentations at the recent International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy in Washington, DC found otherwise

Epclusa: The Newest Hepatitis C Treatment
By Lucinda K. Porter, RN
It’s been nearly two years since the FDA approved Harvoni, Gilead’s game changing hep C drug with high cure rates and mild side effects. After Harvoni, the FDA approved Viekira Pak, Zepatier, Daklinza, and Technivie. These drugs were much more affordable than Harvoni, but weren’t as easy to take.

Last but not least, here is a patient friendly article about Epclusa written by Liz Highleyman a Senior Staff Writer at with a breakdown of HCV genotypes, cure rates, and risk of drug-drug interactions; US regulators approve Gilead's Epclusa combo pill for all hepatitis C genotypes.

But I hate to read - what about a video?
If reading isn't high on your list, Dr. Joseph S. Galati with Liver Specialists of Texas just published a great video with an overview of new and current medications to treat HCV which include: Epclusa, Zepatier, Harvoni, Sovaldi, Viekira Pak, and Olysio. Dr. Galati can be found on

In the December 2015 issue of the New England Journal Of Medicine three articles were published with results from clinical trials using Epclusa (sofosbuvir and velpatasvir) in patients with or without cirrhosis.  An article written by Donald Jensen, MD provides a nice summary of each NEJM study; Hepatitis C treatment studies from NEJM: Closer to One Size for All

Epclusa Cost
Bloomberg reported Epclusa will cost $74,760 for a 12-week course of treatment, less than Gilead’s Sovaldi Harvoni, at $84,000 or $94,500 before any discounts, read the article here.

Here is an article about the cost in Canada; New Health Canada approved drug costs more than $700 a pill. The list price in Canada is set at $60,000 for a 12-week course

Of Interest
Advocates hope shaming drugmakers can discourage big price hikes

Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance
Published on Jun 23, 2016

Dr. Vincent Lo Re discusses his manuscript "Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance."
To view article click

Other Links
HEP Drug Interaction Checker
Access our comprehensive, user-friendly, free drug interaction charts. Providing clinically useful, reliable, up-to date, evidence-based information

HCV treatment according to genotype
For updates and research with a focus on treating HCV according to genotype, click here.

Publication Updates

HCV Next, July issue:

A Moving Target: Tracking Down HCV in the Homeless

In case you missed it the following articles appeared in the July 2016 print edition of HCV Next published online at Healio.

Table of Contents

5 Questions
A Conversation With Kara Chew, MD
What area of research in hepatology most interests you right now and why?
I am most interested in extrahepatic manifestations of hepatitis C — thinking of hepatitis C not just as a disease of the liver, but one with systemic manifestations (including bone, renal and potentially cardiovascular disease) that can also significantly and adversely affect health outcomes.

The barriers to treating HCV in the homeless are multifactorial and often work in synergy with one another. Simply finding them is a task unto itself.

With the approval of yet another important regimen, sofosbuvir/valpatasvir, on the day that this editorial is being written, and other regimens still to come, we can all rejoice at the increasing opportunities for clinicians to choose what they consider to be the optimal treatments for their patients. These recent developments in regards to access will continue to have ever more important practical ramifications.

When considering treatment of hepatitis C, women of childbearing age present clinicians with a handful of unique clinical characteristics, some of which are manageable and have little bearing on outcomes, and some of which are not.

In a case series analysis, researchers found reactivation of herpesvirus in patients with hepatitis C virus infection treated with direct-acting antivirals is uncommon. However, clinicians should be mindful and monitor for all infections after clearance.
Recent findings published in the Journal of Viral Hepatitis showed that race was a nonfactor in the early mortality of patients with hepatitis C virus infection. African-American patients with kidney disease and low albumin, however, were at greater risk for HCV-related mortality.
A global economic analysis of pricing of a 12-week duration of treatment with Sovaldi or Harvoni in 30 countries indicated prices varied according to country wealth and both treatments were unaffordable in many countries, according to new data published in PLoS Medicine.

Alcohol Intake Increases Risk for HCC in Patients With HCV-Related Cirrhosis
Alcohol consumption — including light-to-moderate — was associated with an increased risk for hepatocellular carcinoma among patients with hepatitis C virus infection-related cirrhosis, according to published findings.

Trend Watch
EMA Panel Recommends Approval of Sofosbuvir/Velpatasvir for all HCV Genotypes
The European Committee for Medicinal Products for Human Use granted a positive opinion for Gilead Science’s Marketing Authorization Application for Epclusa for the treatment of all chronic hepatitis C genotypes, according to a press release from the manufacturer.

Court Bars Merck from Prosecuting Gilead in Patent Infringement Case
A jury of the U.S. District Court barred Merck from further asserting the patent suit for hepatitis C treatments against Gilead Sciences after they found Merck to be guilty of “unclean hands” and their patent attorney’s actions to be “dishonest and duplicitous,” according to court documents.
It is heartening to see the speed and quality of the advances in the treatment of hepatitis C in the last two years. Our challenge now is to implement treatment to the millions of people around the world with a goal of eradicating HCV. A key barrier to eradication is the cost of the medicines. Merck launched their product in January at a substantial reduction from previous list prices of drugs ($54,000); Gilead has launched their new combination at $75,000, which is less than their previous product (sofosbuvir/ledipasvir; Harvoni at $90,000).

New Opportunities and Challenges in Hepatitis C
The American Journal of Managed Care

Hepatitis C is an enormously common disease that is often initially asymptomatic. New drugs are very effective, but expensive, and there has been reluctance to cover these treatments. Authors that published research in the hepatitis C special issue present their findings.

Introduction to HCV Briefing
Jay Bhattacharya, MD, PhD, opens up the hepatitis C virus (HCV) briefing, which highlighted research published in The American Journal of Managed Care's special issue on HCV. He provided a brief overview of the scope of HCV infection in the US and around the world, as well as the reluctance on the part of payers to cover the expensive drugs, even though they essentially cure the disease.

Dr Darius Lakdawalla on the "Dismal Economics" of Paying for HCV Treatments
Darius Lakdwalla, PhD, gave attendees a better understanding of "the dismal science of economics" as it relates to the HCV cures. Since hepatitis C is largely asymptomatic for a number of years, it takes a while for the benefit of treatment to accrue, he explained. "If you compare people who are successfully treated, essentially cured with no viral load in their body, and compare them to other people with hepatitis C, who still are infected with the virus, over the first couple of years there's not a really big difference in death rates among those 2 populations," he explained.

Dr Anupam Jena Outlines the Wider Public Health Value of Treating HCV
Anupam Jena, MD, PhD, outlined the wider public health value of treating HCV. As an infectious disease, curing one person reduces the likelihood of other people getting infected, which changes the way the value of drugs that treat and cure HCV is viewed.

Ryan Clary Addresses Discriminatory Practices that Reduce Access to HCV Treatments
Ryan Clary and the National Viral Hepatitis Roundtable, which co-hosted the briefing with the journal, have been working to expand access to treatments and end discriminatory restrictions against people who have HCV.

Read more... The American Journal of Managed Care

Stay safe, keep your loved ones close, and keep France in your thoughts.


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