Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.
For more information on how to use this blog click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here
Drugs in Development / Clinical Trials—Updated March 11, 2014
Tuesday, March 11, 2014
Like one about how he met his wife. Or how he was discovered by David Crosby -- yes, of Stills & Nash and sometimes Young. Or how a developer named Steve Silverman decided to throw a benefit for him at NJPAC on Friday.
Monday, March 10, 2014
—Alan Franciscus, Editor-in-Chief
After being infected the women were diagnosed with non-A/non-B hepatitis based on symptoms and elevated liver enzymes—most people with hepatitis C are not diagnosed until many years later—if diagnosed at all.
The women were counseled after diagnosis to avoid alcohol and were given self-help counselling messages.
The women were medically monitored on a regular basis.
Generally, women have a slower disease progress than men, especially women who are pre-menopausal.
Volume 59, Issue 1, pages 49–57, January 2014
Merck’s Investigational Hepatitis C Treatment Regimen MK-5172/MK-8742 Shows Robust Anti-HCV Activity in HIV/HCV Co-Infected Patients with HCV Genotype 1 Infection
At 12 weeks, 100 percent (29/29) of co-infected patients who received MK-5172/MK-8742 and ribavirin (RBV), and 90 percent (26/29) of co-infected patients who received MK-5172/MK-8742 alone had HCV RNA levels of less than 25 IU/mL, versus 100 percent (13/13) in patients with HCV alone treated with MK-5172/8742. The data were presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI).
“We are encouraged by the potential of MK-5172/MK-8742 for the treatment of people living with HIV/HCV co-infection, where there remains a need for additional therapeutic options,” said Dr. Eliav Barr, vice president, Infectious Diseases, Merck Research Laboratories.
About the MK-5172/MK-8742 Data Presented at CROI
After 4 weeks of treatment, all co-infected patients showed a reduction in HCV RNA levels to below 25 IU/mL with or without RBV administration. HCV kinetics over the first 4 weeks of therapy were similar in patients with or without HIV co-infection.
Virologic Response: Intent-to-Treat Population
There were three treatment failures in the HIV/HCV co-infected study arms; one subject completed the treatment regimen but was lost to follow-up (HCV RNA undetectable at the last visit on record); and two co-infected subjects with low pharmacokinetic levels of MK-5172 and/or MK-8742 experienced virologic breakthrough at the 8 week time point (both cases with low blood levels of MK-5172 and/or MK-8742).
The most common adverse events observed in this cohort were fatigue (7%) and headache (8%). The incidence of these adverse events was not increased in patients with HIV. No co-infected patients discontinued due to either an adverse event or study medication intolerance.
About HIV/HCV Co-Infection
Globally, approximately seven million patients are co-infected with HIV and HCV. HCV is the leading cause of morbidity and mortality among those living with HIV-1, and compared to the general population, the overall prevalence of HCV infection is higher among those infected with HIV-1. Furthermore, HIV/HCV co-infected patients have a three times higher rate of progression to cirrhosis and a six times higher risk of hepatic decompression than HCV patients infected with HCV alone, underscoring the need for new therapeutic options for this patient population.
About the C-WORTHY Clinical Trial
C-WORTHY is a randomized, dose-responsive, parallel-group, multiple-site, open-label trial comparing different patient populations exposed to different durations of treatment of MK-5172 (100 mg QD) in combination with MK-8742 (50 mg QD) with or without RBV in patients with chronic HCV infection. A total of 450 patients with HCV GT1 and HCV RNA levels of ≥10,000 IU/mL have been enrolled in C-WORTHY and randomized across 16 arms to examine difficult-to-treat subpopulations.
The primary objective of C-WORTHY is to evaluate the safety and efficacy of MK-5172 in combination with MK-8742 with or without RBV as assessed by the proportion of patients achieving sustained virologic response at 12 weeks (SVR12) in treatment-naïve patients and more complex patient groups including prior peginterferon alfa and ribavirin treatment failures, cirrhotic patients and co-infected patients. The aim of the HIV/HCV co-infected arms is to compare on-treatment HCV RNA responses (defined as proportion of patients with HCV RNA <25 IU/mL) in GT1 HIV/HCV co-infected patients treated with MK-5712/MK-8742 with or without RBV with those in mono-infected patients.
In the HIV/HCV co-infection arms, 59 treatment-naïve, non-cirrhotic, GT1 HIV/HCV co-infected patients on a stable antiretroviral regimen (raltegravir + tenofovir or abacavir with either 3TC or FTC) were examined. These subjects were randomized at a 1:1 ratio to receive 12 weeks of MK-5172 (100 mg QD) administered concomitantly with MK-8742 (50 mg QD), with or without twice daily (BID) RBV.
Additional data from Merck’s Phase 2 program for MK-5172/MK-8742 will be presented at the 49th Annual Meeting of the European Association of the Study of the Liver, April 9-13 in London. Details on the C-WORTHY Study, as well as additional Phase 2 trials for MK-5172 and MK-8742, can be viewed on www.merck.com/clinical-trials.
In October 2013, Merck announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to MK-5172/MK-8742 for treatment of chronic HCV infection.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Read complete release here:
Hepatitis C is often misunderstood as only a concern for "junkies", and those who associate with dirty needles. A key audience that had a misconception around hepatitis C was 18-24-year-olds. In fact only 5% saw themselves at any risk. (Source: TNS for NSW Government)
This demonstrated a problem, how can you hope to make a message stick with a famously hard-to-reach group when the message is about something they feel is someone else's problem? A big budget awareness campaign targeting all of the 18-24-year-olds in NSW wasn't an option; the budget was just $200k. Mediacom had to be clever with the money by closely relating the message to occasions where Hep C is contracted. This was the key task.
Sunday, March 9, 2014
At first glance, the declining prevalence of HCV might seem like good news. But the authors of the new study in Annals think something else is going on.
If better treatments were curing patients, then the statistics would show a decrease in the number of people with current HCV infections and an increase in the number of people infected with HCV. Instead, the number of people in both groups has been falling in parallel. This "supports the suggestion that mortality among chronically infected persons has increased," they wrote.
Friday, March 7, 2014
(Reuters Health) - At least one percent of Americans are chronically infected with the hepatitis C virus, which over time can severely damage the liver, according to a new study.
"Hepatitis C has a severe impact on the health and well-being of millions of Americans, especially baby boomers (those born from 1945 through 1965)," Dr. Scott D. Holmberg told Reuters Health in an email. He worked on the study at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.
"The new data from a nationally representative survey of the general United States population (the National Health and Nutrition Examination Survey, or NHANES) found about 2.7 million people have chronic hepatitis C infection," he added.
A public health showdown is brewing over a virus that affects the lives of millions of people every year.
The face-off will involve activists on one side and pharmaceutical companies on the other. It will play out in the richest cities in North America and the poorest countries in Africa. The viral scourge at the centre of this brewing confrontation is spread through blood-to-blood contact, but is treatable with expensive medicines.
This scenario may remind some of the decades-long struggle to obtain access to life-saving medicines for HIV and Aids. But here we are talking about another public health threat: hepatitis C.