Snapshots, by Alan Franciscus, Editor-in-Chief

Article:  Treatment with ledipasvir and sofosbuvir improves patient-reported outcomes: Results from the ION-1, -2, and -3 clinical trials—ZM Younossi—et. al
   Source: Hepatology 2015 Jun;61(6):1798-808. doi: 10.1002/hep.27724. Epub 2015 Mar 18.

Results and Conclusions:  In the phase 3 clinical trials of ledipasvir and sofosbuvir with and without ribavirin patient report outcomes were measured.  There was a total of 1,952 patients in the study.  Patients were treated for 8, 12 or 24 weeks. In the groups that received ledipasvir and sofosbuvir (without ribavirin) who had early viral load suppression there was improved quality of life that was maximized by the end of treatment.  In the group that received ledipasvir/sofosbuvir and ribavirin their quality of life decreased regardless of treatment duration until the end of treatment. 

The Bottom Line:  Ribavirin during treatment reduced quality of life, but achieving a cure improved quality of life for all of the groups including the groups who received ribavirin.

 

Editorial Comments:  This is a no-brainer, but we need more of these studies to show that being cured improved quality of life and improved overall survival.  I hope that insurance companies are hearing this and loosen up the restrictions.

Article:  Antigenic cooperation among intrahost HCV variants organized into a complex network of cross-immunoreactivity—P Skums
  Source: Proc Natl Acad Sci USA. 2015 May 26;112(21):6653-8.doi:10.1073/pnas.1422942112. Epub 2015 May 4.

 

Results and Conclusions:
Most people who become acutely infected with hepatitis C become chronically infected – up to 85%.  The reason there is such a high rate of chronic infection is not completely understood, but there are many theories.  The current paper presented a mathematical model to show how the virus contributes to hepatitis C chronicity. 

What is interesting is that various proteins of the hepatitis C virus seem to act together to escape the human host—that is certain proteins of the virus work together to draw off parts of the immune system cells so that other parts of the hepatitis C virus can survive and persist in the body and infect liver cells. This enables the hepatitis C virus to act as a network of parts to establish a chronic infection.   

The Bottom Line:  As with any discovery in science these findings need to be replicated.  If the exact mechanism can be understood an effective protective vaccine could be developed. 

Editorial Comment:  Isn’t science interesting?  The hepatitis C virus is a wily little bugger and endlessly fascinating.  The key would be to understand why this strategy works for some and not others.   This could lead to the development of an effective vaccine.

 

Article: Differentiation of acute from chronic hepatitis C virus infection by nonstructural 5B deep sequencing: A population-level tool for incidence estimation—V. Montoya et. al
   Source:  Hepatology Volume 61, Issue 6, pages 1842–1850, June 2015

 

Results and Conclusions:  In the current study the authors examined the viral proteins from 13 acute and 54 chronic individuals by sequencing the NS5B region of the virus.  They were able to differentiate the viral diversity between the acute and chronic infection.  The viral diversity was significantly different between acute vs. chronic infection. 

 
Editorial Comment:  This and the last issue of the HCV Advocate have discussed the difficult task of trying to diagnose an acute infection of HCV.  If this study is replicated and IF the tool is made available at a reasonable cost it could be a game changer in the way we understand how many people are acutely infected with hepatitis C.

Source:  http://hcvadvocate.org/news/newsLetter/2015/advocate0815.html#3

Snapshots—Lucinda K. Porter, RN

Article: Systematic Review: Patient-Reported Outcomes in Chronic Hepatitis C - The Impact of Liver Disease and New Treatment Regimens - Z. Younossi and L. Henry
  Source: Alimentary Pharmacology and Therapeutics January 23, 2015

How do we measure successful hepatitis C (HCV) treatment? Is it strictly by clinical trial data showing how safe and effective a treatment is? Alternatively, is it by patients’ experiences, outcomes, and overall quality of life? This ambitious study examined patients’ experiences of living with hepatitis C and its treatment. 

They found that current data support the fact that HCV patients suffer substantially. This burden was much worse during interferon/ribavirin treatment and worse yet if that treatment used telaprevir or boceprevir. The newer interferon-free treatments showed that patients reported improvements in quality of life and productivity; and even bigger improvements with ribavirin-free regimens. Patients who reported easier treatment were more likely to complete therapy and respond to it.

This study also looked at fibrosis stage, finding significant fatigue and impairment among those with early stage liver disease. Patients with early fibrosis reported significant benefits, similar to the gains achieved by those with advanced fibrosis.

 

The Bottom Line: Using fibrosis stage to limit the cost of HCV treatment does not take in to account the other costs of HCV, such as its effect on work productivity, quality of life, etc.

 

Editorial Comment: This study validates what patients have been reporting for decades—that having hepatitis C is hard, and that the newer treatments offer hope for improved quality of life. Denying access to treatment violates human rights.

Article: Seven Years of Chronic Hepatitis C Virus Infection in an HIV-Infected Man without Detectable Antibodies – Joost Vanhommerig, et al.
  Source: AIDS 2015, Vol 29 No 3

After an HCV exposure, about half of those exposed will form antibodies in 5 to 10 weeks.

It averages 10 to 13 weeks for HCV antibodies to be detectable in HCV/HIV-coinfected men who have sex with men (MSM). There have been reports of some HIV-infected individuals for whom HCV antibodies didn’t show up for more than 3 years. In this case study, an HIV-positive man had positive HCV viral load results for 7 years but never had a positive HCV-antibody test result. 

The Bottom Line: These researchers recommend HCV viral load testing rather than relying solely on antibody testing for HIV-infected MSM.

 

Editorial Comment: I am both fascinated and irritated when there are rare exceptions in medical science, but they do exist. 

Article: Hepatitis C Virus Infection: A Risk Factor for Parkinson’s Disease – Wendy Wu, et al.
  Source: Journal of Viral Hepatitis January 21, 2015

Recent evidence indicates that HCV may invade the central nervous system.  In rat studies, researchers observed that HCV and Parkinson’s disease both overexpress inflammatory biomarkers. Analyzing data from 62,276 subjects, researchers found similarities between HCV and Parkinson’s.

 

The Bottom Line: This study demonstrated an association between HCV infection and Parkinson’s and confirms the observation of dopaminergic toxicity of HCV similar to that found in rats.

 

Editorial Comment: As horrifying as these results are, perhaps this research will shed light on the nature of “brain fog,” which is experienced by so many HCV patients. 

Article: Hepatitis A hospitalizations in the United States, 2002-2011 – Melissa Collier, et al.
  Source: Hepatology February 2015

This study reviewed hospitalization rates for hepatitis A from 2002-2011. The number of hepatitis A-related hospitalizations hasdeclined significantly, but patients who are hospitalized for hepatitis A are older and more likely to have liver diseases and other comorbid medical conditions.

 

The Bottom Line: Immunization could prevent hepatitis A infection and ensuing hospitalizations.

 
Editorial Comment: Hepatitis A vaccination is recommended for hepatitis C patients.

http://hcvadvocate.org/news/newsLetter/2015/advocate0315.html#4