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Alan Franciscus

Editor-in-Chief

HCV Advocate



Wednesday, April 15, 2015

Snapshots —Alan Franciscus, Editor-in-Chief

Article:  Improvement of health-related quality of life and work productivity in chronic hepatitis C patients with early and advanced fibrosis treated with ledipasvir and sofosbuvir—ZM Younossi
  Source: J Hepatol.2015 Mar 17. pii: S0168-8278(15)00192-0. doi: 10.1016/j.jhep.2015.03.014. [Epub ahead of print]

The main goal of HCV treatment is viral eradication or being cured of hepatitis C. However, there are equally important reasons and objectives besides being cured—better overall mental and physical functioning and being able to increase work productivity (and being able to increase income). 

The aim of the current study was to examine what being cured of hepatitis C with sofosbuvir plus ledipasvir with or without ribavirin means with respect to improving health-related quality of life—mainly physical functioning and work productivity.  There were 1,005 patients in the current study that were drawn for the ION-1,2,3 clinical trials.  The patient’s fibrosis stage was determined pretreatment based on the Metavir fibrosis staging system:
  • F0: 94 patients (pts);
  • F1: 311 pts;
  • F2: 301 pts ;
  • F3: 197 pts;
  • F4:102 pts
Four questionnaires [Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, during, and after treatment.

The Bottom Line:  It is not surprising that patients with the most advanced fibrosis (F4) had the most impairment in health-related quality of life with respect to physical functioning compared to those who were stage F0. 

This continued during and post-treatment.  After being cured there was a significant improvement from baseline in most areas of health-related quality of life regardless of the level of fibrosis stage. 

After analysis, not surprisingly, advanced fibrosis was associated with impairment of health-related quality of life and work productivity. However, it was noted that health-related quality of life and work productivity after being cured was not related to the stage of fibrosis.

Editorial Comment: This is an important study because it proved that curing people of hepatitis C improved physical well-being and work productivity.  I am eager to see more of these types of studies because we all need more information about every aspect of being cured of hepatitis C—this helps people living with hepatitis C to make the treatment decision and it will further justify the expense and need to treat people with hepatitis C.

Abstract: Chronic hepatitis C virus infection and lymphoproliferative disorders: Mixed cryoglobulinemia syndrome, monoclonal gammopathy of undetermined significance, and B-cell non-Hodgkin lymphoma—GP Caviglia
  Source: J Gastroenterol Hepatol.2015 Apr;30(4):742-7. doi: 10.1111/jgh.12837.

The researchers reviewed a study of 1,313 HCV patients who had enrolled in previous studies from January 2006 and December 2013.  There was a total of 121 people with HCV and lymphoproliferative disorders (LPDs) and 130 without LPDs.  The two groups were evenly divided between age and gender.  In the groups with LPDs—25 had mixed cryoglobulinemia (MCS)*; 55 had monoclonal gammopathy of undetermined significance (MGUS)**; 41 had B-cell non-Hodgkin Lymphoma (B-HNL)***.  The patients with LPDs did not differ in age, severity of disease, HCV genotype, and response HCV therapy. 

The Bottom Line:  After analyzing the data, it was found that there was an association between MGUS and B-NHL and cirrhosis, but there was no association between MCS and cirrhosis. 

Editorial Comment:  It is interesting that there was a correlation between MGUS and cirrhosis.  However, both conditions typically take many years before serious disease progression occurs.  In regards to MCS it can occur earlier in the course of HCV infection.  Still, it is important that people living with hepatitis C understand this information and talk with their medical providers to be tested for these conditions and for medical providers to make sure they are tested.  If someone infected with hepatitis C does have these serious conditions they may be more likely to qualify for treatment.  It would be, however, best medical and patient practice to nip these and HCV in the bud by treating and curing hepatitis early before any disease or associated condition has a chance to occur. 

*Mixed cryoglobulinemia (MCS) is one of the most common disorders associated with hepatitis C.  Cryoglobulinemia (cryo for short) is a blood disorder caused by abnormal proteins in the blood called cryoglobulins that precipitate or clump together when blood is chilled and then dissolve when warmed.  Cryo can lead to many other disorders. 

**Monoclonal gammopathy of undetermined significance (MGUS) are abnormal proteins in the blood.   They can be associated with another disease (such as hepatitis C).  They rarely cause disease, but in some people with certain conditions, such as hepatitis C, MGUS’s can progress to other diseases. 

***B-cell non-Hodgkin Lymphomas (B-HNL) are cancers of the lymphoid tissues.  The cancers are typically uncommon and usually occur after many years of infection with hepatitis C. 

More detailed information can be found on our fact sheet page.

Warning: Pegasys plus Ribavirin Pediatric Use

Pegasys (peginterferon alfa-2a)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2015

WARNINGS AND PRECAUTIONS

Impact on Growth in Pediatric Patients
  • During combination therapy for up to 48 weeks with PEGASYS plus ribavirin growth inhibition was observed in pediatric subjects 5 to 17 years of age. Decreases in weight for age z-score and height for age z-score up to 48 weeks of therapy compared with baseline were observed. At 2 years post-treatment, 16% of pediatric subjects were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve.
  • The available longer term data on subjects who were followed up to 6 years post-treatment is too limited to determine the risk of reduced adult height in some patients [see Clinical Trials Experience (6.1)].

Read more...

Tuesday, April 14, 2015

Caffeinated drinks associated with decreased risk of liver scarring

Modest daily consumption of caffeinated drinks is associated with less advanced liver scarring in people with hepatitis C, according to a recent study by Baylor College of Medicine researchers that appears online in the journal Clinical Gastroenterology and Hepatology.

Dr. Hashem El-Serag, chief of gastroenterology and hepatology at Baylor and at the Michael E. DeBakey Veterans Affairs Medical Center and lead author of the study, said the results showed that the risk of liver scarring in hepatitis C patients was decreased when individuals regularly consumed caffeinated coffee, and to a lesser extent tea and soda.

“We found that participants who drank caffeinated coffee daily had the best results,” he said. “This is most likely do to the fact that one coffee drink has more caffeine than tea or sodas.”

Read more....

See Also: The Five: Coffee

Monday, April 13, 2015

UK: Ten year drive to wipe out hepatitis C in Bradford

CASES of hepatitis C could be eradicated in Bradford by 2025, according to leading liver expert Dr Sulleman Moreea.

The consultant hepatologist at Bradford Royal Infirmary said the dream of wiping out the virus that could be affecting up to 4,000 people in the city really is "an achievable goal".

There are about 1,200 patients who have been referred to the hospital with Hepatitis C but the total number of people with it in Bradford is estimated to be between 3,000 to 4,000, according to Dr Moreea.

Read more...

Maine sets a record for drug needle exchanges

The total hit 564,847 last year, up 238 percent since 2010, as heroin use surged and clinics like Portland's worked to prevent cases of HIV and hepatitis C.

State law has allowed needle exchanges in Maine since 1997, but the program only became active in 2002. There are four state-certified needle exchange programs, operating at six sites: Portland, Lewiston, Augusta, Bangor, Ellsworth and Machias.

All of Maine’s programs operate without federal or state funding. Federal funding for needle exchange has been banned since 1988 (except for a period from 2009 to 2012) and states often don’t provide funding either, so the programs run mainly on private grants or donations.

Read more...

Weekly Special Topic: HCV Diagnostic Tools


 

HCV Diagnostic Tools

We have updated and condensed our HCSP Fact Sheet Series "HCV Diagnostic Tools" into one fact sheet: 


An Overview of HCV Diagnostic Tests 



Thursday, April 9, 2015

Janssen Highlights Hepatitis C Virus Development Programme at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL)

Presentations include late-breaking final results from the Phase 3 OPTIMIST trials and interim results from the Phase 2 IMPACT trial of simeprevir


CORK, Ireland--()--Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), today announced that clinical data for simeprevir, its NS3/4A protease inhibitor for the treatment of hepatitis C virus (HCV) infection, will be presented at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) taking place in Vienna from April 22-26. Early-stage data on the investigational nucleotide analog polymerase inhibitors AL-335 and AL-516, which were recently obtained through Janssen’s acquisition of Alios BioPharma, will also be presented.
“Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”
Several key presentations will report on the efficacy and tolerability of simeprevir in interferon-free combination regimens in Phase 2, Phase 3 and real-world clinical settings.

“Hepatitis C remains a serious health problem. The breadth of data we are presenting at The International Liver Congress™ reinforces our commitment to reducing the significant burden of this infectious disease around the world,” said Gaston Picchio, hepatitis disease area leader, Janssen. “Janssen has an extensive and ongoing clinical trial programme for hepatitis C, including confirmatory and new exploratory studies, and we look forward to sharing these results. We remain focused on investigating alternative and more immediate treatment options for patients with a high unmet need.”

A total of 14 company-sponsored abstracts supporting Janssen’s marketed and investigational therapies for HCV will be presented, including three abstracts on simeprevir accepted as late-breaking presentations. The scope and rigor of these data underscore Janssen’s commitment to being a positive catalyst in the fight against this serious public health threat.

“These data highlight the strength of our commitment to advancing research in the area of viral hepatitis,” said Lawrence M. Blatt, Ph.D., global head therapeutics, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma. “We are delighted to present additional data for simeprevir in combination with other currently available therapeutic options alongside early-stage data for our nucleotide portfolio.”

Studies on Janssen’s HCV portfolio to be presented at The International Liver Congress™ 2015 include:

 
Late-Breaking Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.
  • A Phase 3, randomised, open-label study to evaluate the efficacy and safety of 12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF)▼ in treatment-naïve and -experienced patients with chronic HCV genotype 1 infection without cirrhosis: The OPTIMIST-1 study1
    • Abstract LP14
    • Lead Author: P. Kwo; Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, IN, USA
  • A Phase 3, open-label, single-arm study to evaluate the efficacy and safety of 12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or -experienced patients with chronic HCV genotype 1 infection and cirrhosis: The OPTIMIST-2 study2
    • Abstract LP04
    • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA
  • Simeprevir (SMV) plus daclatasvir (DCV)▼ and sofosbuvir (SOF) in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease: Interim results from the Phase 2 IMPACT study1
    • Abstract LP07
    • Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA
Oral Presentation
  • On-treatment virologic response and tolerability of simeprevir, daclatasvir and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation (OLT): Interim data from the Phase 2 SATURN Study1
    • Abstract 0004: Thursday 23 April, 16:45 – 17:00, Hall D
    • Lead Author: X. Forns; Liver Unit, Hospital Clinic, Barcelona, Spain
Poster Presentations
All posters will be displayed electronically from Thursday 23 April, 07:30 to Saturday 25 April, 20:00 in Hall B.
  • Significant drug-drug interaction between simeprevir and cyclosporine A but not tacrolimus in patients with recurrent chronic HCV infection after orthotopic liver transplantation: The SATURN study1
    • Abstract P0834
    • Lead Author: S. Ouwerkerk-Mahadevan; Janssen Research & Development, Beerse, Belgium
  • Deep sequencing analyses in HCV genotype 1-infected patients treated with simeprevir plus sofosbuvir with/without ribavirin in the COSMOS study6
    • Abstract P0780
    • Lead Author: B. Fevery; Janssen Infectious Diseases BVBA, Beerse, Belgium
  • Effectiveness of simeprevir (SMV)-containing regimens among patients with chronic hepatitis C virus (HCV) in various U.S. practice settings: Interim analysis of the SONET study7
    • Abstract P0826
    • Lead Author: I. Alam; Austin Hepatitis Center, Austin, TX, USA
  • Study protocol for a partly randomised, open-label Phase 2a trial of once-daily simeprevir combined with sofosbuvir for the treatment of HCV genotype 4-infected patients with or without cirrhosis (OSIRIS)8
    • Abstract P1346
    • Lead Author: M. El Raziky, Departments of Pediatrics, Cairo University, Cairo, Egypt
  • Baseline factors associated with increased SVR rates in 123 treatment-naïve chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus pegylated interferon and ribavirin regimen: A multivariate analysis9
    • Abstract P0792
    • Lead Author: T. Asselah, Beaujon Hospital, University of Paris, France
  • Clinical characteristics and outcomes of chronic hepatitis C (CHC) patients treated with newer direct-acting antiviral (DAA)-based regimens from a large U.S. payer perspective10
    • Abstract P0852
    • Lead Author: N. Tandon; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
  • A descriptive analysis of a real-world population with chronic hepatitis C (CHC) treated with simeprevir (SMV)-and/or sofosbuvir (SOF)-based regimens: Findings from a U.S. payer database11
    • Abstract P0827
    • Lead Author: J.B. Forlenza; Janssen Scientific Affairs, LLC, Titusville, NJ, USA
  • Real world effectiveness and cost of simeprevir- and/or sofosbuvir-based HCV treatments: $175,000 per SVR1212
    • Abstract P0881
    • Lead Author: K. Bichoupan; Division of Liver Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY, USA
Alios BioPharma Poster Presentations
  • Derisking the potential for mitochondrial toxicity of nucleoside analogs13
    • Abstract P0679
    • Lead author: Z. Jin; Alios BioPharma, San Francisco, CA, USA
  • Preclinical characterization of AL-335, a potent uridine based nucleoside polymerase inhibitor for the treatment of chronic hepatitis C14
    • Abstract P0682
    • Lead Author: H. Tan; Alios BioPharma, San Francisco, CA, USA
Full session details and data presentation listings for The International Liver Congress™ 2015 can be found at http://www.ilc-congress.eu.

Press Release Source: