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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated September 17, 2014

Wednesday, September 17, 2014

CVS Health Research Institute Provides First Look at Treatment with New Hepatitis C Therapies

WOONSOCKET, R.I., Sept. 17, 2014 /PRNewswire/ -- An analysis done by the CVS Health Research Institute provides insights regarding patients taking Sovaldi® (sofosbuvir), a new and expensive treatment for Hepatitis C introduced in December. The data shows that over the last several months (May through August 2014) there has been a plateau and actual downward trend in Sovaldi utilization. This suggests another surge of patients will begin therapy when a number of new therapeutic regimens of similar efficacy and shorter duration are introduced in the Fall.

In clinical trials for Sovaldi, more than 95 percent of patients achieved cure rates and almost all patients completed therapy, with only about two percent discontinuing treatment. However, clinical trials rarely capture the real-life challenges faced by patients taking a new drug. The new CVS Health data also provides a first look at the drug's use outside of the clinical trial setting and shows therapy discontinuation rates of 8.1 percent, approximately four times higher than in trials. Furthermore, patients who were completely new to Hepatitis C treatment were more likely to discontinue therapy, a finding which has substantial implications for clinicians and their patients. 

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Australia: Hepatitis C patients push for access to a new drug with 90pc cure rate

ELEANOR HALL: The health lobby Hepatitis Australia is warning that, without immediate government intervention, there will be a tidal wave of life-threatening liver disease as a result of hepatitis C infections.

New drugs with a cure rate of 90 per cent have become available in many countries but not yet in Australia.

Mandie Sami reports.

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Newlyweds already practicing love 'in sickness and in health'

La Habra couple says ‘I do’ after 24 years together and a looming terminal illness.

Brad and Dolores Cha wanted to join together forever – before it’s too late.

Brad, 52, was diagnosed with stage IV liver cancer and has only a few months left to live.

The couple, who have been together 24 years, was married Tuesday afternoon in the living room of their modest La Habra home in front of nearly 20 family members and close friends.

The wedding was “something I felt I needed to do,” Brad said. Brad was given six months to a year to live in July 2013. 

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$6 million grant awarded for King County hepatitis C treatment

A $6 million grant has been awarded to Public Health – Seattle & King County to improve testing, treatment and cure of people with hepatitis C.

The four-year grant from the federal Health and Human Services and Centers for Disease Control and Prevention will fund the Hepatitis C Test & Cure Project, the public-health department announced on Tuesday. Hepatitis C infects the liver and is transmitted primarily by exposure to an infected person’s blood.
 
The grant will provide funding for the project to train clinicians on the diagnosis, evaluation and treatment of hepatitis C and connect them to specialists, the health department said. It will also enhance the ability to track patients who may have fallen out of treatment.

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New Hepatitis C medication showing positive results

SHERMAN, TX -- There is now hope for millions of Americans suffering from the potentially fatal virus Hepatitis C. Sovaldi, approved by the FDA just last December, is showing positive results.
Health experts say after treatment the liver-destroying virus is no longer detectable in 90 percent of patients who are infected with the most common strain.

In 2005 Linda Nunn got the news, she had Hepatitis C.

"You feel like you're in between a rock and a hard place. You wait for the liver to fail, you wait for cancer to show up, or you wait for a cure," Nunn said.

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Australia: World first prison-based hepatitis C treatment – just one tablet a day

UNSW will lead a world-first study to evaluate the effectiveness of a one tablet per day hepatitis C treatment as a means of preventing the spread of the virus in prisons.

The SToP-C study (Surveillance and Treatment of Prisoners with hepatitis C) is being undertaken in collaboration with the Justice Health and Forensic Mental Health Network, Corrective Services NSW, NSW Health, Hepatitis NSW, NSW Users and AIDS Association, and the Community Restorative Centre.

The study will begin recruiting prisoners in selected correctional facilities in New South Wales starting in September 2014. UNSW researchers and project partners will investigate whether a significant reduction in hepatitis C infections in NSW prisons is possible with a “treatment as prevention” strategy, which will seek to treat consenting prisoners for their hepatitis C infection, both to improve their own health and to make onward transmission to others less likely.

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Predictors of poor mental and physical health status among patients with chronic hepatitis C infection: The chronic hepatitis cohort study (CHeCS)


—Alan Franciscus, Editor-in-Chief     


It should not surprise anyone with hepatitis C (HCV) that having hepatitis C can lead to depressive symptoms and a reduction in quality of life.   Would it be a surprise that being cured of hepatitis C would reduce the symptoms of depression and improve quality of life?  Probably not!  I will be very interested to read the entire research paper about this study to learn more. 

Lucinda Porter, RN will report on another study that looked at people who had minimal disease who had to wait for treatment and what effect it had on their emotional state.  The recap of the study will appear in the next issue of the HCV Advocate newsletter.   Alan

Predictors of poor mental and physical health status among patients with chronic hepatitis C infection: The chronic hepatitis cohort study (CHeCS).
Boscarino et al.
Hepatology. 2014 Sep 9. doi: 10.1002/hep.27422. [Epub ahead of print]

ABSTRACT

Aims:
Our objective was to assess the extent and risk factors for depression and poor physical health among patients with chronic hepatitis C virus (HCV) infection.

Methods:
We surveyed HCV-infected patients seen at four large healthcare systems participating in the Chronic Hepatitis Cohort Study (CHeCS).

Survey data included demographics, depression and physical health measures, substance use history, current social support, recent stressor exposures, and, from the electronic medical record, treatment history, and Charlson Comorbidity Index scores.

Results:
There were 4,781 respondents, who were a mean of 57 years old, 71% White, and 57% male. Altogether, 51.4% reported past injection drug use, 33.9% were current smokers, and 17.7% had abused alcohol in the previous year. Additionally, 47.4% had been previously treated for HCV and 14.8% had a 12-week sustained viral response (SVR) following HCV therapy. Overall, 29.7% of patients met criteria for current depression and 24.6% were in poor physical health.
In multivariate analyses, significant predictors of depression and poor health included:
  • Male gender (vs. female, OR, 0.70 and 0.81),
  • Black race (vs. white, ORs, 0.60 and 0.61),
  • Having education less than high school (vs. college, ORs, 1.81 and 1.54),
  • Being employed (vs. not, ORs, 0.36 and 0.25),
  • Having high life stressors (vs. low, ORs, 2.44 and 1.64),
  • Having low social support (vs. high, ORs=2.78 and 1.40), and
  • Having high Charlson scores (vs. none, ORs=1.58 and 2.12).
Achieving a 12- week SVR was found to be protective for depression.

Conclusions:
This large survey of US HCV patients indicates the extent of adverse health behaviors and mental and physical comorbidities among these patients. (Hepatology 2014;).

Copyright © 2014 American Association for the Study of Liver Diseases.