Hepatitis C - Efficacy and safety of sofosbuvir-based therapies in advanced liver disease in a real-life cohort

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Efficacy and safety of sofosbuvir-based therapies in patients with advanced liver disease in a real-life cohort
Kutala BK,Mouri F,Castelnau C,Bouton V,Giuily N,Boyer N,Asselah T,Marcellin P

Published 18 December 2017 Volume 2017:9 Pages 67—73

DOI https://doi.org/10.2147/HMER.S149578

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Background: The combination of sofosbuvir (SOF) with ribavirin (RBV) or daclatasvir (DCV) or simeprevir (SIM) for the treatment of patients infected by chronic hepatitis C (CHC) have led to significantly increased rates of sustained virological response (SVR). However, there is only limited data regarding factors associated with treatment failure in a “real-life” cohort.

Patients and methods: Consecutive treatment-naive and treatment-experienced patients F3–F4 were treated with SOF-based interferon-free therapy in our hospital from November 2013 to July 2015. The primary endpoint was the proportion of patients with sustained virological response 12 weeks after cessation of therapy (SVR12).

Results: A total of 167 treatment-naive and 207 treatment-experienced patients were treated and followed up for 2 years (n=383). Overall, 71% were men; among them, 54% had cirrhosis and the median age was 53 years. SVR12 was achieved by 82% of the patients receiving SOF+RBV, 92% receiving SOF+DCV, and 79% receiving SOF+SIM. Metavir  F4 and albumin serum were found as independent risk factors associated with treatment failure in groups receiving SOF+RBV (p=0.008 and p=0.001), SOF+DCV (p=0.038 and p=0.043), and SOF+SIM±RBV (p=0.014 and p=0.017), respectively. The most common adverse events were fatigue, nausea, headache, and anemia. Three patients discontinued the treatment due to an adverse event.

Conclusion: These findings suggest that 12-week SOF-based regimen plus RBV or DCV or SIM is an efficacious and well-tolerated treatment in CHC patients with fibrosis stage F3–F4. Patients, who display risk factors for cirrhosis, should be referred to an experienced viral hepatitis center. 

Continue to full article: https://www.dovepress.com/efficacy-and-safety-of-sofosbuvir-based-therapies-in-patients-with-adv-peer-reviewed-fulltext-article-HMER

MedPage Today - 2018: What's Next in Infectious Diseases?

2018: What's Next in Infectious Diseases?

Antibiotics, opioids, and the flu top expert predictions
by Molly Walker, Staff Writer, MedPage Today
January 04, 2018

The field of infectious diseases is certainly not immune to the opioid epidemic. Myron Cohen, MD, of the University of North Carolina Chapel Hill, said that "infections and the opioid crisis" could be a major issue in the coming year

..... opioid epidemic will likely continue to drive new HIV and hepatitis C infections, which have the potential to affect pregnant women and newborn babies. Back in May, the CDC found that the rate of maternal HCV infection nearly doubled from 2009 to 2014....

Continue to article: https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/70300

Improvements in Quality of Life: A New Hepatitis C Virus Treatment Indication in Persons with Substance Use Disorders

Accepted Manuscript

The Journal of Infectious Diseases, jix682, https://doi.org/10.1093/infdis/jix682
Published: 26 December 2017

Editorial
Improvements in Quality of Life: A New Hepatitis C Virus Treatment Indication in Persons with Substance Use Disorders

Ponni V Perumalswami, MD Andrew H Talal, MD, MPH

Globally, hepatitis C virus (HCV) infection occurs in an estimated 52% of the 15 million injection drugs users (IDUs) between 15 and 64 years (1). In the United States (US), HCV prevalence estimates range from 43% to 95% of the 6.6 million IDUs (2-4). Recent increases in opioid use have had unintended consequences, a 294% increase in HCV incidence in the US between 2010 and 2015 (5). HCV infection demographics have also shifted with increases in those 30 years or younger who reside in rural areas (6). Elimination of HCV infection has been prioritized in persons with substance use disorders (PWSUD) with the recent development of a national HCV elimination strategy (7). Many challenges, unfortunately, remain toward achieving this goal including insurance coverage restrictions, limited availability of harm reduction services, restrictive HCV medication policies, and low rates of engagement by PWSUD into HCV screening and linkage-to-care....

Full Article : PDF available for download 

New at Healio - Virtual touch quantification accurately measures fibrosis stage

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2017 saw record number of FDA approvals for drugs
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The FDA approved 46 drugs in 2017, tying a record set for approvals in 2015. Cancer medications led the way, with 16 oncology and 11 hematology drugs approved. There…

From Retirement To The Front Lines Of Hepatitis C Treatment

From Retirement To The Front Lines Of Hepatitis C Treatment  
Julio Ochoa Transcript January 2, 20184:13 PM ET

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Transcript

When a hepatitis C treatment called Harvoni was released in 2014, Dr. Ronald Cirillo knew it was big.

"It's the reason that dragged me out of retirement!" he says.

Cirillo specialized in treating hepatitis C for more than 30 years in Stamford, Conn., before retiring to Bradenton, Fla. During his time in Connecticut, the only available treatment for hepatitis C had terrible side effects and it didn't work very well. It cured the viral infection less than half the time. But the newer drugs Harvoni and Solvaldi cure almost everybody, with few adverse reactions.

Read full article: Heard on All Things Considered

Eight-Week Outcomes of Ledipasvir/Sofosbuvir in Noncirrhotic Treatment-Naive Patients with Hepatitis C: Analysis of Pharmacy-Based Data

Eight-Week Outcomes of Ledipasvir/Sofosbuvir in Noncirrhotic Treatment-Naive Patients with Hepatitis C: Analysis of Pharmacy-Based Data
Jennifer Andres , PharmD, BCPS1*, Stephen Lott , PharmD, MS, CSP3, Kamran Qureshi , MD2

J Manag Care Spec Pharm, 2018 Jan;24(1):23-28.

https://doi.org/10.18553/jmcp.2018.24.1.23

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BACKGROUND: Clinical trials have demonstrated that 8 weeks of ledipasvir and sofosbuvir (LDV/SOF) achieved high rates of sustained virologic response at 12 weeks (SVR12) in patients with hepatitis C viral (HCV) genotype 1 infection. The effectiveness of this combination was noted to be robust in treatment-naive noncirrhotic patients and in patients with an HCV viral load of < 6 million IU/mL before treatment. Generalizability of these results to community clinical practice, however, was advised with caution due to the variability of staging methods, fluctuating nature of viral loads, lack of prospective trials, and real-life confirmation.

OBJECTIVE: To evaluate the efficacy, defined as SVR12, of LDV/SOF in a real-world setting.

METHODS: Patients met inclusion criteria if given 8 weeks of LDV/SOF by a specialty pharmacy from October 2014 to October 2015 and if SVR12 was assessed after therapy completion. Clinical outcomes data were obtained from the pharmacy database.

RESULTS: Of the 6,391 prescriptions of LDV/SOF received by the pharmacy, 3,648 (57%) were covered by insurance, and among them, only 511 (14%) were for an 8-week regimen. SVR12 data were available for 380 (74%) patients who completed an 8-week regimen. 230 different prescribers wrote prescriptions, and 57 different insurance plans approved the 8-week regimen. The majority (74%) of patients were followed by gastroenterology clinics. The 380 patients included in the analysis were all treatment-naive HCV genotype 1 patients. Overall, SVR12 was achieved in 97% of patients, while 10 patients relapsed. The SVR12 rates were lower (93%) in patients with stage 3 fibrosis, particularly in African Americans (29 of 35: 83%).

CONCLUSIONS: Outcomes were favorable for the 8-week use of LDV/SOF in a noncontrolled real-world setting in treatment-naive noncirrhotic patients with a baseline viral load < 6 million IU/mL. Use of this approach in African Americans with evidence of advanced fibrosis should be avoided.

This work was presented in part as a poster at the 2016 International Liver Conference; Barcelona, Spain; April 13-17, 2016.

What is already known about this subject

• Initial evidence for an 8-week treatment duration of ledipasvir/sofosbuvir comes from a post hoc analysis of a clinical trial.
• Real-world analyses have agreed with the hepatitis C viral (HCV) RNA threshold of < 6 million IU/mL to qualify for 8 weeks of treatment.
• Current guidelines recommend that patients with HCV RNA < 6 million IU/mL can use ledipasvir/sofosbuvir for 8 weeks if they are not African American or HIV coinfected.

What this study adds

• This study provided results that were consistent with current guideline recommendations.
• Sustained virologic response at 12 weeks was high in the African American patient population, except in patients with stage 3 fibrosis, and also high in the HIV-coinfected patient population.

Continue to article : http://www.jmcp.org/doi/10.18553/jmcp.2018.24.1.23

Hepatitis C 2018 - Its A New Year

Updated

Tuesday, January 1, 2019 

 Hep C Review: 2019 Newsletters & Updates

 

Here's what new in the world of HCV in 2018

2018 HCV Genotypes/Treatment

Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved and investigational medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities.

 

Research Articles: 

Cure - Achieving sustained virologic response (SVR) in hepatitis C
Fibrosis
FibroScan® Understanding The Results
Cirrhosis
Liver Cancer
Liver Transplant
Fatty Liver Disease
HCV-Elderly 
Possible Side Effects Of HCV Therapy 
Other Conditions Related To HCV

HCV Newsletters
HCV Education

Of Interest

The Long Road To Safe and Effective HCV Drugs: A Tribute To The People Who Helped Us Get There

HCV in Southeast Asia - Ledipasvir and Sofosbuvir for HCV Genotype 6

HCV Genotype 6 Responds to 8-Week Oral Treatment

Kenneth Bender

The successful treatment of hepatitis C virus genotype 6 (HCV-GT6) with a non-interferon-based fixed dose oral regimen of ledipasvir and sofosbuvir (LDV/SOF) bodes well for treating HCV in Southeast Asia, where newer pangenotypic agents are not available to treat this region's most prevalent genotype.

Continue reading......

On This Blog
2018 HCV Genotypes and Treatment
Offered on this page is research updates with a focus on treating HCV according to genotype using FDA approved medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities.