Epidemiology and Outcomes of Hepatitis C Infection in Elderly US Veterans

Epidemiology and Outcomes of Hepatitis C Infection in Elderly US Veterans

Patients with hepatitis C infection are getting older in the United States, yet are underrepresented in clinical trials. How does age impact outcomes with and without antiviral treatment?

September 23, 2016

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Abstract

The chronic hepatitis C (CHC) cohort in the United States is getting older. Elderly patients with CHC may be at a high risk of cirrhosis and hepatocellular carcinoma (HCC), but also other nonhepatic comorbidities that negatively impact their likelihood of receiving or responding to antiviral treatment. There is little information on the clinical epidemiology or outcomes of CHC and its treatment in the elderly.

We conducted a retrospective cohort study of 1 61 744 patients with a positive Hepatitis C virus RNA in the Veterans Health Administration Hepatitis C Clinical Case Registry to examine the association between age subgroups (20–49, 50–64, 65–85 years) and risk of cirrhosis, HCC or death using Cox proportional hazards models. We also examined the effect of treatment with a sustained viral response (SVR) on these outcomes in each age subgroup.

The age distribution was 36.8% 20- to 49-year-olds, 57.6% 50- to 64-year-olds and 5.6% 65- to 85-year-olds (i.e. elderly). Risk of cirrhosis, HCC and death was significantly elevated in elderly patients [HR cirrhosis = 1.14 (1.00–1.29), HR HCC = 2.44 (1.99–2.99); HR death 2.09 (1.98–2.22)] compared with younger patients. The incidence of HCC was than 8.4 per 1000 PY in the elderly compared with 2.6 per 1000 PY and 5.7 per 1000 PY, among the 20–49 and 50–64 age groups, respectively. Elderly patients were significantly less likely to receive antiviral treatment (3.8% vs 14.8% and 19.1%, P < 0.0001), but among those who received treatment SVR was not different among the age groups (33.5% vs 33.2% and 32.1%).

In an analysis limited to those who received treatment, SVR compared to treatment receipt with no SVR was associated with a reduction in risk of developing cirrhosis (HR = 0.34; 0.18–0.66) and HCC (HR = 0.60; 0.22–1.61) and all-cause mortality risk (HR = 0.52, 0.33–0.82).

Elderly patients with CHC are more likely to develop HCC than younger patients but have traditionally received less antiviral treatment than younger patients. However, receipt of curative treatment is associated with a benefit in reducing cirrhosis, HCC and overall mortality, irrespective of age.

Methods

Results

Discussion

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AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® for Genotype 1b

AbbVie Presents Data on Eight-Week Treatment of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C

- 98 percent of previously untreated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected patients without cirrhosis achieved SVR12 in Phase 3b GARNET study1

- First study evaluating 8 weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets)1

- GT1b is the most common subtype globally,2 accounting for 47 percent of the nine million people infected with chronic HCV in Europe alone3,4

- GARNET study results on 8-week treatment duration included in newly published 'EASL Recommendations on Treatment of Hepatitis C'

NORTH CHICAGO, Ill., Sept. 23, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data showing high response rates with just eight weeks of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) treatment. In the Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published 'EASL Recommendations on Treatment of Hepatitis C.' VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.

"VIEKIRAX + EXVIERA has already achieved high cure rates with 12 weeks of treatment," said Stefan Zeuzem, M.D., study author and Chief of the Department of Medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "These results now show the potential for cure in just eight weeks with VIEKIRAX + EXVIERA in HCV genotype 1b infected patients without liver cirrhosis. The efficacy in this population is particularly important as GT1b is the most common subtype of hepatitis C virus globally."

Approximately 160 million people worldwide are infected with HCV.5 Genotype 1 is the most prevalent of the six major HCV genotypes, affecting an estimated 83 million people worldwide.6 In Europe, GT1b is the most predominant subtype accounting for 47 percent of the nine million people infected with chronic HCV.3,4,6

"AbbVie remains focused on continuing to explore and understand the expectations of HCV care, including a shorter treatment duration with VIEKIRAX + EXVIERA in GT1b patients," said Rob Scott, M.D., Vice President, Development and Chief Medical Officer, AbbVie.

In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1

About the GARNET Study1
The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).

Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.

Additional information about the GARNET study can be found on www.clinicaltrials.gov.

VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with compensated cirrhosis. VIEKIRAX is approved in the European Union for the treatment of genotype 4 (GT4) chronic HCV infection.

VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV), dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in genotype 1a patients with compensated cirrhosis (Child-Pugh A), who should take it for 24 weeks with RBV.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.

Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.

EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of CHC in adults.

Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.

Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.

Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis should be monitored for signs and symptoms of hepatic decompensation, including hepatic laboratory testing at baseline and during treatment.

ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.

Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when VIEKIRAX with or without EXVIERA is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.

Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.

Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.

Full summary of product characteristics is available at www.ema.europa.eu

EASL Recommendations on Treatment of Hepatitis C 2016

Watch
Summary Presentation - EASL Recommendations on Treatment of Hepatitis C 2016
Watch the livestreamed EASL updated  HCV recommendations with a follow-up Q&A session.

More on EASL HCV recommendations
The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments
​Continue reading...

EASL Recommendations on Treatment of Hepatitis C 2016

Download 2016 - Update of the HCV EASL recommendations

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide [1]. The long-term impact of HCV infection is highly variable, ranging from minimal histological changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC).

The number of chronically infected persons worldwide is estimated to be about 180 million [2], but most are unaware of their infection. Clinical care for patients with HCV-related liver disease has advanced considerably during the last two decades, thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy and prevention.

Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan

Surprise: Gilead's hep C wonder Harvoni costs less in U.S. than in EU, Japan
by Tracy Staton

It’s no secret that Gilead Sciences’ ($GILD) slowdown in hepatitis C sales growth has caused consternation among investors, to the point where the company is under intense pressure to make some deals.

It's also no secret that Gilead had to offer some steep discounts to win formulary spots for its blockbuster hep C meds Sovaldi and Harvoni, which initially enjoyed a monopoly on the next-gen hep C market--a key reason for the crimp in their sales growth.

Now, we have some numbers that illustrate just how big Gilead’s discounts are--and how its U.S. hep C prices after those discounts compare with similar figures overseas.

Continue reading..

New study to discover how “super” immune system can prevent HCV-infection

New study to discover how “super” immune system can prevent HCV-infection



New study launched to discover how “super” immune system can prevent hepatitis c

The scientists will seek the genetic basis for resistance to the virus (HCV). They invite all women who received HCV-contaminated anti-D in 1977-79 to volunteer.

20 September 2016
Scientists from Trinity College Dublin are seeking volunteers who were exposed to anti-D contaminated with hepatitis C virus (HCV) between 1977 and 1979 as they attempt to discover why some people are naturally protected from HCV infection, while others are not.

In 1977-79, hundreds of Irish women fell victim to HCV infection when they were given virus-contaminated anti-D. Usually anti-D is a blood product of great benefit given to women with blood groups incompatible with their new-born baby. It prevents the mother from building cells and molecules that would attack and destroy the foetus during a second pregnancy. Hence, it saves the life of the unborn child that would otherwise become ill or perhaps die.

However, in 1977-79 this normally beneficial product was unknowingly contaminated with HCV, which can invade and gradually destroy the liver. Until recently, researchers believed that receiving HCV-contaminated blood products, where high viral loads directly enter the blood stream, would inevitably lead to infection.

But in the aftermath of the 1977-79 outbreak, researchers made an interesting discovery: when screened for HCV almost half of the women who clearly had contact with the virus showed no signs of infection.

Professor of Comparative Immunology at Trinity College Dublin, Cliona O’Farrelly, said: “That means these women must have been naturally protected from the virus. We believe these women have an extra-special ‘super’ immune system that is able to fight viral invaders. We now want to find out why – and how – this system does such a good job.”

To do this, Professor O’Farrelly and her team will look at the information stored within the genes of naturally resistant people. The team will then compare it to the information from the genes of people who are unable to resist infection. If they uncover the mechanism behind the mystery of natural HCV-resistance, they can exploit this knowledge to find new ways to make vaccines and anti-viral drugs.

For this research project, the team seek volunteers who were exposed to HCV via contaminated anti-D in 1977-79 to help with the study. Women who became infected with HCV as well as those who show no signs of infection are invited to participate. Participation in the study is easy, and non-invasive, but could have a major impact on fighting viruses. All that is needed is a saliva sample, which can be easily collected at home and mailed to the team.

If you are interested in participating or would like to receive further information, please contact us by phone (087-791-3600) or email (TCDStudy2016@tcd.ie). Visit our website for more information: https://www.tcd.ie/Biochemistry/research/cig_hepatitisc.php

The project is funded by Science Foundation Ireland and is led by Cliona O’Farrelly, Professor of Comparative Immunology at Trinity College Dublin.

About hepatitis C-contaminated anti-D immunoglobulin

• In Ireland two hepatitis C virus (HCV) outbreaks have occurred due to HCV-contaminated anti-D immunoglobulin – the first occurred between 1977 and 1979, and the second between 1991 and 1994
• Anti-D immunoglobulin is a blood-derived medical product given to women who have the rhesus negative (Rh-) blood group and who have a rhesus positive (Rh+) baby. The anti-D immunoglobulin prevents the development of rhesus haemolytic disease of the newborn, which arises in subsequent pregnancies
• Over 1,000 women were infected with HCV in Ireland due to HCV-contaminated anti-D immunoglobulin. Of these women, approximately half had evidence of past infection (antibodies) but no circulating virus, while the other half developed chronic infection
• During the 1977-1979 outbreak ~50% of women who received high-risk HCV-contaminated anti-D batches were infected, but the rest of the women who received these high-risk batches were able to resist this infection

About hepatitis C (HCV)

• Hepatitis C was not discovered until 1989. Prior to this, it was known in medicine as non-A, non-B viral hepatitis
• The hepatitis C virus is a blood-borne virus. The most common mode of infection prior to the discovery of the virus was via medical equipment that had been inadequately sterilized, and via the transfusion of unscreened blood and blood products. This mode of infection remains a problem in developing countries.
• Presently, the most common mode of infection in developed countries is via unsafe injection practices
• Hepatitis C is a virus that targets, invades and gradually damages the liver. This irreversible liver damage is called liver cirrhosis
• Up to 20% of chronically infected individuals will develop cirrhosis of the liver over a 20 to 25-year period. Approximately 3% - 4% of patients with cirrhosis will develop hepatocellular carcinoma (HCC) per year
• Over 1% of the world’s population is chronically infected with HCV
• Approximately 700,000 people die each year from HCV-related liver diseases
• New antiviral medicines available in the last 2-3 years can cure up to 90% of persons with hepatitis C infection, but these therapies are extremely expensive.
• There is currently no vaccine for hepatitis C

Source - New study launched to discover how “super” immune system can prevent hepatitis c

Watch - Hepatitis C Medication Update

Hepatitis C Medication Update
Abigail Yancey, '02/'03, associate professor of pharmacy practice, provides an update on Hepatitis C medications and their place in therapy.

Highlights
Therapy Options
2016 Therapy Updates
Therapy Options: Which one to use?
Hepatitis C: Other Helpful Tips
Safety Of Statins
Aches and Pains? What OTC is Safe?
Pricing

Uploaded Sept 21, 2016
By STLCOP 1864

Hepatitis Australia - Pharmaceutical Benefits Advisory

First pan-genotypic, interferon-free regimens for hepatitis C a step closer
20 September 2016

Hepatitis Australia will be gathering information from people living with hepatitis C who will benefit from the latest medicines to be considered by the Pharmaceutical Benefits Advisory Committee. In particular we would like input from people living with hepatitis C genotypes 2, 3, 4, 5 and 6.

Hepatitis Australia will be making a submission and would welcome your input ahead of the November PBAC meeting.

The medicines being considered at the November meeting of PBAC include:

• Sofosbuvir (400mg) + velpatasvir (100mg) – Epclusa® by Gilead Sciences
• Ledipasvir (90mg) + sofosbuvir (400mg) – Harvoni® by Gilead Sciences
• Paritaprevir (75mg) + ritonavir (50mg) + ombitasvir (12.5mg) – Technivie® by AbbVie

The most significant thing to note regarding these applications is that it heralds the first pan-genotypic, interferon-free regimens for hepatitis C. Epclusa is a new treatment for genotypes 1-6 and Gilead is also seeking to expand the use of Harvoni to other genotypes. Technivie is for the treatment of genotype 4.

Further details
Add your voice for the upcoming PBAC submission in November

La. Officials Say Several Hundred People Now Getting Life-Saving Treatment Through Medicaid

La. Officials Say Several Hundred People Now Getting Life-Saving Treatment Through Medicaid

Louisiana health officials point to specific examples of treatment for breast cancer, diabetes and colon cancer screening to highlight Medicaid expansion efforts. In other news, the ACLU sues Colorado for its policy denying some Medicaid enrollees hepatitis C treatment, and insurers sue Pennsylvania over a Medicaid contract.

The (Baton Rouge, La.) Advocate: Medicaid Expansion Enrollment Tops 300K In Louisiana
Louisiana leaders say that hundreds of residents newly added to the state's Medicaid rolls have received potentially life-saving treatment since the health care program was expanded earlier this year. Twenty-four women are getting breast cancer treatment after positive screenings, 160 adults have been diagnosed with diabetes and are receiving treatment and more than 100 patients had polyps removed after they were found during colonoscopies. ... More than 305,000 adults have been been added to Medicaid since the state expanded eligibility for the health care program in July. (Crisp, 9/19)
 

New Orleans Times-Picayune: Louisiana Medicaid Expansion: 10 Things John Bel Edwards Wants You To Know
Two and half months after Medicaid expansion came to Louisiana, Gov. John Bel Edwards' administration is touting figures that show people are taking advantage of broader access to health care. ... Louisiana is the first state in the Deep South to implement Medicaid expansion, but the 31st state in the nation to adopt the program. (O'Donoghue, 9/19)
 

Denver Post: ACLU Sues Colorado Medicaid Over Denial Of Treatment For Thousands Of Hep C Patients 
Colorado’s Medicaid department was slapped with a federal class-action lawsuit Monday led by a Denver man denied treatment for the life-threatening hepatitis C virus because he has government insurance. ... Colorado covers the 12-week, $40,000 prescription only for people whose livers have reached stage two in scarring, on a scale of zero to four. (Brown, 9/19)
 

The Philadelphia Inquirer: Aetna, Three Other Firms Appeal Long-Term Care Loss In Pa.
Four losing bidders have protested the Pennsylvania Department of Human Services' award last month of three-year contracts to manage long-term care for Medicaid beneficiaries, the agency said Monday. Pennsylvania's Community HealthChoices represents a major overhaul of how the state pays for  nursing home stays, home care, and other supports for the elderly and the physically disabled older than 21. The affected population totals about 420,000, including 120,000 to 130,000 seniors. (Brubaker, 9/19)
 

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