Methadone users’ misconceptions about HCV hinders treatment

Methadone users may delay seeking treatment for hepatitis due to misconceptions about the disease and its treatment options, according to study results presented at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection.

“The results of this study showed clear conceptual differences about barriers, benefits and beliefs about HCV treatment between methadone clients who did and did not have HCV,” Sarah B. Bass, PhD, MPH, associate professor of public health at Temple University in Philadelphia, told Healio.com/Hepatology. “Those who were HCV [positive] believed that treatment was ‘worth it,’ but were also concerned about others believing they might have HIV and that not having symptoms was a reason for not being treated.”

Bass and colleagues surveyed 150 patients — 100 with HCV — undergoing methadone maintenance treatment and used perceptual maps to illustrate their findings.
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J&J firms up efficacy data on hep C triple combo | Suzanne Elvidge

Dive Brief:

  • Updated results of an ongoing Phase 2a study carried out by Janssen subsidiary Alios BioPharma showed all patients who received a triple therapy of AL-335, odalasvir and Olysio (simperevir) had undetectable levels of hepatitis C virus sustained 12 weeks after finishing treatment.

 

  • Efficacy was seen even in the cohort of patients who were given the combo over six weeks, underscoring the potential of the therapy to be a speedier alternative to current hepatitis C drugs on the market.

 

  • Development will continue with a once-daily dose of odalasvir (25 mg), AL-335 (800 mg) and Olysio (75 mg) for treatment durations of both six and eight weeks. The Phase 2a study will continue to assess the combination in patients with or without compensated cirrhosis and HCV genotype 3 infections.

 

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Test Hepatitis C Patients for Hepatitis B Before Treatment, Panel Advises – Christina Mattina

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America Guidance Panel has updated its guidelines concerning patients beginning antiviral therapies for the treatment of hepatitis C virus (HCV).

The Guidance Panel now recommends that all such patients be screened for the hepatitis B virus (HBV) as well.   The changes to the guidelines came after researchers observed cases of HBV reactivation in HBV/HCV co-infected patients during direct acting antiviral (DAA) treatment for HCV.

“The severity of these cases have ranged from mild to severe fulminant liver injury that can be life threatening,” Raymond Chung, MD, co-chair of the HCV Guidance Panel, said in a statement.

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Shooting heroin: A quick fix, a dangerous injection | CALLIE GINTER Sentinel Staff

For 12 hours, Matt S.C. Lambert, 29, sat alone in his Swanzey apartment, researching. He wanted to make sure he did it right; he could die if he made a mistake.

“How to shoot heroin,” he typed into the Google search bar.

He never thought he’d use a needle. But after sniffing heroin for three years and dating a girl who shot it, his mentality was, “if you can’t beat ‘em, join ‘em.”

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EASL releases 2016 HCV recommendations

During a special conference, EASL released its 2016 recommendations for the treatment of hepatitis C. The findings were simultaneously published in the Journal of Hepatology.

“HCV elimination will require national plans together with forecasted budgeting to expedite unrestricted access to treatment,” Jean-Michel Pawlotsky, MD, PhD, professor of medicine at the University of Paris-Est, and member of the recommendations panel, and colleagues wrote. “All treatment-naive and treatment-experienced patients with compensated or decompensated chronic liver disease related to HCV, who are willing to be treated and who have no contraindications to treatment, must be considered for therapy.”

The new recommendations add Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) and Zepatier (grazoprevir/elbasvir, Merck) to the arsenal of treatments recommended in 2015.
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Researchers describe course of hepacivirus infection in four young horses

Researchers have provided the first description of the clinical course of naturally acquired non-primate hepacivirus (NPHV) infection in young horses.

NPHV is the closest known relative of the hepatitis C virus, a major human pathogen with about 146 million people infected worldwide. Most end up with chronic disease, which can lead to hepatic fibrosis, cirrhosis and cancer.

The study of NPHV has the potential to improve our  understanding of the disease process and immunity around the hepatitis C virus.

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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

Globally, prescribing information varies; refer to the individual country product label for completeinformation.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Welzel, T. et al. GARNET: High SVR Rates Following Eight-Week Treatment with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir for Patients with HCV Genotype 1b Infection. Presented at the European Association for the Study of the Liver Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, Paris, France on September 23-24, 2016.
2 Gower E. et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of Hepatology Update: Hepatitis C, 2014; 61: S45-S57.
3 O’Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier. 2010:1313-1335.
4 Hatzakis A. et al. The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference. Journal of Viral Hepatitis, 2011; 18 (Suppl. 1): 1-16.
5 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
6 Messina, J. et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015; 61: 77-87.

 

Contact(s)

Media
Jane Woo
+1 (847) 937-4754
jane.woo@abbvie.com
Carlos Taveras
+33 1 41 73 92 64
carlos.taveras@abbvie.comInvestor Relations
Liz Shea
+1 (847) 935-2211
liz.shea@abbvie.com

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NICE backs Gilead’s hepatitis C drug Epclusa

The National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales, has recommended Epclusa (sofosbuvir-velpatasvir), from US biotech major Gilead Sciences (Nasdaq: GILD), as a treatment option for all genotypes of hepatitis C in draft guidance published today.

Sofosbuvir-velpatasvir is one of the newer direct acting anti-viral treatments for hepatitis C and works by blocking the virus from multiplying and infecting new cells. As trials for the drug showed high cure rates of 89% and above, the NICE appraisal committee concluded that sofosbuvir-velpatasvir was clinically and cost-effective, and should be routinely available on the National Health Service.

The committee also recognized that there was a need for treatment without adverse side effects, particularly for patients with genotype 3, who account for around 44% of the patient population with chronic hepatitis C. This population are currently treated with the earlier types of anti-viral treatments, such as peginterferon alpha with ribavirin, which can cause adverse side effects.

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