Showing posts with label Mavyret (glecaprevir/pibrentasvir). Show all posts
Showing posts with label Mavyret (glecaprevir/pibrentasvir). Show all posts

Wednesday, June 13, 2018

High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1–6 patients without cirrhosis

High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1–6 patients without cirrhosis


Open Access

Highlights
•A short-duration, pangenotypic cure for HCV infection may help treat more patients.
•Glecaprevir plus pibrentasvir (G/P) therapy for 8 weeks had an overall cure rate of 98%.
•The efficacy of 12-week G/P therapy (99%) was not significantly higher than that of 8-week G/P therapy (p = 0.2).
•Treatment responses were high irrespective of any baseline patient or viral trait.
•G/P demonstrated a favourable safety profile regardless of treatment duration.

Background & Aims
Glecaprevir plus pibrentasvir (G/P) is a pangenotypic, once-daily, ribavirin-free direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) infection. In nine phase II or III clinical trials, G/P therapy achieved rates of sustained virologic response 12 weeks after treatment (SVR12) of 93–100% across all six major HCV genotypes (GTs). An integrated efficacy analysis of 8- and 12-week G/P therapy in patients without cirrhosis with HCV GT 1–6 infection was performed.

Methods
Data were pooled from nine phase II and III trials including patients with chronic HCV GT 1–6 infection without cirrhosis who received G/P (300 mg/120 mg) for either 8 or 12 weeks. Patients were treatment naïve or treatment experienced with peginterferon, ribavirin, and/or sofosbuvir; all patients infected with HCV GT 3 were treatment naïve. Efficacy was evaluated as the SVR12 rate.

Results
The analysis included 2,041 patients without cirrhosis. In the intent-to-treat population, 943/965 patients (98%) achieved SVR12 when treated for eight weeks, and 1,060/1,076 patients (99%) achieved SVR12 when treated for 12 weeks; the difference in rates was not significant (p = 0.2). A subgroup analysis demonstrated SVR12 rates > 95% across baseline factors traditionally associated with lower efficacy. G/P was well tolerated, with one DAA-related serious adverse event (<0.1%); grade 3 laboratory abnormalities were rare.

Conclusions
G/P therapy for eight weeks in patients with chronic HCV GT 1–6 infection without cirrhosis achieved an overall SVR12 rate of 98% irrespective of baseline patient or viral characteristics; four additional weeks of treatment did not significantly increase the SVR12 rate, demonstrating that the optimal treatment duration in this population is eight weeks.

Lay summary
In this integrated analysis of nine clinical trials, patients with chronic HCV genotype 1–6 infection without cirrhosis were treated for either 8 or 12 weeks with the direct-acting antiviral regimen glecaprevir/pibrentasvir (G/P). The cure rate was 98% and 99% following 8 and 12 weeks of treatment, respectively; the difference in rates was not significant (p = 0.2), nor was there a significant difference in the cure rates across the two treatment durations on the basis of baseline patient or viral characteristics. These results, along with a favourable safety profile, indicate that G/P is a highly efficacious and well-tolerated pangenotypic eight-week therapy for most patients with chronic HCV infection.

Friday, April 13, 2018

First real-world data on Mavyret showing safety & effectiveness in HCV Genotype 1-6

Shared on Twitter today by @HenryEChang - First real-world data from the Deutsches Hepatitis C-Register (DHC-R) showing favorable safety & excellent effectiveness of G/P in HCV GT1-6 patients with 97% SVR12 & no virologic failures to date.

FIRST REAL - WORLD DATA ON SAFETY AND EFFECTIVENESS OF GLECAPREVIR/PIBRENTASVIR FOR THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION: DATA FROM THE GERMAN HEPATITIS C - REGISTRY


Download it here.... http://jmp.sh/VthHp48



Mavyret (glecaprevir/pibrentasvir)
Liver Congress™ 2018 First real-world studies report glecaprevir/pibrentasvir to be effective and well tolerated in chronic HCV infection
April 12, 2018
The results of the first real-world studies assessing the effectiveness and safety of glecaprevir/pibrentasvir (G/P) in patients with chronic hepatitis C virus (HCV) infection have confirmed high rates of viral suppression and a favourable safety profile in patients receiving 8-16 weeks of treatment.

Real-world experience confirms Mavyret efficacy in HCV
April 12, 2018
PARIS — Two real-world studies presented at the International Liver Congress 2018 confirmed the efficacy and safety of Mavyret in Italy and…

Thursday, April 12, 2018

Liver Congress™ 2018 First real-world studies report glecaprevir/pibrentasvir to be effective and well tolerated in chronic HCV infection

Related: Real-world experience confirms Mavyret efficacy in HCV
April 12, 2018
PARIS — Two real-world studies presented at the International Liver Congress 2018 confirmed the efficacy and safety of Mavyret in Italy and…

First real-world studies report glecaprevir/pibrentasvir to be effective and well tolerated in chronic HCV infection 
European Association for the Study of the Liver

12 April 2018, Paris, France: The results of the first real-world studies assessing the effectiveness and safety of glecaprevir/pibrentasvir (G/P) in patients with chronic hepatitis C virus (HCV) infection have confirmed high rates of viral suppression and a favourable safety profile in patients receiving 8-16 weeks of treatment. Two real-world studies from Italy and Germany which will be presented at this week's International Liver Congress™ 2018 in Paris, France, reported high rates of sustained virological response (SVR), defined as undetectable HCV RNA, at 4 and 12 weeks after the end of treatment.

'The efficacy and safety of G/P as a treatment for HCV-infected patients have so far only been evaluated in controlled clinical trials', explained Dr Roberta D'Ambrosio from the University of Milan in Italy. 'Our real-world study involving more than 700 patients with chronic HCV infection confirmed that the effectiveness and safety profile of G/P were excellent across a range of different patient types'.

Glecaprevir (an NS3/4A protease inhibitor) coformulated with pibrentasvir (an NS5A inhibitor) is a relatively new direct-acting antiviral (DAA) combination that was approved in multiple countries during 2017 for the treatment of chronic HCV infection in adults.1 Phase 2 and 3 studies involving tightly defined patient groups with HCV infection have reported high rates of SVR12 and a favourable safety profile.1-6 Until now, no real-world studies with G/P in broader groups of patients with HCV infection have been reported.

The Italian study being presented this week is an interim analysis evaluating the outcomes of 723 consecutively treated patients within the Lombardy Navigator-II Network, with G/P administered according to the drug label. Of those with available data, 99.7% achieved SVR4 (346/347). HCV RNA was reported to be undetectable in 74% of patients at Week 4, and in 98% of patients at end of treatment for the entire cohort. The prevalence of treatment-related adverse events was low, mainly of mild severity, and only three patients discontinued G/P treatment prematurely.

The ongoing German real-world study, also being reported this week, evaluated 638 patients from the German Hepatitis C-Registry (DHC-R) who received G/P treatment according to the local label. Adult patients with HCV genotypes 1-6, with or without compensated cirrhosis, who were either treatment-naïve or treatment-experienced were included in this interim analysis. The majority of patients were treatment-naïve without cirrhosis and treated with 8 weeks of G/P.

According to Prof. Dr Thomas Berg from the University of Leipzig in Germany, who will present the study findings in Paris, among the 49 patients with available data, 100% achieved SVR12, excluding four patients who prematurely discontinued treatment for reasons other than virological failure. Of those four patients, two discontinued treatment due to adverse events. No grade 3 or higher elevations in alanine aminotransferase (ALT) have been observed.

'Our real-world study in patients receiving G/P in everyday clinical practice has yielded favourable effectiveness and safety results that were consistent with the clinical trial data', said Prof. Dr Thomas Berg. 'We have found G/P to be a very useful addition to our HCV treatment armamentarium as it simplifies treatment decisions for the majority of patients; G/P has the potential to expand the treated population and support the goal of HCV elimination'.

'These data are important because they confirm the high cure rates of more than 98% observed in Phase 3 trials', said Prof. Markus Cornberg from the Hannover Medical School, Germany, and EASL Governing Board Member. '8 weeks of therapy is possible for all naïve, non-cirrhotic patients, regardless of genotype, and although we still lack data in some difficult-to-treat genotype 3 patients, prevalence of these seems to be declining as shown by the German registry'.

References
1. AbbVie Limited. Maviret Summary of Product Characteristics, 28 February 2018. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004430/WC500233677.pdf. Last accessed: March 2018.

2. Zeuzem S, et al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378(4):354-69.

3. Gane E, et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med. 2017;377(15):1448-55.

4. Forns X, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017;17(10):1062-8.

5. Asselah T, et al. Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis. Clin Gastroenterol Hepatol. 2018;16(3):417-26.

6. Kwo PY, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017;67(2):263-71.

Tuesday, February 6, 2018

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™

AbbVie receives a positive recommendation from the CADTH Canadian Drug Expert Committee for MAVIRET™ - an oral therapy for the treatment of patients with hepatitis C

MAVIRET is the first and only 8-week, pan-genotypic treatment for chronic hepatitis C patients without cirrhosis and who are new to treatment*1
MAVIRET previously received a Notice of Compliance from Health Canada on August 16, 2017
MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease

MONTREAL, Feb. 6, 2018 /CNW/ - AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced that the CADTH Canadian Drug Expert Committee (CDEC) issued a positive recommendation for MAVIRET™ (glecaprevir/pibrentasvir tablets), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6)2. MAVIRET is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment,* who make up a large portion of HCV patients in Canada. 

The recommendation states that glecaprevir/pibrentasvir be reimbursed for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis, including patients with HCV genotype 1 infection who were previously treated with either a regimen of NS5A inhibitor or with a NS3/4A protease inhibitor but not both classes of inhibitors, if specific conditions are met.3

"Continued efforts are fundamental to the ultimate goal of eliminating hepatitis C, which is a serious and complex disease in Canada. It is vital that as many patients as possible are able to achieve a virologic cure, as quickly as possible, and we hope that patients throughout Canada will be able to benefit from this latest treatment, which has the potential to cure most HCV patients in eight weeks," states Dr. Samuel Lee, Hepatologist and Professor, Cumming School of Medicine, University of Calgary.

Approximately 300,000 Canadians are infected with hepatitis C.4 In 2012 alone, more than 10,000 new cases of hepatitis C were reported, but 40 percent of patients are estimated to be living unaware of their disease.5 GT1 is the most common genotype in Canada and GT3 is the most difficult to treat.4,6 Over time chronic hepatitis C can lead to chronic liver diseases, with a risk of developing cirrhosis of up to 30 percent within 20 years7 of infection. Additionally, HCV is common among people with severe chronic kidney disease (CKD), and some of these patients previously did not have a direct-acting antiviral (DAA)-based treatment option.8

"Our goal is to see Canada meet its commitment to the World Health Organization's Global Strategy on Viral Hepatitis by eliminating hepatitis C by 2030. This is within our reach, but we need a coordinated national response with a comprehensive action plan to prevent, screen, diagnose and treat Canadians living with hepatitis C," says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation and Toronto-based hepatologist. "The Canadian Liver Foundation recommends screening for hepatitis C based on risk factors, plus a one-time test for all Canadians born 1945 – 19759. Furthermore, treatment eligibility restrictions that currently exist need to be removed, so that physicians and their patients have affordable and equitable access to all available treatment options, regardless of background, disease severity or the province in which they live."

The efficacy and safety of MAVIRET was evaluated in nine Phase 2-3 clinical trials, in over 2,300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

"AbbVie is deeply committed to curing Canadians of hepatitis C. We strongly believe in providing patient and doctor choice when selecting the appropriate medication," explains Stéphane Lassignardie, General Manager, AbbVie Canada. "The CADTH positive recommendation reinforces our belief that there is a need for innovative therapies like MAVIRET in order to reach the goal set out by the World Health Organization to eliminate HCV by 2030 in Canada and across the world."

About MAVIRET™
MAVIRET™ is approved in Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6).2 MAVIRET is a new, pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets.2

MAVIRET is an 8-week, pan-genotypic virologic cure** for use in patients without cirrhosis and who are new to treatment,*1 such patients comprising the majority of people living with HCV. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) and those with genotype 3 infection.2 It is the only pan-genotypic treatment approved for use in patients across all stages of CKD.2

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients without cirrhosis and new to treatment with DAAs [either treatment-naive or not cured with previous IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.
2 MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017.
3 CADTH Canadian Drug Expert Committee Recommendation – Final: https://www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed February 2018.
4Messina, JP et al. "Global distribution and prevalence of hepatitis C virus genotypes." Hepatology, 2015; 61: 77–87. Supporting information http://onlinelibrary.wiley.com/wol1/doi/10.1002/hep.27259/full. Accessed January 2018.
5 Hepatitis C: Get the Facts. Government of Canada. https://www.canada.ca/en/public-health/services/publications/diseases-conditions/poster-hepatitis-c-get-facts.html. Accessed February 2018.
6 Wyles, D et al. SURVEYOR-II, Part 3: Efficacy and Safety of ABT-493/ABT-530 in Patients with Hepatitis C Virus Genotype 3 Infection with Prior Treatment Experience and/or Cirrhosis. Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, US on November 11-15, 2016.
7 Hepatitis C Fact Sheet. World Health Organization. World Health Organization, July 2017. Web. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 2018.
8 Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
9 The Canadian Liver Foundation, press release: https://www.newswire.ca/news-releases/not-getting-the-message-too-many-canadians-born-between-1945-1975-unaware-of-their-increased-risk-of-undiagnosed-hepatitis-c-587783871.html. Accessed February 2018.

SOURCE AbbVie Canada

Sunday, January 28, 2018

HCV Updates & A Look At The Most Intense Flu Season In Years

Welcome, sit back and catch up on notable research articles and blog updates on the topic of viral hepatitis. However, we begin with updates on this year's flu season, with experts reporting it's the worst in nearly a decade

A Look At The Most Intense Flu Season In Years


CDC
Keep up with the latest flu news as it is posted on the CDC's website.

Transcript for CDC Update on Widespread Flu Activity
Tuesday, January 16, 2018
We called this briefing to get you the latest FluView numbers and to provide advice on preventing the flu and information about what people can do to reduce the risk of flu or serious illness.
Listen here

The American Council on Science and Health
This Year's Flu Is Different - It Kills In Two Ways
Jan 29, 2018
It is the 100th anniversary of the 1918 Spanish flu (1,2) pandemic, and the date is not the only similarity between the two. While it is impossible that the morbidity and mortality that is being caused by this year's H3N2 strain (3) will even approach that of the monster that infected 5% of the world, killing 2% of it, there is one troubling feature that this year's strain shares with its centennial cousin. Flu typically kills because of secondary infections, usually pneumonia. While both "18s" do this, they also kill people directly. This is the scary part. The latter is mercifully rare but it dominates the news. Children seem to be more susceptible rapid deaths. Cases have been recently reported in Florida, California, and Connecticut. And it may be growing, especially as new strains emerge (4). The cause of fast deaths is very different from that normally seen in flu death. It is more insidious, harder to prevent and can nothing can be done about it. One hundred years ago there were reports of people dying within hours of becoming ill.

Journal: New England Journal Of Medicine
January 25, 2018
J.C. Kwong and Others
Patients who had a positive laboratory test for influenza were six times as likely to be hospitalized for acute myocardial infarction during the 7 days after specimen collection (the “risk interval”) as during the year before and the year after the risk interval.

NPR
Rob Stein
The flu is hitting the 65-and-over age group hardest, but the next-hardest hit is the 50-to-64 age group. Usually, children are the second-hardest hit. The reason is unclear. Jernigan says it may be because the strains of the flu to which baby boomers were exposed when they were young are different from the strains circulating this year, so they have less immunity.

Healio
CDC: Flu hospitalizations, deaths high; vaccination still urged
January 26, 2018
Influenza-related deaths this season have remained elevated for weeks, and hospitalization rates are comparable to the severe 2014-2015 influenza…

American Thinker
January 28, 2018
By Rick Moran
“We often see different parts of the country light up at different times, but for the past three weeks the entire country has been experiencing lots of flu, all at the same time,” he said, adding: “We have several weeks to go.”

NBC News
Virus looks like flu, acts like flu, but it's not influenza
by Maggie Fox
Jan.28.2018
There’s another virus out there that could be adding to the seasonal misery, but it’s not being identified. The virus is called adenovirus, and it can cause very severe flu-like symptoms. It’s so risky that the U.S. military vaccinates recruits against two major strains.

In The News
England could become first country to eradicate Hepatitis C in 2025
Jan 29, 2018
NHS leaders today called on the pharmaceutical industry to work with them to provide best value for money for treatments so that in its 70th year, the NHS can commit to eliminating Hepatitis C in England at least five years earlier than the World Health Organisation goal of 2030.

HepCBC
Read today's news or check out the latest issue of Weekly Bull.

CDEC Recommends MAVIRET™ and VOSEVI™ for Reimbursement for Chronic HCV
January 27, 2018
On January 25, 2018 the federal CADTH Canadian Drug Expert Committee (CDEC) released its extensive reviews of two new "pan-genotypic" hepatitis C treatments: Maviret™ (AbbVie) and Vosevi™ (Gilead). In both cases, the drugs were recommended for reimbursement by provincial PharmaCares for "adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis." And, for both, reimburseme...

New Online
Medscape: CME Video
Treating Genotype 1-6
HCV Treatment: Incorporating Glecaprevir/Pibrentasvir and sofosbuvir/Velpatasvir/Voxilaprevir Into Clinical Practice
This 15-minute activity features a brief video introduction by faculty expert Dr. Muir in which he discusses how the new combination therapies glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir have changed the treatment landscape. The activity then continues with a text-based review of the recent advances in direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) and the clinical trials that led to the approval of these new agents.
Free registration is required 

Journal Updates
Journal: Alimentary Pharmacology and Therapeutics
Hepatitis C virus re-treatment in the era of direct-acting antivirals: projections in the USA
The introduction of oral direct-acting antivirals (DAAs) has dramatically changed the landscape of HCV treatment. However, a small percentage of patients fail to achieve sustained virologic response (SVR). Understanding the number of people who fail on DAAs and require re-treatment is important for budget impact and disease burden projections.

Journal: World Journal of Gastroenterology                   
This review addresses general aspects of vitamin D deficiency and, in particular, the significance of vitamin D hypovitaminosis in the outcome of HBV- and HCV-related chronic liver diseases. Furthermore, current literature was reviewed in order to understand the effects of vitamin D supplementation in combination with IFN-based therapy on the virological response in HBV and HCV infected patients.

Journal: World Journal of Hepatology
Efficacy of direct-acting antiviral treatment for chronic hepatitis C: A single hospital experience
Direct-acting antivirals have been approved for the treatment of hepatitis C virus (HCV) genotype 1 and 2 infections in Japan since 2011. In the new era of DAA therapy, predictors who fail to respond to DAA might be compromised by resistance-associated substitutions. There have been few reports of daclatasvir/asunaprevir failure because daclatasvir/asunaprevir is limited in Japan. Therefore, it might be important to report these cases for future research and treatment of HCV.

The following articles downloaded and shared by @HenryEChang via Twitter

Journal: Liver International
NVHR and the Center for Health Law Policy and Innovation at Harvard Law co-hosted this webinar on highlights from the "Hepatitis C: State of Medicaid Access" report, including methodology and key findings.

Contagion Live
Hepatitis C-Related Hospitalizations Rise By Almost 50%
EINAV KEET
The new report found that the number of inpatient hospital stays for patients seeking treatment solely for hepatitis C rose by nearly 49% from 2005 to 2014. In addition, hospital stays for hepatitis C patients also seeking treatment for hepatitis B, HIV, or alcoholic liver disease rose by about 11%. Overall, adults ages 52 to 72 years saw a more than 67% increase in hepatitis C-related hospitalizations –the most of any age group –while those ages 18 to 51 years saw a nearly 15% decrease in hospitalizations. Hospital stays involving hepatitis C were also longer, more expensive, and more likely to result in death than stays that did not involve hepatitis C.

HEPATITISC.NET
By Kimberly Morgan Bossley - January 26, 2018
After curing hep C in 2014 many things changed in my life. I sold off half of my company and took the other with me and put in my home. After bringing the...

Getting Dumped with Hepatitis C 
By Karen Hoyt - January 25, 2018
After years of living with hepatitis C, I was very sick. My husband gave up on my low-energy self. He was about done with having a brain foggy wife. Within months of...

By Daryl Luster - January 24, 2018
It has become evident to me that there are people who are treating their hep C with drugs that they purchase from countries where generic drugs are produced. These drugs are produced... 

HEP Blog
The Fire and Fury of Hep C 
January 26, 2018 
Growing up with Hep C colors the world very differently. Because I knew early, I avoided alcohol from the get-go. I’d like to think it allowed my liver to keep going to thirty. My biggest fear wasn’t dying, but accidentally infecting someone else. Over time I found my paranoia getting the better of me. I abhorred physical contact, because it added to the layered stress of social interaction. Having notified the school of my condition I was kept out of PE. I wasn’t shy about the topic, and the stigma merely fueled my rebellious teenage self. I clung to that rage, it felt justified, but often when we’re young we misidentify the real emotions at play.

By Karen Hoyt
A glimpse at an easily overlooked tool for healing.

Hepatitis C Reactivation: What It Is and What It Isn’t 
By Lucinda K. Porter, RN
Hepatitis C reactivation may occur in people receiving cancer treatment. However, hep C reactivation may not mean what you think it does.

By Greg Jefferys
In Ireland, the rate of Hepatitis C infection is one of the highest in the EU at about twice the international average.
Jennifer Variste, MD
January 27, 2018 
So you heard the flu shot is 10 percent effective. With so many sources of information available, the primary care provider’s role increasingly becomes that of educator. It is important to me that the parents of my patients make informed decisions, so when I have a parent decline the influenza vaccine, I make an effort to ask why. The number one response I hear has been “What’s the point? The flu ...

Hepatitis B Foundation
Timothy Block, PhD
Welcome to Journey to the Cure. This is a web series that chronicles the progress at the Hepatitis B Foundation and Baruch S. Blumberg Institute towards finding the cure for hepatitis B.

Healthy You
Why herbal supplements taken with prescription drugs may be risky



Recommended Reading
Herbal Supplements May Be Dangerous When You Take Certain Prescription Drugs
By Amanda MacMillan
January 24, 2018 
A number of common herbal supplements, including green tea and Ginkgo biloba, can interact with prescription medications, according to a new research review published in the British Journal of Clinical Pharmacology. These interactions can make drugs less effective—and may even be dangerous or deadly. 
The new review analyzed 49 case reports of adverse drug reactions, along with two observational studies. Most people in the analysis were being treated for heart disease, cancer or kidney transplants, and were taking warfarin, statins, chemotherapy drugs or immunosuppressants. Some also had depression, anxiety or neurological disorders, and were being treated with antidepressant, antipsychotic or anticonvulsant medications.
Continue reading: http://time.com/5116664/are-herbal-supplements-safe/

Medical News Today
What to eat if you have hepatitis C
Last reviewed Thu 25 January 2018
By Tom Seymour
Reviewed by Natalie Olsen, RD, LD, ACSM EP-C
Hepatitis C can damage the liver and lead to cirrhosis, or scarring of the liver. Damage to the liver may mean that a person needs to modify their diet.

May we all remain healthy this flu season.
Tina

Thursday, January 25, 2018

Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection

Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection
Stefan Zeuzem, M.D., Graham R. Foster, Ph.D., Stanley Wang, M.D., Armen Asatryan, M.D., Edward Gane, M.D., Jordan J. Feld, M.D., M.P.H., Tarik Asselah, M.D., Ph.D., Marc Bourlière, M.D., Peter J. Ruane, M.D., Heiner Wedemeyer, M.D., Stanislas Pol, Ph.D., Robert Flisiak, M.D., Ph.D., Fred Poordad, M.D., Wan-Long Chuang, M.D., Ph.D., Catherine A. Stedman, M.B., Ch.B., Ph.D., Steven Flamm, M.D., Paul Kwo, M.D., Gregory J. Dore, Ph.D., M.P.H., Gladys Sepulveda-Arzola, M.D., Stuart K. Roberts, M.D., Ruth Soto-Malave, M.D., Kelly Kaita, M.D., Massimo Puoti, M.D., John Vierling, M.D., Edward Tam, M.D., Hugo E. Vargas, M.D., Rafi Bruck, M.D., Francisco Fuster, M.D., Seung-Woon Paik, M.D., Franco Felizarta, M.D., Jens Kort, M.D., Ph.D., Bo Fu, Ph.D., Ran Liu, Ph.D., Teresa I. Ng, Ph.D., Tami Pilot-Matias, Ph.D., Chih-Wei Lin, Ph.D., Roger Trinh, M.D., M.P.H, and Federico J. Mensa, M.D.et al.

Full Text Article
https://jumpshare.com/v/9GtWUYi3hENIx8GnabyH

Article shared and downloaded via Twitter by Henry E. Chang 

Abstract
Background
Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.

Methods
We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir–pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir–pibrentasvir or sofosbuvir–daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir–pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment.

Results
In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1–infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3–infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir–pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir–daclatasvir; 8 weeks of treatment with glecaprevir–pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group.

Conclusions
Once-daily treatment with glecaprevir–pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157.)

View full text article: https://jumpshare.com/v/9GtWUYi3hENIx8GnabyH

Thursday, January 11, 2018

Ira M. Jacobson MD: 8-week therapy for patients with HCV infection

Clinical Care Options 
How New Data From AASLD 2017 Inform the Use of 8-Week Regimens for HCV
Ira M. Jacobson MD - 1/9/2018
Several studies presented at the 2017 AASLD meeting in Washington, DC, assessed 8-week therapy for patients with HCV infection. In this commentary, I discuss how key data from these studies may have an impact on management of patients with HCV infection.

Studies discussed:
8-Week GZR/EBR for Treatment-Naive, Noncirrhotic Patients With Genotype 1b HCV Infection
GLE/PIB for Treatment-Naive Genotype 3 HCV
8-Week LDV/SOF for Acute Genotype 1 or 4 HCV and HIV Coinfection


New At Clinical Care Options 
New Insights on NAFLD/NASH From AASLD 2017
Philip Newsome PhD, FRCPE - 1/8/2018
Here’s my take on how new data from AASLD 2017 on noninvasive imaging modalities and emerging investigational agents may affect the NAFLD/NASH patient management landscape.

How Injection Drug Use Affects HCV Treatment
Norah Terrault MD, MPH - 1/3/2018
Here’s my take on why colocalization of HCV treatment with other medical and social services may be ideal for persons who inject drugs. 

Saturday, January 6, 2018

Mavyret (glecaprevir/pibrentasvir) for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial

In case you missed it

Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial
Authors David Wyles, Fred Poordad, Stanley Wang, Laurent Alric, Franco Felizarta, Paul Y. Kwo, Benedict Maliakkal, Kosh Agarwal, Tarek Hassanein, Frank Weilert, Samuel S. Lee, Jens Kort, Sandra S. Lovell, Ran Liu, Chih-Wei Lin, Tami Pilot-Matias, Preethi Krishnan, Federico J. Mensa

First published: 4 January 2018
DOI: 10.1002/hep.29541

Full Text
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Abstract
This study assessed the efficacy and safety of ribavirin-free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. SURVEYOR-II, Part 3 was a partially randomized, open-label, multicenter, phase 3 study. Treatment-experienced (prior interferon or pegylated interferon ± ribavirin or sofosbuvir plus ribavirin ± pegylated interferon therapy) patients without cirrhosis were randomized 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily. Treatment-naive or treatment-experienced patients with compensated cirrhosis were treated with G/P for 12 or 16 weeks, respectively. The primary efficacy endpoint was the percentage of patients with sustained virologic response at posttreatment week 12 (SVR12). Safety was evaluated throughout the study. There were 131 patients enrolled and treated. Among treatment-experienced patients without cirrhosis, SVR12 was achieved by 91% (20/22; 95% confidence interval [CI], 72-97) and 95% (21/22; 95% CI, 78-99) of patients treated with G/P for 12 or 16 weeks, respectively. Among those with cirrhosis, SVR12 was achieved by 98% (39/40; 95% CI, 87-99) of treatment-naive patients treated for 12 weeks and 96% (45/47; 95% CI, 86-99) of patients with prior treatment experience treated for 16 weeks. No adverse events led to discontinuation of study drug, and no serious adverse events were related to study drug. Conclusion: Patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or compensated cirrhosis achieved high SVR12 rates following 12 or 16 weeks of treatment with G/P. The regimen was well tolerated.
(Hepatology 2017)

In summary, SURVEYOR-II Part 3 enrolled and treated some of the most difficult-to-cure HCV patients: those with GT3 infection and prior treatment experience and/or cirrhosis. Overall, the fixed-dose combination of once-daily RBV-free G/P was well tolerated and demonstrated high SVR12 rates (≥95%) in treatment-naive patients with cirrhosis treated for 12 weeks and treatment-experienced patients with or without cirrhosis treated for 16 weeks. Therefore, G/P provides an efficacious and well-tolerated once-daily RBV-free treatment option for patients with HCV genotype 3 and prior treatment experience and/or cirrhosis.

Wednesday, December 6, 2017

HCV Patients SVR with Mavyret After Previous DAA Failure

HCV Patients SVR with Mavyret After Previous DAA Failure
DECEMBER 05, 2017
Gail Connor Roche

“The few patients who fail a primary treatment attempt with direct acting antivirals have over a 90% chance of cure using a 16-week regimen of the newly approved glecaprevir and pibrentasvir,’’ author Fred Poordad, MD, Professor of Medicine at University of Texas Health, San Antonio, told MD Magazine. “This means we should be able to cure over 99% of all hepatitis C patients.’’

Saturday, December 2, 2017

Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection

Published as part of the Biochemistry series “Biochemistry to Bedside”
Department of Biochemistry and Molecular Pharmacology, University of Massachusetts Medical School, Worcester, Massachusetts 01605, United States
DOI: 10.1021/acs.biochem.7b01160
Publication Date (Web): December 1, 2017
Copyright © 2017 American Chemical Society

Viewpoint
Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection
Ashley N. Matthew, Nese Kurt Yilmaz, and Celia A. Schiffer

Hepatitis C virus (HCV), a virus that infects more than 180 million people worldwide, is the causative agent of chronic liver disease, which often progresses to fibrosis, liver cirrhosis, and hepatocellular carcinoma (HCC). According to the World Health Organization, almost half a million patients infected with HCV die each year from cirrhosis and HCC alone. In the last several years, treatment of HCV infections has been revolutionized by the development of small molecular inhibitors that target essential proteins encoded by the viral genome. These inhibitors, known as direct-acting antivirals (DAAs), have improved treatment option and outcomes and eliminated the need for interferon injections. However, the emergence of resistance-associated variants (RAVs) and high genetic variation among the six distinct genotypes of the virus have been presenting challenges, even leading to treatment failure.

Newer all-oral DAA combination regimens for HCV infection consist of inhibitors that target the NS3/4A, NS5A, and NS5B viral proteins. Of note, NS3/4A protease inhibitors have become a mainstay of treatment as most new therapies contain an inhibitor from this class. While highly effective against other genotypes, treatment of genotype 3 infections has been the most challenging, especially in patients who failed previous therapy or have cirrhosis. Recently, AbbVie received Food and Drug Administration (FDA) approval for one of the first pan-genotypic combination therapies, Mavyret, consisting of glecaprevir and pibrentasvir, an NS3/4A protease and an NS5A inhibitor, respectively (Figure 1). Given the excellent pan-genotypic response and safety profile in patients, Mavyret was approved for the treatment of genotypes 1–6 in patients without cirrhosis, or with compensated cirrhosis. In patients with non-cirrhotic chronic HCV who were treatment-naïve or had previously been treated with pegylated interferon or ribavirin, the sustained virological response (SVR) rate was 83–100% across all genotypes.(1) In treatment-naïve patients with compensated liver disease, 99% of patients achieved SVR with a 12-week course.(2) Mavyret was approved as an 8-week course for treatment-naïve patients without cirrhosis, shortening the previous standard of care by an additional 4 weeks.

One component of the Mavyret combination, pibrentasvir (ABT-530), has excellent potency across all HCV genotypes and retains potency against common RAVs. Pibrentasvir had EC50 values across genotypes ranging from 1.4 to 5 pM against the HCV replicon in antiviral assays.(3) Under the selective pressure of inhibitors, RAVs emerge at positions 28, 30, 31, and 93 in the NS5A protein. In fact, all current NS5A inhibitors are susceptible to mutations at Tyr93. In vitro studies indicate pibrentasvir also selects these mutations, including Y93H, that confer resistance to other NS5A inhibitors.(3) However, pibrentasvir maintained good potency against many single-site NS5A mutations, suggesting double or triple mutants need to emerge to confer high levels of resistance against this inhibitor.

The other component of Mavyret, glecaprevir (ABT-493), is a P2–P4 macrocyclic NS3/4A protease inhibitor with subnanomolar to low nanomolar activity against all genotypes, including genotype 3.(4) NS3/4A protease inhibitors are often susceptible to single-site mutations at residues Arg155, Ala156, and Asp168. Most if not all protease inhibitors are susceptible to mutations at Asp168, which are often present in patients who fail therapy with a protease inhibitor. Notably, this active site residue is not conserved in genotype 3 and is Gln168 instead, contributing to the natural resistance of genotype 3 to most treatments. While potent against 168 variations, including genotype 3, glecaprevir is highly susceptible to A156T and A156V mutations. We have shown that inhibitors containing P2–P4 macrocycles, as in glecaprevir, are susceptible to changes at Ala156, as substitutions with a larger side chain result in steric clash with the inhibitor’s macrocycle.(5) Luckily, mutations at Ala156 do not occur alone because of reduced replicative capacity; however, additional mutations could restore the enzymatic fitness, which can lead to clinically viable multi-mutant resistant variants.

Thus, both components of Mavyret have good resistance profiles against wild type genotypes and single-mutant variants of HCV. What needs to be considered is the emergence of double, triple, or other multi-mutant variants that may have high levels of resistance to one or both components of this combination. Such multi-mutant variants potentially pose a threat to the longevity and success of HCV treatment. There are already double- and triple-mutant variants that have been isolated from patients who failed therapy with previously FDA-approved combination therapies. Considering the similarity in the inhibitor scaffolds and modes of action, there is a danger that these variants may be cross-drug resistant and not respond to any current treatment option, including Mavyret. As new drugs and combinations are developed, it will be important to understand the mechanisms of resistance for these multi-mutant variants and incorporate those insights into drug design. Rather than concentrating all effort into inhibitors from the same class with highly similar scaffolds, diversifying the arsenal of DAAs and considering triple-combination therapy may be required to avoid cases of incurable HCV infection.

The approval of Mavyret dual-combination therapy marks another milestone in the treatment of HCV infections. There had been a major effort to develop an all-oral combination therapy with activity against all genotypes. With the approval of Mavyret, this goal has been met. The newer-generation inhibitors and various combinations provide treatment options for patients and improve SVR rates across all genotypes. For many cases, Mavyret has decreased the standard of care from 24 to 8 weeks. More importantly, treatment options for patients with compensated liver disease are now available. One major remaining concern is the possible emergence of drug resistance. The newer inhibitors have better activity against single-site RAVs, but highly resistant multi-mutant strains may become clinically relevant. Preventing the emergence and spread of cross-resistant variants and developing inhibitors with improved potency against such variants may be the next challenge.

Full Text

Saturday, November 18, 2017

Vosevi & Mavyret: The Impact of New Options for DAA-Experienced Patients With HCV

Updated
Latest ClinicalThought commentaries from Clinical Care Options (CCO).

Over at Clinical Care Options, using an easy to follow patient case scenario experts discuss treatment options with newly approved drugs: Mavyret (glecaprevir/pibrentasvir) GLE/PIB and Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) SOF/VEL/VOX.

11/16/2017
The Impact of New Options for DAA-Experienced Patients With HCV
Jordan J. Feld MD, MPH - 11/16/2017
With the approvals of SOF/VEL/VOX and GLE/PIB, what is the new management approach for DAA-experienced patients with HCV infection?

In this viral hepatitis case series, we highlight common patient case scenarios and the critical decision making that informs selection of optimal patient management strategies. This commentary features a woman with cirrhosis who is seeking retreatment after failure of first-line direct-acting antiviral (DAA) therapy. The impact of the recent approvals of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) and glecaprevir (GLE)/pibrentasvir (PIB) on treatment for this class of patient is discussed.

Case Details
A 59-year-old white woman with compensated cirrhosis (elastography 24 kPa) and genotype 1a HCV infection was previously treated with SOF/ledipasvir (LDV) for 12 weeks, but she experienced a relapse at posttreatment Week 6. She reports strict adherence to her previous regimen and is seeking advice on retreatment options.
Continue reading @ CCO

11/15/2017
How Recent Drug Approvals Have Affected First-line HCV Treatment
Nancy Reau MD, FAASLD, AGAF - 11/15/2017
What parameters now qualify a patient infected with HCV for shortened first-line therapy?

In this viral hepatitis case series, we highlight common patient case scenarios and the critical decision making that informs selection of optimal patient management strategies. This commentary features a treatment-naive, noncirrhotic patient who is infected with HCV and ready to begin therapy. The candidacy of this patient for 8-week vs 12-week therapy is discussed, with a focus on the latest treatment options and guidelines.

Case Details
A 56-year-old white man newly diagnosed with genotype 1a HCV infection presents for initiation of treatment. His baseline HCV RNA is 8,500,000 IU/mL and he has F2 fibrosis. He expresses a desire to take as short a course of HCV treatment as possible.
Continue reading @ CCO

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Monday, October 23, 2017

The Liver Meeting® 2017 - Mavyret (Glecaprevir/Pibrentasvir) for Treatment-Naive Patients With HCV Genotype 3

NAM Publications
An integrated analysis of clinical trial data showed that glecaprevir/pibrentasvir taken for 8 weeks cured 98% of people without cirrhosis with hard-to-treat genotype 3, while a 12-week course cured 100% of people with genotype 3 with cirrhosis. A related analysis showed that the combination taken for 12 or 16 weeks cured 96% of people with compensated cirrhosis across all genotypes.

Steven Flamm of Northwestern Feinberg School of Medicine in Chicago and colleagues performed an integrated analysis of efficacy and safety data from phase 2 and 3 clinical trials of glecaprevir/pibrentasvir for previously untreated people with HCV genotype 3, either without cirrhosis or with compensated cirrhosis.
Read the article @ aidsmap

aidsmap coverage
Conference news: The Liver Meeting

NATAP
WASHINGTON, DC -- October 23, 2017 -- Glecaprevir/pibrentasvir was well-tolerated and resulted in high virologic response rates in treatment-naive patients with hepatitis C virus (HCV) genotype 3 infection, according to a study presented here at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
Read the article @ FirstWord Pharma

Of Interest - HCV Genotype 3
Of Interest - FirstWord Pharma
By Andrew D. Bowser
The findings add new perspective to the ongoing discussion among researchers and clinicians as to whether adding ribavirin might prevent a relapse in patients with HCV genotype 3, particularly if they were previously treated.

Results of the current study represent “real world” experience with patients with HCV genotype 3 treated at 9 sites in Germany, according to Stefan Christensen, MD, Department of Infectious Diseases, Center for Interdisciplinary Medicine, Muenster, Germany.

“We could confirm the high SVR12 rates [sustained virologic response at 12 weeks] from the clinical phase 3 studies with sofosbuvir/velpatasvir, [but] in our cohort, it seems like the addition of ribavirin in cirrhotic patients did not have further benefit for those patients,” he said.
Read the article @ FirstWord Pharma

FirstWord Pharma

Tuesday, October 17, 2017

The changing HCV treatment cascade

Pharmacology Consult
The changing HCV treatment cascade
Infectious Disease News, October 2017
Jocelyn Mason, PharmD; Kimberly D. Boeser, PharmD, MPH, BCPS, AQ-ID
The rapid development of DAA combinations provides simplified regimens, shorter durations, improved efficacy and greater tolerability, unlike the previous interferon and ribavirin cornerstone regimens. Although the IDSA/AASLD guidelines provide the map to managing HCV, they do not identify the ideal interferon-free regimen to begin with, nor have they given a clear path to treating genotype 3 and those with decompensated cirrhosis. This ever-changing field will require collaboration among health care providers, including those specializing in infectious diseases, hepatology and gastroenterology, as well as pharmacists, to optimize treatment strategies. As the landscape of HCV continues to update with new literature and new medications, this subspecialty continues to be dynamic.
Continue to article - https://www.healio.com/infectious-disease/hepatitis-c/news/print/infectious-disease-news/%7B87b74536-f358-43d3-a804-f37a98402b0b%7D/the-changing-hcv-treatment-cascade

Thursday, October 12, 2017

Mavyret (Glecaprevir and Pibrentasvir) - Combo confirmed as safe and effective for HCV patients with chronic kidney disease


Sustained Response with HCV Combo Drug in CKD
Patients with both diseases had virologic response and no failure

by Molly Walker, Staff Writer, MedPage Today
October 11, 2017
A combination therapy for patients with chronic kidney disease (CKD) and hepatitis C (HCV) was confirmed as safe and effective, according to researchers in New Zealand.

Overall, 102 of 104 patients (98% virologic response rate, 95% CI 95-100) treated with the combination of NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir (Mavyret) for 12 weeks had a sustained virologic response rate, with no patients reporting virologic failure, reported Edward Gane, MD, of Auckland City Hospital, and colleagues.

Preliminary results were first presented at the 2016 American Association for the Study of Liver Diseases (AASLD) annual meeting. Gane's group have now published the full peer-reviewed results of the phase III trial in the New England Journal of Medicine. The combination therapy received FDA approval in August 2017, and is indicated for the treatment of all major genotypes (GT1-6) of chronic HCV.

Wednesday, October 11, 2017

AbbVie Demonstrates Leadership in HCV with New MAVYRET™ Data to be Presented at The Liver Meeting® 2017

AbbVie Demonstrates Leadership in HCV with New MAVYRET™ (glecaprevir/pibrentasvir) Data to be Presented at The Liver Meeting® 2017

16 HCV abstracts to be presented including 12 data presentations on the safety and efficacy of MAVYRET
- MAVYRET is recommended in new AASLD guidelines as a first line treatment option for 8 weeks in treatment-naïve non-cirrhotic HCV patients across all genotypes (GT1-6)

NORTH CHICAGO, Ill., Oct. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced that it will present new data evaluating MAVYRET™ (glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6), at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts have been accepted, including two oral presentations studying the use of MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis and treatment-naïve patients with genotype 3 (GT3) HCV. These populations have historically had limited treatment options. A third oral presentation evaluates adherence to treatment with MAVYRET in the clinical development program. The Liver Meeting® 2017 will take place in Washington, D.C., from October 20 – 24, 2017.

"AbbVie's data presentations at this year's The Liver Meeting reinforce our commitment to people living with hepatitis C," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "These data add to a robust collection of clinical trial results to further enhance scientific knowledge of MAVYRET's safety and efficacy across a number of patient populations."

Researchers will also present data obtained from the MAVYRET clinical program evaluating patients with cardiovascular, metabolic and renal conditions as well as data on HCV patient preferences.

"On the heels of AASLD's newly released HCV treatment guidance, we are excited to see additional data on MAVYRET across a broad range of patients," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "The updated recommendations on available treatments, including the use of MAVYRET in the majority of patients, serve as an additional source of information to help physicians make treatment decisions."

Select AbbVie clinical presentations include:
MAVYRET Abstracts
  • Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-Infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program - Abstract 198; Oral Presentation; Monday, October 23, 2017; 4:15 p.m. ET
  • Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis - Abstract 62; Oral Presentation; Sunday, October 22, 2017; 1:15 p.m. ET
  • Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis - Abstract 74; Oral Presentation; Sunday, October 22, 2017; 3:15 p.m. ET
  • Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Infected with HCV GT1-3 by Renal Impairment Status: A Pooled Analysis of Two Phase 3 Japanese Trials - Abstract 1179; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1–6 and Recent Drug Use - Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients Aged 65 Years or Older With Chronic Hepatitis C: A Pooled Analysis of Phase 2 and 3 Clinical Trials - Abstract 1188; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Impact of Hepatitis C Treatment With Glecaprevir + Pibrentasvir on Patient`s Health-Related Quality of Life: Results From Phase 3 CERTAIN Trials - Abstract 1187; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Exposure-Safety Response Relationship for Glecaprevir and Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1189; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Exposure-Response Analyses of Virologic Response to Glecaprevir and Pibrentasvir in HCV Subjects from Phase 2 and 3 Studies - Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
  • Glecaprevir and Pibrentasvir Exposures in Hepatitis C Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract 1190; Poster Session; Saturday, October 21, 2017; 2:00 – 7:00 p.m. ET
HCV Health Outcomes Abstract
  • Assessing Patient Preferences for and Relative Importance of Features of New Direct Acting Antiviral (DAA) Treatments for Chronic Hepatitis C Virus (HCV) Infections - Abstract 741; Poster Session; Friday, October 20, 2017; 8:00 a.m.5:30 p.m. ET

The full AASLD 2017 scientific program can be found at www.aasld.org.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.

MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
Full prescribing information can be found here.

Source

Sunday, October 1, 2017

Weekend Reading - Sofosbuvir-Velpatasvir-Voxilaprevir for Chronic Hepatitis C – A Review

Weekend Reading
Greetings, hope you're enjoying this lovely Sunday, thanks for stopping by.

Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
We begin with a recent review article about Gilead's Vosevi, titled; “Sofosbuvir-Velpatasvir-Voxilaprevir for Chronic Hepatitis C – A Review” published September 22, 2017, in Gastroenterology & Hepatology.

HCV Genotype 3
Over at NEJM Journal Watch, a small study for HCV genotype 3 patients is reviewed by Atif Zaman, MD, MPH, published last week in Hepatology. The study; Glecaprevir/pibrentasvir for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase III clinical trial, is available for download over at NATAP

New Online
Make sure to check out HCV Advocate's October Newsletter, published today!

Shared on Twitter, by @HenryEChang, is one must read article: Chronic hepatitis C virus infection: Everyone should be treated, published in the multimedia journal Clinical Liver Disease. Here are a few other updates over at CLD as well.

Reviews - Controversies in HCV Management
Chronic hepatitis C virus infection: Everyone should be treated
Authors Steven Flamm
First Published: 29 September 2017
Abstract
Full Text (HTML)
PDF (91.3KB)
PDF (91.3KB)
References
Watch a video presentation of this article
Watch the interview with the author

Reviews - Controversies in HCV Management
Authors Philippe J. Zamor, Mark W. Russo
First Published: 29 September 2017

Reviews - From Operation to the First 30 Days
Innovative care models after liver transplant
Authors C. Burcin Taner, Andrew P. Keaveny
First Published: 29 September 2017
Abstract
Full Text (HTML)
PDF (217.7KB)
PDF (217.7KB)
References
Watch a video presentation of this article
Watch the interview with the author

Begin here...

Enjoy the rest of your weekend!
Tina