AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation

AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
Sep 30, 2016

- Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)
- Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6
- Breakthrough Therapy Designation is granted to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement over existing therapies

NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.

The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.1

"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."

AbbVie will present new Phase 3 data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

About AbbVie's Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and clinical care of people with chronic HCV infection by investigating a pan-genotypic (genotypes 1-6) regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). G/P is currently in Phase 3 of clinical development.

AbbVie's investigational regimen includes glecaprevir (GLE), an NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor dosed once daily as three oral tablets.

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

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.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies.
http://www.fda.gov
Accessed September 1, 2016.

On eve of rollout, fears under-funding may restrict hep C treatment

Regular news from the New Zealand Doctor newsroom

On eve of rollout, fears under-funding may restrict hep C treatment
Cliff Taylorctaylor@nzdoctor.co.nz
Friday 30 September 2016, 3:20PM

The RNZCGP fears under-funding threatens a ground-breaking hepatitis C treatment even as GPs prepare to start prescribing it from tomorrow.

The college has written an urgent letter to the Ministry of Health saying it supports the treatment, but extensive GP input is needed and the cost “will have a significant impact on patient’s ability to obtain a cure”.

It is urging the ministry to consider funding options, including direct funding for free GP visits.

GPs have been preparing for three months for the rollout of Viekira Pak, shown in trials to cure more than 95 per cent of patients with hepatitis C genotype 1. The drug was financially out of reach for most people, until it was funded by Pharmac from 1 July.

Patients will be knocking on GPs’ doors

Pharmac and drug company Abbvie have been preparing GPs for the rollout with educational materials and seminars. Pharmac’s deputy medical director for primary care, GP Bryan Betty, says it is one of the biggest changes in general practice prescribing in decades.

Auckland liver specialist Ed Gane says GPs should expect to have patients “knocking on their door” from tomorrow.

“GPs need to ensure they are educated about this new treatment,” Professor Gane says in a media release. “This is our chance to offer a life-changing cure to many people living with hepatitis C.”

College endorses training but queries cost

RNZCGP chief executive Helen Morgan-Banda is in Australia today and unable to be interviewed. She sent an email saying the college is endorsing both face-to-face training via DHBs and an online module for GPs prescribing Viekira Pak. It is also promoting the training via its weekly e-newsletter to members.

Ms Morgan-Banda wrote to the ministry last Friday saying the college welcomes the new treatment as a great development that will have positive benefits for a large number of New Zealanders.

But she says the college is very concerned the cost of GP visits will present a barrier to patients. She suggested two alternative avenues for funding:

* direct funding for free visits, such as the ministry currently provides for dioxin exposed people, and

* funding through a DHB Primary Options for Acute Care (POAC) programme.

“Our view is that whichever model is deemed appropriate, action needs to be taken urgently to ensure that it is in place and funding is available as soon as possible after the 1 October date when access to treatment becomes available,” she wrote in the letter.

In today’s email, Ms Morgan-Banda says the medicines have been funded, but GP appointments have not. The college is concerned this will affect the success of the programme.

She says patients with hepatitis C tend to be more deprived than the general population and are also often transient. She is concerned the lack of funding will result in inequity of access to treatment.

New Zealand Doctor sought comment from the ministry, but did not receive a reply before deadline.

‘Game-changing’ – despite the cost

ProCare associate clinical director and GP Jamie Shepherd says the issue of cost has been discussed at the PHO and he understands why the college has concerns.

But he says he and colleagues are well prepared and excited about being able to offer the treatment.

“We would love to have it funded, but we recognise as a GP it’s our role to deliver this as best we can. We have been aware of the rollout since July. It will be a big change for general practice, but it’s been well highlighted.

“This is game-changing for people with hepatitis C in New Zealand.”

Huge improvement in treatment

Professor Gane is hailing the new drug’s efficacy. Viekira Pak is taken orally, usually for 12 weeks and will cure over 95 per cent of patients, he says. It is also well tolerated, with 99 per cent of people completing treatment.

“This is a huge improvement compared to previous Interferon treatments, which consisted of weekly injections for a year, associated with bad side effects. Almost 20 per cent of people had to stop the treatment and less than half were cured.”

However, he says an effective oral treatment is still needed for almost half of the New Zealanders infected with hepatitis C who have other genotypes (2, 3, 4, 5 and 6).

Buyers’ Club an option for some

He is calling for Pharmac to fund other pan-genotypic drugs, but says in the meantime personal importation of generic versions could be a viable option.

He says to date more than 500 New Zealanders and Australians have accessed generics through the Fix Hep C Buyers’ Club run by Australian GP James Freeman.
“The generic medications cured more than 95 per cent of patients and were extremely safe, proving that these generic drugs are the real deal,” Professor Gane says. “These medications cost less than five per cent of the price of brand drugs — which is about $2,100.”

Related link
October 1: a momentous day for many people living with hepatitis C in New Zealand - The Hepatitis Foundation of New Zealand

Baby Boomers - Get Your Flu Shot

We Are Getting Older Folks
Currently information on this blog is aimed at people living with or treating hepatitis C, for the most part that is the baby boomer generation born between 1946 to1964. This year the oldest baby boomers will reach the age of 70. That certainly is disturbing news, I am 60 - where did the time go? With that said, the focus today is on this years influenza season, and yes that annual flu shot.

We begin with a link to the CDC's 2016-2017 influenza vaccination recommendations, which will take forever to read, if you just want the facts why not start by watching a few Medscape videos offered below explaining this years vaccine options, or instead view "The flu shot for patients, 2016 - 2017."  Further down this page is information about the importance of vaccination in persons with chronic liver disease, cirrhosis, transplant receipts and people 65 years and older.  Yesterday the CDC reported a decrease in people getting vaccinated against the flu this year; up to a 3.4 percentage-point drop in people 50 to 64, and a 3.3 percentage-point drop among those ages 65 and older, read the story here.  Of course nothing is mandatory, well except maybe one thing - never tip your doctor after getting vaccinated, they hate that.

Information From The CDC

CDC - Weekly U.S. Influenza Surveillance Report
While current U.S. flu activity is low overall, in the past 2 weeks CDC has received reports of a small number of localized influenza outbreaks. This is not unusual for September. It is not possible to make any predictions about the timing or severity of the upcoming influenza season based on these outbreaks. More than 90 million doses of seasonal influenza vaccine have been distributed at this time. Influenza vaccine distribution information for the 2016-2017 season is posted here as CDC receives it, typically on Fridays.

Who Should Get A Flu Shot?
The bottom line is the CDC recommends a yearly flu vaccine for everyone 6 months and older.  The upcoming season's flu vaccine will protect against the influenza viruses that research indicates will be most common during the season. This includes an influenza A (H1N1) virus, an influenza A (H3N2) virus, and one or two influenza B viruses, depending on the flu vaccine. After vaccination, it takes a person about two weeks to build up immunity against the flu.

Changes and Updates

In June the CDC released a statement stating the “nasal spray” flu vaccine; live attenuated influenza vaccine (LAIV) should not be used during the 2016-2017 flu season.

Show Me A Video

Adults Ages 18 And Older - The flu shot for patients, 2016 - 2017
David Z Hirsch, MD



Children
No more needle-free flu vaccine for now.
FOX 5 Atlanta            



Medscape Videos
Medscape published three videos with Lisa Grohskopf from CDC's Influenza Division discussing changes and updates in the recommendations for this influenza season.

Free registration is required to view the following videos

1 - CDC Provides Vaccine Recommendations for the 2016-2017 Influenza Season
Recommended 2016-2017 influenza vaccines include a number of inactivated injectable vaccines as well as recombinant influenza vaccine. Both trivalent and quadrivalent injectable vaccines will be available this season. Trivalent vaccines are designed to protect against three different influenza viruses. Quadrivalent influenza vaccines protect against the same three viruses plus an additional B virus from a different lineage of influenza B viruses.

2 - No LAIV (Nasal Spray) Flu Vaccine This Season
In this commentary, I will discuss an important change in the US 2016-2017 influenza vaccine recommendations. Specifically, I will explain why we are recommending that only injectable influenza vaccines (inactivated influenza vaccine [IIV] or recombinant influenza vaccine [RIV]) should be used during the upcoming influenza season.

3 - Flu Vaccine for People With Egg Allergies
People with egg allergies no longer need to be observed for an allergic reaction for 30 minutes after receiving a flu vaccine; and people with a history of severe allergic reaction to egg (ie, any symptom other than hives) can now be vaccinated in a medical setting, under the supervision of a healthcare provider who is able to recognize and manage severe allergic conditions.

News Article
The nose is out. The arm is in
A federal agency and a national pediatric association are pushing pediatricians and other doctors not to provide the nasal spray influenza vaccination, FluMist, and instead to rely only on shots.

Of Interest
Commentary - Healio
Citing a lack of evidence of efficacy, the AAP’s Committee on Infectious Diseases recommends that clinicians not administer the FluMist quadrivalent live-attenuated vaccine during the upcoming influenza season.

The Flu In People 50 And Over
Persons that are 50 and over may be more likely to have chronic medical conditions that put them at higher risk of severe influenza illness, especially in people 65 and over. According to the CDC; "In recent years, it’s estimated that between 71 percent and 85 percent of seasonal flu-related deaths have occurred in people 65 years and older and between 54 percent and 70 percent of seasonal flu-related hospitalizations have occurred among people in that age group. So influenza is often quite serious for people 65 and older."

High-dose Flu Shot For People 65 And Older

There are two vaccines designed specifically for people 65 and older:
Fluzone and FLUAD

Fluzone - The high dose vaccine has been approved for use in the United States since 2009.
The “high dose vaccine fluzone” is designed specifically for people 65 and older and contains 4 times the amount of antigen as the regular flu shot. It is associated with a stronger immune response following vaccination (higher antibody production).

A 2014 study published in the New England Journal of Medicine of more than 30,000 participants showed that adults 65 years and older who received Fluzone High-Dose vaccine had 24% fewer influenza infections as compared to those who received the standard dose Fluzone vaccine.

FLUAD - vaccine will be available for the first time in the United States during the 2016-2017 season.
The adjuvanted flu vaccine, Fluad, is made with MF59 adjuvant which is designed to help create a stronger immune response to vaccination. In a Canadian observational study of 282 persons aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots.

*There are no randomized studies comparing Fluad with Fluzone High-Dose.

The high dose and adjuvanted flu vaccines may result in more of the mild side effects that can occur with standard-dose seasonal shots. Mild side effects can include pain, redness or swelling at the injection site, headache, muscle ache and malaise.

Over 65? Is Timing Important?
The CDC recommends that you should try to get your flu vaccine anytime between now and the end of October. Flu activity typically peaks between December and March . However, immunologist Laura Haynes suggests people over 65 wait until Halloween to get their flu shots to make sure the immunity lasts through the flu season, read the article over at NPR. Along with this piece by Kaiser Health News; Yes, It Is Possible To Get Your Flu Shot Too Soon. Or check out this new article; CDC Urges Americans To Get A Flu Shot As Soon As Possible

Liver Disease

Evidence suggests people living with chronic liver disease, cirrhosis and liver transplant recipients are particularly at risk from the flu and its complications.

Cirrhotic Patients
Multiple studies indicate that vaccination might be beneficial for persons with chronic liver disease. In a prospective 2007 study influenza vaccination decreased influenza-related complication rates in patients with liver cirrhosis. The study included 311 persons with cirrhosis, 198 of whom were vaccinated with a trivalent influenza vaccine and the rest were not vaccinated. Most of the cirrhotic patients with influenza had fever (91.6%) and complained of myalgia (83.3%) without respiratory symptoms, which were not typical clinical presentations of influenza. Influenza vaccination decreased influenza-related complication rates in patients with liver cirrhosis (14% versus 23%).

Transplant Recipients
Influenza is one of the common endemic viral diseases that is associated with higher morbidity and mortality in solid organ transplant (SOT) recipients than in immunocompetent patients.

This review summarizes current information and the evidences regarding the efficacy and safety of immunization in adult solid organ transplant candidates and recipients.
Read the 2016 article, here.

Viral Hepatitis
In a more recent 2015 study, data from Taiwan’s National Health Insurance program was reviewed from 2000 through 2009  to evaluate hospitalization and mortality in patients with chronic hepatitis B who received an annual influenza vaccination vs those who did not. The study concluded that not only was there a lower hospitalization rate among persons with chronic hepatitis B infection who had been vaccinated against the flu compared with those who had not, but annual influenza vaccination can lower the risk of mortality in patients with chronic HBV infection.

Remember getting your flu shot not only protects you, it also helps protect the people you love.

Stay well, until next time.

Tina

Record numbers accessing hepatitis C treatment, but who is missing out?

10th Australasian Viral Hepatitis 2016 Conference 
Thursday 29 September - Saturday 1 October 2016, Gold Coast, Australia
View Updates: Conference Reports

Record numbers accessing hepatitis C treatment, but who is missing out?

A mistrust of the health system and ongoing stigma from health workers against injecting drug users are two significant barriers that could prevent people living with hepatitis C from accessing and continuing life-saving treatment, according to a new report by UNSW's Centre for Social Research in Health.

The Annual Report of Trends in Behaviour Supplement 2016 on viral hepatitis, released today at the 10th Australasian Viral Hepatitis 2016 Conference, found some sections of the community are unaware that a cure is now available for hepatitis C.

The report, which also examines risks factors, attitudes and knowledge regarding hepatitis B, highlighted that about one third of people living with the diseases are yet to be diagnosed and only 6% have been treated.

A survey of 416 Australians, who acquired hepatitis C through use of non-sterile injecting equipment, found experiencing discrimination from health workers lessened their likelihood of engaging in future treatment.

UNSW Professor Carla Treloar, Director of the Centre for Social Research, said with record numbers of people in 2016 seeking new hepatitis C treatments, the impact of stigma as a treatment barrier was now clearer.

"To capitalise on the opportunities provided by these new treatments, we need to keep working to make sure we understand who isn't coming forward for treatment and why, and how we can deliver services that best address these barriers," Professor Treloar said.

Only one in five (22%) people living with hepatitis C at the end of 2015 had ever received treatment.

A survey of 405 gay and bisexual men found a lack of knowledge regarding testing and treatment for hepatitis C, with only 35% indicating awareness of a treatment that could cure hepatitis C.

Further, in a study of 534 men (86 HIV positive men; 347 HIV negative men; 101 men who had not had HIV testing), the UNSW researchers found an individual's HIV status influenced their knowledge and attitudes towards people who inject drugs and people with hepatitis C.

The finding suggests hepatitis C education and prevention for gay men would not be best served by a 'one size fits all approach', but should be tailored according to their HIV status.

In a survey of 203 Aboriginal people living with hepatitis C, those who felt more attached to their Aboriginal community were more likely to show greater resilience and reported having a better quality of life and less hepatitis C-related stigma than those who were not as attached to their Aboriginal community.

Attachment to an Aboriginal community was associated with positive lifestyle changes such a changed diet, reduced alcohol or illicit drug use, increased exercise and more regular check-ups after a hepatitis C diagnosis.

According to the report, Hepatitis B also remains a significant concern. The Kirby Institute's Hepatitis B and C in Australia Annual Surveillance Report Supplement 2016, released alongside the Annual Report of Trends in Behaviour Supplement 2016, found one third of the estimated 232,600 people living with chronic hepatitis B infection remain undiagnosed, with only 6% receiving treatment.

"Analysis of the evidence regarding best practice in hepatitis B from around the world suggests that management in Australia's general practice setting can be improved through greater community-based outreach programs and education programs for health professionals," Professor Treloar said.

"Stigma should also be recognised as a factor influencing decisions about care and treatment for people living with hepatitis B."

More information: The Annual Report of Trends in Behaviour Supplement 2016 can be found here: csrh.arts.unsw.edu.au/research/publications/reports-trends-in-behavior/

Provided by: University of New South Wales

Hep C virus RNA persists in liver explants awaiting liver transplantation

Hep C virus RNA persists in liver explants awaiting liver transplantation

October's issue of Gastroenterology reports that hepatitis C Virus RNA persists in liver explants of most patients awaiting liver transplantation treated with an interferon-free regimen.

Dr Xavier Forns and colleagues from Spain assessed the presence of hepatitis C virus (HCV) RNA in liver explants from 39 patients awaiting liver transplantation.

The patients were treated with an interferon-free regimen and had undetectable serum HCV RNA at the time of liver transplantation.

The team found that HCV RNA was detected in 67% of liver explants.

Patients with HCV RNA–positive explants had received shorter courses of treatment, and HCV RNA was undetectable in serum for shorter periods before transplantation compared to patients with HCV RNA–negative explants.

The team noted that levels of HCV RNA in explants were significantly higher in patients with a relapse of HCV infection than patients who responded to treatments.

Dr Forns' team comments, "Most patients with residual HCV-RNA in the explant achieved a sustained virologic response after receiving their liver transplant."


A Fighter by Nature – Tatjana Reic and the Viral Hepatitis Story

A Fighter by Nature – Tatjana Reic and the Viral Hepatitis Story

The experts in the European Liver Patients Association (ELPA) Hep-CORE advisory group provide a window on the broad range of hepatitis activities and perspectives in Europe today. Hep-CORE PI Jeffrey Lazarus has been interviewing some of them about how they came to work with viral hepatitis, how the field has been changing, and what new research is called for.

Jeffrey V. Lazarus 26 Sep 2016

The ninth interview in the series is with Tatjana Reic, President of the European Liver Patients Association (ELPA).

How did you initially get involved with viral hepatitis?

Today when I look back it seems like it must have been somehow written in the stars – me and the viral hepatitis story.

36 years ago, at the age of 20 in the middle of the summer of 1980, I was hospitalized with a diagnosis of Acute Hepatitis B (HBV). At that time in my medical record, besides positive so-called Australian antigen, the clinicians also had written “NON A NON B.” I didn’t know what that meant. The doctors also did not pay a lot of attention to non A non B. After 35 days spent in the hospital I simply continued with my life; as a reconvalescent I was not the best model of patient. However, per the doctor’s instructions I regularly checked my liver enzymes for the next 5-6 years and then practically forgot about my illness.

So at the age of 34 I got married and pregnant – the most exciting period in my life – I was going to become a mother, oh how great that feeling was! Although by that time it was 1994 – and there was war in Croatia. Because of my history of hepatitis B, I was referred for a blood test on viral hepatitis during my pregnancy. And that’s how I became aware of my diagnosis: Chronic Hepatitis C (cHCV). The illness was unknown to me at the time so I tried to find out more about it but found little help even from close family members who were medical professionals.

My daughter was born anti-HCV positive, PCR undetectable. Although I was advised by my treating physician that her antibodies should be eliminated in 6-12 months it did not happen. Instead it took 4 years and gave me sleepless nights for the first 4 years of her life. I thought, “Oh my God, what have I done to the most precious person in my life, I transmitted her a deadly threat disease”.

In the meantime, I lost my job and started my first treatment with interferon monotherapy – injections 3 times per week for 52 weeks. That was really tough. At that time the was war coming to the end and I was looking for a job as doctor of veterinary medicine. But with a small child, at the age of almost 40 and with a chronic (stigmatized) disease, it was practically impossible. On top of this I was still going through multiple strenuous treatments. Deep depression overtook me.

However, since I am a fighter by nature I decided to do take things into my own hands, so I completed my degree as a Master of Science. In 2000 my life started to completely change. I established the first Croatian hepatitis patient group, joined the European Liver Patients Association (ELPA) in 2005, became ELPA Vice-President in 2007 and since 2011 have been the ELPA President.

I was a patient highly motivated to fight for my life, integrity, dignity, dissent job and the future of my children

Finally, in 2010, when WHO endorsed World Hepatitis Day as only the fourth disease-specific official day, coincidentally appointing it to the day of my birthday – July 28, I began to truly realize my mission and my passion on this Earth – to contribute in the global fight for hepatitis patients’ rights and the right to not be neglected any more.

So my short answer to your question is – I was a patient highly motivated to fight for my life, integrity, dignity, decent job and the future of my children.
How has the viral hepatitis field, especially HCV, been changing?

I can easily speak about that topic from my own experience as I failed 6 very, very tough interferon treatments: 4 out of 6 treatments were with “old” non-pegylated IFN and 1 was a 72-week PEG/RIBA treatment. In total I have spent 5-6 years of my life on IFN treatment. This is the equivalent of 292 weeks, or 2,044 days – after all that the treatments still failed.

Going through treatment with DAAs was like chewing gum compared with IFN treatments.

Later, luckily, I spent 12 more weeks dedicated to my 7th treatment, this time with direct-acting antivirals (DAAs), and today I am cured. Going through treatment with DAAs was like chewing gum compared with IFN treatments.

But I have no regrets. I am sure that the interferon helped postpone the progression of liver fibrosis and kept my liver damage at a comparatively mild level for all those decades, about 22 years after being diagnosed and 35 years since I initially contracted the virus, helping me survive.

Besides my own experience it is evident that viral hepatitis, in particular the field of HCV, has significantly changed.

We have seen revolutionary achievements in the field of treatment. The dreams of every patient who went under IFN treatments finally came true – drugs that can cure almost 100% of patients with almost no side-effects during 4 times shorter duration of treatment. That’s real perfectavir.

Additionally, global awareness of viral hepatitis in general is much higher since the WHO endorsement of World Hepatitis Day.

At the end it is important to stress that with recent 69th World Health Assembly’s adoption of first-ever Global Health Sector Strategy (GHSS) on Viral Hepatitis in Geneva has generated strong political will. The GHSS states a goal to eliminate hepatitis B and C by 2030 and includes prevention and treatment targets to reduce annual deaths by 65% and increase treatment by 80%. It was unanimously adopted by 194 Member States in a historic commitment, signaling the greatest global policy development in the field of viral hepatitis ever.

What areas of viral hepatitis research do you think are still being neglected?

Let’s not fool ourselves – in the past decade a lot has been done in the viral hepatitis field, but a lot more is still on our TO DO list.
In the research area – a treatment to cure cHBV,
In the research area – a vaccine to prevent HCV
Diagnosis and screening – case finding of the undiagnosed HCV population; which is the majority of cases
Secure global access to the best care and treatment options for all patients
Development of national strategies for viral hepatitis
Implementation of national strategies, especially in terms of prevention


Previous interviews in the Hep-CORE advisory group 2016 series:
Let’s not forget ‘prevention as prevention’ ; interview with Eberhard Schatz
The task now is identifying people who don’t know they’re infected and connecting them to care ; interview with Luis Mendão
Without a vaccine, eliminating HCV will be a huge challenge ; interview with Antons Mozalevskis
The same debates, 25 years later ; interview with Marie Jauffret-Roustide
Outside the biomedical box of hepatitis C research ; interview with Magdalena Harris
Changing to a holistic approach towards hepatitis policy ; interview with Achim Kautz
Patient associations: a key catalyst for hepatitis advocacy and impact ; interview with Charles Gore
A clinician’s career in viral hepatitis: a powerful history and optimistic future ; interview with Mojca Maticic