Friday, June 23, 2017

Hepatitis C: AbbVies MAVIRET (glecaprevir/pibrentasvir) and Gilead’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Receives CHMP Positive Opinion

AbbVies  MAVIRET (glecaprevir/pibrentasvir) and Gilead’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Receives CHMP Positive Opinion

Two new medicines recommended for the treatment of chronic hepatitis C

Maviret and Vosevi evaluated under accelerated assessment

The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

HCV infection is a major public health challenge. It affects between 0.4% and 3.5% of the population in different EU Member States and is the most common single cause of liver transplantation in the EU. Approximately 15 million people are chronically infected with HCV throughout Europe.

Both Maviret and Vosevi are active against all genotypes of the virus and, with some differences between the two medicines, may be specifically useful in some patients who failed or cannot use previously available therapies. As this is considered to be of major public health interest in terms of therapeutic innovation, both medicines were evaluated under the EU’s accelerated assessment mechanism, which aims to speed up patients’ access to new medicines where there is an unmet medical need.

Maviret and Vosevi belong to the direct acting antivirals against HCVs which have reshaped the way chronic HCV infection is treated. By blocking the action of proteins essential for HCV replication, this type of medicine achieves high cure rates of the infection and does not require the concomitant use of interferons, medicines which are associated with poor tolerability and potentially serious side effects.

Despite the rapid development of new therapies there is still a need for a range of alternative treatment options to serve the different medical needs of the millions of people suffering from the disease. The more treatment options that are available, the better chance a patient has to get the right treatment to cure the disease and to lead a longer and healthier life.

Maviret and Vosevi are the first medicines for which accelerated assessment has been carried out within 120 days, after a recent review of the timetable for this mechanism.

Maviret contains two next generation direct-acting and antiviral agents: glecaprevir, an inhibitor of HCV NS3/4A protease, and pibrentasvir, an inhibitor of HCV NS5A. Both components are pangenotypic.

The effects of Maviret were studied in a total of 2,376 patients who participated in eight pivotal and three supportive clinical trials. The hepatitis C virus could no longer be detected in over 90% of patients 12 weeks after the end of treatment. If the blood of patients is clear of hepatitis C virus for more than 12 weeks they are generally considered as being cured of the infection. Adverse events reported with Maviret were generally mild, including headache, fatigue, diarrhoea, nausea and abdominal pain.

The applicant for Maviret received scientific advice from the Agency during the development of the medicine.

Vosevi is composed of sofosbuvir (a nucleotide analogue non-structural protein NS5B polymerase inhibitor), velpatasvir (an HCV NS5A inhibitor), which were previously approved in other medicinal product, to which is added voxilaprevir (a novel pangenotypic HCV NS3/4A protease inhibitor).

The effects of Vosevi were studied in four main clinical trials involving over 1,700 patients. Two studies were in previously untreated patients and two in patients in whom previous treatment (in some cases with an NS5A inhibitor) had not cleared the virus. Treatment was given for 12 weeks in the previously treated patients and eight weeks in the untreated. The hepatitis C virus could no longer be detected in over 90% of patients 12 weeks after the end of treatment with Vosevi. Mild nausea, headache and diarrhoea were the most common side effects observed. Other potentially related adverse effects were decreased appetite, vomiting, muscle spasms and rash.

The opinions adopted by the CHMP at its June 2017 meeting are an intermediary step on Maviret's and Vosevi’s path to patient access. The CHMP opinions will now be sent to the European Commission for the adoption of decisions on EU-wide marketing authorisations through an accelerated procedure. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of these medicines in the context of the national health system of that country.

Notes
The applicant for Maviret is AbbVie Ltd.
The applicant for Vosevi is Gilead Sciences International Ltd.


Press Release
European CHMP Adopts Positive Opinion for Gilead’s Vosevi® (Sofosbuvir/Velpatasvir/Voxilaprevir) for the Treatment of All Chronic Hepatitis C Genotypes
– Vosevi is Gilead’s Fourth Sofosbuvir-Based Treatment to Receive CHMP Positive Opinion for the Treatment of Chronic HCV Infection –
  
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 23, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vosevi®, an investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients. The data included in the application support the use of SOF/VEL/VOX in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen.
  
The CHMP positive opinion was adopted following an accelerated assessment procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.
  
The MAA for SOF/VEL/VOX is supported by data from four Phase 3 studies. Two studies (POLARIS-1 and POLARIS-4), evaluated 12 weeks of the single tablet regimen in patients with genotypes 1-6 HCV infection previously treated unsuccessfully with DAA-containing regimens, including NS5A inhibitors. Two other studies (POLARIS-2 and POLARIS-3) evaluated 8 weeks of SOF/VEL/VOX in DAA-naïve patients with genotypes 1-6 HCV infection. Across POLARIS-1 and POLARIS-4, 97 percent of patients treated with SOF/VEL/VOX (n=431/445) achieved the primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of patients with genotypes 1-6 HCV infection with and without cirrhosis treated with SOF/VEL/VOX (n=477/501) achieved the primary efficacy endpoint of SVR12. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX in the POLARIS studies were headache, fatigue, diarrhea and nausea.
  
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014, under the trade name Sovaldi®, for use in combination with other agents. The single tablet regimen of sofosbuvir (400 mg) and ledipasvir (90 mg) received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®. The single tablet regimen of sofosbuvir (400 mg) and velpatasvir (100 mg) received marketing authorization in the European Union on July 8, 2016, under the trade name Epclusa®.
  
Gilead has also submitted a regulatory application for SOF/VEL/VOX in the United States. Gilead filed the New Drug Application for SOF/VEL/VOX on December 8, 2016, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act of August 8, 2017.
  
SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established and is not approved anywhere globally.
http://www.gilead.com/news/press-releases/2017/6/european-chmp-adopts-positive-opinion-for-gileads-vosevi-sofosbuvirvelpatasvirvoxilaprevir-for-the-treatment-of-all-chronic-hepatitis-c-genotypes

Press Release
AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
- If approved, MAVIRET™ will provide a shorter, 8-week, pan-genotypic (GT1-6), once-daily option for the majority of people living with the hepatitis C virus (HCV)(1)*
- MAVIRET would also be an additional HCV treatment option for patients with specific treatment challenges, such as those with compensated cirrhosis, chronic kidney disease and genotype 3
- Final European Commission decision expected Q3 2017

NORTH CHICAGO, Ill., June 23, 2017 /PRNewswire/ -- AbbVie ABBV 0.32%, a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV.1 The European Commission will now review the CHMP opinion and a final decision is expected in Q3 2017.

"MAVIRET represents a new generation of HCV therapy and has the potential to be a shorter, 8-week option for patients living with this serious, chronic illness," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Today's CHMP positive opinion takes us closer to delivering on AbbVie's mission to address continued unmet needs by bringing a new pan-genotypic option to people living with HCV in Europe."

The CHMP positive opinion is supported by 97.5 percent (n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6 chronic HCV infected patients without cirrhosis and who are new to treatment, with varied patient and viral characteristics.2 In an integrated analysis (n=2,265), less than 0.4 percent of patients discontinued treatment.3 The reported adverse reactions (incidence greater than or equal to 10 percent) were headache and fatigue.3 The type and severity of adverse reactions in patients with cirrhosis were overall comparable to those seen in patients without cirrhosis.3

"While the HCV treatment landscape has transformed significantly over recent years, the disease continues to be a global public health problem and treatment challenges remain," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "In clinical studies, MAVIRET demonstrated high SVR rates across all genotypes of HCV patients (GT1-6). If approved, MAVIRET would remove many of the complexities of pre-treatment patient evaluation and has the potential to help facilitate the care and management of HCV."

MAVIRET is also intended to be an additional option for patients with specific treatment challenges. This includes chronic HCV patients with compensated cirrhosis (Child-Pugh A), and those who currently have limited treatment options, such as patients with severe chronic kidney disease, including those on dialysis, and patients infected with genotype 3.

The marketing authorization application (MAA) for MAVIRET is under an accelerated assessment by the EMA, which is granted to new medicines of major public health interest. The MAA evaluation is conducted under the centralized licensing procedure, and if approved, will result in a marketing authorization valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. AbbVie's investigational, pan-genotypic regimen has also been granted accelerated review designations by other regulatory authorities including the U.S. Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare. MAVIRET is an investigational regimen and its safety and efficacy have not been established. 

About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) clinical development program was designed to investigate a pan-genotypic, once-daily, ribavirin-free treatment with the potential to provide a faster path to virologic cure** for all major HCV genotypes (GT1-6) and with the goal of addressing specific treatment challenges, including compensated cirrhosis (Child-Pugh A), chronic kidney disease and genotype 3. MAVIRET is being evaluated as a potential 8-week, pan-genotypic treatment for the majority of people living with HCV,1 those without cirrhosis and who are new to treatment,* and regardless of viral and patient characteristics.

MAVIRET is a fixed-dose combination of two distinct antiviral agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals ENTA 1.16% for HCV protease inhibitors and regimens that include protease inhibitors.

*Patients who are treatment-naive or had prior treatment experience with 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. 
http://www.prnewswire.com/news-releases/abbvie-receives-chmp-positive-opinion-for-maviret-glecaprevirpibrentasvir-for-the-treatment-of-chronic-hepatitis-c-in-all-major-genotypes-gt1-6-630334863.html

Thursday, June 22, 2017

Listen Or Watch: Mark Sulkowski, MD discuss current treatment options for all HCV genotypes

Managing Chronic Hepatitis C in the Primary Care Setting: Best Practices From Screening to Treatment

Source: PeerView CME/CE Audio Podcast - Gastroenterology

Podcast
Listen to Mark Sulkowski, MD discuss HCV screening, diagnosis, noninvasive tests for assessing liver fibrosis and current treatment options for all HCV genotypes (1-6). Although this podcast and online CME is aimed at clinicians the use of clinical vignettes make it easy for patients to understand.

Either listen only to the podcast or click here to access the complete two part presentation. The second part of this learning activity will discuss: A Closer Look at Current Recommendations and Options for the Treatment of HCV. Topics include HCV guidelines, liver disease staging "FibroTest" and treating HCV according to genotype.

Pick Me
I highly suggest you choose the patient friendly online learning activity, the program is uncomplicated and easy to navigate. The user can skip through any part of the program by clicking on the "next" button located in the upper right hand corner of the presentation.



Managing Chronic Hepatitis C in the Primary Care Setting: Best Practices From Screening to Treatment
Activity Overview
Join us for one of the live, in-person meetings we will be carrying out at state chapters of the AAFP. A nationally recognized expert will review age-based and risk-based HCV screening recommendations, approaches to diagnosis, optimal treatment and counseling strategies for HCV-infected patients, and the parameters that warrant referral to specialist care.

Activity Description
Enormous progress has been made in recent years toward effectively treating and curing patients with chronic hepatitis C. However, at least half of the possible 7 million individuals infected with hepatitis C virus (HCV) in the US remain undiagnosed. The formidable task of increasing the number of patients diagnosed, and subsequently linked to appropriate care has fallen to primary care clinicians. In this activity, the guest speaker will address the challenges encountered by primary care clinicians faced with the increasing societal need to screen for HCV and make appropriate diagnoses. The importance of counseling patients regarding current HCV treatment options will be examined, and the guest speaker will also provide a discussion focused on identifying HCV-infected patients who can be managed in primary care versus those requiring linkage to specialist care.

Recommended Links
HCVguidelines.org

On This Blog
HCV Education

Helpful Links
Premier Hepatitis C Websites, Blogs and Support Forums

10 year HCV treatment programme in people who inject drugs: No effect of recent or former injecting drug use on treatment adherence or SVR

Outcomes from a large 10 year hepatitis C treatment programme in people who inject drugs: No effect of recent or former injecting drug use on treatment adherence or therapeutic response
Omar Elsherif , Ciaran Bannan, Shay Keating, Susan McKiernan, Colm Bergin, Suzanne Norris

Full Text Article
Download PDF
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Abstract
Background and aims
People who inject drugs (PWID) are historically viewed as having “difficult to treat” hepatitis C disease, with perceived inferior treatment adherence and outcomes, and concerns regarding reinfection risk. We evaluated for differences in treatment adherence and response to Peginterferon-alfa-2a/Ribavirin (Peg-IFNα/RBV) in a large urban cohort with and without a history of remote or recent injection drug use.

Methods
Patient data was retrospectively reviewed for 1000 consecutive patients—608 former (no injecting drug use for 6 months of therapy), 85 recent (injecting drug use within 6 months) PWID, and 307 non-drug users who were treated for chronic hepatitis C with Peg-IFNα/RBV. The groups were compared for baseline characteristics, treatment adherence, and outcome.

Results
There was no significant difference in treatment non-adherence between the groups (8.4% in PWID vs 6.8% in non-PWIDs; RR = 1.23, CI 0.76–1.99). The overall SVR rate in PWID (64.2%) was not different from non-PWIDs (60.9%) [RR = 1.05, 95% CI 0.95–1.17]. There was no significant difference in SVR rates between the groups controlling for genotype (48.4% vs 48.4% for genotype 1; 74.9 vs 73.3% for genotype 3). Former and recent PWID had similar adherence rates.

Conclusions
PWID have comparable treatment adherence and SVR rates when compared to non-drug users treated with Peg-IFNα/RBV. These data support a public health strategy of HCV treatment and eradication in PWID in the DAA era.

Published: June 21, 2017 https://doi.org/10.1371/journal.pone.0178398
PLOS ONE

Wednesday, June 21, 2017

Medscape New HCV Video Series - Hepatitis C Virus: Containing the Threat

Medscape - New Video Series
Hepatitis C Perspective

Hepatitis C Virus: Containing the Threat
About this Series
In the past few years, a new class of direct-acting antiviral agents has made the treatment of HCV easier and more effective than ever before, with cure rates nearing 100%, even among HIV-positive patients. But not all patients with HCV who are eligible for antiviral treatment are identified, and even fewer are being referred for care. Thus, HCV infection remains a significant risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. Liver specialists at two prestigious Chicago medical centers confront the key issues in the management of patients with chronic HCV infection.

View: Episode 1/ Strides and Obstacles

Coming Soon


Begin here
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Safety of the 2D/3D direct acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - a pooled analysis

Journal of Hepatology -
Articles in Press

DOI: http://dx.doi.org/10.1016/j.jhep.2017.06.011
Publication stage: In Press Accepted Manuscript
Published online: June 20, 2017

Safety of the 2D/3D direct acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - a pooled analysis
Fred Poordad Correspondence information about the author Fred Poordad Email the author Fred Poordad , David R. Nelson, Jordan J. Feld, Michael W. Fried, Heiner Wedemeyer, Lois Larsen, Daniel E. Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R. Foster

Highlights
  • OBV/PTV/r ± DSV ± RBV was well-tolerated in patients with Child-Pugh A cirrhosis.
  • Low rates of serious adverse events and those leading to discontinuation of study drugs.
  • Events consistent with hepatic decompensation occurred in 1.2% of patients (13/1066)
  • Decompensation events occurred across the treatment period and post-treatment.
  • Rates of decompensation events were comparable in treated and untreated patients.

Abstract
Background & aims

Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit–risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis.

Methods

Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment. The number and percentage of patients with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs consistent with hepatic decompensation were reported.

Results

In 1066 patients with Child-Pugh A cirrhosis, rates of serious TEAEs and TEAEs leading to study drug discontinuation were 5.3% (95% CI: 4.1–6.8) and 2.2% (95% CI: 1.4–3.2), respectively. Thirteen patients (1.2%; 95% CI: 0.7–2.1) had a TEAE that was consistent with hepatic decompensation. The most frequent TEAEs consistent with hepatic decompensation were ascites (n=8), esophageal variceal hemorrhage (n=4), and hepatic encephalopathy (n=2).

Conclusions

This pooled analysis in 1066 HCV-infected patients with Child-Pugh A cirrhosis confirms the safety of OBV/PTV/r ± DSV ± RBV in this population. These results support the use of OBV/PTV/r ± DSV ± RBV in this high-priority population.

Lay summary

This pooled safety analysis in 1066 HCV-infected patients with compensated cirrhosis, receiving treatment with ombitasvir, paritaprevir, and ritonavir with or without dasabuvir, with or without ribavirin, shows that the rate of hepatic decompensation events was comparable to rates from historical reports for untreated patients.

Hepatitis C - CDC New Surveillance for Viral Hepatitis

Of Interest
Medscape - New Video Series
About this Series
In the past few years, a new class of direct-acting antiviral agents has made the treatment of HCV easier and more effective than ever before, with cure rates nearing 100%, even among HIV-positive patients. But not all patients with HCV who are eligible for antiviral treatment are identified, and even fewer are being referred for care. Thus, HCV infection remains a significant risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. Liver specialists at two prestigious Chicago medical centers confront the key issues in the management of patients with chronic HCV infection.
View: Episode 1/ Strides and Obstacles



Surveillance for Viral Hepatitis – United States, 2015
The Centers for Disease Control and Prevention’s (CDC) National Notifiable Diseases Surveillance System (NNDSS) (1) receives viral hepatitis case reports electronically each week from state and territorial health departments in the United States (U.S.) via CDC’s National Electronic Telecommunications System for Surveillance (NETSS), a computerized public health surveillance system. The surveillance system accepts case reports of acute and chronic infections from all states and the District of Columbia, though not all jurisdictions report their data. In 2015, a total of 48 states submitted reports of acute hepatitis B virus (HBV) infection, 40 submitted reports of acute hepatitis C virus (HCV) infection, 40 submitted reports of chronic HBV infection, and 40 submitted reports of chronic HCV infection.

View Report Online - Commentary

Hepatitis C: 
Reported cases of acute HCV infection increased more than 2.9-fold from 2010 through 2015, rising annually throughout this period. Examining annual trends beginning in 2011, reported cases of acute HCV infection increased 44.3% from 2011 to 2012 (n=1,232 and 1,778 cases, respectively), increased 20.3% to 2,138 cases in 2013, increased 2.6% to 2,194 cases in 2014, and increased 11% to 2,436 cases in 2015. The increase in acute HCV case reports reflects new infections associated with rising rates of injection-drug use, and, to a much lesser extent, improved case detection (15). Several early investigations of newly acquired HCV infections reveal that most occur among young, white persons who live in non-urban areas (particularly in states within the Appalachian, Midwestern, and New England regions of the country) (16); trends in these states likely indicate an overall increase in HCV incidence throughout the country (15, 17). States with the highest rate of new HCV infections (e.g., West Virginia, Kentucky, and Tennessee) did not receive CDC support for case finding during these reporting years (2011-2015). After adjusting for under-ascertainment and under-reporting (2), an estimated 33,900 (95% CI=26,800–115,000) new HCV infections occurred in 2015.

Based on the data from national health surveys conducted in the 2003-2010 time period, approximately 3.5 million persons are currently infected with HCV (18). Mortality among HCV-infected persons—primarily adults aged 55–64 years—increased during 2006-2010 (19, 20). In 2013, HCV associated deaths exceeded the combined number of deaths with 60 other infectious diseases as underlying causes (21). CDC data indicate the number of HCV-associated deaths increased 10.9% from 2011 through 2014 and decreased 0.2% to 19,629 in 2015. Approximately one-half of all deaths in 2015 occurred among persons aged 55-64 years. However, deaths associated with HCV are largely underestimated; the only large U.S. study of deaths among persons with confirmed HCV infection indicated that only 19% had HCV listed anywhere on the death certificate despite 75% having evidence of substantial liver disease (20). To increase the proportion of persons with HCV who are tested and linked to recommended care including curative treatment for HCV (12, 13), CDC and USPSTF recommend one-time testing for HCV infection among all adults born during 1945–1965 and among others at increased risk for HCV infection (22).

Continue reading report @ https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm

Funding the war on hepatitis – deploying innovative finance mechanisms to eliminate hepatitis C in Europe

Funding the war on hepatitis – deploying innovative finance mechanisms to eliminate hepatitis C in Europe

"In this blog, co-authors Rob Walton (
Cello Health Public Affairs), Jeffrey V Lazarus (CHIP, WHO Collaborating Centre on HIV and Viral Hepatitis at Rigshospitalet, the University of Copenhagen and Editor-in-Chief of Hepatology, Medicine and Policy), Homie A. Razavi (Center for Disease Analysis), Jagpreet Chhatwal (Harvard Medical School), Charles Gore (Hepatitis C Trust), Pierre Van Damme (Vaccine & Infectious Disease Institute – VAXINFECTIO, University of Antwerp), Luís Mendão (GAT –Treatment Activist Group), and Angelos Hatzakis (Athens University Medical School and Hepatitis B & C Public Policy Association), discuss an innovative financing mechanism to eliminate Hepatitis C in Europe."

Rob Walton
20 Jun 2017
It is no coincidence that the emerging international consensus to tackle HCV has come at the same time as the arrival of new and highly effective range of direct-acting antiviral (DAA) treatments for hepatitis C virus (HCV). These new drugs offer, for the first time, a realistic opportunity for the elimination of the disease across Europe by 2030. While effective, the high price of these treatments could pose a significant financial challenge to healthcare systems. But the costs of failing to take action could potentially be even higher. If HCV is left untreated, in many cases it can lead to liver failure and liver cancer which means that a liver transplant is the only viable course of treatment available.

"Speak Up" on World Hepatitis Day - The Hepatitis C Trust Patient Conference programme announced

The Hepatitis C Trust Patient Conference programme announced



The Hepatitis C Trust is delighted to confirm the programme for this year's Patient Conference, which is being held in London on 28th July to coincide with World Hepatitis Day. Speakers will include Professor Graham Foster (Professor of Hepatology, Queen Mary University), Sam May (Head of Support Services, The Hepatitis C Trust), and Dr Magdalena Harris (Lecturer, London School of Hygiene and Tropical Medicine), and there will also be an opportunity to share personal stories about the impact of hepatitis C.

The event is free to attend for all patients and professionals and you can secure your place here.

Continue reading....

Investigational Hepatitis C Drugs Show Promising Results

Investigational Hepatitis C Drugs Show Promising Results



June 20, 2017

Newer hepatitis C (HCV) drugs have shown very good sustained viral response (SVR) rates and little risk of resistance-associated substitutions, David L. Wyles, M.D., of Denver Health Medical Center reported in an International Antiviral Society-USA (IAS-USA) webinar.

He summarized studies on various direct-acting antiviral agents (DAAs) from the recent International Liver Congress (EASL) in Amsterdam.
Continue reading...