HCV: 4 Weeks Too Short for Treatment With New Drugs

Medscape Medical News

HCV: 4 Weeks Too Short for Treatment With New Drugs
Veronica Hackethal, MD
November 24, 2015

Four weeks of triple or quadruple combination therapy using new drugs for hepatitis C virus (HCV) results in only limited cure rates in patients with early-stage liver fibrosis, according to a study published online November 23 in the Annals of Internal Medicine.

"In this proof-of-concept study involving treatment-naive noncirrhotic patients with chronic HCV genotype 1 infection, 4 weeks of treatment with ledipasvir, sofosbuvir, and GS-9451 with or without GS-9669 was well-tolerated; however, only 30% (15 of 50) of patients achieved [a sustained viral response at 12 weeks]," write Anita Kohli, MD, from the University of Maryland, Baltimore, and colleagues "Thus, a treatment duration of 4 weeks with 3 or 4 potent [direct-acting antivirals] is not sufficient to cure HCV infection in most patients."

Current treatment regimens for HCV require 12 or more weeks of therapy. Shorter-term regimens have the potential to simplify therapy, increase adherence, reduce toxicity, and increase cost-effectiveness.

A previous study with the investigational drugs GS-9451 (a protease inhibitor) and GS-9669 (a nonnucleoside polymerase inhibitor), combined with ledipasvir and sofosbuvir, showed a sustained viral response rate of 95% (39 of 40 patients) in just 6 weeks.

To try to abbreviate therapy further, Dr Kohli and colleagues designed the current trial. The open-label nonrandomized phase 2a trial took place at the National Institutes of Health Clinical Center in Bethesda, Maryland, from January 2014 to May 2015. It included mostly African Americans (76%; 38/50), who are disproportionately affected by the HCV epidemic. Participants had not been previously treated and had early-stage liver fibrosis. Most were male (72%; 36/50) and had HCV 1a genotype (68%; 34/50).

Researchers divided participants sequentially into two groups. Twenty-five participants received a triple drug regimen of ledipasvir and sofosbuvir plus GS-9451 for 4 weeks. The second group of 25 participants received the four-drug regimen of ledipasvir, sofosbuvir, GS-9451, and GS-9669 for 4 weeks. Dosages included ledipasvir 400 mg and sofosbuvir 90 mg as a single combination tablet taken once daily, GS-9451 80 mg once daily, and GS-9669 250 mg once daily. All but one patient completed the trial.

Among participants in the triple-drug group, 10 patients (40%; 95% confidence interval [CI], 21% - 61%) reached a sustained viral response at 12 weeks, defined as unquantifiable HCV RNA levels at week 12, as did five patients (20%; 95% CI, 7% - 41%) in the four-drug group.

At baseline, 10 participants had HCV variants that increased resistance to at least one of the antivirals in the study. All these participants experienced viral relapse.

Adverse events, mostly mild, occurred among 48% (12/25) of patients in the triple-drug group and 72% (18/25) in the four-drug group. None of the patients discontinued therapy because of adverse events.

Lower baseline viral load, younger age, HCV genotype 1b, and absence of resistance mutations were linked to increased likelihood of a sustained viral response at 12 weeks. This subgroup may achieve acceptable response rates using a 4-week regimen, the authors suggest, and the possibility warrants further investigation.

"Our data suggest that for most patients, a treatment duration longer than 4 weeks is required to achieve [a sustained viral response]," they conclude. "However, some patients are capable of achieving [a sustained viral response] with 4 weeks of therapy, which could be attributable to the presence of several favorable factors, such as early fibrosis, low viral burden, and absence of [resistance-associated variables]."

The nonrandomized nature of the study and small sample size could have limited the study.

One or more coauthors reports research agreements, grants, personal fees, and/or stock ownership in one or more of the following: National Institutes of Health, Gilead Sciences, Merck, Pfizer, Johnson & Johnson, and Bristol-Myers Squibb. Two coauthors were employees of Gilead Sciences.

Ann Intern Med. Published online November 24, 2015. Abstract

Sofosbuvir, Velpatasvir Promising in Several Hep C Genotypes
New Treatments Not Enough to Eliminate Hepatitis C
Viekira Pak Results Reassuring for Compensated Cirrhosis

Keeping Up With Rapid Advances in Hepatitis C Treatment

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Keeping Up With Rapid Advances in Hepatitis C Treatment 

Pharmacy Practice News

At the 2015 American College of Clinical Pharmacy’s Global Conference on Clinical Pharmacy, Linda Spooner, PharmD, BCPS (AQ-ID), FASHP, a professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences University, in Worcester, provided an overview of what pharmacists need to know.
Drug interaction assessments are critical, because some of the new medications won’t work when taken with certain drugs. For example, the fixed-dose combination ombitasvir-paritaprevir-ritonavir plus dasabuvir (Viekira Pak, AbbVie) is most susceptible to drug interactions with immunosuppressants and antiretroviral therapy, mainly due to the influence of ritonavir on multiple enzymes (Ann Pharmacother 2015;49[6]:674-687).


Hepatitis C - NICE publishes final drug recommendations for the treatment of four separate medical conditions

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NICE publishes final drug recommendations for the treatment of four separate medical conditions

The National Institute for Health and Care Excellence (NICE) has published its final recommendations on whether six different drug treatments should be routinely funded by the NHS.

Each piece of guidance looked at the cost-effectiveness of a particular drug to treat a specific medical condition. They cover major depressive disorder, hepatitis C, melanoma and psoriasis.

Vortioxetine for the treatment of major depressive disorder

NICE recommends vortioxetine be made available as a third-line treatment for major depressive episodes. 

Vortioxetine (marketed as Brintellix by Lundbeck and Takeda) should be considered as a treatment option for adults whose condition has responded inadequately to two antidepressants within the current episode.

New options for hepatitis C

NICE recommends three new treatments for some adults with hepatitis C:
Ledipasvir-sofosbuvir (Harvoni, Gilead Sciences)
Ombitasvir-paritaprevir-ritonavir with or without dasabuvir (Viekirax with or without Exviera, Abbvie)
Daclatasvir (Daklinza, Bristol-Myers Squibb)

It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.

Pembrolizumab for the treatment of melanoma

NICE recommends pembrolizumab (also called Keytruda and manufactured by Merck, Sharp & Dohme) as a treatment for some patients with advanced melanoma. It is recommended as an option in adults:
for treating advanced melanoma that has not been previously treated with ipilimumab, and
when the company provides pembrolizumab with the discount agreed in the patient access scheme.

Apremilast for the treatment of Psoriasis

NICE does not recommend apremilast (also called Otezla and manufactured by Celgene) for treating some adults with moderate to severe chronic plaque psoriasis.

People whose treatment with apremilast was funded by the NHS before this guidance was published should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Trinity Scientists Homing in on New Hepatitis C Vaccine

Trinity Scientists Homing in on New Hepatitis C Vaccine

23 November 2015

Trinity researchers have just commenced a major new study to evaluate a new vaccine for the prevention of Hepatitis C infection in HIV patients, who are at increased risk of contracting the common infection.

Around 180 million people worldwide and an estimated 20,000 to 50,000 people in Ireland have Hepatitis C. It is a blood borne viral infection which is spread through direct contact with the blood of an infected individual and can lead to fibrosis (scarring of the liver), liver failure and cancer. Currently, there is no effective vaccine available for Hepatitis C and treatment is costly, often in the region of €50,000 per individual, lengthy, associated with side effects and is not 100% effective.

Numerous recent outbreaks of Hepatitis C in HIV-infected individuals internationally have highlighted the urgent need for a vaccine to prevent infection. HIV-infected individuals are at increased risk of Hepatitis C infection due to similar routes of acquisition. Hepatitis C infection also progresses more rapidly to liver damage in HIV-infected individuals. Approximately 20-30% of people with HIV are co-infected with Hepatitis C.

“A safe, affordable and effective vaccine for Hepatitis C would have a huge impact on combatting Hepatitis C given the multitude of people who are unaware of their diagnosis and represent a potential source for new infections,” said Dr Ciaran Bannan, a research fellow in Trinity College Dublin and the Department of GU Medicine and Infectious Diseases at St James’ Hospital who is leading the research with Professor Colm Bergin, Clinical Professor of Infectious Diseases, School of Medicine.

The study, which is the first phase-1 vaccine study in HIV infected people in Ireland, is also the first of a planned number of early intervention studies to be carried out in the Wellcome Trust-HRB Clinical Research Facility, a joint enterprise between Trinity College Dublin and St James’s Hospital.

The research team are evaluating the safety and the ability of a new vaccine to produce an immune response against Hepatitis C. Previous healthy volunteer studies in the University of Oxford have shown encouraging results. If effective, this vaccine could also be made available to other high risk groups such as intravenous drug users.

The study, which will run for 20 months, will follow 20 patients have in Dublin and St Gallen, Switzerland. Patients will be given two vaccines eight weeks apart and then followed closely to assess safety and the development of immune responses to Hepatitis C following vaccination. The vaccines being tested in this study are called AdCh3NSmut1 and MVA-NSmut and have been developed by ReiThera Srl and GlaxoSmithKline Biologicals SA.

This study is the result of collaboration between the University of Oxford, Kantonsspital, St. Gallen and GlaxoSmithKline Biologicals SA and has been funded by an EU Seventh Framework Program (FP7) grant.

AbbVie's TECHNIVIE™ Receives Health Canada Approval for Genotype 4 Chronic Hepatitis C Infection

AbbVie's TECHNIVIE™ Receives Health Canada Approval for Genotype 4 Chronic Hepatitis C Infection

TECHNIVIE provides an opportunity to treat adults who have genotype 4 (GT4) chronic hepatitis C virus (HCV) infection without cirrhosis, a population historically considered difficult-to-treat

TECHNIVIE is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in Canada for adult patients with GT4 chronic HCV infection

Approval is supported by a Phase II clinical trial of 135 chronic HCV GT4 patients, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR 12) in patients who took TECHNIVIE with ribavirin (RBV)

MONTREAL, Nov. 24, 2015 /CNW/ - AbbVie, a global, biopharmaceutical company, today announced that Health Canada granted a Notice of Compliance (NoC) to TECHNIVIE (ombitasvir/paritaprevir/ritonavir tablets) in combination with ribavirin (RBV) for the treatment of adults with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection without cirrhosis who are either treatment naïve or previously treated with peginterferon and ribavirin.

"Over the last several years, there has been a major focus on hepatitis C genotype 1 disease. The optimal protocol for treating hepatitis C genotype 4 patients was not well defined. As a practicing hepatologist, I am thrilled that finally there is a cure for people living with hepatitis C genotype 4, which is relatively hard to eradicate," explains Dr. Magdy Elkhashab, Gastroenterologist/Hepatologist, Director of the Toronto Liver Centre. "This new therapy, which is given orally, can cure the disease in genotype 4 patients in almost 100% of cases. These are really exciting times. When I started my practice 20 years ago, I saw cure rates of 4 to 6%. I can truly say that I have seen the whole hepatitis C story unfold."

HCV GT4 has historically been difficult to treat. Egypt has the highest prevalence with more than 90% of infections due to genotype 4. Genotype 4 has been spreading in several Western countries, including Canada, due to variations in population structure, immigration, routes of transmission, travel and tourism. 1,2

"The approval of TECHNIVIE by Health Canada is further proof of AbbVie's ongoing commitment to help address the burden of hepatitis C. We are determined to provide best-in-class solutions for people living with hepatitis C in Canada, especially through our support program AbbVie Care," said Stéphane Lassignardie, general manager, AbbVie Canada.

Virologic cure is defined as a sustained virologic response (SVR), which is when the virus is no longer detectable in the patient's blood 12 weeks after treatment (SVR12).3

About the PEARL-I Study
This approval of TECHNIVIE is based on data from the PEARL-I study, which demonstrated 100 percent sustained virologic response rates at 12 weeks post-treatment (SVR12) in patients who received TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b study that evaluated the efficacy and safety of TECHNIVIE in GT4 chronic HCV patients without cirrhosis. The study included GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49). Additionally, 91 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking TECHNIVIE without RBV. In the treatment-naïve group without RBV, on-treatment virologic failure was reported in one patient (two percent), and two patients (five percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.

There were no discontinuations due to adverse events in these patients. The most commonly reported treatment-emergent adverse events (greater than 10 percent) observed in patients receiving TECHNIVIE with RBV were asthenia, fatigue, and headache.

TECHNIVIE is an all-oral antiviral treatment consisting of the fixed-dose combination of ombitasvir/paritaprevir/ritonavir (12.5/75/50 mg) taken as 2 tablets once daily and taken with food, which is co-administered with weight-based RBV (1000mg or 1200mg in divided doses, twice daily), taken with food. The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.

About AbbVie Care
Canadians prescribed TECHNIVIE will have the opportunity to be enrolled in AbbVie Care, AbbVie's signature care program. AbbVie Care provides support to people living with hepatitis C. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services coordination with pharmacies trained in hepatitis C, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond.

For more information, call 1-844-471-CARE (2273) or consult www.abbviecare.ca.

Important Safety Information4

TECHNIVIE (ombitasvir/paritaprevir/ritonavir tablets) is a prescription medicine used with ribavirin to treat adults with genotype 4 chronic (lasting a long time) hepatitis C (hep C) virus infection without cirrhosis.

To help avoid side effects and make sure you are using your medicines correctly, talk to your doctor before you take TECHNIVIE. Talk about any health problems you may have, including if you:
are taking birth control medicines of any kind or using a medicine that has ethinyl estradiol. Ethinyl estradiol is usually found in birth control pills. However, not all birth control pills have ethinyl estradiol. You must not use medicines that have ethinyl estradiol while taking TECHNIVIE. Your doctor will ask you to stop or change to a different type of birth control while you are taking TECHNIVIE.
have had a liver transplant.
have liver problems other than HCV infection.
are breastfeeding or plan to breastfeed. It is not known if TECHNIVIE passes into your breast milk. You and your doctor should decide if you will take TECHNIVIE or breastfeed. You should not do both.

Pregnancy and Birth Control
Females must have a negative pregnancy test before starting TECHNIVIE and ribavirin, every month while on the medicine, and for 6 months after stopping them.
You or your partner should not become pregnant while taking TECHNIVIE with ribavirin and for 6 months after you have stopped taking them.
You and your partner must use 2 kinds of birth control while taking TECHNIVIE and ribavirin and for 6 months after you have stopped taking them.
Talk to your doctor about the kind of birth control that you can use.
If you or your partner becomes pregnant while taking TECHNIVIE and ribavirin or within 6 months after you stop taking them, tell your doctor right away.

Other warnings you should know about:
Rises in liver tests have occurred when TECHNIVIE was taken in studies. Contact your doctor right away if you have symptoms like those listed below since these may mean you have a serious problem with your liver:
loss of appetite (do not feel like eating),
stomach ache,
nausea (feeling sick in the stomach),
feeling tired or weak,
yellowing of the skin and eyes,
dark urine and pale stool.

It is not known if taking TECHNIVIE is safe or will work in children under 18 years of age.
Your doctor may do blood tests before you start taking, and while you are on your medicines. This is to help check if the medicines are working for you.

Tell your doctor all the medicines, drugs, vitamins and minerals, natural supplements or alternative medicines you are already taking, as interactions are possible with TECHNIVIE.

The complete TECHNIVIE Product Monograph is available on the manufacturer's websitewww.abbvie.ca, or by calling 1-888-704-8271.

Additional information about AbbVie's chronic hepatitis C clinical program can be found onwww.clinicaltrials.gov.

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.ca and www.abbvie.com. Follow @abbvieon Twitter or view careers on our Facebook or LinkedIn page.

Accessed on November 10, 2015

2 PUBMED. Hepatitis C genotype 4: What we know and what we don't yet know. Kamal SM, Nasser IA.
Accessed on November 10, 2015

3 AASLD/IDSA/IAS–USA. When and in Whom to Initiate HCV Therapy.

Accessed on November 10, 2015

4 TECHNIVIE (ombitasvir/paritaprevir/ritonavir tablets) Product Monograph. Date of Preparation:October 20, 2015
Accessed on November 10, 2015

Expensive drugs that cure hepatitis C are worth the cost, even at early stages of liver fibrosis

Related: November 2015 Updates
Reducing the cost of new hepatitis C drugs

An index of articles pointing the reader to the current controversy over the high price of Sovaldi, Harvoni (ledipasvir/sofosbuvir) and AbbVie Viekira Pak.

Expensive drugs that cure hepatitis C are worth the cost, even at early stages of liver fibrosis


It is worthwhile to give patients expensive new drugs that can cure their hepatitis C much earlier than some insurers are now willing to pay for them, according to a UC San Francisco study that models the effects of treating the disease early versus late in its development.

Researchers said they were surprised by the findings, since the drugs can cost up to $100,000 for a full course of treatment. But when they factored in the long-term medical cost of delaying treatment for hepatitis C, they found the savings, in combination with improvements in the quality of patients' lives, were enough under current standards to justify using them even at early stages of liver fibrosis. Researchers said the drugs were therefore cost effective.

Cost effectiveness is a measure of broad social benefit that health economists use to make decisions about whether medical treatments are warranted. The researchers said the balance was tipped in favor of the drugs because the hepatitis C virus can cause so much damage. Hepatitis C is one of the leading causes of liver cancer, liver transplants and liver-related death, yet the drugs can prevent much of that with an early cure. Moreover, even if costly hepatitis C treatments are delayed, they eventually will be given to many patients once the infection causes enough damage to their livers.

About 3.2 million people have hepatitis C in the United States. The vast majority were infected by blood transfusions before testing of blood donors became available in 1992. Today, most people get infected from injecting drugs.

Left unchecked, hepatitis C causes varying degrees of liver fibrosis in a majority of those infected, and causes cirrhosis in 20 to 30 percent. This damage is classified in five stages of increasing severity, from zero to four. Using sofosbuvir-ledipasvir, which is sold as Harvoni, and is one several new drugs for hepatitis C, researchers compared the costs of treating patients at all stages of fibrosis, zero through four, with the cost of waiting until stages three or four, which is when some patients are usually treated.

They found that, at current drug prices, treating half of those who are currently infected and are aware of their status but have not yet been treated would cost about $53 billion over five years, while treating these patients only at stages three and four would cost $30 billion. Since many of those patients are likely to be given the drugs at later stages of their disease, much of this cost is likely unavoidable, even if it gets delayed. But treating people early would at least avoid the costs of treating the damage from long-term infection. Researchers estimated the lifetime health care savings from treating all stages of liver fibrosis, compared to treating just three and four, at $3.3 billion.

"The budgetary implications of widespread treatment are quite large at current drug prices," said James G. Kahn, MD, MPH, a professor in the UCSF department of epidemiology and biostatics, as well as medicine. "However, these costs are time-limited, and they are lower than some other treatments that are less effective. In the U.S., we spend more than $140 billion a year treating cancer, often with less health benefit than is provided by the new hepatitis C treatments."

The researchers said it was important to broaden the discussion beyond cost-effectiveness, to include the price of drugs.

"The benefits of early therapy are significant, since it increases the number of healthy life years for patients and decreases their chances of getting serious liver diseases, like liver failure and liver cancer," said Harinder Chahal, PharmD, MSc, an assistant adjunct professor in the UCSF department of clinical pharmacy. "But the current prices are keeping early treatment out of reach for many patients, and this needs to be addressed."


Other authors include Rena Fox, MD, and Jeffrey Tice, MD, of UCSF; Elliot Marseille, PhD, of Health Strategies International; and Daniel Ollendorf, PhD, and Steve Pearson, MD, MSc, of the Institute for Clinical and Economic Review in Boston.

The study was supported by the Blue Shield of California Foundation, the California Health Care Foundation, the UCSF Clinical and Translational Sciences Institute and the National Institute on Drug Abuse.

UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy, a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences, as well as a preeminent biomedical research enterprise and two top-ranked hospitals, UCSF Medical Center and UCSF Benioff Children's Hospital San Francisco. Please visit http://www.ucsf.edu.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

Platelets promote the liver's regeneration process following surgery

Platelets promote the liver's regeneration process following surgery

(Vienna, 23 November 2015) A team of researchers at the MedUni Vienna has discovered that certain platelet-derived growth factors are of major significance for the liver's regeneration processes. It has been shown that platelets can encourage the regrowth of liver tissue in patients who have had parts of their liver removed surgically. This may also act as a starting point for the prediction of potential post-operative problems. The work has been published in the key journal on liver medicine, "Hepatology".

Platelets are a vital part of wound healing processes. They can specifically secrete key growth factors at the site of the injury and therefore start the damaged tissue's regeneration processes. In the latest study, which involved collaboration between the University Department of Surgery at the MedUni Vienna led by Patrick Starlinger and the Institute of Physiology led by Alice Assinger, scientists were able to demonstrate that the specific release of growth factors from the α granules was associated with post-operative liver regeneration.

The authors of this study demonstrated back in 2014 that serotonin stored in platelets can play a key role in post-operative liver regeneration. Serotonin is stored in the electron-dense granules (storage organelles) of platelets and is secreted after activation. As part of the platelet activation process, the contents of a second type of granule, known as the α granule, are also released. It has now been possible for the first time to prove a highly selective release of α granules in vivo and demonstrate the resulting pathophysiological consequences.

These granules contain both growth-promoting and growth-inhibiting factors. In vitro data from previous years have shown that platelets can be present not just, as was previously thought, in an activated or non-activated state, but instead that they are able, depending on the underlying stimulus, to release growth-promoting or growth-inhibiting factors on a highly specific basis. In the past, it was not known whether this mechanism also has a role to play in vivo and therefore has pathophysiological consequences.

The liver is the only organ that is able to regenerate itself, even after extensive damage or after parts of it have been surgically removed (resected). Up to 75 per cent of the liver tissue can be removed without the organ's metabolic functions being permanently impaired.

The liver's tremendous potential for regeneration and advancing developments in the field of liver surgery mean that even patients with impaired liver function are able to undergo intricate resections. However, impairment of liver function still occurs in a certain percentage of patients following surgery. This liver impairment can develop into life-threatening complications and is associated with a relatively high degree of mortality. The exact causes of liver failure are so far not fully understood.

Hepatic vein blood pressure could determine selective α granule release
The scientists have now also been able to show that there is a relationship between platelet-derived growth factors and hepatic vein blood pressure. Pre-existing liver disease, which causes changes to the blood pressure in the hepatic vein, is regarded as a risk factor for post-operative complications. "We were able to demonstrate that, in patients with high hepatic vein blood pressure, the release of growth-promoting substances is suppressed and increased levels of growth-inhibiting factors are released. These findings will help us to better understand the dangerous consequences of changes in hepatic vein blood pressure," explains Starlinger. The findings obtained from the study could make a major contribution towards the development of new treatment strategies aimed at ensuring improved liver regeneration following liver resection surgery and therefore also reducing the risk of liver failure that has to date been untreatable.

Service: Hepatology
The Profile of Platelet α-Granule Released Molecules Affects Postoperative Liver Regeneration. Starlinger P, Haegele S, Offensperger F, Oehlberger L, Pereyra D, Kral JB, Schrottmaier WC, Badrnya S, Reiberger T, Ferlitsch A, Stift J, Luf F, Brostjan C, Gruenberger T, Assinger A. 2015 Nov 3. doi: 10.1002/hep.28331http://www.ncbi.nlm.nih.gov/pubmed/26528955

Five research clusters at the MedUni Vienna
There are a total of five research clusters at the MedUni Vienna. The MedUni Vienna is increasingly focusing on fundamental and clinical research in these areas. The research clusters include medical imaging, cancer research / oncology, cardiovascular medicine, medical neurosciences and immunology. Surgical and hepatology research at the MedUni Vienna falls under the remit of the immunology cluster.

Daklinza(Daclatasvir): Bristol-Myers Lets Low-Income Countries Copy Hepatitis C Pills

Bristol-Myers Lets Low-Income Countries Copy Hepatitis C Pills
Caroline Chen

Bristol-Myers Squibb Co. has signed a broad agreement with Medicines Patent Pool, allowing the United Nations-backed organization to distribute licenses for generic-drug companies to copy its hepatitis C treatment in more than 100 developing and middle-income nations.
The agreement allows the generics makers to produce copies of the drug Daklinza, known chemically as daclatasvir, without paying any royalties, Medicines Patent Pool said in a statement Monday. The liver ailment is a new treatment area for the organization, which has helped developing nations gain access to HIV medicines.
Continue reading.... 

Bristol-Myers signs deal with UN group for generic hep C drug
Source: Reuters - Mon, 23 Nov 2015 14:19 GMT

Nov 23 (Reuters) - A United Nations-backed organization working to cut the price of HIV drugs said it had signed a deal with Bristol-Myers Squibb Co to allow generic versions of the company's hepatitis C drug to be sold in 112 low- and middle-income countries.

The drug, Daklinza, is on the World Health Organization's list of essential medicines.

Hepatitis C affects about 150 million people globally and kills around half a million each year, the World Health Organisation estimates.

The Medicines Patent Pool said on Monday that Daklinza would now be available to nearly two-thirds of people affected by the disease in low- and middle-income countries.

The list price in the United States for Daklinza is $63,000 for a 12-week regimen, or about $750 per day at wholesale costs, according to pharmacy benefits manager Express Scripts.

Other drugs used to treat hepatitis C include Gilead Sciences' Sovaldi. A single Sovaldi pill costs $1,000 in the United States, according to Express Scripts.

The deal with Bristol-Myers allows drugmakers anywhere in the world to develop generic versions of Daklinza.

The Medicines Patent Pool had earlier signed a deal with Bristol-Myers for generic versions of its HIV treatment Reyataz. (Reporting by Vidya L Nathan in Bengaluru; Editing by Ted Kerr)