HCV Research and News

March 24, 2014

Bristol-Myers Squibb to Present Data for Daclatasvir in Multiple Investigational All-oral Combinations across Hepatitis C Genotypes at The International Liver CongressTM

Daclatasvir data demonstrates potential to address high unmet needs, including cirrhotic and treatment-experienced patients, and those with genotypes 1, 2, 3 and 4

Breadth of viral hepatitis data underscores Company’s commitment to advancing research of liver diseases

Monday, March 24, 2014 5:39 am EDT

"The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe."

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 12 abstracts have been accepted for presentation at The International Liver CongressTM, the 49th annual meeting of the European Association for the Study of the Liver (EASL), in London, April 9 – 13.

Key presentations include:

Two sets of pivotal results from a global, Phase III study (HALLMARK DUAL) investigating the efficacy and safety of an all-oral, interferon- and ribavirin-free regimen of daclatasvir and asunaprevir, including data in cirrhotic and non-cirrhotic patients with HCV genotype 1b infection, will be presented as late-breakers.
Virologic response results from analyses investigating daclatasvir in combination with sofosbuvir across genotypes 1, 2 and 3.
Virologic response and safety data for the investigational all-oral 3DAA regimen (daclatasvir/asunaprevir/BMS-791325) in genotype 4 patients, as well as bioequivalence data for the daclatasvir 3DAA regimen, which is being studied as a fixed-dose-combination treatment with twice daily dosing.

“These results are encouraging and show the potential of daclatasvir across multiple treatment regimens, with the goal of helping patients achieve cure regardless of genotype, stage of disease or response to previous therapies,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The wealth of data we are sharing at the International Liver Congress continue the positive momentum for daclatasvir after the Marketing Authorization Application was validated for Accelerated Regulatory Review by the European Medicines Agency, highlighting the important potential role for daclatasvir-based regimens in Europe.”

Bristol-Myers Squibb is studying a broad portfolio of compounds in hopes of providing flexible treatment options to address the diverse unmet medical needs of a global HCV patient population. These investigational compounds include daclatasvir, an investigational NS5A replication complex inhibitor that has shown high antiviral potency and pan-genotypic activity across HCV genotypes in vitro; asunaprevir, an investigational NS3 protease inhibitor; BMS-791325, an investigational non-nucleoside inhibitor of the NS5B polymerase; and peginterferon lambda-1a (Lambda), an investigational type III interferon that has the potential to offer an alternative to alfa-interferon.

The complete list of Bristol-Myers Squibb data presentations is below. Abstracts can be accessed on the ILC/EASL website at http://www.ilc-congress.eu.

Title Date/Time Hepatitis C: Direct-Acting Antiviral Data

Oral Presentation (late-breaker): All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1b infection: Phase 3 study results -- April 12, 15:30 - 17:30

Poster (late-breaker): Efficacy and safety of daclatasvir in combination with asunaprevir (DCV+ASV) in cirrhotic and non-cirrhotic patients with HCV genotype 1b: Results of the HALLMARK DUAL study -- April 10, 09:00 - April 12, 18:00

Oral Presentation: Effect of baseline NS5A polymorphisms on virologic response to the all-oral combination of daclatasvir + sofosbuvir ± ribavirin in patients with chronic HCV infection -- April 11, 16:00 - 18:00

Poster: Effect of ribavirin on the safety profile of daclatasvir + sofosbuvir for patients with chronic HCV infection -- April 12, 09:00 - 18:00

Poster: All-oral therapy with daclatasvir in combination with asunaprevir and BMS-791325 for treatment-naive patients with chronic HCV genotype 4 infection -- April 12, 09:00 - 18:00

Poster: Daclatasvir, asunaprevir, and BMS-791325 in a fixed-dose combination: A phase 1 bioavailability study in healthy volunteers -- April 12, 09:00 - 18:00

Hepatitis B: Peginterferon Lambda-1a Data

Poster: Peginterferon Lambda-1a pharmacokinetics in subjects with impaired renal function -- April 12, 09:00 - 18:00

Oral: Peginterferon Lambda for the treatment of chronic hepatitis B (CHB): A phase 2b comparison with peginterferon alfa in patients with HBeAg-positive disease -- April 12, 15:30 - 17:30

Hepatitis C: Global Health Economics and Outcomes Research (GHEOR)

Oral Presentation: External validation of the risk-prediction model for hepatocellular carcinoma (HCC) from the REVEAL-HCV study using data from the U.S. Veterans Affairs (VA) health system -- April 10, 16:00 - 18:00

Poster: The impact of fibrosis on the risk of long-term morbidity and mortality in chronic hepatitis C patients treated in the veterans administration health care system -- April 11, 09:00 - 18:00

Poster: Early virologic responses and adverse events from the comparative assessment of effectiveness of antiviral therapies in hepatitis C study (CMPASS) -- April 12, 09:00 - 18:00

Poster: Determining the comparative effectiveness of emerging treatment regimens for hepatitis C virus (HCV) infection from single arm phase III trials -- April 12, 09:00 - 18:00

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer. In the European Union (EU) an estimated 9 million people are living with hepatitis C, and an estimated 170 million people worldwide are infected with the virus.

About Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.

In 2014, the U.S. Food and Drug Administration (FDA) granted Bristol-Myers Squibb’s investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation, which helped to expedite the start of the ongoing Phase III UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of these compounds will support regulatory filings, or that DCV or any other compounds mentioned in this release will receive regulatory approval or, if approved, that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:

Bristol-Myers Squibb Company
Media:
Jeff Smith,
Office: +33(0)1 58 83 83 21; Cell: +33(0) 6 03 99 40 18
jr.smith.paeurope@bms.com
or
Carrie Fernandez,
Office: +1-609-252-4831; Cell: +1-215-859-2605
carrie.fernandez@bms.com
or
Julie Ferguson,
Office: +1-609-252-5597; Cell: +1-312-385-0098
julie.ferguson@bms.com
or
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com

Source

Simeprevir has now been approved in Russia

Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that that the Russian Ministry of Health has approved Sovriad® (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir, which represents a significant advance in hepatitis C treatment.

“The Russian approval is another important event for simeprevir and provides the hepatitis C patients in Russia with a new HCV treatment” said Maris Hartmanis CEO, Medivir.

Statistics provided by the World Health Organization in 2011 showed that Russia has the third-highest prevalence of HCV, with an estimated 3.7 million infected[1]). Though exact data for current rates is not available, in January 2014 alone, there were 4.858 new cases of HCV diagnosed in Russia. This reflects an increase of 3.5 percent in comparison to January 2013[2]).

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292.

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 24 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S.
The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

1) World Health Organization. Hepatitis C. http://www.who.int/csr/disease/hepatitis/Hepc.pdf

2) Federal Service on Surveillance for Consumer Rights Protection and Human Wellfare

Source

New Simeprevir data will be presented at The International Liver Congress 2014 of the European Association for the Study of the Liver, (EASL)

Presentations Include late-breaking final results from the phase II COSMOS study

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that new data from the clinical development program for simeprevir in the treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL). The International Liver Congress 2014 will take place from April 9-13 in London, United Kingdom.

Eight oral and poster presentations spanning over the phase II and phase III development program for simeprevir in treatment combinations with and without ribavirin and interferon are planned. New analyses of data from the phase III QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with pegylated interferon and ribavirin, as well as final data from the phase II COSMOS study will be presented during the Congress.

The data to be presented at the International Liver Congress 2014 include:

Late-Breaking Presentations

Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2)
- Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, USA
Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12 results of a Phase 3 trial (RESTORE Study)
- Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium

Oral Presentations

Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis
- Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine, Baltimore, USA
Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the PROMISE trial
- Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and QUEST-2 Phase 3 trials
- Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK
Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three Phase 3 studies
- Lead Author: Jane Scott; Janssen
Virology analyses of simeprevir in Phase 2b and 3 studies
- Lead Author: Oliver Lenz; Janssen
Deep sequencing analyses of minority baseline polymorphisms and persistence of emerging mutations in HCV genotype 1-infected patients treated with simeprevir
- Lead Author: Bart Fevery; Janssen

Full session details and data presentation listings for The International Liver Congress 2014 can be found at

http://www.ilc-congress.eu.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 10.15 CET on 24 March 2014.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. and in March 2014 in Russia. The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.

Source

Merck to Present New Data for Investigational Hepatitis C Treatments MK-5172 and MK-8742 at EASL Annual Meeting/The International Liver Congress™ 2014

Company to Initiate Phase 3 Clinical Development Program in Q2 2014

March 24, 2014 07:30 AM Eastern Daylight Time

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new Phase 2 data for its two investigational hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor – are scheduled to be presented at the 49^th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014. The data are from Merck’s overall Phase 2 clinical program. The meeting will take place in London, United Kingdom, April 9 - 13, 2014.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV”

Based on the results of the Phase 2 program, Merck is initiating a Phase 3 clinical trial program, to be named C-EDGE. The C-EDGE program is designed to evaluate these investigational treatments across genotypes and in different HCV subpopulations, including patients with chronic kidney disease, HIV/HCV co-infection, and cirrhosis.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious Disease, Merck Research Laboratories. “Based on these data, we are pursuing a Phase 3 clinical program for these potentially important investigational medicines.”

In October 2013, Merck announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the investigational combination MK-5172/MK-8742 for treatment of chronic HCV infection.

Selected Presentations for MK-5172/MK-8742:

Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response: The C-WORTHY Study. Lawitz, E. et al. Oral presentation #O61: April 11, 2014, 4:00-4:15 p.m. BST.
Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for 12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY Study. Sulkowski, M. et al. Oral presentation #O63: April 11, 2014, 4:30-4:45 p.m. BST.
Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ± Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.

Merck’s Commitment to HCV

For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community, and expanding global access to medicines. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Merck
Media Contacts:
Caroline Lappetito, 267-305-7639
Sarra Herzog, 908-423-6154
or
Investor Contacts:
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

Source

March 22, 2014

Metabolic syndrome is associated with poor treatment response to antiviral therapy in chronic hepatitis C genotype 3 patients

Eur J Gastroenterol Hepatol. 2014 Mar 17. [Epub ahead of print]

Aziz H¹, Gill U, Raza A, Gill ML.

Abstract

INTRODUCTION: Hepatitis C viral (HCV) infection is caused by an RNA virus. HCV infection is considered to induce systemic disease that causes steatosis, alters lipid metabolism, and results in metabolic syndrome. This study aimed to investigate the therapeutic outcome in HCV genotype 3 patients with metabolic syndrome.

MATERIALS AND METHODS: A total of 621 HCV-positive patients who visited the hospital for treatment were screened. Among these, 441 patients were enrolled for antiviral therapy. These enrolled patients were assessed for metabolic syndrome according to the International Diabetes Federation criteria. Group A included patients with metabolic syndrome and group B included patients without metabolic syndrome. All patients received peginterferon-α2a (180 μg/week) and ribavirin (10 mg/kg/day) for 6 months.

RESULTS: The prevalence of metabolic syndrome in chronic HCV patients was 37.9%. We observed that metabolic syndrome was more common among female compared with male participants (43.9 vs. 28.8%, P=0.005). It was found that sustained virologic response (SVR) rates were significantly higher in the patients in group B (without metabolic syndrome) compared with the patients in group A who had metabolic syndrome (72.2 vs. 43.7%, P<0.05). Older patients were at a higher risk for metabolic syndrome and a correlation of metabolic syndrome with nonresponse to antiviral therapy was observed. An interesting correlation among metabolic syndrome, age, and SVR was found: with age, SVR decreases, while metabolic syndrome increases.

CONCLUSION: Metabolic syndrome has an influence on therapeutic outcomes in terms of SVR. Moreover, this information can identify patients who might have a low chance of attaining an SVR and a timely decision may protect the patients from the adverse effects of therapy.

PMID: 24642690 [PubMed - as supplied by publisher]

Source

Long-term maintenance of sustained virological response in liver transplant recipients treated for recurrent hepatitis C

Dig Liver Dis. 2014 Mar 10. pii: S1590-8658(14)00207-2. doi: 10.1016/j.dld.2014.01.157. [Epub ahead of print]

Ponziani FR¹, Viganò R², Iemmolo RM³, Donato MF⁴, Rendina M⁵, Toniutto P⁶, Pasulo L⁷, Morelli MC⁸, Burra P⁹, Miglioresi L¹⁰, Merli M¹¹, Di Paolo D¹², Fagiuoli S⁷, Gasbarrini A¹³, Pompili M¹³; on behalf of AISF RECOLT-C Group, Belli L, Gerunda GE, Marino M,Montalti R, Di Benedetto F, De Ruvo N, Rigamonti C, Colombo M, Rossi G, Di Leo A, Lupo L, Memeo V, Bringiotti R, Zappimbulso M,Bitetto D, Vero V, Colpani M, Fornasiere E, Pinna AD, Morelli MC, Bertuzzo V, De Martin E, Senzolo M, Ettorre GM, Visco-Comandini U,Antonucci G, Angelico M, Tisone G, Giannelli V, Giusto M.

Abstract

BACKGROUND: The recurrence of hepatitis C viral infection is common after liver transplant, and achieving a sustained virological response to antiviral treatment is desirable for reducing the risk of graft loss and improving patients' survival.

AIM: To investigate the long-term maintenance of sustained virological response in liver transplant recipients with hepatitis Crecurrence.

METHODS: 436 Liver transplant recipients (74.1% genotype 1) who underwent combined antiviral therapy for hepatitis Crecurrence were retrospectively evaluated.

RESULTS: The overall sustained virological response rate was 40% (173/436 patients), and the mean follow-up after liver transplantation was 11±3.5 years (range, 5-24). Patients with a sustained virological response demonstrated a 5-year survival rate of 97% and a 10-year survival rate of 93%; all but 6 (3%) patients remained hepatitis C virus RNA-negative during follow-up. Genotype non-1 (p=0.007), treatment duration >80% of the scheduled period (p=0.027), and early virological response (p=0.002), were associated with the maintenance of sustained virological response as indicated by univariate analysis. Early virological response was the only independent predictor of sustained virological response maintenance (p=0.008).

CONCLUSIONS: Sustained virological response achieved after combined antiviral treatment is maintained in liver transplant patients with recurrent hepatitis C and is associated with an excellent 5-year survival.

KEYWORDS: HCV antiviral treatment, Hepatitis C recurrence, Liver transplantation, Sustained viral response

PMID: 24635906 [PubMed - as supplied by publisher]

Source

March 21, 2014

Coffee Is Probably Good For Your Liver

Provided by International Business Times

By Nat Rudarakanchana
on March 21 2014 1:39 PM

Mounting scientific evidence has shown that coffee prevents and mitigates liver disease, even among the thousands of Americans who may not realize they have the disease, according to the Canadian Liver Foundation.

Several studies from the late 1990s to date have shown that coffee helps prevent liver inflammation, which is often related to hepatitis C, cirrhosis and liver cancer. One April 2013 overview study showed that 16 studies, which surveyed more than 500,000 subjects over several years, all demonstrated coffee’s benefits on the liver.

But awareness among the general public about coffee’s benefits for the liver remains “very poor,” Canadian Liver Foundation Chairman Dr. Morris Sherman told IBTimes on Thursday, at a New Orleans coffee conference.

That holds true of the coffee industry itself, which may not know much about the scientific connection, Sherman added.

It’s unclear if caffeine or other ingredients in coffee are responsible for the health benefits, Sherman said at an industry presentation called “Coffee and Liver Health: A Growing Nexus.” One study in Japan showed that green tea failed to help those suffering from liver diseases, Sherman said. Other evidence indicates that tea has little effect on liver diseases.

“Tea doesn’t seem to have any benefit” on the liver, Sherman said.

Still, coffee alone can hardly treat liver disease, and more solid scientific data in coming years is needed to strengthen the evidence of its health benefits. “It is unclear whether any of these benefits [from drinking coffee] are significant enough to 'treat' patients with chronic liver disease,” the 2013 overview study concluded. “In the interim, moderate daily unsweetened coffee ingestion is a reasonable adjunct to therapy.”

Obesity is a leading cause of nonalcoholic fatty liver disease, which many Americans have but don't know it. The disease may affect up to 25 percent of U.S. adults, though the actual figure may be closer to 10 to 15 percent. But if 5 percent of those with a liver disease were aware of it, that would be a significant improvement over the status quo, Sherman said.

Liver diseases don’t cause any symptoms until the liver actually fails, he said.

“The evidence has been slowly building," Sherman said. "These studies are not easy. It’s not easy to find a population large enough, and where someone has had the foresight to ask them about their coffee consumption.”

Coffee’s other health benefits may be dubious, however. The federal Food and Drug Administration (FDA) on Wednesday warned consumers against buying Vitaccino Coffee, which contains harmful substances, despite labelling claiming that the coffee can help drinkers lose weight safely.

Seven coffees that claim to boost weight loss have been found to contain harmful ingredients since 2011, according to the FDA's website.

Mortality rates for liver cancer are rising faster than many other cancers, though the Center for Disease Control and Prevention's data show that liver cancer isn't among the 10 most common cancers in the United States.

Source

New HCV Guidance: Rapid Updates for Clinicians

Medscape Gastroenterology

Laura A. Stokowski, RN, MS, Helen W. Boucher, MD, Paul Martin, MD
March 21, 2014

HCV Science Catching Up to Medical Need

In just 2 or 3 years, the pace of progress in the treatment of hepatitis C virus (HCV) infection has been fairly dramatic. A swift and steady stream of new drugs has challenged clinicians to keep up with the latest recommendations for therapy, and the pipeline is far from dry. The next wave of direct-acting antivirals will continue to target the HCV life cycle from different angles, and combining molecules with different mechanisms of action, different resistance profile, and high antiviral activity will be the name of the game.^[1]

Safer, shorter, and more durable treatments are anxiously awaited by many patients already infected with HCV, who have been forestalling treatment or retreatment while waiting for all-oral, interferon-free regimens that will cure their infections without the adverse effects associated with previous drugs. For the rest of the estimated 2-3 million individuals infected with HCV in the United States, all the new drugs in the world are of scant worth if these infections remain undiagnosed.

The recommendation to add a 1-time HCV birth cohort screening for "baby boomers" to exposure risk-based screening^[2] is expected to identify more than 800,000 new cases of chronic HCV infection in the United States.^[3] Many clinicians -- from those on the frontlines of primary care to the specialists who are experienced in managing HCV and its complications -- will be needed to cope with the burgeoning newly diagnosed population.

The rapid advances in the field of HCV prompted the Infectious Diseases Society of America (IDSA) and the American Association for the Study of Liver Diseases (AASLD), in collaboration with the International Antiviral Society-USA (IAS-USA), to sponsor an effort to synthesize the current evidence in the field, from which was derived a set of expert-developed recommendations for the management of HCV infection, a feat that was accomplished remarkably quickly. The first phase of the HCV guidance, available online at HCVguidelines.org, details the methodology used to develop the guidance, and covers the following sections related to diagnosis, referral, and management:

HCV Testing and Linkage to Care;
Initial Treatment of HCV Infection in Patients Starting Treatment;
Retreatment of Persons in Whom Prior Therapy Has Failed; and
Unique Patient Populations (HIV/HCV coinfection, cirrhosis, transplantation, renal impairment).

Sections ("coming soon") that are now being developed for updates of the guidance include:

In Whom and When to Initiate Treatment;
Monitoring Patients Who Are On or Have Completed Therapy; and
Management of Acute HCV Infection.

Clinicians will appreciate the color-coded treatment guidance within the report, allowing them to distinguish at a glance "recommended" (outlined in green) from the "not recommended" (outlined in red) treatment regimens. Each section of the report ends with a quick reference summary of recommendations, and useful resources are provided at exactly the point they might be needed. For example, the section on testing includes a table of commercially available, US Food and Drug Administration-approved anti-HCV screening assays, and a simple algorithm of the recommended sequence for screening, testing, and linking patients to care for ongoing evaluation and management.

Medscape Talks to Paul Martin, MD, and Helen W. Boucher, MD, for Perspectives on New HCV Guidance

Medscape recently spoke with Dr. Paul Martin, a hepatologist and member of the guidance writing panel, and Dr. Helen W. Boucher, an infectious diseases specialist, about the new HCV guidance, including key points of emphasis about the content of the guidance, the implications for clinical practice, and what clinicians can expect in the way of updates.

Medscape: HCV treatment is still in flux -- it almost seems impossible to settle on treatment guidelines. How did the HCV guidance first come about?
Dr. Boucher: The HCV guidance was sponsored by the IDSA and the AASLD, with IAS-USA as the collaborating partner. The 2 societies have decided that the best way forward with the treatment of hepatitis C infection is to collaborate, and I think what is so exciting about this new guidance is the partnership behind it. We have recognized the need to provide up-to-date information, and that is what our societies have done with this guidance. The speed with which the guidance document was achieved was extremely noteworthy.

Medscape: You refer to the HCV guidance as a "living document." How does this differ from the model that we are accustomed to in medicine?

Dr. Martin: The whole area of hepatitis C treatment is evolving so rapidly that we felt that it was crucial that treating healthcare providers have access to up-to-date information. The more traditional practice guidelines go through a detailed process and take some time to appear in print. Clearly, however, this whole field is moving so rapidly that we felt that it was best to have our recommendations online as soon as possible. As far as updating it, the same panel will be involved, and additional experts may be invited to participate for specific topics. The idea is that this will be updated on a regular basis. We plan to add additional sections later on. Clearly, however, the HCV guidance reflects treatment options in the United States, as these new drugs may not yet be licensed in other countries where different standards of care exist.

I think this is probably going to be the wave of the future, because we are all now so dependent on the Internet for information. We use the Internet in the office to research clinical questions when a patient is being seen, and I think practice guidelines in the future will reflect what we have done and mirror this sort of model. Speed and completeness are going to be the watchwords of the future.

Medscape: Is it significant that the document is called "HCV Guidance" rather than "HCV Guidelines"?

Dr. Martin: Yes. We view it that guidelines are typically developed after a protracted process, and the word "guidance" reflects the need to make recommendations available to potential treaters in a relatively short period. The recommendations are still based on a combination of review of the literature and consensus of expert opinion, but we view guidance as reflecting an up-to-date process.

Dr. Boucher: We were (and still are) experiencing an explosion of information about how best to treat patients with HCV, similar to what happened with HIV years ago The IAS-USA has done something similar, in a very high-quality way, for HIV/AIDS.

Medscape: With the recommendation to test all "baby boomers" (people born between 1945 and 1965) in addition to risk-based screening, the numbers of individuals with active hepatitis C infection are going to climb in the near future, and concerns have been raised about having enough healthcare providers to evaluate and treat all of these individuals.

In the section on testing and linkage to care, it says, "All patients with current HCV infection and a positive HCV RNA test result should be evaluated by a practitioner with expertise in assessment of liver disease severity and HCV treatment." Does this mean that primary care/internal medicine practitioners should refer all newly diagnosed patients to liver specialists?

Dr. Martin: We didn't restrict management of HCV to any particular discipline. The key thing is in managing hepatitis C is that although you are managing a viral disease, you are also managing the liver disease. We didn't seek to preclude any type of healthcare practitioner from caring for these patients, but we wanted to recommend that patients be seen by somebody who can not only treat the viral infection but also understands that the severity of the liver disease needs to be addressed -- because ultimately that is going to determine, or be an important component of determining, the patient's prognosis.

Dr. Boucher: The important point is that the patient ends up with a healthcare practitioner who is expert in managing his or her disease. Many physicians are expert in treating HCV. Some are infectious diseases trained, and some are gastroenterology/hepatology trained. It differs by medical center; there are no absolutes.

Medscape: In the section about initiating treatment, as written today, what would you most like to draw clinicians' attention to?

Dr. Martin: The most important point is endorsing the use of the combination of sofosbuvir and simeprevir in the treatment of hepatitis C and discouraging the use of telaprevir- and boceprevir-containing regimens. These drugs are still approved for use, although they are associated with higher rates of adverse effects, such as rash and anemia.

Medscape: If a patient has already been started on a regimen involving either telaprevir or boceprevir, would you switch to a different combination, or allow the patient to complete the treatment?
Dr. Martin: If a patient is already doing well on treatment, there is no need to switch therapy.

Medscape: How important is genotyping in tailoring treatment to the patient?

Dr. Martin: Genotyping is key to picking the optimal regimen.

Medscape: Can you speak a little about the progress toward an all-oral, interferon-free treatment for hepatitis C?
Dr. Martin: In my mind, it has already arrived. We are in the first phase of it already. Obviously, interferon is still part of a number of regimens, but as we speak, many patients are receiving all oral therapies

It depends on the genotype. For patients with genotype 1, we have the COSMOS protocol, which is a combination of simeprevir and sofosbuvir. For patients with some non-genotype 1 infections, there is the option of using sofosbuvir with ribavirin, for instance.

In general, therefore, we are seeing an increased use of these all-oral regimens. This reflects what has been approved as of the date that the guidance was generated. A drug such as the NS5A replication complex inhibitor daclatasvir will be part of the revised treatment strategy if and when it has been approved.

Medscape: We hear talk of an "avalanche" of drugs in the HCV pipeline, and that some of the drugs are pan-genotypic: For example, a drug such as the NS5A replication complex inhibitor daclatasvir might become part of a revised treatment strategy if approved. Can we really expect this many new drugs, and how will you keep this manageable for clinicians who must keep up to date with new drugs all the time?

Dr. Martin: "Avalanche" might be overstating it. I would describe it as a very good developmental pipeline, and I think we are going to see continued advances related to the licensing of new drugs. We will probably see several more drugs licensed in the next 1-2 years. It will certainly be challenging to help clinicians keep them all straight, but that is one of the reasons we were interested in developing these guidelines and, in fact, the reason that they are called hepatitis C "guidance" rather than "guidelines." It is a huge amount of information, and it needs to be updated frequently.

Medscape: How much concern do you have about the development of resistance to these drugs?

Dr. Martin: When we are seeing sustained virologic response rates now routinely in excess of 90%, clearly resistance is going to be substantially less of a concern, because most patients are going to be cured by a single course of treatment. That being said, I don't think anybody thinks resistance is going to go away. However, the key to managing or preventing resistance is to very effectively treat the infection with the best drug combination available and to eradicate the infection the first time around.

Medscape: In the guidance document, you don't mention cost of treatment at all. It is understandable that you wouldn't want to get into that, but would you be willing to comment on the reports about the high cost of these drugs?

Dr. Martin: It is fair to say that the more treatment options that there are, the more price pressure there will be on the individual companies to license or sell their drugs at a competitive price. It is very expensive to take care of a patient with advanced liver disease -- not just the cost of a liver transplant, but a patient with advanced liver disease who is in and out of hospital with one complication after another is enormously resource-intensive for the system. If we can abort the progression of liver disease, we are ultimately going to have a major impact on healthcare costs related to hepatitis C. Many patients with hepatitis C may elect to wait for less expensive regimens if their liver disease is mild.

Medscape: Is there anything else practice-changing about the guidance document, as it stands today, that you would like to mention?

Dr. Martin: It is critically important that patients are seen by practitioners who are comfortable managing and treating hepatitis C. We don't want to restrict anyone from taking care of these patients, but we want to make sure that patients have the appropriate work-up. Patients with advanced liver disease who may need additional consideration, such as a liver transplant, should be referred for specialty care. Another group of patients who might need referral are those who are coinfected with HIV, who might need expertise in HIV management.

Dr. Boucher: We hope that primary care practitioners will use the guidance to help them decide who needs a referral and when.

Medscape: How do you plan to disseminate the guidance to clinicians, both now and when there is updated guidance that you want to make them aware of?

Dr. Boucher: I believe that the plan is to use the Website www.hcvguidelines.org as the major point of dissemination.

Source

Gilead offers Egypt new hepatitis C drug at 99 percent discount

By Maggie Fick and Ben Hirschler
CAIRO/LONDON Fri Mar 21, 2014 4:10pm EDT

(Reuters) - Gilead Sciences, facing mounting criticism over the high price of its new hepatitis C pill Sovaldi, has offered to supply the medicine to Egypt at a 99 percent discount to the U.S. price.

While the drug will still cost $900 for a 12-week course of treatment, that is a fraction of the $84,000 charged for a course of treatment in the United States.

The high price tag in America prompted questions from U.S. lawmakers on Friday, after U.S. health insurers said they were seeking help from state health officials to foot the bill.

Gilead said it was "pleased to have finalized an agreement" for the introduction of Sovaldi in Egypt, which has the highest prevalence rate of hepatitis C in the world.

"We believe Sovaldi could have a major impact on public health in Egypt by significantly increasing the number of people who can be cured of hepatitis C," Gregg Alton, head of corporate and medical affairs at Gilead, said in an emailed statement.

Egyptian health minister Adel El-Adawi said Cairo had struck a deal with U.S.-based Gilead for the government to buy Sovaldi for $300 for a one-month box, according to a recent report on the state news agency MENA.

That would imply a cost of $900 if Sovaldi is used as part of a 12-week drug regimen, although the cost would be higher if it was used for 24 weeks, which is also an option based on different drug combinations.

El-Adawi said Gilead's offer would apply to Sovaldi supplies used in government clinics, adding that access programmes would start in the second half of 2014, following completion of registration procedures in Egypt.

Sovaldi is in the vanguard of a wave of pills which could cure the liver-destroying disease in millions of people worldwide, or even eradicate it entirely. But that will only happen if the new therapies are affordable enough to allow widespread use.

Nowhere is the problem more acute than in Egypt, which has the world's highest prevalence of the virus, following the use of poorly sterilized needles in campaigns dating back to the 1970s to stamp out the parasitic disease schistosomiasis.

Like HIV, hepatitis C (HCV) can be spread through blood, often via contaminated needles.

The World Health Organization estimates that more than 150 million people worldwide are chronically infected, most of them in developing countries, putting them at risk of cirrhosis and liver cancer.

Other companies such as Johnson & Johnson, AbbVie, Bristol-Myers Squibb and Merck & Co are also developing oral treatment regimens for HCV that have shown dramatic results in clinical trials, while reducing the need for debilitating interferon injections.

Doctors and industry analysts believe the new drugs will transform HCV treatment - and prove hugely profitable. In the developed world, they are tipped to become major blockbusters, with consensus sales forecasts for Sovaldi alone standing at $9.1 billion in 2017, according to Thomson Reuters Pharma.

But the risk of a gulf in access between patients in the rich and poor parts of the world is causing alarm among health campaigners who warn of a potential re-run of the battle over HIV drugs in Africa more than a decade ago.

Medecins du Monde, a non-profit group that provides medical care around the world, highlighted Egypt as a country in dire need of the new hepatitis C drugs in a report this week.

Gilead has also said it plans to license Sovaldi to a number of Indian generic pharmaceutical manufacturers, which would be able to sell lower-priced copies of the medication.

(Additional reporting by Deena Beasley; Editing by James Dalgleish)

Source

Minimal impact of sofosbuvir and ribavirin on health related quality of life in Chronic Hepatitis C (CH-C)

Journal of Hepatology
Volume 60, Issue 4 , Pages 741-747, April 2014

Zobair M. Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M. Jacobson, Eric Lawitz, David Nelson, Fatema Nader, Sharon Hunt

Received 17 September 2013; received in revised form 29 November 2013; accepted 4 December 2013. published online 11 December 2013

Abstract

Background & Aims

Treatment for CH-C contains interferon with substantial associated side effects and health-related quality of life (HRQL) impairment. Currently, there is no published data assessing the impact of interferon-free regimens on HRQL. The aim is to report the HRQL of patients who participated in clinical trials of sofosbuvir (SOF) for CH-C.

Methods

CH-C patients were treated with sofosbuvir (SOF), pegylated interferon (PegIFN), ribavirin (RBV), or placebo in different combinations and duration (POSITRON, FISSION, FUSION, and NEUTRINO phase III trials). HRQL was assessed using SF-36 at baseline, during treatment, at the end of treatment, and at follow-up, and compared between treatment arms.

Results

HRQL scores decreased over the course of treatment for all treatment arms in all studies; however, patients returned to their baseline score by the end of follow-up. Compared to placebo, SOF and RBV was not associated with HRQL impairment (POSITRON). Compared to SOF and RBV, HRQL was significantly more impaired in the PegIFN and RBV arm (FISSION). For those treated with SOF and RBV, there was no difference in HRQL between 12weeks or 16weeks of treatment (FUSION). Multivariate analysis demonstrated that depression, fatigue, and insomnia were important predictors of patients’ HRQL prior, during or after treatment. Additionally, anemia and receiving interferon were predictors of HRQL impairment during treatment. Achieving sustained virologic response after 12weeks of follow-up (SVR-12) with SOF and RBV was associated with improvement in HRQL scores from baseline.

Conclusions

Treatment-related HRQL impairment during SOF and RBV regimen is mild, and does not increase with longer treatment duration. Achieving SVR-12 with SOF and RBV is associated with an improvement in HRQL.

Keywords: Quality of life, Clinical trials, Hepatitis C

Source

Simeprevir receives positive CHMP opinion for the treatment of adults with chronic hepatitis C in the European Union

Positive opinion for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.

“The recommendation is one additional step in the global strategy that our partner Janssen has for simeprevir, to offer a new and efficacious treatment option to the many hepatitis C patient groups suffering from this devastating disease” said Maris Hartmanis CEO, Medivir.

Simeprevir is a new generation, NS3/4A protease inhibitor administered as a once daily 150 mg capsule with pegylated interferon (PegIFN) and ribavirin (RBV) offering proven efficacy across a range of different HCV patient types.

The CHMP opinion was based on positive and consistent results from three pivotal phase III studies in patients with GT1 HCV; QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients (who have relapsed after previous interferon-based therapy). QUEST-1 and QUEST-2 included 785 treatment-naïve patients with chronic HCV GT1 infection. PROMISE included 393 relapsed patients with chronic HCV GT1 infection. All three studies met their primary end points and demonstrated simeprevir in combination with PegIFN/RBV achieves superior cure rates when compared with PegIFN/RBV alone, in treatment naïve and relapsed patients.

Hepatitis C in the European Union
Hepatitis C is a major health problem in the European Union, where nine million people are living with the disease. The current standard of care is not always tolerable due to significant side effects of interferon based therapy and improvements in efficacy for difficult to treat patients, such as prior null responders, represent a high medical need. Treatment of HCV is complex because of the heterogeneous population of patients it affects and that treatment efficacy is highly dependent on the genotype of the virus.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 15.45 CET on 21 March 2014.

For more information about Medivir AB, please visit the Company’s website: www.medivir.com

Source

Democratic Leaders Request Briefing by Gilead on Hepatitis C Drug Pricing

Mar 20, 2014

Today Ranking Member Henry A. Waxman, Health Subcommittee Ranking Member Frank Pallone, Jr., and Oversight and Investigations Subcommittee Ranking Member Diana DeGette sent a letter to Gilead Sciences Inc. Chief Executive Officer John C. Martin to request a briefing on pricing of the company’s recently approved Hepatitis C drug, Sovaldi. Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment, which will affect coverage for patients with public or private insurance.

FDA approved Sovaldi in December 2013 after the drug received an FDA Priority Review and Breakthrough Therapy designation, which is intended to expedite review of drugs for serious or life-threatening conditions.

The full text of the letter is available below and online here.

March 20, 2014

Dr. John C. Martin, PhD
Chief Executive Officer
Gilead Sciences Inc.
333 Lakeside Drive
Foster City, CA 94404

Dear Dr. Martin:

We are writing to request a briefing from Gilead Sciences Inc. to answer important questions about the pricing of the company's recently approved Hepatitis C drug, Sovaldi.
A breakthrough treatment for Hepatitis C could result in significant public health benefits. Approximately 3.2 million Americans have a chronic Hepatitis C infection, and the illness causes approximately 15,000 deaths in the United States annually. There is no vaccine for Hepatitis C, which causes fatal cirrhosis or liver cancer in up to 5% of affected individuals.

There is evidence that Sovaldi could be a breakthrough treatment. According to FDA, “Sovaldi was effective in treating multiple types of the hepatitis C virus. … demonstrat[ing] efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.”

Our concern is that a treatment will not cure patients if they cannot afford it. Reports indicate that Gilead intends to sell Sovaldi at $84,000 per treatment. In cases where Sovaldi is prescribed with other treatments the costs could be even higher. According to a recent Reuters report, “many doctors are requesting a $150,000 combination of Sovaldi … and Olysio.”

These costs are likely to be too high for many patients, both those with public insurance and those with private insurance. Because Hepatitis C is “concentrated in low-income, minority patients,” the affordability problems are likely to be particularly acute for state Medicaid programs and those patients served by these programs. Colorado and Pennsylvania have already announced that their Medicaid programs will be limiting use of the new drug to “only the sickest patients,” such as those already suffering from liver disease. California’s Medicaid program is still considering how and when to reimburse for the drug. The large pharmacy benefit manager Express Scripts has said it is “encouraging some doctors in its networks to delay prescribing Sovaldi.” Even in cases where public or private insurers pay for the medication, it will impose substantial costs on taxpayers and could cause premium increases for those with employer or individual coverage.

The extraordinarily high cost of your drug raises additional concerns because of the role of the federal government in speeding its approval. In April 2013, Gilead submitted a New Drug Application to the Food and Drug Administration for approval of Sovaldi for the treatment of Hepatitis C. As part of the request, Gilead filed for and received a Priority Review and Breakthrough Therapy designation, which reduces the FDA review goal date from ten to six months. This designation is awarded to medicines that meet certain criteria, including “that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” The FDA approved Sovaldi on an expedited basis on December 6, 2013.

This history raises many questions about Gilead's approach to pricing this drug and the impact the high cost may have on public health. In order to address these issues, we ask that you brief Committee staff on a number of key questions, including:

(1)        The methodology used by Gilead to establish Sovaldi's pricing.
(2)        The extent to which Gilead is providing discounts to low-income patients and to key government or private-sector purchasers of the drug.
(3)        The value to the company of the expedited review provided under the Priority Review and Breakthrough Therapy designation and how any savings provided by the expedited review factored into pricing decisions for the drug.
(4)        The public health impact of insurers’ and public health programs’ decisions not to cover Sovaldi for all patients with Hepatitis C.

We ask that you provide this briefing no later than April 3, 2014. Please contact Brian Cohen of the Committee staff at (202) 225-3641 if you have any questions.

Sincerely,

Henry A. Waxman
Ranking Member

Frank Pallone, Jr.
Ranking Member
Subcommittee on Health

Diana DeGette
Ranking Member
Subcommittee on Oversight and Investigations

March 20, 2014

Does it really matter?

by Opiferum
March 20, 2014

Story telling has always been a powerful medium for humans to express their experiences, so as to share with an audience that might be moved and enlightened by the details of a personalized series of events. Each of us has a very unique story regarding our lives spent with or without the hepatitis C virus (HCV). As well, we all have a distant memory of when we discovered being infected with the virus and how it felt to hear those impending words, “You’ve got hepatitis C.” But can you remember when it came to trying to explain it to someone else? No doubt you can, whether it was your GP, liver specialist or a loved one asking the dreaded question, “So how did you get it?” Your first thought might have been, “Does it really matter?” It still might be that you do not think it really matters, especially if you have undergone treatment and come out the other end without the need to think about these things anymore. But the way in which a person comes to be infected with hepatitis C does matter, even if someone chooses not to disclose it.

Yet discussion amongst people living with hepatitis C often focuses on the question of whether source of transmission really counts. On the other hand, much debate circulates about the level of risk associated with certain behaviors known to spread the virus. Whilst the majority of current HCV infections are a result of unsafe drug use, surprisingly, this isn’t always the topic of conversation, either. Not surprisingly, there still are many, many people living with hep C that are too scared to come forth and admit to the way in which they were infected. Some people argue that it does not matter how an individual was infected with HCV. When someone says that it doesn’t matter, it could be their way of trying to help someone feel better who might be affected by stigma because of a past or present history of drug use. After all, the hep C virus is often assumed only to affect “druggies” or “junkies”. Whilst such unacceptable language is slowly fading within the hepatitis C community, for those that remain ignorant and know nothing better, this kind of discriminating language and association still prevails.

If the way in which a person gets infected with the hepatitis C virus was simply not an issue, then awareness regarding the fact it is a blood-to-blood disease would not be a point in need of further clarification. After all, why not just say it is a disease of the liver that can lead to cancer? Simply because it is not just a disease of the liver. More specifically, it is a blood-borne virus that infects the liver and will lead to cirrhosis of the liver if left untreated. What is more, the way I was infected with hepatitis C is not necessarily the same way in which you were infected. Between you and I, there are similarities and differences that might also reflect the chronological timeline of the virus, such as when some sources of transmission were previously very risky but are not so much anymore, such blood transfusions. Today, I belong to the highest risk group, not to mention the most stigmatized and therefore marginalized: people who have a past or present history of using drugs which has led to exposure to the virus.

The way in which you or a loved one came to live with the hepatitis C virus is a very personal and sometimes sensitive subject. However, it can also be a question with an answer that can help the HCV community to build a much greater awareness, if only we can all take the time and effort to remain mindful and knowledgeable of each other’s experience. From our personal stories, we can learn from one another how to bring our attention to where it might not have been focused previously. We can create a more extensive support system as we continue to become more mindful of what it means to live with hepatitis C, because hepatitis C simply does not discriminate for the reasons we might. When a person comes forth with their story, it also allows for someone else to see and feel first-hand that it is ok not only to live with hepatitis C, but to own their own unique story, too.

Visit Opiferum on Facebook

-------------------------------------------------

Baby Boomer Hep C Screening Practical in Emergency Department

Medscape Medical News

Fran Lowry
March 20, 2014

Baby boomers account for about 75% of hepatitis C infections in the United States, but most don't know they are infected. Now, several studies have shown that the emergency department is an ideal place to screen this population.

Hepatitis C disproportionately affects nonwhites, Medicaid recipients, the uninsured, and people of lower economic status. These are populations known to use the emergency department as a primary source of medical care.

"We now have data from 2 different sites in the country that are doing hepatitis C screening of baby boomers in the emergency department," said James Galbraith, MD, from the University of Alabama at Birmingham.

"We are showing similar yields of previously unknown hepatitis C infection in 2 different demographic groups. The important thing is that such screening is very feasible," he told Medscape Medical News.

The screening of baby boomers has been done in the Alabama emergency department since September 2013. Dr. Galbraith presented preliminary findings at The Liver Meeting in 2013, as reported at the time by Medscape Medical News.

He presented additional data from his continuing experience in Alabama and new data from the Memorial Hermann–Texas Medical Center, in Houston, at the International Conference on Viral Hepatitis 2014 in New York City.

"Memorial Hermann has been screening baby boomers for hepatitis C using a little different methodology, but they have had very similar results," Dr. Galbraith said.

“The important thing is that such screening is very feasible.”

In Alabama, all emergency patients get a primary assessment by a nurse. If they were born between 1945 and 1965, they are asked if they have ever been tested for hepatitis C and, if so, what was the result.

If they do not know the answer to either question, they are informed of the Centers for Disease Control and Prevention (CDC) 2012 recommendation that all baby boomers get a 1-time screening test for hepatitis C, and that such a test will be performed during their emergency department visit unless they decline.

If they do not opt out, the electronic record automates an order for a hepatitis C screen that is performed in the emergency department lab, using the Abbott ARCHITECT anti-hepatitis C assay, which returns a result in 29 minutes.

If required, linkage to care starts 2 or 3 days later with a phone call to the patient from the linkage-to-care coordinator, Dr. Galbraith explained.

The procedure at Memorial Hermann is somewhat different.

The decision to offer hepatitis C screening is made by residents and physicians on the basis of the patient's history and physical exam. The screening tests, if done, are batched and run once a day, not while the patient is actually in the emergency department. People who test positive get a letter in the mail reporting their result and then a phone call from a nurse who provides linkage to care.

Despite these procedural differences, prevalence rates are similar at the 2 sites, Dr. Galbraith said.

Of the 1421 baby boomers screened at Memorial Hermann, 9.9% tested positive for the hepatitis C antibody. Of the 1259 screened at Alabama, 11.1% tested positive.

Black Patients at Greatest Risk

At Memorial Hermann, 61% of people testing positive were men; at Alabama, 65% were. The higher prevalence in men is the trend "we see nationally," Dr. Galbraith said.

The prevalence is also higher in black people. At Memorial Hermann, 51% of patients testing positive were black; at Alabama, 61% were. White patients accounted for 37% of patients testing positive at both emergency departments.

For baby boomers tested at Alabama, the prevalence of positive results was higher in black than in white patients (13.3% vs 8.0%).

"This definitely fits with what we know. Based on data from the CDC, black people are disproportionately affected and are accounting for a high number of individuals testing positive," he said.

Virtually all of the patients at both sites were uninsured or were covered by Medicaid. "Only 11% of antibody-positive patients at Alabama had private insurance," Dr. Galbraith reported.

High Cost of Screening

Such screening programs do come with a high cost. At Alabama, the annual cost of screening was $250,000, which could be a barrier to widespread baby boomer screening in the United States.

This study reinforces the feasibility of birth-cohort-based hepatitis C screening in the academic emergency department setting, said José Zuniga, PhD, MPH, president of the International Association of Providers of AIDS Care.

However, "it also highlights some of the obstacles, including unreimbursed costs and the need to make adjustments in the clinical practice culture to convince already busy physicians and nurses to add hepatitis C screening to their many responsibilities," Dr. Zuniga told for Medscape Medical News.

The study was funded by the Centers for Disease Control Foundation and Gilead Focus. Dr. Galbraith and Dr. Zuniga have disclosed no relevant financial relationships.

International Conference on Viral Hepatitis (ICVH) 2014: Abstract 59. Presented March 17, 2014.

Source

You're not alone: Medical conspiracies believed by many

By Andrew M. Seaman

NEW YORK Wed Mar 19, 2014 7:33am EDT

(Reuters Health) - About half of American adults believe in at least one medical conspiracy theory, according to new survey results.

Some conspiracy theories have much more traction than others, however.

For example, three times as many people believe U.S. regulators prevent people from getting natural cures as believe that a U.S. spy agency infected a large number of African Americans with the human immunodeficiency virus (HIV).

J. Eric Oliver, the study's lead author from University of Chicago, said people may believe in conspiracy theories because they're easier to understand than complex medical information.

"Science in general - medicine in particular - is complicated and cognitively challenging because you have to carry around a lot of uncertainty," Oliver said.

"To talk about epidemiology and probability theories is difficult to understand as opposed to 'if you put this substance in your body, it's going to be bad,'" he said.

For the new study, he and his colleague used data from 1,351 adults who answered an online survey between August and September 2013. The data were then weighted to represent the U.S. population.

The participants read six popular medical conspiracy theories and then indicated whether they had heard of them and whether they agreed or disagreed with them.

Like the theories about conspiracies to infect African Americans with HIV and to prevent citizens from accessing alternative medicines, the other theories on the list had mistrust of government and large organizations as themes.

They include the theory that the government knows cell phones cause cancer but does nothing about it, that genetically modified organisms are being used to shrink the world's population, that routine vaccinations cause autism and that water fluoridation is a way for companies to dump dangerous chemicals into the environment.

Some 49 percent of the survey participants agreed with at least one of the conspiracies.

In fact, in addition to the 37 percent of respondents who fully agreed that U.S. regulators are suppressing access to natural cures, less than a third were willing to say they actively disagreed with the theory.

With regard to the theory that childhood vaccines cause psychological disorders like autism and the government knows it, 69 percent had heard the idea, 20 percent agreed with it and 44 percent disagreed.

The only conspiracy theory with which more than half of the respondents disagreed was that a U.S. spy agency infected a large number of African Americans with HIV.

The survey results suggest people who believe in medical conspiracy theories may approach their own health differently, the researchers said.

For example, while 13 percent of people who did not believe in any conspiracies took herbal supplements, 35 percent of those who believed in three or more theories took supplements.

Overall, the researchers say people who believed in conspiracies were more likely to use alternative medicine and to avoid traditional medicine.

"Although it is common to disparage adherents of conspiracy theories as a delusional fringe of paranoid cranks, our data suggest that medical conspiracy theories are widely known, broadly endorsed, and highly predictive of many common health behaviors," the researchers write in JAMA Internal Medicine.

Oliver said the findings may have implications for doctors.

Instead of viewing patients who believe in conspiracy theories as crazy, he said doctors should realize those patients may be less likely to follow a prescription regimen.

"It's important to increase information about health and science to the public," he said. "I think scientific thinking is not a very intuitive way to see the world. For people who don't have a lot of education, it's relatively easy to reject the scientific way of thinking about things."

SOURCE: bit.ly/1lLueQV JAMA Internal Medicine, online March 17, 2014.

Source

Hep C incidence up among most races/ethnicities

By: RICHARD FRANKI, Family Practice News Digital Network

03/20/14

The incidence of acute hepatitis C increased 51.6% among whites from 2010 to 2011, the last year for which data are available, the Centers for Disease Control and Prevention reported.

Over a 2-year period, American Indians and Alaskan Natives had a 137% increase in acute hepatitis C virus (HCV) infections, going from 0.46 reported cases per 100,000 population in 2009 to 1.09 cases per 100,000 in 2011, according to data from the CDC’s National Notifiable Diseases Surveillance System.

These increases were accompanied by smaller rises in HCV incidence among blacks (up 27.3% from 2010 to 2011) and Hispanics (up 21.4% from 2010 to 2011). Asians and Pacific Islanders, who have the lowest rate among the major racial/ethnic groups, saw their HCV incidence drop almost 29% – from 0.07 per 100,000 to 0.05 – from 2010 to 2011, the CDC noted.

rfranki@frontlinemedcom.com

Source