ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients

Daclatasvir+sofosbuvir regimen achieves SVR12 in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 patients

ALLY-3 is the first Phase 3 study of an all-oral, ribavirin-free treatment regimen for genotype 3 HCV patients with a 12-week treatment duration

Genotype 3 is the second most common genotype worldwide and has emerged as one of the most difficult to treat

Saturday, November 8, 2014 9:00 am EST

"Both treatment naïve and treatment experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced late-breaking data from the landmark ALLY Trial investigating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients, a patient population that has emerged as one of the most difficult to treat. The results of the study, which showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients, will be presented at The Liver Meeting^® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, MA, November 7 – 11.

“Both treatment naïve and treatment experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat,” said David R. Nelson, M.D., Professor of Medicine, Molecular Genetics and Microbiology Director, UF Clinical and Translational Science Institute, and Assistant Vice President of Research for the University of Florida. “Genotype 3 is associated with a more rapid progression of disease and remains a challenge to the efficacy of even newer regimens. The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen.”

These results build upon the existing body of data on the daclatasvir and sofosbuvir combination. Data from an open-label, randomized study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated that the 24-week regimen of daclatasvir and sofosbuvir (± ribavirin) achieved SVR12 in 89% of patients with genotype 3. The ALLY study presented at The Liver Meeting investigates the regimen for 12 weeks, halving the previous treatment duration. Other ongoing ALLY studies examine diverse HCV populations across all genotypes: cirrhotic and post-liver transplant patients, as well as treatment-naïve and treatment-experienced patients who are co-infected with HIV.

“HCV is a complex disease, and the treatment community needs multiple options to address the remaining unmet medical needs,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “Daclatasvir has shown pan-genotypic activity in bench research, a factor which is becoming increasingly important as we learn more about the complexity of HCV. Further, daclatasvir’s potential to be combined with many other agents, including sofosbuvir, is significant in continuing to develop additional treatment options that may help patients of all genotypes achieve cure.”

In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.

About ALLY-3: Study Design

This Phase 3 open-label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients.

The full abstract for the presentation is available at The Liver Meeting website.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7–3.9 million chronically infected in the United States. 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 20 percent may progress to liver cancer.

About Genotype 3

Genotype 3 is estimated to affect 54.3 million people and is the second most common worldwide behind genotype 1 (83.4 million). It is now potentially the most difficult-to-treat genotype, and the more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis and a disproportionately increased risk of hepatocellular carcinoma.

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, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities.

Daklinza (daclatasvir) was recently approved in the EU for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daklinza is also approved in Japan in combination with Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.

In 2013, Bristol-Myers Squibb’s investigational all-oral DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase 3 UNITY program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. In addition to UNITY 1 and 2, both the UNITY-3 study among Japanese treatment-naïve and -experienced genotype 1 patients and UNITY-4, which studies the DCV-TRIO regimen without ribavirin in cirrhotic and non-cirrhotic patients in Korea, Russia and Taiwan, are currently ongoing. The DCV-TRIO regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

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 daclatasvir will receive regulatory approval in the United States, or if approved, that it will become a commercially successful product. 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:
Carrie Fernandez, Office: 609-419-5448
Cell: 215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com

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Achillion Reports 100% SVR12 in a Phase 2 Combination Study With ACH-3102 at the Liver Meeting 2014 (AASLD)

- Achillion Achieves 100% SVR12 in Eight-Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy Study") Including Nine of 12 Patients With Viral Loads Higher Than 6 Million IU/ml at Baseline -

- Reports Additional Preclinical Results for ACH-3422, Uridine-Analog Nucleotide NS5B Polymerase Inhibitor -

NEW HAVEN, Conn., Nov. 8, 2014 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the presentation of results from the ongoing Phase 2 study of ACH-3102 in a late breaker poster and data in three preclinical posters on ACH-3422. The poster presentations are being made at the 65^th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting 2014, which takes place through November 11, 2014 in Boston, MA.

Late Breaker Poster Presentation: Phase 2 pilot study evaluating eight week treatment of ACH-3102 in combination with sofosbuvir for genotype 1 treatment-naïve HCV

In a late breaker poster presentation, Achillion reported updated interim results from an ongoing interferon-free, ribavirin-free, Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight weeks or six weeks of ACH-3102 and sofosbuvir, a marketed nucleotide polymerase inhibitor, without ribavirin, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after the completion of therapy. Eighteen patients were enrolled, including six observational patients. Twelve patients completed eight weeks of treatment consisting of 50 mg of ACH-3102 and 400 mg of sofosbuvir administered once daily while observational patients received no drug during this phase of the trial.

Of the 12 patients treated, 100 percent (n=12/12) achieved SVR12. Of the 12 patients treated in this study, nine of 12 patients had a baseline viral load substantially greater than 6 million IU/ml at baseline. No on-treatment viral breakthrough or post-treatment viral relapse has been observed.

Preclinical poster presentations on ACH-3422

Achillion presented three posters at AASLD which reported updated preclinical results on ACH-3422. The in vitro results demonstrated that this nucleotide pro-drug has improved potency against genotype 3 HCV as compared to sofosbuvir. In addition, in a separate poster presentation, Achillion reported that ACH-3422 displays additive to synergistic activity when combined with ACH-3102 or sovaprevir, Achillion's Phase 2 NS3/4A protease inhibitor, in vitro. Furthermore, the high barrier to resistance for ACH-3422 was supported with the ability of the agent to block, in vitro, the appearance of resistant colonies in combination with other direct-acting antiviral agents.

"The antiviral activity and safety profile observed to date for ACH-3422 both in preclinical studies and in the ongoing 422-001 Phase 1 trial support further development with this nucleotide in combination with Achillion's other direct-acting antivirals, and represents an exciting treatment option for HCV," commented Professor Edward Gane, M.D., Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and Lead Investigator in the ACH-3422 Phase 1 proof-of-concept study and Phase 2 proxy study of ACH-3102 and sofosbuvir.

Reprints of the posters are available on the Company's website at www.achillion.com/resources.

About HCV

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death.

About Achillion Pharmaceuticals

Achillion is seeking to apply its expertise in biology and structure-guided design and a deep understanding of patient and clinician needs to develop innovative treatment solutions aimed at improving patients' lives. The company's scientific excellence, integrated capabilities and experienced team position it to successfully achieve its goal of advancing new products along the entire continuum from the bench to the patient. Achillion's pipeline is currently focused on small molecule therapeutics for infectious disease and complement-related diseases. www.achillion.com

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the Company's reiteration that it remains on track to initiate all-oral ribavirin-free regimens with ACH-3422, ACH-3102 and sovaprevir for the treatment of HCV in 2015; the Company's expectations that the Phase 1 study of ACH-3422 could inform the potential initiation of combination studies of ACH-3422 and ACH-3102; and the Company's expectations that it may report preliminary results from its Phase 1 program during the fall of 2014. Achillion may use words such as "expect," "anticipate," "project," "intend," "plan," "aim," "believe," "seek," " estimate," "can," "focus," "will," and "may" and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; advance the preclinical and clinical development of its drug candidates, including ACH-3422, ACH-3102 and sovaprevir, under the timelines it projects in current and future clinical trials; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2013, and its subsequent SEC filings.

In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.

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Janssen Highlights its Hepatitis C Clinical Development Program in Advance of 2014 AASLD

Janssen Highlights its Hepatitis C Clinical Development Program in Advance of 2014 American Association for the Study of Liver Diseases (AASLD) Annual Meeting

-- Studies focused on patients where there is a high unmet need today or anticipated in the near future --

BOSTON, Nov. 7, 2014 /PRNewswire/ -- Janssen R&D Ireland (Janssen) highlights its hepatitis C (HCV) clinical development program in advance of The Liver Meeting^®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held November 7-11, 2014 in Boston, Massachusetts.

Given the size, complexity and diversity of the HCV patient population, physicians will continue to need multiple treatment options and combinations in order to offer patients an opportunity for cure into the next decade.

The Janssen HCV clinical development program includes studies that investigate the use of simeprevir in several interferon-free regimens using selected combinations of direct-acting antivirals with different mechanisms of action targeting diverse patient populations. These studies are focused on potentially offering alternative and more immediate treatment options for physicians and patients where there is a high unmet need today or anticipated in the near future. Ongoing clinical studies include:

• Phase 3 OPTIMIST studies examining the safety and efficacy of simeprevir and the nucleotide analog NS5B polymerase inhibitor sofosbuvir without interferon or ribavirin for the treatment of chronic HCV infection for treatment-naïve and treatment-experienced patients with and without cirrhosis.
• Phase 2 IMPACT study evaluating the efficacy, safety and pharmacokinetics of simeprevir administered once daily in combination with sofosbuvir and the NS5A replication complex inhibitor daclatasvir in treatment-naïve and treatment-experienced patients with HCV genotype 1 and 4 infection and decompensated liver disease.

With the closing of the acquisition of Alios Biopharma, Inc. earlier today, Janssen now holds a platform of nucleotide analog polymerase inhibitors, the early-clinical stage compounds AL-335 and AL-516. 

"Janssen is committed to combating hepatitis C by exploring the potential to bring forth, in a timely manner, an in-house interferon-free combination regimen to make a difference in patients' lives," said Gaston Picchio, Ph.D., Hepatitis disease area leader, Janssen.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is a major global public health concern. Approximately 170 million people are infected with hepatitis C worldwide and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

About Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen R&D Ireland is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OLYSIO^®?

• If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO^®. It is not known if OLYSIO^® will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO^®.
  • Females must use an effective form of birth control during treatment with OLYSIO^®. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO^®.
• OLYSIO^® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO^®.
  • Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO^®.
  • Limit sunlight exposure during treatment with OLYSIO^®.
  • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO^®.
  • Call your healthcare provider right away if you get any of the following symptoms:
    • burning, redness, swelling or blisters on your skin
    • mouth sores or ulcers
    • red or inflamed eyes, like "pink eye" (conjunctivitis)

• You should not take OLYSIO^® alone. OLYSIO^® should be used together with other medicines to treat chronic hepatitis C infection.

What should I tell my healthcare provider before taking OLYSIO^®?

Before taking OLYSIO^®, tell your healthcare provider if you:

• have liver problems other than hepatitis C virus infection
• have ever taken any medicine to treat hepatitis C virus infection
• had a liver transplant
• are receiving phototherapy
• have any other medical condition
• are of East Asian descent
• are breastfeeding. It is not known if OLYSIO^® passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO^® or breastfeed. You should not do both.

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• OLYSIO^® and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO^® or other medicines in your body, which may affect the way OLYSIO^® or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

• Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone^®, Pacerone^®), amlodipine (Norvasc^®), atazanavir (Reyataz^®), atorvastatin (Lipitor^®, Caduet^®), carbamazepine (Carbatrol^®, Epitol^®, Equetro^®, Tegretol^®), cisapride (Propulsid^®, Propulsid Quicksolv^®), clarithromycin (Biaxin^®, Prevpac^®), cobicistat-containing medicine (Stribild^®), cyclosporine (Gengraf^®, Neoral^®, Sandimmune^®), darunavir (Prezista^®), delavirdine mesylate (Rescriptor^®), dexamethasone, digoxin (Lanoxin^®), diltiazem (Cardizem^®, Dilacor XR^®, Tiazac^®), disopyramide (Norpace^®), efavirenz (Sustiva^®, Atripla^®), erythromycin (E.E.S.^®, Eryc^®, Ery‑Tab^®, Erythrocin^®, Erythrocin Stearate^®), etravirine (Intelence^®), felodipine (Plendil^®), flecainide (Tambocor^®), fluconazole (Diflucan^®), fosamprenavir (Lexiva^®), indinavir (Crixivan^®), itraconazole (Sporanox^®, Onmel^®), ketoconazole (Nizoral^®), lopinavir (Kaletra^®), lovastatin (Advicor^®, Altoprev^®, Mevacor^®), mexiletine (Mexitil^®), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept^®), nevirapine (Viramune^®, Viramune XR^®), nicardipine (Cardene^®), nifedipine (Adalat CC^®, Afeditab CR^®, Procardia^®), nisoldipine (Sular^®), oxcarbazepine (Oxtellar XR^TM,Trileptal^®), phenobarbital (Luminal^®), phenytoin (Dilantin^®, Phenytek^®), pitavastatin (Livalo^®), posaconazole (Noxafil^®), pravastatin (Pravachol^®), propafenone (Rythmol SR^®), quinidine (Nuedexta^®, Duraquin^®, Quinaglute^®), rifabutin (Mycobutin^®), rifampin (Rifadin^®, Rifamate^®, Rifater^®, Rimactane^®), rifapentine (Priftin^®), ritonavir (Norvir^®), rosuvastatin (Crestor^®), saquinavir mesylate (Invirase^®), sildenafil (Revatio^®, Viagra^®), simvastatin (Zocor^®, Vytorin^®, Simcor^®), sirolimus (Rapamune^®), St. John's wort (Hypericum perforatum) or products containing St. John's wort, tadalafil (Adcirca^®, Cialis^®), telithromycin (Ketek^®), tipranavir (Aptivus^®), triazolam (Halcion^®), verapamil (Calan^®, Covera‑HS^®, Isoptin^®, Tarka^®), voriconazole (Vfend^®).
• This is not a complete list of medicines that could interact with OLYSIO^®. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
• Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of OLYSIO^®?

• The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea.

• The most common side effects in combination with sofosbuvir are tiredness, headache and nausea.

• Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO^®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

When taking OLYSIO^® in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO^® in combination with sofosbuvir, you should also read its Patient Information leaflet.

Please see full Prescribing Information and Patient Information for more details.  

MEDIA CONTACTS:

Daniel de Schryver
+49 173 76 89 149
ddschryv@its.jnj.com

Ronan Collins
+47 488 425 00
Rcollin5@its.jnj.com

INVESTOR RELATIONS:
Stan Panasewicz
+1 732 524 2524

Louise Mehrotra
+1 732 524 6491

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Largest ever genomic study of liver cancer identifies mutations that distinguish Asian and Western disease

Baylor College of Medicine News

Glenna Picton
713-798-4710
Houston, TX - Nov 7, 2014

The largest ever study of the genomes of liver tumors identified a mutation signature that contributes more to cases of the disease in Japanese males that in men of European ancestry, said an international consortium of researchers in a report online in the journal Nature Genetics.

“The novelty of this study involves associating mutation patterns with different ethnic groups,” said Dr. David Wheeler, professor in the Baylor College of Medicine Human Genome Sequencing Center and a corresponding author of the report. Researchers from the University of Tokyo, The National Cancer Center Research Institute and the National Cancer Center Hospital in Tokyo, Japan, were also colleagues on this work.

“Patients are subject to different environmental factors or they are genetically different,” said Wheeler, also a member of the NCI-designated Dan L. Duncan Cancer Center at Baylor. The profiles of the tumors were not associated with hepatitis B, hepatitis C or cirrhosis, which are known environmental factors associated with hepatocellular carcinoma (liver) cancers.

“Liver cancer occurs in males at two to five times the frequency of females,” he said.

Data from 503 liver cancer genomes derived from different populations identified 30 candidates as genes that drive the cancer and 11 cancer pathways. In addition, the collaboration of two large-scale genome projects analyzed the changes found in 608 liver cancer cases and in doing so, identified the mutational pattern associated in the disease in Japanese men, said Wheeler.

The study found more extensive mutation in the mTOR pathways than had been realized before, suggesting that drugs that inhibit that pathway might be useful. One such drug is everolimus, an anti-cancer drug used in treating kidney as well as some types of pancreatic, breast and brain cancers, might also be effective in liver cancer, said Wheeler. (The mTOR pathway is an intracellular pathway important in programmed cell death and, thus, cancer.)’

The study’s first authors include Yasushi Totoki of the Division of Cancer Genomics at the National Cancer Center Research Institute in Tokyo, Kenji Tatsuno of the Genome Science Division of the Research Center for Advanced Science and Technology at the University of Tokyo and Kyle R. Covington of the Human Genome Sequencing Center at Baylor College of Medicine. Research also took place at the National Cancer Center Hospital in Tokyo and Nihon University School of Medicine in Tokyo.

Corresponding authors include Wheeler, Dr. Hiroyuki Aburatani of the Genome Science Division, Research Center for Advanced Science and Technology, University of Tokyo and Dr. Tatsuhiro Shibata of the Division of Cancer Genomics, National Cancer Center Research Institute in Tokyo, Japan.

Funding came from Grants-in-Aid from the Ministry of Health, Labour and Welfare of Japan for the third-term Comprehensive 10-Year Strategy for Cancer Control, grants from the U.S. National Human Genome Research Institute ( 5U54HG003273) and National Cancer Institute (HHSN261201000053C), the Program for Promotion of Fundamental Studies in Health Sciences from the National Institute of Biomedical Innovation (NIBIO) and the National Cancer Center Research and Development Funds (23-A-8). The National Cancer Center Biobank is supported by the National Cancer Center Research and Development Fund, Japan. The supercomputing resource SHIROKANE was provided by the Human Genome Center at the University of Tokyo.

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New Hepatitis C Vaccine May Overcome Previous Barriers

Medscape Medical News

Lara C. Pullen, PhD

November 06, 2014

A prophylactic hepatitis C virus (HCV) vaccine produces a long-lasting, sustained T-cell response that is characteristic of the T-cell response associated with a controlled HCV infection. Researchers have evaluated the vaccine in humans, and it is now ready for phase 2 efficacy studies.

Leo Swadling, a graduate student in the Nuffield Department of Medicine at the University of Oxford in the United Kingdom, and colleagues published the results from the phase 1 trial published online November 5 in Science Translational Medicine. They described their heterologous T-cell vaccine, which combines replication-defective chimpanzee adenovirus (ChAd3) and modified vaccinia Ankara (MVA) vectors, both encoding the HCV nonstructural (NS) proteins. The vaccine is referred to as ChAd3/MVA.

T-cell immunity appears to be critical in protection against natural infection from HCV. In particular, CD4+ T cells generate the CD8+ T-cell immunity that is associated with HCV viral control in both natural infection in humans and chimpanzee challenge studies. Thus, vaccinologists anticipate that an effective HCV vaccine will generate a robust T-cell response.

The ChAd3/MVA vaccine induced a large HCV-specific T-cell response in humans. In most individuals, vaccination induced T-cell responses against all six NS antigenic pools. Vaccination also increased CD8+ T-cell polyfunctionality. The investigators found no signs that the vaccine induced regulatory T cells that might suppress an anti-HCV immune response.

Vaccinated individuals possessed antigen-experienced T cells that were on a continuum from naive to memory populations. Vaccinated individuals also generated CD8+ memory T cells. All told, the phenotype of T cells after vaccination with ChAd3/MVA resembled T-cell populations after vaccination with the highly efficacious yellow fever and smallpox vaccines.

The ChAd3/MVA vaccine appeared to be significantly better than the previously tested ChAd3/Ad6 vaccine. It elicited a higher magnitude of T-cell response immediately, as well as long term after boost immunization.

The diversity of the HCV genome represents an additional barrier to the development of protective HCV vaccine. ChAd3/MVA appears to overcome this barrier though generation of cross-reactive T-cell responses between heterologous viral genotypes.

"I am impressed by the ability of this combination of ChAd3 prime/MVA boost with the NSmut HCV sequence to recapitulate the natural human immune response to HCV infection, to sustain a strong response, and to impart some cross-reactive response to other HCV genotypes. On a public health note, development of a vaccine against HCV has traditionally been challenging and the disease burden remains significant in the US. In particular, the disease is generally asymptomatic initially but has a high probability to become chronic, leading to bad outcomes," Litjen Tan, PhD, from the Immunization Action Coalition in St. Paul, Minnesota, told Medscape Medical News.

Several authors of the study are named inventors for patent applications covering the vaccine. Dr Tan has received honoraria from Baxter, Pfizer, Novartis, Temptime Corp, TruMedSystems, and Sanofi Pasteur for service as a scientific consultant.

Sci Transl Med. Published online November 5, 2014. Abstract

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New drug for common liver disease improves liver health

For Immediate Release: Friday, November 7, 2014

An experimental drug aimed at treating a common liver disease showed promising results and potential problems in a multicenter clinical trial funded by the National Institutes of Health. The FLINT study found that people with nonalcoholic steatohepatitis (NASH) who took obeticholic acid (OCA) had improved liver health during that period, including decreased inflammation and fat in the liver and decreased body weight versus people receiving a placebo. OCA was also associated with increases in itching and total cholesterol.

“NASH is a common and potentially serious disease that currently has no approved treatment.”

—Averell Sherker, M.D.
NIDDK program official for the NASH Clinical Research Network (NASH CRN)

The findings of FLINT, or the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment Trial, were published online Nov. 6 in The Lancet. FLINT was sponsored by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases.

“NASH is a common and potentially serious disease that currently has no approved treatment. Management typically includes weight loss through diet and exercise,” said Averell Sherker, M.D., NIDDK program official for the NASH Clinical Research Network (NASH CRN), which performed the FLINT study.

Liver health improved in 45 percent of people on OCA versus 21 percent of the placebo group. “Although obeticholic acid did not eliminate liver disease in FLINT participants, it demonstrated a promising effect. Larger studies will be required to determine the drug’s safety and efficacy,” Sherker said.

FLINT enrolled 283 people at eight centers across the country. At the study’s start, participants were 18 and older and had been diagnosed with definite or borderline NASH. They were randomly assigned to one of two groups: one took 25 milligrams of OCA daily and one received a placebo that resembled the OCA pill. The study was double-blinded, so neither participants nor investigators knew which person was in which group.

Trial investigators intended for the groups to receive the drug or placebo for 72 weeks, with an additional 24 weeks of follow-up off treatment. However, planned interim analysis for safety and efficacy showed that OCA had significant beneficial effects on NASH-related liver health.

The analysis also found unanticipated increases in total cholesterol in the OCA group. They had increased LDL cholesterol (“bad” cholesterol) and decreased HDL cholesterol (“good” cholesterol) – notable because NASH patients are already at higher risk for cardiovascular diseases. As cholesterol treatment was not standardized as part of the study, further research is needed to fully understand the potential effect of OCA on cholesterol.

Because of both factors, and with the concurrence of the Data Safety and Monitoring Board, NIDDK decided to stop treatment but continue the study, move all patients into the follow-up phase, and perform no additional liver biopsies – which carry their own risks. Adverse cholesterol increases were not sustained after stopping OCA.

“The FLINT trial represents an important advance in the search for treatments of NASH. The causes of NASH are not fully understood, and causes and treatments may be different among patients,” said the study’s lead author, Brent Neuschwander-Tetri, M.D., a professor at St. Louis University. “We need to study the changes in cholesterol levels more to know if the increases caused by obeticholic acid increase the risk of hardening of the arteries. We found that the improvement in liver enzymes with obeticholic acid were not sustained after treatment was stopped, so we would expect that treatment would need to be indefinite, much like the medications for diabetes and hypertension.”

The major feature of NASH is fat in the liver, along with inflammation and damage.  Over time, these may lead to loss of liver function, the need for liver transplantation and death. NASH may have no symptoms and can only be diagnosed with a liver biopsy. Beyond maintaining a healthy weight, people with NASH are advised to avoid alcohol and unnecessary medications. New cases of NASH have grown alongside the obesity epidemic. NASH is the third leading diagnosis requiring U.S. liver transplantation.

The FLINT trial (Clinical Trials No. NCT01265498) was supported by the NIDDK, National Cancer Institute and National Center for Advancing Translational Sciences, all part of NIH. Intercept Pharmaceuticals, Inc. provided partial funding and supplies.

The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and kidney, urologic and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see http://www.niddk.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health^®

Source

Watchful waiting: role of disease progression on uncertainty and depressive symptoms in patients with chronic Hepatitis C

Journal of Viral Hepatitis

Volume 21, Issue 10, pages 727–733, October 2014

Original Article

J. P. Colagreco^1,*, D. E. Bailey², J. J. Fitzpatrick³, C. M. Musil³, N. H. Afdhal¹ and M. Lai¹

Article first published online: 7 NOV 2013

DOI: 10.1111/jvh.12207

© 2013 John Wiley & Sons Ltd

Abstract

Background and Aims: New therapies for HCV are rapidly emerging and providers are advising select patients to defer treatment and elect ‘watchful waiting’. During the watchful waiting period, patients have been shown to have high rates of illness uncertainty and depression. We sought to answer the question of whether reassuring histological data (showing minimal fibrosis or no fibrosis progression over time) is associated with less illness uncertainty and depressive symptoms.

Methods: This was a single-centre outpatient prospective cohort study to determine whether stage of fibrosis, fibrosis progression and reasons for treatment deferral were related to illness uncertainty and depressive symptoms in patients following watchful waiting.

Results: Illness uncertainty was significantly related to depressive symptoms (r = 0.49, P < 0.01). More than half of the participants (54%) had moderate levels of uncertainty. About 40% of the participants were at risk for clinical depression (21.7% at mild to moderate risk and 18.5% at high risk). Treatment naïve subjects had lower mean scores on both the CES-D (depressive symptoms measure) and the MUIS-A (illness uncertainty measure) total score, MUIS-A Ambiguity subscale and MUIS-A Inconsistency subscale than subjects who failed treatment or were interferon intolerant or ineligible. Surprisingly, liver fibrosis stage and progression were not significantly associated with overall illness uncertainty or depressive symptoms.

Conclusion: Patients with chronic hepatitis C on watchful waiting are at high risk for significant illness uncertainty and depressive symptoms. Reassuring histological data does not seem to correlate with less uncertainty or depressive symptoms.

Source

AASLD: HCV Not Main Attraction Anymore

Published: Nov 6, 2014

By Michael Smith, North American Correspondent, MedPage Today

As the therapeutic picture for hepatitis C begins to settle down, the volume of abstracts on the topic is plateauing at the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

That's not to say that new HCV therapies won't get a lot of play, according to Gary Davis, MD, president of MedLogician Consulting of Ponte Vedra Beach, Fla., and secretary of the liver association.

But, he told MedPage Today in advance of the meeting, "there's a big shift toward fatty liver disease ... that reflects what people are seeing in the clinics."

Over the past several years, direct-acting HCV medications have stolen the show, with a host of new drugs and drug combinations working through the clinical trials process.

Now, with many of those drugs approved and others in the home stretch, meeting participants will be getting mature data, he said.

For instance, the meeting will get an update on the research that underpinned the recent approval of Gilead's ledipasvir/sofosbuvir combination, trade-named Harvoni.

And, Davis said, they can look forward to seeing the data that AbbVie is using to support its multidrug combination -- dubbed 3D -- which is now under review at the FDA.

"It's going to be pretty exciting to see where that's at," he said.

Gilead famously unleashed a firestorm of debate when it priced sofosbuvir (Sovaldi) at $1 a pill and Davis said participants might take all the drug-makers to task over pricing of HCV drugs.

"I'm anxious to hear the audience questions on this, what with the whole controversy over pricing," he said.

The picture in fatty liver disease is less clear than in HCV, but the condition is increasingly prevalent and researchers are now turning their attention to it, looking at the basic mechanisms as well as drug therapy.

It's a "hot area," he said.

Among the hot topics this year:

• The role of bariatric surgery in non-alcoholic steatohepatitis.
• Prednisone and pentoxifylline in alcoholic hepatitis
• Combinations of direct-acting HCV agents post-transplant.
• A recombinant enzyme in liposomal acid lipase deficiency.

Davis also said that there is increased interest in possible curative options for hepatitis B, an area of research that has been "stuck in the mud for years." HBV is tricky to cure, because the virus integrates itself into host cells and -- rather like HIV -- therapy has aimed at suppressing the virus rather than getting rid of it.

But several new compounds in the early stages of investigation aim to change that and the "HBV people are quite excited about it," Davis said.

As well, he said, participants will get results from a major trial of terlipressin, a drug for hepatorenal syndrome that is approved in several countries but not the U.S.

An initial report from the so-called REVERSE study -- of terlipressin plus albumin versus albumin alone -- will attract considerable interest, Davis said, since improvement in renal function in patients with the syndrome is correlated with improved survival.

Source

Maintenance Opioid Agonists Protect Against HCV in Injection Drug Users

Judith I. Tsui, MD, MPH^1,2; Jennifer L. Evans, MS³; Paula J. Lum, MD, MPH⁴; Judith A. Hahn, PhD^3,4; Kimberly Page, PhD, MPH⁵

[+-] Author Affiliations

¹Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts
²Department of Medicine, Boston Medical Center, Boston, Massachusetts
³Department of Epidemiology and Biostatistics, University of California, San Francisco
⁴Department of Medicine, University of California, San Francisco
⁵Division of Epidemiology, Biostatistics and Preventive Medicine, Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque

JAMA Intern Med. Published online October 27, 2014. doi:10.1001/jamainternmed.2014.5416

Abstract

Importance Injection drug use is the primary mode of transmission for hepatitis C virus (HCV) infection. Prior studies suggest opioid agonist therapy may reduce the incidence of HCV infection among injection drug users; however, little is known about the effects of this therapy in younger users.

Objective To evaluate whether opioid agonist therapy was associated with a lower incidence of HCV infection in a cohort of young adult injection drug users.

Design, Setting, and Participants Observational cohort study conducted from January 3, 2000, through August 21, 2013, with quarterly interviews and blood sampling. We recruited young adult (younger than 30 years) injection drug users who were negative for anti-HCV antibody and/or HCV RNA.

Exposures Substance use treatment within the past 3 months, including non–opioid agonist forms of treatment, opioid agonist (methadone hydrochloride or buprenorphine hydrochloride) detoxification or maintenance therapy, or no treatment.

Main Outcomes and Measures Incident HCV infection documented with a new positive result for HCV RNA and/or HCV antibodies. Cumulative incidence rates (95% CI) of HCV infection were calculated assuming a Poisson distribution. Cox proportional hazards regression models were fit adjusting for age, sex, race, years of injection drug use, homelessness, and incarceration.

Results Baseline characteristics of the sample (n = 552) included median age of 23 (interquartile range, 20-26) years; 31.9% female; 73.1% white; 39.7% who did not graduate from high school; and 69.2% who were homeless. During the observation period of 680 person-years, 171 incident cases of HCV infection occurred (incidence rate, 25.1 [95% CI, 21.6-29.2] per 100 person-years). The rate ratio was significantly lower for participants who reported recent maintenance opioid agonist therapy (0.31 [95% CI, 0.14-0.65]; P = .001) but not for those who reported recent non–opioid agonist forms of treatment (0.63 [95% CI, 0.37-1.08]; P = .09) or opioid agonist detoxification (1.45 [95% CI, 0.80-2.69]; P = .23). After adjustment for other covariates, maintenance opioid agonist therapy was associated with lower relative hazards for acquiring HCV infection over time (adjusted hazard ratio, 0.39 [95% CI, 0.18-0.87]; P = .02).

Conclusions and Relevance In this cohort of young adult injection drug users, recent maintenance opioid agonist therapy was associated with a lower incidence of HCV infection. Maintenance treatment with methadone or buprenorphine for opioid use disorders may be an important strategy to prevent the spread of HCV infection among young injection drug users.

Source

OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection

--Expanded indication includes both treatment-naive and treatment-experienced adult patients with or without cirrhosis--

TITUSVILLE, N.J., Nov. 5, 2014 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved OLYSIO^® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

HCV is a blood-born infectious disease of the liver that affects an estimated 3.2 million people in the U.S.[1] Approximately 75 to 85 percent of people who become infected with HCV develop chronic infection.[2] Most persons with CHC infection are asymptomatic, which means they do not show symptoms of the disease.[3] When left untreated, CHC infection may cause significant liver damage, including cirrhosis, which is severe scarring of the liver. CHC may also increase the risk of developing complications from cirrhosis, which may include liver failure.[4]

Data supporting the OLYSIO^® and sofosbuvir combination regimen are from the COSMOS study, an open-label, randomized Phase 2 clinical trial that investigated the efficacy and safety of 12 or 24 weeks of OLYSIO^® (150 mg once daily) in combination with sofosbuvir (400 mg once daily) with or without ribavirin in HCV genotype 1 chronically infected treatment-naive and treatment-experienced adult patients with compensated liver disease.

"It's a very encouraging time for patients with chronic hepatitis as the advent of new direct-acting treatment combinations, like OLYSIO^® plus sofosbuvir offer all-oral, interferon- and ribavirin-free treatment options," said Eric Lawitz, M.D., primary investigator for the COSMOS clinical study, and vice president, Scientific and Research Development, The Texas Liver Institute and professor of medicine, University of Texas Health Science Center. "The availability of multiple treatment options is important to physicians and patients so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population."

"I lived with hepatitis C for nearly thirty years," said Norman Walsh, a COSMOS clinical trial patient. "I will never forget the moment that my clinical trial healthcare team told me the news following my treatment with the combination of OLYSIO^® and sofosbuvir. I was elated, relieved – and cured."*

OLYSIO^® in Combination with Sofosbuvir in HCV Adult, Genotype 1 Patients
The recommended treatment duration of OLYSIO^® with sofosbuvir is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis.

The data for this expanded indication are based on two cohorts in the COSMOS study, published in The Lancet. Cohort 1 included prior non-responder patients (patients who failed prior interferon-based therapy) with no to moderate liver fibrosis (defined as METAVIR F0 to F2 scores), and Cohort 2 included treatment-naive patients (patients who have not received other treatments previously) and prior non-responder patients to peginterferon alfa and ribavirin near cirrhosis (METAVIR F3) and with cirrhosis (METAVIR F4). METAVIR scores measure the severity or stage of liver fibrosis, from early to advanced.

In pooled analyses of both cohorts, 95 percent of patients (20/21) with METAVIR F0-F3 receiving 12 weeks of OLYSIO^® with sofosbuvir achieved sustained virologic response (SVR12) or cure, the absence of HCV detected in the blood 12 weeks after the end of treatment. Viral relapse occurred in 5 percent (1/21) and 0 percent (0/20) of patients with METAVIR F0-F3 after 12 or 24 weeks of combination therapy, respectively. Regardless of whether patients were treatment-naive or treatment-experienced, 86 percent of patients (6/7) with METAVIR F4 receiving 12 weeks of OLYSIO^® in combination with sofosbuvir achieved SVR12, while 100 percent of patients (10/10) with cirrhosis who were treated with the combination for 24 weeks achieved SVR12. Viral relapse occurred in 14 percent (1/7) and 0 percent (0/10) of patients with cirrhosis after 12 or 24 weeks of combination therapy, respectively.

For all patients in the COSMOS trial (treatment-naive and treatment-experienced, METAVIR F0-F4), 93 percent (26/28) achieved SVR12 after 12 weeks and 97 percent (30/31) achieved SVR12 after 24 weeks of treatment. Viral relapse occurred in 7 percent of patients (2/28) after 12 weeks and 0 percent of patients (0/30) after 24 weeks of treatment overall.

In the COSMOS trial, the most common (> 10 percent) adverse reactions reported during 12 weeks of treatment with OLYSIO^® in combination with sofosbuvir without ribavirin were fatigue (25 percent), headache (21 percent), nausea (21 percent), insomnia (14 percent) and pruritus (11 percent). Rash and photosensitivity were reported in 11 percent and 7 percent of patients, respectively. During 24 weeks of treatment with OLYSIO^® in combination with sofosbuvir, dizziness (16 percent), and diarrhea (16 percent) were also commonly reported.

Prior to initiation of treatment with OLYSIO^® with sofosbuvir, screening patients infected with HCV genotype 1a for the presence of virus with the NS3 Q80K polymorphism is not strongly recommended but may be considered.

Janssen is continuing its clinical development program for OLYSIO^®, including Phase 3 study commitments. For more information please visit www.clinicaltrials.gov.

"We're pleased that an interferon-free, ribavirin-free OLYSIO^®-based combination is now approved in the United States for patients with genotype 1 chronic hepatitis C infection. The availability of multiple treatment options is important to help offer an opportunity for cure and we believe OLYSIO^® will play a meaningful role in this respect," said Gaston Picchio, PhD., Hepatitis disease area leader, Janssen Research & Development, LLC. "We're passionate about finding new treatment options for patients living with hepatitis C worldwide and will continue to pursue innovative approaches to help address this disease."

Access and Support for OLYSIO^®
Janssen partners with a variety of stakeholders to support patient access and compliance to medicines. A substantial part of this effort is working closely with public and private payers to ensure that patients who need OLYSIO^® can obtain access to it.

For patients, Janssen offers OLYSIO^® Support, a comprehensive support program designed to assist in the HCV treatment journey so that they, their caregivers and their healthcare providers can help them focus on treatment. OLYSIO^® Support provides benefit verifications, assistance with the prior authorization process, and information about a variety of affordability programs, including those for patients with commercial insurance, federally-funded insurance or no insurance coverage.

Eligible patients with commercial insurance coverage for OLYSIO^® may pay only $5 per fill with the OLYSIO^® Savings Card. This is subject to a $50,000 annual maximum benefit or 12 months from the card activation date, whichever comes first. For more information about OLYSIO^® Support, visit www.OLYSIO.com or call 1-855-5-OLYSIO (1-855-565-9746), 8 a.m. - 8 p.m. (EST), Monday through Friday.

"The approval of OLYSIO^® in combination with sofosbuvir is welcome news for people living with chronic hepatitis C infection and their families," said Gloria Searson, ACSW, founder and president, Coalition on Positive Health Empowerment (COPE). "As an organization focused on serving people trying to make sense of their HCV diagnosis, we're encouraged by the work Janssen is doing to provide new treatment options and support programs to help patients navigate their journey."**

About OLYSIO^® (simeprevir)
OLYSIO^® is an HCV NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of CHC infection as a component of a combination antiviral treatment regimen.

Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. Simeprevir was approved in September 2013 in Japan, in November 2013 in Canada and the U.S., in March 2014 in Russia, and in July 2014 in Mexico and Australia. In May 2014 simeprevir was granted marketing authorization by the European Commission (EC) (indications vary by market).

For additional information about OLYSIO^®, please visit www.OLYSIO.com.

What is OLYSIO^®?

• OLYSIO^® is a prescription medicine used with other antiviral medicines to treat chronic (lasting a long time) hepatitis C infection in adults. OLYSIO^® should not be taken alone. It is not known if OLYSIO^® is safe and effective in children under 18 years of age.

Important Safety Information

What is the most important information I should know about OLYSIO^®?

• If you are pregnant, or plan to become pregnant, talk with your healthcare provider before taking OLYSIO^®. It is not known if OLYSIO^® will harm your unborn baby. Also read the Medication Guides for peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) if your healthcare provider prescribes these medications for you in combination with OLYSIO^®.
  • Females must use an effective form of birth control during treatment with OLYSIO^®. Talk with your healthcare provider about birth control methods that you may use during treatment with OLYSIO^®.

• OLYSIO^® combination treatment may cause rashes and skin reactions to sunlight. These rashes and skin reactions to sunlight can be severe and you may need to be treated in a hospital. Rashes and skin reactions to sunlight are most common during the first 4 weeks of treatment, but can happen at any time during combination treatment with OLYSIO^®.
  • Use sunscreen, and wear a hat, sunglasses, and protective clothing when you will be exposed to sunlight during treatment with OLYSIO^®.
  • Limit sunlight exposure during treatment with OLYSIO^®.
  • Avoid use of tanning beds, sunlamps, or other types of light therapy during treatment with OLYSIO^®.
  • Call your healthcare provider right away if you get any of the following symptoms:
    • burning, redness, swelling or blisters on your skin
    • mouth sores or ulcers
    • red or inflamed eyes, like "pink eye" (conjunctivitis)

• You should not take OLYSIO^® alone. OLYSIO^® should be used together with other medicines to treat chronic hepatitis C infection.

What should I tell my healthcare provider before taking OLYSIO^®?
Before taking OLYSIO^®, tell your healthcare provider if you: 

• have liver problems other than hepatitis C virus infection
• have ever taken any medicine to treat hepatitis C virus infection
• had a liver transplant
• are receiving phototherapy
• have any other medical condition
• are of East Asian descent
• are breastfeeding. It is not known if OLYSIO^® passes into your breast milk. You and your healthcare provider should decide if you will take OLYSIO^® or breastfeed. You should not do both.

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• OLYSIO^® and other medicines may affect each other. This can cause you to have too much or not enough OLYSIO^® or other medicines in your body, which may affect the way OLYSIO^® or your other medicines work, or may cause side effects. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

• Especially tell your healthcare provider if you take any of the following medicines (when taken by mouth or given by injection, where applicable): amiodarone (Cordarone^®, Pacerone^®), amlodipine (Norvasc^®), atazanavir (Reyataz^®), atorvastatin (Lipitor^®, Caduet^®), carbamazepine (Carbatrol^®, Epitol^®, Equetro^®, Tegretol^®), cisapride (Propulsid^®, Propulsid Quicksolv^®), clarithromycin (Biaxin^®, Prevpac^®), cobicistat-containing medicine (Stribild^®), cyclosporine (Gengraf^®, Neoral^®, Sandimmune^®), darunavir (Prezista^®), delavirdine mesylate (Rescriptor^®), dexamethasone, digoxin (Lanoxin^®), diltiazem (Cardizem^®, Dilacor XR^®, Tiazac^®), disopyramide (Norpace^®), efavirenz (Sustiva^®, Atripla^®), erythromycin (E.E.S.^®, Eryc^®, Ery‑Tab^®, Erythrocin^®, Erythrocin Stearate^®), etravirine (Intelence^®), felodipine (Plendil^®), flecainide (Tambocor^®), fluconazole (Diflucan^®), fosamprenavir (Lexiva^®), indinavir (Crixivan^®), itraconazole (Sporanox^®, Onmel^®), ketoconazole (Nizoral^®), lopinavir (Kaletra^®), lovastatin (Advicor^®, Altoprev^®, Mevacor^®), mexiletine (Mexitil^®), midazolam, milk thistle (Silybum marianum) or products containing milk thistle, nelfinavir (Viracept^®), nevirapine (Viramune^®, Viramune XR^®), nicardipine (Cardene^®), nifedipine (Adalat CC^®, Afeditab CR^®, Procardia^®), nisoldipine (Sular^®), oxcarbazepine (Oxtellar XR^TM,Trileptal^®), phenobarbital (Luminal^®), phenytoin (Dilantin^®, Phenytek^®), pitavastatin (Livalo^®), posaconazole (Noxafil^®), pravastatin (Pravachol^®), propafenone (Rythmol SR^®), quinidine (Nuedexta^®, Duraquin^®, Quinaglute^®), rifabutin (Mycobutin^®), rifampin (Rifadin^®, Rifamate^®, Rifater^®, Rimactane^®), rifapentine (Priftin^®), ritonavir (Norvir^®), rosuvastatin (Crestor^®), saquinavir mesylate (Invirase^®), sildenafil (Revatio^®, Viagra^®), simvastatin (Zocor^®, Vytorin^®, Simcor^®), sirolimus (Rapamune^®), St. John's wort (Hypericum perforatum) or products containing St. John's wort, tadalafil (Adcirca^®, Cialis^®), telithromycin (Ketek^®), tipranavir (Aptivus^®), triazolam (Halcion^®), verapamil (Calan^®, Covera‑HS^®, Isoptin^®, Tarka^®), voriconazole (Vfend^®).
• This is not a complete list of medicines that could interact with OLYSIO^®. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
• Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of OLYSIO^®?

• The most common side effects in combination with Peg-IFN-alfa and RBV are skin rash, itching and nausea.

• The most common side effects in combination with sofosbuvir are tiredness, headache and nausea.

• Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of OLYSIO^®. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

When taking OLYSIO^® in combination with Peg-IFN-alfa and RBV, you should also read those Medication Guides. When taking OLYSIO^® in combination with sofosbuvir, you should also read its Patient Information leaflet.

Please see full Prescribing Information and Patient Information for more details.

About Janssen Pharmaceutical Companies 
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in hepatitis C, HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Visit www.JanssenTherapeutics.com for more information and follow us on Twitter at @JanssenUS.

* Norman Walsh is a patient representative. Individual results may vary.

^**Janssen has provided funding to the Coalition on Positive Health Empowerment for educational and support initiatives benefiting hepatitis C patients and their families.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Products, LP, Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of healthcare products and services; changes to laws and regulations and domestic and foreign healthcare reforms; and general industry conditions including trends toward healthcare cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)

[1] Center for Disease Control and Prevention. "Hepatitis C FAQs for the Public." Available at: http://www.cdc.gov/hepatitis/c/cfaq.htm. Accessed October 2014.

[2] World Health Organization (WHO). "Hepatitis C." Available at: www.who.int/csr/disease/hepatitis/Hepc.pdf. Accessed October 2014.

[3] National Institute of Health, Medline Plus Dictionary. "Hepatitis C." Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000284.htm. Accessed October 2014.

[4] World Health Organization (WHO). "Hepatitis C." Available at: www.who.int/csr/disease/hepatitis/Hepc.pdf. Accessed October 2014.

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Source

GSK hepatitis C shot shows promise, bodes well for Ebola vaccines

By Kate Kelland

LONDON Thu Nov 6, 2014 12:31am IST

(Reuters) - A new hepatitis C vaccine from GlaxoSmithKline based on the same technology as an experimental Ebola shot being fast-tracked through human trials has shown promise in early clinical tests, prompting strong and broad immune responses.

Researchers testing the vaccine -- the first hepatitis C vaccine to reach second stage clinical trials -- said their results in a group of 15 healthy human volunteers showed it was very safe and well tolerated, and generated immune responses of a strength never seen before in a vaccine against this disease.

"This is as good at it could be for a first go, and I'm optimistic that it will work (in second stage trials)," said Ellie Barnes, a professor at Britain's Oxford University who led the initial human tests.

She said results also bode well for GSK's experimental Ebola vaccine currently being tested in healthy volunteers in Britain, Africa and the United States, as well as another experimental Ebola shot from Johnson & Johnson.

The vaccines are based on similar science, using a common cold virus called an adenovirus to take the key ingredient into the cells.

The idea is that the adenovirus infects cells in a vaccinated person, causing them to take up genes from the target virus - be it Ebola or hepatitis C - and produce their proteins.

This primes the immune system to attack the proteins of the pathogenic viruses when an infection occurs.

"What's special about adenovirus vaccines is that they are trying to induce a totally separate part of the immune response -- the T-cells," Barnes explained in a telephone interview. "And T-cells target the inner machinery of a pathogen."

Publishing their results in the journal Science Translational Medicine on Wednesday, Barnes' team explained that the hepatitis C vaccine uses a "prime-boost" strategy with two separate vaccine formulations.

CLEAR THE VIRUS

The first, or prime, vaccine is based on a chimpanzee adenovirus called ChAd3 developed by the Italian biotech firm Okairos -- now owned by GSK -- to which genes encoding four proteins from hepatitis C are added.

The second, or boost, vaccine adds the same four hepatitis C genes to a different viral vaccine base -- a so-called modified vaccininia Ankara (MVA) virus.

Neither the adenovirus nor MVA is able to replicate, so they cannot cause infection. The four genes packaged up inside cannot cause a hepatitis C infection either.

An estimated 180 million people worldwide are infected with hepatitis C, a chronic infection where the virus stays in the body for many years. It is a leading cause of liver cirrhosis and can in some cases lead to liver failure and liver cancer.

However, around a quarter of people infected are naturally able to clear the virus from their body. This suggests it is possible for the body to mount an immune response to fight off the infection.

"In our lab we spent a lot of time looking at the immune response of people who are able to clear the virus," Barnes said. "We know from that work that you need a strong immune response that targets multiple parts of the virus and that is sustained over time -- and those are the characteristics that we've been able to reproduce in this vaccine trial."

Leading drugmakers said last month they will work together to speed the development of an Ebola vaccine designed to help beat a vast epidemic of the disease which has killed more than 5,000 people, mainly in Guinea, Sierra Leone and Liberia.

Clinical tests on GSK's vaccine and another from NewLink Genetics are under way, while human tests on J&J's vaccine will start in January.

(Reporting by Kate Kelland; Editing by Tom Heneghan)

Source

What's Hot at the Liver Meeting 2014

Medscape Medical News > Conference News

Neil Osterweil

November 04, 2014

BOSTON — The 2014 Liver Meeting returns to Boston, home of splendors such as beans, cod, the Boston Red Sox, world-class medical centers, and pharmaceutical research hubs.

The meeting, during which the American Association for the Study of Liver Diseases (AASLD) struts it stuff each year, will be held at the John B. Hynes Veterans Memorial Convention Center from November 7 to 11.

The Hynes, sandwiched between Boylston Street — the city's liveliest thoroughfare — and the hotels, shops, and restaurants of the Prudential Center complex, has hosted many previous Liver Meetings, and is ideally located to take advantage of the wealth of science the conference provides and all of the amenities that Boston has to offer.

Nearly 3000 abstracts were submitted by clinicians and scientists for this year's event, covering the latest clinical trial results, practice-changing clinical findings, and basic research into the mechanisms and molecular targets of diseases of the liver.

"We're going to hear a lot about fatty liver disease; the number of abstracts about fatty liver disease this year just exploded, as did the number of abstracts about complications of cirrhosis," Gary Davis, MD, AASLD secretary, told Medscape Medical News.

"This reflects what people are seeing in the clinic. The buzz for hepatitis C has died down a bit, I think because the treatment is so effective now and it's so easy to administer," he said.

Cutting Edge

That the care of patients with hepatitis C would become almost routine — or indeed that such an entity as hepatitis C ever existed — would have seemed like wild fantasy 40 years ago.

But that's just what attendees can expect to hear during the President's Choice Lecture from Willis Maddrey, MD, from the University of Texas Southwestern Medical Center at Dallas.

"Dr Maddrey is always a pretty dynamic speaker," Dr Davis said.

He pointed out that Dr Maddrey has witnessed the advent of genetic research into fatty liver disease, pegylated interferons, protease inhibitors, and other discoveries in his more than 40 years in the trenches.

Of course, with the advent of effective combination therapies for hepatitis C comes the inevitable increase in costs, just as pressures for accountability and value in medical care rise.

"There will be some presentations on cost-effectiveness, but surprisingly not a lot, given all the press it has gotten over the past year, but I want to be in the room for those. I think the discussions after the abstracts are presented will be pretty good," Dr Davis said.

On a related theme, new this year will be a symposium on value-based medicine in hepatology. The session will focus on coping in the era of Accountable Care Organizations and the Affordable Care Act. Or as the Liver Meeting program describes it, "the concept of value-based medicine and the importance of returning the practice of hepatology to its appropriate focus: enabling the health and effective care of patients with liver disease."

The $1000-per-dose therapies for hepatitis C viral infections are a challenge in this era.

The Thomas E. Starzl Transplant Surgery State-of-the-Art Lecture, by Jean Edmond, MD, from New York Presbyterian Hospital and Columbia Medical Center in New York City, will focus on the controversial topic of living-donor transplantation. Dr Edmond will outline patient and donor selection and describe the most up-to-date methods of harvesting and transplantation.

The Emerging Trends Symposium, which will follow Dr Edmond's talk, will center on a topic that might be new to some conference goers: acute on chronic liver failure. The condition is defined as acute decompensation of a patient with cirrhosis and characterized by multiple organ failure. Attendees will learn about the pathophysiology of acute liver failure, clinical issues associated with the syndrome, and investigational therapies.

The Hans Popper Basic Science State-of the-Art Lecture will be devoted to induced pluripotent stem cells and their use in the study of liver disease and development. Stephen Duncan, DPhil, from the Medical College of Wisconsin in Milwaukee, is expected to describe his groundbreaking work coaxing stem cells to differentiate into hepatocytes, Dr Davis said.

Abstract Sessions and Late-Breakers

The scientific sessions kick off on Saturday, November 8, with the first of four poster sessions covering more than 2000 research projects, from basic science findings to the latest in clinical practice, drug development, and clinical trials.

Sunday will feature transplant plenary sessions, Monday basic science and clinical plenary, and Tuesday the hepatitis plenary.

Late-breaking oral abstracts will be presented on Monday afternoon, and late-breaking posters will be on view all day Monday, with presenters available from 12:30 to 3:00 pm.

This year's late-breakers will include:

• Results of the STOPAH trial comparing steroids with pentoxifylline for alcoholic hepatitis

• Phase 3 results from the UNITY-2 trial of an oral fixed-dose combination therapy for patients with chronic hepatitis C genotype 1 infections and compensated cirrhosis

• Results of the phase 3 ALLY-3 study looking at an oral ribavirin-free combination for the treatment of hepatitis C genotype 3

• A study of post-transplant direct-acting antiviral agents for hepatitis C

• Results from a phase 3 randomized controlled trial of an enzyme replacement therapy in children and adults with lysosomal acid lipase deficiency

• A report on a phase 2a proof-of-concept trial of a hepatitis B and hepatitis D entry inhibitor

Ticketed educational sessions will run the gamut, from endoscopy, transplantation, pediatric hepatology, and basic research, to practical matters such as competency training and career development.

As you can still hear in some of Boston's more traditional neighborhoods, this year's Liver Meeting promises to be "wicked good."

Dr Davis have disclosed no relevant financial relationships.

Source

Re-treatment of Chronic Hepatitis C Virus Genotype 1 Infection After Relapse: An Open-Label Pilot Study Re-treatment of Chronic HCV Genotype 1 Infection After Relapse

Original Research | 4 November 2014

Anu Osinusi, MD; Anita Kohli, MD; Miriam M. Marti, BS; Amy Nelson, RN; Xiaozhen Zhang, MS; Eric G. Meissner, MD, PhD; Rachel Silk, RN; Kerry Townsend, BA; Phillip S. Pang, MD, PhD; G. Mani Subramanian, MD, PhD; John G. McHutchison, MD; Anthony S. Fauci, MD; Henry Masur, MD; and Shyam Kottilil, MD, PhD

[+-] Article and Author Information

Ann Intern Med. 2014;161(9):634-638. doi:10.7326/M14-1211

Background: The interferon (IFN)–free regimen of sofosbuvir and ribavirin for 24 weeks was recently approved to treat chronic hepatitis C virus (HCV) genotype 1 (GT-1) infection for patients ineligible for IFN. However, sofosbuvir plus ribavirin therapy is associated with relapse in 15% to 30% of patients with HCV GT-1. Neither the mechanism of relapse nor the optimal re-treatment strategy for these patients is defined.

Objective: To assess the safety and efficacy of sofosbuvir plus ledipasvir in patients with chronic HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy.

Design: Phase 2a, open-label study. (ClinicalTrials.gov: NCT01805882)

Setting: Single U.S site.

Patients: 14 patients with HCV GT-1 that relapsed after treatment with sofosbuvir plus ribavirin for 24 weeks were re-treated with sofosbuvir plus ledipasvir for 12 weeks.

Measurements: HCV RNA concentration and population sequencing to detect NS5B S282T mutations.

Results: All 14 patients treated with sofosbuvir plus ledipasvir for 12 weeks achieved a sustained virologic response, including 7 with advanced liver disease (Knodell Histology Activity Index score of 3 or 4) and 1 with a detectable NS5B S282T mutation after sofosbuvir plus ribavirin therapy. Sofosbuvir plus ledipasvir was well-tolerated with few adverse events. Four grade 3 events (elevated serum creatinine in a patient with baseline renal insufficiency, hypercholesterolemia, and hypophosphatemia) occurred. There were no grade 4 events or treatment discontinuations.

Limitation: Small sample size.

Conclusion: The fixed-dose combination of sofosbuvir plus ledipasvir was efficacious in a small cohort of patients with HCV GT-1 that relapsed after sofosbuvir plus ribavirin therapy, even in the setting of advanced liver disease. Larger studies are needed to confirm these preliminary efficacy results.

Primary Funding Source: National Institute of Allergy and Infectious Diseases, National Institutes of Health, National Cancer Institute, and Gilead Sciences.

Source

Hepatitis C Care: Check Your Biases at the Door

Medscape Infectious Diseases

International Conference on Viral Hepatitis (ICVH) 2014

Helen-Maria Lekas, PhD, Gloria J. Searson, MSW, Alyson L. Harty, RN, BSN, William Thompson

June 23, 2014

Editor's Note: During the International Conference on Viral Hepatitis, held in New York, some of the participants in a panel discussion titled "Patient Perspectives on What Providers Need to Know About Stigma and Other Barriers to Hepatitis Care"^[1] convened afterwards for a discussion. During the conversation, they discussed the stigma surrounding hepatitis C and some of the barriers to diagnosis and treatment for patients.

Living With Hepatitis C

Helen-Maria Lekas, PhD: My name is Helen-Maria Lekas. I am from Columbia University, and I am in New York at the International Conference on Viral Hepatitis. I'm here with a panel of experts, including Gloria Searson, Alyson Harty, and William Thompson. I would like to start by asking you about stigma. As patients and experts living with hepatitis C virus (HCV) infection, what do you want your providers to know about the stigma associated with the disease?

Gloria J. Searson, MSW: Stigma is horrible. I don't want to be looked at or judged, and I don't want you to bring your biases into the room with us. I just want you to treat me as a human being and take care of the problem.

Alyson Harty, RN, BSN: I agree, from both the provider and patient perspective. When I was 17 and I found out I had HCV, I didn't want to tell any of my friends. You don't want your friends knowing that you have a virus because it's often associated with other viruses that have a broad stigma against them, and there is no need. You got it -- however you got it, you got it -- let's solve the problem.

Dr. Lekas: What can providers do to ameliorate the stigma associated with HCV?

William Thompson: One thing that I find very important is the support group that I go to. We get a lot of information from the doctor and we also get a lot of information from other patients. To me, stigma is like "sticks and stones can break my bones." It doesn't really affect me. I don't think anybody can say anything to me that would make me feel bad about my condition, especially when you have conditions yourself. It's all up to the individual in how you feel about it.

Persisting Barriers to Diagnosis and Treatment

Dr. Lekas: I'm very glad to hear that you don't internalize other people's stigmatizing attitudes. If we leave stigma aside, what are some of the other barriers that patients are encountering in getting care for HCV?

Ms. Searson: Patients don't have the same care teams available to them for HCV that they did for other diseases. One of the good things about HIV was that they had funding and manpower to help deal with teaching the patient things that the doctor may not have been able to get through to the patient, or convince the patient of the urgency of something. They even had someone there to provide the education and support so that they can buy into the fact that they had the disease. There are some systemic barriers that we have to fix in healthcare in general. It is disproportionately dispensed in different areas, in different ways, and we have to make sure that people can access the same things wherever they are geographically. That's one of the largest barriers. The treatments are good, but we can't just take them without understanding them. So, who is going to provide that education is the key.

Dr. Lekas: Do you think that patients with HCV know about the new treatments coming down the pipeline?

Ms. Harty: It varies. You have your highly educated patients who know that they have HCV and who have been following the disease and the press releases, and then you have patients who were told back in the late 1990s and early 2000s that they have this problem but nothing can be done about it. There is a wide variety, and we need re-education for those patients who were turned away from care. For example, they may have been told that because they were black or obese that the treatment wouldn't work for them. We need to relink these patients back to care, as well as screen the 80% of patients who we know haven't been tested.

Ms. Searson: The campaigning and awareness are out there for those who access social media or the Internet or who watch television, but there is a whole group of people who do not access information the way it is being disseminated. If you are not in the healthcare system or working with a substance abuse group, a senior population, or a veterans' group, you still may be out of the loop for hepatitis. We need the healthcare team around patients who get HCV to understand them as a whole -- where they are and what may or may not be necessary for this particular patient to get through treatment. The pills and the medications only address one barrier, and that's the biological barrier. They don't address the personal issues or the systemic barriers, and they certainly don't address the infrastructure and lack of healthcare providers able to deal with this disease.

Improving on the HIV Model for Hepatitis C

Dr. Lekas: Would you propose a team-based approach for hepatitis C, like that for HIV, with a provider, a medical physician, and a nurse?

Ms. Harty: We need a lot more funding for that. Personally, working in a private office, I know that we don't have the funds to hire a psychiatrist. I am the social worker, psychiatrist, and nurse -- all of the above. It takes a lot of manpower to put people through this therapy, and the providers also need more support from the states and the private insurers who don't pay for psychological therapy unless the patient has Medicaid and can access a therapist. It is very hard for privately insured people to get the psychological therapy that they need.

Dr. Lekas: Do you think the HIV model is a good one?

Ms. Harty: Definitely.

Ms. Searson: Yes, especially because this is a complicated thing to explain, and you want to have people you can trust, like we have with case managers in HIV. But here is one thing I would like to see be different from the HIV model: We did not bring the case managers along in the science, so they were not able to offer the support to patients around understanding the disease and the importance of medication, because they were left out of the education. If you create a team, then all of them have to have the necessary information. In HIV, that is where we made some missteps; we kept the science separated from the prevention and services, and there was no interaction. The patient was better known by the people who knew the least about the disease itself and the benefits of treatment. Without that knowledge, how could those who have the confidence of the patient convince the patient of the importance of being treated? That is why we have people who are still not detectable, as well as the continuing struggles of being on multiple regimens, because the patients didn't get buy-in from the people that they trust.

Mr. Thompson: At the facility that I go to, Mount Sinai, the doctors work as a team. They all discuss the patient and reach a conclusion about where they are going with the patient and what their expected results are. They are very informative. I didn't know that I had stage 4 cirrhosis or that it could be stabilized. To me, stage 4 meant I was going to continue to decline. I didn't know that the liver repairs itself, and that with the elimination of the HCV infection the liver can regroup and reverse, to a point -- it's not going to be a completely healthy liver again. But I learned all of this from the doctors and the team where I get care. How well the doctors work together depends on the facility that you go to.

Dr. Lekas: With the massive restructuring of our healthcare system, this is a good note to end on. How HCV treatment will be integrated into this restructuring is an important issue. Thank you all.

References

1. Lekas HM, Levin J, Searson G. Patient perspectives on what providers need to know about stigma and other barriers to hepatitis care; March 17-18, 2014; New York, New York. Panel 1.

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