FDA Approved Gilead's Epclusa® (Sofosbuvir/Velpatasvir) to treat Genotype 1-6

As a quick reference click the links following Gilead's press release for study results (full text) from ASTRAL 1-4 clinical trials.

Prescribing Information: EPCLUSA
News and Updates: EPCLUSA

Gilead’s New Hepatitis C Drug Approved by FDA, Priced at $74,760
Gilead has set a list price of $74,760 for a 12-week course of treatment, Chief Executive Officer John Milligan said by telephone. That’s lower than the list prices of its best-selling treatments Sovaldi, at $84,000, and Harvoni, $94,500. The Foster City, California-based company has been criticized in the past for the costs of its drugs.
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FDA Press Release

FDA Approves Epclusa for Treatment of Chronic Hepatitis C Virus Infection


First regimen to treat all six major HCV genotypes

Silver Spring, Maryland–(ENEWSPF)–June 28, 2016. The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6. According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.

The safety and efficacy of Epclusa for 12 weeks was evaluated in three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis (mild cirrhosis). Results demonstrated that 95–99 percent of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, suggesting the patients’ infections had been cured. The safety and efficacy of Epclusa was also evaluated in a clinical trial of 267 subjects with decompensated cirrhosis (moderate to severe cirrhosis), of whom 87 subjects received Epclusa in combination with ribavirin for 12 weeks, and 94 percent of these patients had no virus detected in the blood 12 weeks after finishing treatment.

The most common side effects of Epclusa include headache and fatigue. Epclusa and ribavirin combination regimens are contraindicated for patients for whom ribavirin is contraindicated.

Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral. Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.

Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: http://www.fda.gov

June 28, 2016 - 10:25 a.m.

Gilead's Press Release

U.S. Food and Drug Administration Approves Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

Date(s): 28-Jun-2016 10:25 AM

- Epclusa is the First and Only All-Oral, Pan-genotypic Single Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead's Third Sofosbuvir-Based Regimen -
  
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 28, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).
  
"The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype," said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Epclusa clinical trials. "Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens."

The FDA granted Epclusa a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over existing options.    
Epclusa's approval is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotype 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B), to receive 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa. The primary endpoint for all studies was SVR12.
  
Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks (83 percent and 86 percent, respectively).
  
Headache and fatigue were the most common adverse reactions (=10 percent) experienced by HCV-infected patients treated with Epclusa in ASTRAL-1, ASTRAL-2 and ASTRAL-3 and occurred at a similar or higher frequency in placebo-treated patients. In the 87 HCV-infected patients with decompensated cirrhosis treated with Epclusa and ribavirin in the ASTRAL-4 study, fatigue, anemia, nausea, headache, insomnia and diarrhea were the most common adverse reactions (=10 percent). Two and four patients treated with Epclusa and Epclusa with RBV respectively discontinued treatment due to adverse events.
  
"Today's approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens," said John Milligan, Ph.D., President and Chief Executive Officer of Gilead. "As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible."
  
Epclusa should not be administered with ribavirin in patients for whom ribavirin is contraindicated. See below for Important Safety Information for Epclusa.
  
U.S. Patient Support Program
To assist eligible hepatitis C patients in the United States with access to Epclusa, Gilead has added the medicine to its Support Path® (www.MySupportPath.com) program. The program consists of an integrated offering of support services for patients and providers, among them:
  • Call center staffed with associates trained to help patients and their providers with insurance-related needs.
  • Education and support, including a 24/7 nursing support service line.
  • The Epclusa Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay.
  • The Support Path Patient Assistance Program, which will provide Epclusa at no charge for eligible patients with no other insurance options.
Gilead also provides support to independent non-profit organizations that provide assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.
To learn more about Support Path for Epclusa, please visit www.MySupportPath.com or call 1-855-769-7284 between 9:00 a.m. - 8:00 p.m. Eastern, Monday through Friday.
  
Global Availability
The prevalence of HCV genotypes varies regionally throughout the world. In resource-limited settings genotype testing can often be costly or unreliable, posing yet another barrier to treatment. As a pan-genotypic therapeutic option, Epclusa eliminates the need for genotype testing and has the potential to accelerate access to treatment for patients worldwide.
Gilead is committed to helping enable access to Epclusa around the world. Gilead works with a network of regional business partners, generic licensing partners, the Medicines Patent Pool and other stakeholders to expand treatment globally. Epclusa is already licensed to Gilead's 11 Indian manufacturing partners who may now begin production and distribution of a generic version of this medicine for 101 developing countries.
  
IMPORTANT SAFETY INFORMATION
  
Contraindications
If EPCLUSA is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Sofosbuvir Is Coadministered with Amiodarone and Another HCV Direct Acting Antiviral: Amiodarone is not recommended for use with EPCLUSA due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8 or CYP3A4: Rifampin, St. John's wort, and carbamazepine are not recommended for use with EPCLUSA as they may significantly decrease sofosbuvir and/or velpatasvir plasma concentrations.

Adverse Reactions
The most common adverse reactions (=10%, all grades) with EPCLUSA were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

Drug Interactions
Coadministration of EPCLUSA is not recommended with topotecan due to increased concentrations of topotecan.
Coadministration of EPCLUSA is not recommended with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more information on potentially significant drug interactions, including clinical comments.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statement
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 factors, including risks that physicians and patients may not see advantages of Epclusa over other therapies and may therefore be reluctant to prescribe the product, and the risk that payers may be reluctant to approve or provide reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
  
U.S. Full Prescribing Information for Epclusa is available at www.gilead.com.
Epclusa is a registered trademark of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Links
Last month Healio published; ASTRAL studies: New combination yields encouraging patient-reported outcomes from patient-reported data presented at Digestive Disease Week 2016. 

HCV Advocate - The Breakdown
November 2015
The Phase 3 clinical trials—ASTRAL-1, ASTRAL-2, and ASTRAL-3. There were 1,035 of whom 116 patients received placebo (sugar pills). There were 267 people in the ASTRAL-4 trial—this trial included the patients with genotypes 1 through 6 with decompensated cirrhosis. There was not a breakdown by genotype. The breakdown is here, from HCV Advocate.

New England Journal Of Medicine
December 2015
ASTRAL 1-4 results published in the December 2015 issue of New England Journal of Medicine (NEJM) *or free online @ NATAP, and presented at EASL 2016, also from NATAP.

New England Journal Of Medicine
Full Text - Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection

New England Journal Of Medicine - Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Full Text NEJM Article @ NATAP

New England Journal Of Medicine - Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis
Full Text NEJM Article @ NATAP

In addition this article; Hepatitis C treatment studies from NEJM: Closer to One Size for All written by Donald Jensen, MD., provides a nice summary of each study.

EASL 2016 Coverage
April 2016
On-Treatment HCV RNA as a Predictor of SVR12 in Patients With Genotype 1-6 HCV Infection Treated With Sofosbuvir/Velpatasvir for 12 Weeks: An Analysis of the ASTRAL-1, ASTRAL-2, and ASTRAL-3 Studies - (04/26/16)

Resistance Analysis in 1284 Patients With Genotype 1-6 HCV Infection Treated With Sofosbuvir/Velpatasvir in the Phase 3 ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4 Studies - (04/15/16)

Drug-Drug Interaction Profile of Sofosbuvir/Velpatasvir Fixed-Dose Combination - 4/21/16

Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks Is Effective Retreatment for Patients Who Failed Prior NS5A-Containing DAA Regimens: Results of the Retreatment Study - (04/15/16)

Complete EASL coverage @ NATAP

And finally here is a sparse list of; Recruiting and upcoming hepatitis C clinical trials including sofosbuvir and velpatasvir, as well as GS-9857, in combination with sofosbuvir and velpatasvir.





Journalists: 9 tips to combat stem cell hype in your news stories

Journalists: 9 tips to combat stem cell hype in your news stories

Joy Victory is deputy managing editor of HealthNewsReview.org. She tweets as @thejoyvictory.

At this moment, only a handful of stem cell therapies have been proven safe and effective through clinical research, according to the International Society for Stem Cell Research (ISSCR).

Yet, that’s not evident from a recent Google News Search for stem cells, which pulls up 800,000+ results of varying quality, as we’ve seen in our examinations of stem cell stories on spinal cord injuries, muscular dystrophy, chronic obstructive pulmonary disease, severe combined immunodeficiency, and multiple sclerosis, among others.

This explosion of news coverage and stem cell hype is partly why, for the first time, ISSCR has added a section on communication to their guidelines for stem cell research and the development of new clinical therapies (see page 28 of the PDF).

Resources to help you avoid these pitfalls include this ISSCR patient information article, this STAT piece on the FDA’s efforts to crack down on clinics, a NEJM report on the “Wild West” of U.S. stem cell clinics, as well as this tipsheet from stem cell scientist Paul Knoepfler.





Regulus Reports Clinical Hold of RG-101

  • Monday, June 27, 2016
  • Posted by HCV New Drugs
  • File Under ,

Regulus Reports Clinical Hold of RG-101

Timelines of On-going Studies are not Expected to be Impacted
Conference Call Today at 5:00 p.m. ET
16:10 ET from Regulus Therapeutics Inc.

LA JOLLA, Calif., June 27, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced it received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on clinical hold. Regulus anticipates it will receive a formal clinical hold letter from the FDA within 30 days and plans to work diligently with the agency to seek the release of the clinical hold.

The FDA initiated the clinical hold after Regulus reported a second serious adverse event (SAE) of jaundice. The SAE occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going Phase I US study 117 days after receiving a single dose of RG-101.

Timelines for Regulus' three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits. Regulus remains on track to deliver follow-up results from these studies at upcoming relevant scientific meetings.

Conference Call Details

Regulus will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss today's announcement. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 41706266. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 41706266. The webcast and telephone replay will be archived on the company's website following the call.

About Regulus

Regulus Therapeutics Inc. (Nasdaq: RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs. Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkersSM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field. Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with AstraZeneca. Regulus is also advancing several programs toward clinical development in renal, hepatic and central nervous systems diseases, both independently and with our strategic alliance partners, Sanofi and AstraZeneca. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi. Regulus maintains its corporate headquarters in La Jolla, CA. For more information, please visit http://www.regulusrx.com.

About microRNAs

The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history. microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs. A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome. microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

About RG-101 for HCV

RG-101 is Regulus' wholly-owned, GalNAc-conjugated anti-miR targeting miR-122 for the treatment of HCV. In a completed Phase I human proof-of-concept study, Regulus demonstrated that treatment with a single subcutaneous dose of RG-101 as monotherapy resulted in significant and sustained viral load reductions in all treated HCV patients, including patients with difficult to treat genotypes, various liver fibrosis status and those who have experienced viral relapse after a prior IFN-containing regimen.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Logo - http://photos.prnewswire.com/prnh/20160519/370141LOGO

Chronic fatigue syndrome is in your gut, not your head

Chronic fatigue syndrome is in your gut, not your head

Physicians have been mystified by chronic fatigue syndrome, a condition where normal exertion leads to debilitating fatigue that isn't alleviated by rest. There are no known triggers, and diagnosis requires lengthy tests administered by an expert.

Now, for the first time, Cornell University researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.

In a study published June 23 in the journal Microbiome, the team describes how they correctly diagnosed myalgic encephalomyeletis/chronic fatigue syndrome (ME/CFS) in 83 percent of patients through stool samples and blood work, offering a noninvasive diagnosis and a step toward understanding the cause of the disease.

"Our work demonstrates that the gut bacterial microbiome in chronic fatigue syndrome patients isn't normal, perhaps leading to gastrointestinal and inflammatory symptoms in victims of the disease," said Maureen Hanson, the Liberty Hyde Bailey Professor in the Department of Molecular Biology and Genetics at Cornell and the paper's senior author. "Furthermore, our detection of a biological abnormality provides further evidence against the ridiculous concept that the disease is psychological in origin."

"In the future, we could see this technique as a complement to other noninvasive diagnoses, but if we have a better idea of what is going on with these gut microbes and patients, maybe clinicians could consider changing diets, using prebiotics such as dietary fibers or probiotics to help treat the disease," said Ludovic Giloteaux, a postdoctoral researcher and first author of the study.

In the study, Ithaca campus researchers collaborated with Dr. Susan Levine, an ME/CFS specialist in New York City, who recruited 48 people diagnosed with ME/CFS and 39 healthy controls to provide stool and blood samples.

The researchers sequenced regions of microbial DNA from the stool samples to identify different types of bacteria. Overall, the diversity of types of bacteria was greatly reduced and there were fewer bacterial species known to be anti-inflammatory in ME/CFS patients compared with healthy people, an observation also seen in people with Crohn's disease and ulcerative colitis.

At the same time, the researchers discovered specific markers of inflammation in the blood, likely due to a leaky gut from intestinal problems that allow bacteria to enter the blood, Giloteaux said.

Bacteria in the blood will trigger an immune response, which could worsen symptoms.

The researchers have no evidence to distinguish whether the altered gut microbiome is a cause or a whether it is a consequence of disease, Giloteaux added.

In the future, the research team will look for evidence of viruses and fungi in the gut, to see whether one of these or an association of these along with bacteria may be causing or contributing to the illness.

###

The study was funded by the National Institutes of Health.
http://mediarelations.cornell.edu/2016/06/27/3770/

Now that we have the hepatitis C virus on the run, can a universal cure be attained?

COMMENTARY

Hepatitis C: Let's Get 'Real'
Digestive Disease Week (DDW) 2016
Clinical trials have shown that current treatment approaches for hepatitis C are highly successful. Can this degree of success be attained in real-world populations?

William F. Balistreri, MD
June 24, 2016

Hepatitis C virus (HCV) infection remains a significant problem worldwide, with risk for progression to cirrhosis, liver failure, and hepatocellular carcinoma. The good news is that with the development and validation of a spate of new direct-acting antiviral (DAA) drugs and novel treatment strategies, a significant proportion of patients can be cured of HCV infection.

Current highly successful strategic treatment approaches have achieved high sustained virologic response (SVR) rates in clinical trials. However, the question remains: Can this degree of success be replicated in a real-world application of these strategies? And will this level of success apply to all patients? Research presented at this year's Digestive Disease Week (DDW) discussed real-world outcomes and the prospects for ensuring the best outcome for all patients with chronic hepatitis C, including certain patient populations—those with cirrhosis or decompensated liver disease and those who failed to respond to treatment—who may require enhanced strategies such as a longer duration of therapy, the addition of ribavirin, or the use of new ribavirin-free combinations. There are also new possibilities, therapeutic agents that will soon be available to add to the expanding armamentarium of DAAs and combination regimens. For example, the next-generation investigational pangenotypic once-daily combination tablet containing 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) was granted priority review designation from the US Food and Drug Administration (FDA) and is scheduled for approval this quarter. A key area of concern is the possibility of treatment failure due to the existence and emergence of resistant variants of the virus. Investigators discussed the potential impact and use of regimens that offer non-overlapping resistance profiles.

Curative treatment has clear advantages compared with the management of end-stage disease, yet treatment costs and access to treatment for HCV infection are ongoing issues, even though increased competition among pharmaceutical manufacturers may ultimately reduce the price of DAA regimens.

Some of the relevant presentations from DDW 2016 in which investigators shed light on these important issues are highlighted herein.

Continue reading commentary.....

* Free registration required
In The Journals
Access to Treatment Regimens in Chronic HCV Patients
Journal of Viral Hepatitis, June 24, 2016

The Direct-acting Antiviral Era in HCV Cirrhosis
Alimentary Pharmacology & Therapeutics, June 24, 2016

HCV Transmission Associated With a CAM Injection Therapy
Morbidity & Mortality Weekly Report, June 23, 2016

Direct Acting Antiviral Therapy After Liver Transplantation
Current Opinion in Gastroenterology, June 22, 2016

Surveillance for Liver Cancer in Hepatitis C Patients
Liver International, June 21, 2016