CLD Updates: Velpatasvir/Sofosbuvir, Serum markers for hepatocellular carcinoma and Type 2 diabetes

View recently published articles in the latest issue of Clinical Liver Disease (CLD).

Volume 8 Issue 2  Issue Publication: August 2016

CLD is the official digital educational resource from the American Association for the Study of Liver Diseases.

Category Reviews New Treatments for HCV

Velpatasvir and sofosbuvir: How will we use a new drug when the old agents work well?
The rapid development of highly efficacious and well-tolerated regimens for treatment of chronic hepatitis C virus (HCV) infection has been a remarkable advance. Direct-acting antiviral combinations are available for each of the six HCV genotypes (GTs). Because sustained virological response (SVR) rates are greater than 95% for most patient populations, it may be questioned why new regimens are under development.​
Watch a video presentation of this article

Biomarkers in Liver Disease
Serum markers for hepatocellular carcinoma
Authors Paul ClarkFirst Published: 29 August 2016
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Biomarkers of immunosuppression

Authors Tiong Yeng Lim, Michael HeneghanFirst Published: 29 August 2016
Watch a video presentation of this article
Watch the interview with the author

Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis
Statins and metformin for chemoprevention of hepatocellular carcinoma

Authors Jonggi Choi, Lewis R. RobertsFirst Published: 29 August 2016
Watch a video presentation of this article Free Article Category

Type 2 diabetes–associated hepatocellular carcinoma: A molecular profile

Authors Manon Allaire, Jean Charles NaultFirst Published: 29 August 2016
Watch a video presentation of this article
Watch the interview with the author

Begin here...

Epclusa among hepatitis drugs that are medical miracles of the 21st century

Dr. Bill Elliott: Epclusa among hepatitis drugs that are medical miracles of the 21st century

Last week the Food and Drug Administration approved a new drug to treat hepatitis C. The approval did not receive much fanfare in the lay press maybe because the new drug is similar to several other medications that are already on the market.... 

The progress on hepatitis C, however, has been nothing short of miraculous. With the approval of Epclusa along with its cousin medications Harvoni, Viekira Pak and Technivie, we are now able to cure most patients infected with hepatitis C — one of the true medical miracles of the 21st century. These drugs are expensive and need to be given by experts, but virtually anyone infected with hepatitis C is now a candidate for treatment...

Continue reading....

Gilead's Epclusa® - European Commission Grants Marketing Authorization

European Commission Grants Marketing Authorization for Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

Date(s): 8-Jul-2016 6:51 AM

- Epclusa is the First and Only All-Oral, Single Tablet Regimen for all Genotypes (1-6) of Chronic Hepatitis C Virus Infection and is Gilead's Third Sofosbuvir-Based Treatment -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 8, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use 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). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

The Marketing Authorization follows an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest. It allows for the marketing of SOF/VEL in all 28 countries of the European Union.

SOF/VEL is Gilead's third sofosbuvir-based treatment to be granted Marketing Authorization by the European Commission for the treatment of chronic HCV infection. Sofosbuvir-based regimens are recommended by global guidelines across all HCV genotypes and disease severities. Today, nearly one million patients worldwide have been prescribed a sofosbuvir-based regimen.

"Built on the foundation of sofosbuvir, SOF/VEL offers a highly effective and tolerable choice which is protease inhibitor free and ribavirin free for the majority of patients. For the first time we have a once-daily single tablet treatment option which works across all genotypes including genotype 3, which is often the least responsive to treatment," said Professor Stefan Zeuzem, Professor of Medicine and Chief of the Department of Medicine at the J.W. Goethe University Hospital, Frankfurt, Germany and an ASTRAL-1, 2 and 3 study investigator. "This approval marks a significant advance in the treatment of HCV and is an important step in our efforts to achieve elimination of the disease throughout Europe."

The authorization of SOF/VEL is supported by data from four 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 genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of SOF/VEL. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of SOF/VEL with or without RBV or 24 weeks of SOF/VEL alone. The primary endpoint for all studies was the sustained viral response rate 12 weeks after treatment (SVR12).

John Milligan, Ph.D., President and Chief Executive Officer of Gilead said, "The burden of hepatitis C across Europe is substantial and growing rapidly with approximately 15 million people chronically infected. The European approval of SOF/VEL reflects our continued focus to bring a cure to all infected patients across the region and we look forward to working with physicians, healthcare providers and governments to make it available as quickly as possible."

Of the 1,035 patients treated with SOF/VEL 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 SOF/VEL with RBV for 12 weeks achieved a higher SVR12 rate (94 percent) compared to those who received SOF/VEL for 12 weeks or 24 weeks without RBV (83 percent and 86 percent, respectively.) The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi®. The fixed-dose combination of sofosbuvir (400mg) and ledipasvir (90mg) received marketing authorization in the European Union on November 18, 2014 under the trade name Harvoni®.

Epclusa was approved by the U.S. Food and Drug Administration on June 28, 2016 for the treatment of adults with genotype 1-6 chronic HCV infection.

HCV Guidelines Update: Reflect Recent Approval of Epclusa (Sofosbuvir/Velpatasvir)

HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) with the International Antiviral Society developed a living document with ever evolving guidelines to treat HCV.

The guidelines have a complex algorithm for practitioners around the country to follow and see what's the right treatment, for the right patients, for the right about of time. The document is easy to comprehend, which benefit patients considering HCV therapy. When new HCV drugs are approved, and new real world data is established, the guidelines are updated.

What’s New and Updates/Changes
Wednesday, July 6, 2016
Download Updates, here..........

This version of the Guidance has been updated to reflect several important developments, including the recent approval of sofosbuvir/velpatasvir, together with new information regarding the use of testing for HCV resistance associated variants....

Updated recommendations reflecting this approval are provided in these sections:
Initial Treatment of HCV Infection
Retreatment of Persons in Whom Prior Therapy has Failed
Unique Patient Populations: Patients with Decompensated Cirrhosis 

Other updates reflecting recent data are provided in:
Unique Patient Populations: Patients who Develop Recurrent HCV Infection Post-Liver Transplantation
Unique Patient Populations: Patients with HIV/HCV Coinfection
Unique Patient Populations: Patients with Renal Impairment
HCV Testing and Linkage to Care

Updated recommendations regarding the monitoring of cirrhotic patients are also provided in:
Monitoring Patients Who Are Starting Hepatitis C Treatment, Are On Treatment, or Have Completed Therapy

Drug-drug interaction updates are also provided, particularly as they relate to antiretroviral agents and calcineurin inhibitors in:
Unique Patient Populations: Patients with HIV/HCV Coinfection
Unique Patient Populations: Patients who Develop Recurrent HCV Infection Post-Liver Transplantation

Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3

Medical News |
Physician's First Watch
July 6, 2016

From the Blogs:

Easier Hepatitis C Treatment
Take a look at what the NEJM Journal Watch bloggers are talking about right now:

HIV and ID Observations: Dr. Paul Sax tells us why the newly approved velpatasvir/sofosbuvir combination makes treatment of hepatitis C infection easier, especially for genotypes 2 and 3.

Velpatasvir/Sofosbuvir Makes HCV Treatment Simpler, Especially For Genotypes 2 and 3
Paul E. Sax, MD

One of the ways ID and hepatology hepatitis C experts like to show off is by discoursing on the nuances of cleverly named clinical trials, and how these impact treatment guidelines.

It usually goes something like this:

“In the EP-CILEON [I made that up] study of [insert HCV regimen here], treatment-experienced patients with genotype [insert non-genotype 1 patients here, usually genotype 3], compensated cirrhosis, and baseline viral loads greater than [some large number], the SVR [why can’t they say “cure”?] to the 12-week regimen was only [insert some number here that we could have only dreamed about in the interferon era, but well shy of the 95% mark we expect today — let’s say “82%”]. That’s why these patients need to be treated for [a longer duration than 12 weeks, a number also divisible by 4] weeks, with the addition of weight-based ribavirin [as opposed to fixed-dose ribavirin? when would we do that?].”

Fortunately, these obscure study results are then quickly incorporated into the excellent HCV guidelines, so we mortals can just look them up.
With the FDA approval last week of velpatasvir/sofosbuvir (VEL/SOF, “Epclusa”), however, bragging rights to these arcane details might now be irrelevant, kind of like knowing how to text with a flip-phone.

Continue reading.....

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.
Continue reading...

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.