HCV New Drugs: Sofosbuvir / Velpatasvir (GS-5816)

Showing posts with label Sofosbuvir / Velpatasvir (GS-5816). Show all posts

Monday, June 6, 2016

June Hep C Newsletters - Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

June Hepatitis Newsletters and Updates

It's that time of the month for our index of June Newsletters, with noteworthy updates from around the web.

Web Updates

Ele Hamburger: Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

Ele Hamburger, one of the plaintiffs’ attorneys in the recent lawsuit against the Washington Health Care Authority, the state Medicaid agency, over its Hepatitis C drug policy, sat down with State of Reform to talk about the case which is already having national implications.

June 6

We cover news in other states where similar policies of cost-based rationing for Hepatitis-C drugs are in place for Medicaid programs. Do you think it likely that other states will begin to model themselves after Washington following this decision?

Ele Hamburger: I think as a result of this case, Medicaid programs should be a taking a long hard look at whether their rationing criteria are justified under the state and federal law. When you have CMS saying it is not proper, and a federal judge saying it is inconsistent with federal Medicaid law, we hope you’re going to start to see other state programs eliminating those restrictions voluntarily.
That’s what just happened in Florida on the same day, Friday May 27. Advocates there went to Florida’s Medicaid Program and asked “do you really want this fight?” And they ended up resolving it.
In New York State, the AG [Attorney General Eric Schneiderman] started going after private insurers over rationing [of HCV medications] and got voluntary agreements from many of them to eliminate it, and then the state Medicaid program followed suit. In Pennsylvania, it has been eliminated through organizing and advocacy without litigation.

Friday, May 27, 2016

EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes

Today The European Medicines Agency (EMA) also recommended granting marketing approval for Mercks ZEPATIER™ (elbasvir and grazoprevir) to treat chronic hepatitis C virus (HCV).

European CHMP Adopts Positive Opinion for Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C

--Epclusa is Gilead’s Third Sofosbuvir-Based Treatment to Receive a CHMP Positive Opinion for the Treatment of Chronic HCV Infection--

FOSTER CITY, Calif.--(BUSINESS WIRE)--May 27, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection. The data included in the application support the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection.

The CHMP positive opinion was adopted following an accelerated review procedure, reserved for medicinal products expected to be of major public health interest. The recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The MAA for Epclusa 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 Epclusa. The ASTRAL-4 study randomized 267 patients with genotypes 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of Epclusa with or without ribavirin (RBV) or 24 weeks of Epclusa. The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (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 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 and ledipasvir received marketing authorization in the European Union on November 18, 2014, under the trade name Harvoni®.

Gilead has also submitted a regulatory application for SOF/VEL in the United States. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the Food and Drug Administration (FDA) has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Epclusa is an investigational product and its safety and efficacy has not yet been established.

About Gilead

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 the risk that the European Commission or other regulatory agencies, including the FDA, may not approve SOF/VEL for the treatment of chronic hepatitis C and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize SOF/VEL for chronic hepatitis C. 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.

Full European Summary of Product Characteristics for Sovaldi and Harvoni are available from the EMA website at www.ema.europa.eu

- See more at: http://www.gilead.com/news/press-releases/2016/5/european-chmp-adopts-positive-opinion-for-gileads-epclusa-sofosbuvirvelpatasvir-for-the-treatment-of-all-genotypes-of-chronic-hepatitis-c#sthash.sSbput3F.dpuf

Monday, May 23, 2016

The Future of Hep C Treatment

The Future of Hep C Treatment
Posted By: DDW Communications
on: May 23, 2016
In: AASLD, By Society, Explore Sessions, Watch Videos

DDW TV covered this exciting and informative State-of-the-Art Lecture which presented the very latest information on hepatitis C. We talked to the session’s speaker, Norah Terrault, MD, MPH, about a range of new therapies coming out that will help difficult to treat populations. Dr. Terrault also talks about the future – and what the discussions around hepatitis C are likely to be in 2017.

Links
DDW 2016 abstracts are available via the Online Planner
1 - Click on Abstracts
2 - Under Abstract Category click on hepatitis C

Of Interest
2016
May 24
Digestive Disease Week 2016
ASTRAL studies: New combination yields encouraging patient-reported outcomes
SAN DIEGO — Treatment with velpatasvir/sofosbuvir was associated with improvements in a number of patient self-reported quality of life measures, according to findings presented at Digestive Disease Week 2016.

May 13
THE FIVE The International Liver Congress
Alan Franciscus, Editor-in-Chief

Gilead Sciences (GILD) Presents at 2016 UBS Global Healthcare Brokers Conference - Transcript
May 23
We have a few other programs in clinical development, the first one is a combination of sofosbuvir and velpatasvir, this is a once-daily Pan-Genotypic single-tablet regimen, the NDA was filed late last year and we've a PDUFA date coming up next month, June 28th. And in the United in the -- this was by the way joined the priority of review and in the Europe we have the similar timelines....

Read the rest of this transcript for free on seekingalpha.com

*Free registration required

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857

Gilead's Press Release
Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM
– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 –

April 14
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857

The International Liver Congress 2016 Press Release
Sofosbuvir/velpatasvir and experimental compound GS-9857 shows promise in Hepatitis C infected patients whose previous treatment has failed
High sustained virologic response achieved with sofosbuvir/velpatasvir and GS-9857, even in patients unsuccessfuly treated with direct-acting antivirals

Nam aidsmap
Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857

Reported by Liz Highleyman
Sofosbuvir/velpatasvir + GS-9857 works well for treatment-experienced hepatitis C patients
A triple combination of Gilead Sciences' sofosbuvir, velpatasvir and GS-9857 demonstrated a high sustained response rate for treatment-experienced people with all hepatitis C virus (HCV) genotypes who previously were not cured with prior direct-acting antivirals (DAAs), according to two presentations yesterday at the 2016 International Liver Congress in Barcelona.Interferon-free DAA therapy has revolutionised treatment for chronic hepatitis C, but there is still room to optimise therapy for difficult-to-treat patients. Ideally such regimens will be pangenotypic, meaning they could be routinely prescribed without the need for HCV genotype testing.
Eric Lawitz of the Texas Liver Institute presented findings from studies of a three-drug regimen consisting of the HCV NS5B polymerase inhibitor sofosbuvir (Sovaldi), the pangenotypic second-generation NS5A inhibitor velpatasvir (formerly GS-5816), and the investigational pangenotypic HCV NS3/4A protease inhibitor GS-9857. Combining drugs that attack multiple steps of the HCV lifecycle improves efficacy and may enable shorter treatment.

Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 -

NATAP - Reported by Jules Levin
Resistance Analysis of Genotype 1 or 3 HCV-Infected Patients Treated With Sofosbuvir/Velpatasvir + GS-9857 for 6 or 8 Weeks

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

Drug-Drug Interaction Profile of Sofosbuvir/Velpatasvir Fixed-Dose Combination

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 -

High Efficacy of Sofosbuvir/Velpatasvir Plus GS-9857 for 12 Weeks in Treatment-Experienced Genotype 1-6 HCV-Infected Patients, Including Those Previously Treated With Direct-Acting Antivirals

Short-Duration Treatment With Sofosbuvir/Velpatasvir Plus GS-9857 in Treatment-Naïve Genotype 1-6 HCV-Infected Patients With or Without Cirrhosis

Saturday, April 16, 2016

Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM

Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies

– Studies Highlight Progress with Approved Therapies and Investigational Pangenotypic Regimens, Including Sofosbuvir/Velpatasvir (SOF/VEL) and SOF/VEL Plus GS-9857 –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 16, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from several Phase 2 and Phase 3 studies evaluating its two investigational, pangenotypic, fixed-dose combination therapies for the treatment of chronic hepatitis C virus (HCV) infection, as well as new data highlighting the potential use of Harvoni^® (ledipasvir/sofosbuvir) in adolescents aged 12 to 17. Data were presented this week at The International Liver Congress^TM 2016 in Barcelona, Spain.

“The data presented this week continue to underscore the high cure rates and safety of our sofosbuvir-based HCV therapies, and support their utility across all patient HCV genotypes and disease stages,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are pleased to have the opportunity to further characterize the pangenotypic profiles of our two new investigational fixed-dose combinations, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir plus GS-9857, and to highlight results from the first study to evaluate interferon-free HCV therapy in adolescents.”

Sofosbuvir/Velpatasvir (SOF/VEL)
Results from the open-label, Phase 3 ASTRAL-5 study (PS104), led by David L. Wyles, MD, Associate Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, California, evaluating once-daily SOF/VEL for 12 weeks among patients with HCV genotype 1-6 who are co-infected with HIV demonstrated that SOF/VEL was well-tolerated and resulted in high SVR12 rates. The SVR12 rate was 95 percent (n=99/104) overall, and 100 percent (n=19/19) and 97 percent (n=28/29) in patients with cirrhosis and prior treatment-failure, respectively. Two patients relapsed, while three patients were lost to follow up or withdrew consent. Two patients achieved SVR4 but have not yet returned for the post-treatment week 12 visit. The most common adverse events (>10 percent) were fatigue and headache.
SOF/VEL is currently being evaluated by regulatory agencies in the United States, Europe and Canada.

Sofosbuvir/Velpatasvir (SOF/VEL) Plus GS-9857
Data from three Phase 2 trials evaluating SOF/VEL plus GS-9857, a pangenotypic protease inhibitor, (Studies GS-US-367-1168 and GS-US-367-1169 and TRILOGY-3) also were selected for presentation.

Studies 1168 and 1169
Studies 1168 and 1169 evaluated 6 and 8 weeks of SOF/VEL plus GS-9857, with or without ribavirin (RBV), among treatment-naïve patients and 12 weeks of SOF/VEL plus GS-9857 among patients who failed prior treatment including those previously exposed to a direct acting antiviral (DAA) regimen. Study 1168 evaluated 197 genotype 1 patients and Study 1169 evaluated 128 genotype 2-6 patients.

•	Treatment-naïve patients: Poster SAT-138 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating SOF/VEL plus GS-9857, with or without ribavirin, in genotype 1-6, treatment-naïve patients, with and without cirrhosis. SVR12 rates were:

		SOF/VEL plus GS-9857		SOF/VEL plus GS-9857 with RBV
		6 weeks	8 weeks	8 weeks
	SVR12	79% (n=53/67)	96% (n=95/99)	81% (n=25/31)

	The most common adverse events (>10 percent) across the three study arms were headache, nausea, fatigue, diarrhea and anemia.

•	Treatment-experienced patients: Oral presentation PS008 highlighted combined safety and efficacy results from Studies 1168 and 1169 evaluating 12 weeks of SOF/VEL plus GS-9857 in genotype 1-6, treatment-experienced patients. Twenty-seven percent of patients were NS5A inhibitor-experienced, 52 percent were non-NS5A inhibitor, DAA-experienced and 21 percent failed interferon-based treatment without a DAA. Overall, the SVR12 rate was 99 percent (n=127/128). One genotype 3 patient with cirrhosis who had failed prior treatment with sofosbuvir plus pegylated interferon/ribavirin relapsed. Frequently reported adverse events (>10 percent) were headache, fatigue, diarrhea and nausea.

Studies 1168 and 1169 were led by Edward J. Gane, MD, Auckland City Hospital, Auckland, New Zealand (SAT-138); and Eric Lawitz, MD, Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas (PS008), respectively.

TRILOGY-3
A late-breaker oral presentation (PS021) featuring data from a Phase 2 trial, led by Dr. Lawitz, evaluated 12 weeks of a fixed-dose combination of SOF/VEL/GS-9857, with or without RBV, among genotype 1, DAA-experienced, HCV-infected patients, including patients with cirrhosis. One hundred percent (n=24/24) of patients receiving 12 weeks of therapy with SOF/VEL/GS-9857 and 96 percent (n=24/25) of patients receiving SOF/VEL/GS-9857 plus RBV achieved SVR12. Among the 49 patients in this trial, 41 percent had prior exposure to an NS5A inhibitor and 47 percent previously received at least two classes of DAA. The most common adverse events (>10 percent) across both treatment arms were fatigue and anemia.
Based on these data a fixed-dose combination of SOF/VEL/GS-9857 is being evaluated in four Phase 3 studies (POLARIS-1, POLARIS-2, POLARIS-3 and POLARIS-4). SOF/VEL/GS-9857 has been granted a Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.

Harvoni
Harvoni is the first single tablet HCV regimen approved in the United States for use in a broad range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients and genotype 1-infected patients with decompensated cirrhosis.
Data from an evaluation of Harvoni in genotype 1 HCV-infected adolescents aged 12 to 17 have been selected for presentation in a late breaker oral session (LB-4597). Presented by Sanjay Bansal, MD, MRCPCH, Kings College Hospital, London, United Kingdom, and led by Kathleen B. Schwarz, MD, Pediatric Liver Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, the Phase 2 study demonstrated that Harvoni is well tolerated and results in high SVR12 in this population. Of the 100 patients enrolled, 97 percent (n=97/100) achieved SVR12. The three patients who did not achieve SVR12 were lost to follow up; no patients experienced virologic failure. The most common adverse events were headache, diarrhea and fatigue. Further evaluation of Harvoni in a pediatric population of children aged 3 to 11 is ongoing.
Further information about the clinical studies described above can be found at www.clinicaltrials.gov.
Uses for Harvoni in certain HCV patient populations highlighted above are investigational and have not been determined to be safe or efficacious. SOF/VEL and SOF/VEL/GS-9857 are investigational products and have not been determined to be safe or efficacious.

Important Safety Information for Harvoni
Contraindications
If Harvoni is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions
Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni 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 of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.

Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.

Drug Interactions
In addition to rifampin and St. John’s wort, co-administration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such co-administration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Co-administration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Co-administration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni 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 the risk that Gilead may observe unfavorable results from additional clinical trials involving SOF/VEL, SOF/VEL/GS-9857 and Harvoni in certain patient populations, including adolescents aged 12 to 18. In addition, the regulatory filings for SOF/VEL and SOF/VEL/GS-9857 may not be approved by regulatory agencies, and marketing approvals, if granted, may have significant limitations on their use. 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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 Harvoni is available at www.gilead.com.

Harvoni 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.

Wednesday, March 16, 2016

HCV Next - Impact of Sustained Virologic Response in Hepatitis C Therapy

HCV NEXT March Issue

"HCV Next" offers information on a range of topics which include new HCV combination therapies, side effects, drug/drug interaction, guidelines, practice management issues, to name a few.

The following articles appeared in the March print edition of HCV NEXT, provided online at Healio.

Table of Contents
5 Questions
A Conversation with Adrian J. Dunlop, PhD, MBBS

Cover Story
Narrowing the Gap: Cause for Optimism for Racial Minorities with HCV in the US

Editorial
Medicare Physician Payment: Prepare to ‘MACRA-Mize’ Your Practice

In the Journals
Few Infants Born to Mothers with HCV in Philadelphia Undergo Testing

Simeprevir/Sofosbuvir Yield High SVR Post-Liver Transplant

Faldaprevir Yields High SVR in Relapsers with HCV Genotype 1

Special Series
Global View Series: Sub-Saharan Africa

The Big Picture
Impact of Sustained Virologic Response in Hepatitis C Therapy

Stevan A. Gonzalez, MD, MS
Trend Watch
FDA Grants Priority Review of Supplemental NDA for Viekira Pak

FDA Approves Expanded Label of Daclatasvir for Additional HCV Patients

Sofosbuvir/Velpastasvir Receives Priority Review for All HCV Genotypes

Wednesday, February 10, 2016

Feb 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials

Feb 2016 Update

The HCV clinical trials in this post are not a complete list; to learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.

Follow the links provided below for current research on both Gileads Sofosbuvir/Velpatasvir and Abbvies ABT-493/ABT-530 investigational hepatitis C regimens;

Gileads Sofosbuvir/Velpatasvir

Gileads Sofosbuvir/Velpatasvir to treat HCV Genotype 1-6 was recently granted FDA Grants Priority Review, read more here, on the blog here. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

Feb 11
Hepatitis C treatment studies from NEJM: Closer to One Size for All
The December 31, 2015 issue of the New England Journal of Medicine (NEJM) published three back-to-back-to-back articles on the results of clinical trials of sofosbuvir and velpatasvir in different hepatitis C populations. These three articles, published in the most prestigious medical journal, will likely form the basis of new HCV recommendations in the near future.

Abbvies ABT-493/ABT-530

Read the press release for Abbvies six global Phase 3 studies for evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus regimen, ABT-493,and ABT-530, in patients with HCV genotypes 1-6 (GT1-6), here. To read additional updates posted on the blog click here.

FDA APPROVED ZEPATIER
Mercks ZEPATIER (Elbasvir (MK-8742) and Grazoprevir (MK-5172) was FDA approved on Jan 28 of this year, here is the Press Release, blog updates here.

For a quick reference guide of drugs under development please visit: HCV Advocate Hepatitis C Treatments in Current Clinical Development – Detailed Reference Guide.

FDA approved Hepatitis C Treatments, click here.

Upcoming and Recruiting Hepatitis C Clinical Trials

The following trials are headed up under Sponsor and in no particular order.

_________________________________________________________

Sponsor: Gilead Sciences

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

‎Friday, ‎January ‎29, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: SOF/VEL
Sponsor: Gilead Sciences
Not yet recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02671500

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, San Francisco, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana , Louisiana, Maryland, , Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin
Australia, New South Wales, Canada, France, Germany, New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
‎Monday, ‎November ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02607800

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, Colorado, Washington, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee Texas, Utah, Virginia, Washington, Wisconsin
Australia, , Canada, France,Germany, New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
‎Monday, ‎November ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF/VEL/GS-9857; Drug: Placebo
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02607735

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, Colorado, District of Columbia, Florida. Georgia. Illinois, Indiana, Louisiana, Maryland. Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington
Australia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom,

Safety and Efficacy of SOF/VEL/GS-9857 FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02639247

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, Colorado, District of Columbia,Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Massachusetts,Michigan, Missouri New Jersey, New York, North Carolina, Pennsylvania,Rhode Island, Tennessee, Texas, Utah, Virginia, Washington
Australia, Canada, France, Germany New Zealand, Puerto Rico,United Kingdom
Safety and Efficacy of SOF/VEL/GS-9857 FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/VEL/GS-9857; Drug: SOF/VEL
Sponsor: Gilead Sciences
Some Locations Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02639338

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, District of Columbia, Florida, Georgia, Indiana, Maryland, Massachusetts, Missouri, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia
Australia, Belgium, Germany, Italy, New Zealand, Russian Federation, United Kingdom

Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
‎Tuesday, ‎June ‎24, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF (oral tablets); Drug: RBV; Drug: SOF (oral granules)
Sponsor: Gilead Sciences
Recruiting - verified February 2016
ClinicalTrials.gov Identifier:NCT02175758

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, Alabama, Arizona, California, Colorado, District of Columbia, Florida
Georgia, Indiana, Kentucky, Maryland, Massachusetts, Missouri, Nebraska, New York,North Carolina, Ohio, Pennsylvania, Tennessee Texas, Washington, West Virginia
Australia, New Zealand, United Kingdom

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin in Adolescents and Children With Chronic HCV-Infection
‎Tuesday, ‎September ‎23, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: Placebo to match LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:
NCT02249182

_________________________________________________________

Sponsor: AbbVie

Locations: United States, California, Florida, New Mexico, New York, North Carolina, Rhode Island

Washington

Belgium, Canada. Germany, South Africa
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
‎Monday, ‎December ‎28, ‎2015, ‏‎12:00:00 PM
Conditions: Hepatitis C Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Some Locations Recruiting - verified January 2016

ClinicalTrials.gov Identifier:NCT02642432

_________________________________________________________

Sponsor: AbbVie

Locations: United States, California, Florida, Georgia, Louisiana, Maryland, New Jersey,Texas, Washington
Belgium, France, Italy, Korea, Lithuania, Portugal, Taiwan

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection (ENDURANCE-2)

Condition: Chronic Hepatitis C Virus (HCV) Infection
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02640482

_________________________________________________________

Sponsor: AbbVie

Locations: United States, Alabama, California, Colorado, Florida, Louisiana, Louisiana

Minnesota, ,New York, North Carolina, Oregon, Rhode Island, Texas
Australia, Canada, France, New Zealand, Russian, Sweden, Switzerland, United Kingdom

A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (ENDURANCE-3)
‎Tuesday, ‎December ‎22, ‎2015, ‏‎12:00:00 PM

Conditions: Chronic Hepatitis C; Hepatitis C Virus; Genotype 3 Hepatitis C Virus
Interventions: Drug: ABT-493/ABT-530; Drug: sofosbuvir; Drug: daclatasvir; Drug: daclatasvir
Sponsor: AbbVie
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02640157

_________________________________________________________

Sponsor: AbbVie

Locations: Belgium, Canada, France, Italy, Portugal, South Africa, Spain, United Kingdom
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4) (ENDURANCE-4)
‎Wednesday, ‎December ‎16, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified February 2016

ClinicalTrials.gov Identifier: NCT02636595

_________________________________________________________

Sponsor: AbbVie

Locations: United States, California, Florida, Illinois, Indiana, Maryland, Michigan, New Jersey

North Carolina, Tennessee, Wisconsin

Australia, Austria, Belgium, Canada, Chile, France, Germany, Hungary, Israel, Italy

Korea, Lithuania, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Sweden, Switzerland,Taiwan, United Kingdom

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
‎Wednesday, ‎November ‎11, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus; HCV
Intervention: Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02604017

_________________________________________________________

Sponsor: AbbVie

Locations: Russian

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
‎Thursday, ‎January ‎28, ‎2016, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Genotype 1
Intervention: Drug: ABBVIE REGIMEN ± RBV
Sponsor: AbbVie
Not yet recruiting - verified January 2016
_________________________________________________________

Sponsor: Bristol-Myers Squibb
A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
‎Thursday, ‎January ‎28, ‎2016, ‏‎12:00:00 PM

Condition: Hepatitis C
Interventions: Drug: DCV; Drug: SOF; Drug: RBV
Sponsor: Bristol-Myers Squibb
Not yet recruiting - verified February 2016
Please refer to this study by its ClinicalTrials.gov identifier: NCT02673489
Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
_________________________________________________________

Sponsor: Merck
Locations: United States, Florida
A Study of the Pharmacokinetics of MK-3682 and MK-8408 in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
‎Monday, ‎January ‎25, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C, Chronic
Interventions: Drug: MK-3682; Drug: MK-8408
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02666352

_________________________________________________________

Sponsor: FixHepC

Locations: Australia, Tasmania
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
‎Thursday, ‎January ‎14, ‎2016, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Sofosbuvir+Ledipasvir; Drug: Sofosbuvir+Daclatasvir
Sponsor: FixHepC
Enrolling by invitation - verified January 2016

Sponsor: AbbVie

Locations: Poland
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C
‎Monday, ‎December ‎21, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsors: AbbVie; IST GmbH, Germany
Recruiting - verified January 2016

_________________________________________________________

Sponsor: AbbVie

Locations: Germany

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
‎Tuesday, ‎November ‎24, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified February 2016
_________________________________________________________

Sponsor: AbbVie
Locations: France
The Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
‎Tuesday, ‎November ‎24, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified February 2016
_________________________________________________________

Sponsor: Gilead Sciences
Locations: Taiwan
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection
‎Monday, ‎November ‎23, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: LDV/SOF
Sponsor: Gilead Sciences
Recruiting - verified February 2016
_________________________________________________________

Sponsor: Merck
Locations: United States, California, Colorado, Florida, Georgia, Indiana, Louisiana, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, North Carolina, Pennsylvania , Texas,Washington
France, Germany, Spain, Sweden
Efficacy and Safety of MK-3682B (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)
‎Friday, ‎November ‎20, ‎2015, ‏‎12:00:00 PM
Conditions: Hepatitis; Hepatitis C; Digestive System Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Liver Diseases; RNA Virus Infections; Virus Diseases
Interventions: Drug: MK- 3682B; Drug: Ribavirin
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02613403
_________________________________________________________

Sponsor: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, California, Illinois, Missouri, New York, Texas
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
‎Thursday, ‎November ‎12, ‎2015, ‏‎12:00:00 PM
Conditions: HIV-1 Infection; Hepatitis C
Interventions: Drug: Ledipasvir/sofosbuvir; Drug: Ribavirin
Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02605304

_________________________________________________________

Sponsor: Merck

Locations: United Kingdom

Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection
‎Monday, ‎November ‎09, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: Elbasvir; Drug: Ribavirin; Drug: Sofosbuvir
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02601573

_________________________________________________________

Sponsor: Erasmus Medical Center
Locations: Belgium, Netherlands

Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
‎Thursday, ‎November ‎05, ‎2015, ‏‎12:00:00 PM
Conditions: Acute Hepatitis C; Human Immunodeficiency Virus; Hepatitis C
Intervention: Drug: Grazoprevir/Elbasvir 100mg/50mg
Sponsor: Erasmus Medical Center
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02600325

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, Florida, Louisiana, Maryland, Minnesota, Missouri
New Jersey, North Carolina, Texas
Canada

Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
‎Thursday, ‎November ‎05, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02600351

_________________________________________________________

Sponsor: Gilead Sciences

Locations: India
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
‎Thursday, ‎October ‎29, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention: Drug: SOF
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02592057

_________________________________________________________

Sponsor: University of Colorado, Denver
Locations: United States, Colorado

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir
‎Monday, ‎October ‎26, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C and HIV Coinfection
Intervention: Other: Blood draws for tenofovir PK, renal function
Sponsor: University of Colorado, Denver
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02588287

_________________________________________________________

Sponsor: Ottawa Hospital Research Institute

Collaborators: Gilead Sciences, CIHR Canadian HIV Trials Network

HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection
‎Wednesday, ‎October ‎21, ‎2015, ‏‎12:00:00 PM
Conditions: Human Immunodeficiency Virus; Hepatitis C, Chronic
Interventions: Drug: E/C/F/TAF;; Drug: Ledipasvir-Sofosbuvir
Sponsors: Ottawa Hospital Research Institute; Gilead Sciences; CIHR Canadian HIV Trials Network
Not yet recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02660905

Contact: Curtis Cooper, MD, FRCPC 613-737-8899 ext 78924 ccooper@ohri.ca

_________________________________________________________

Sponsor: AbbVie

Locations: Austria
Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Austria (REAL)
‎Tuesday, ‎October ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Ireland
The Effectiveness of ABT-450/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
‎Tuesday, ‎October ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Canada - Many Locations
Effectiveness of Paritaprevir/r - Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsors: AbbVie; IST GmbH, Germany; Cato Research
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02581189
Contact: Nabil Ackad, MD 514-832-7439 nabil.ackad@abbvie.com
Contact: Catherine Pinsonnault, BS 514-832-7015 catherine.pinsonnault@abbvie.com

_________________________________________________________

Sponsor: AbbVie

Locations: Japan
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Intervention:
Sponsor: AbbVie
Not yet recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: Belgium
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, +/- Dasabuvir, +/- Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
‎Monday, ‎October ‎19, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C, Genotype 1 or 4
Intervention:
Sponsors: AbbVie; IST GmbH, Germany
Recruiting - verified February 2016
_________________________________________________________

Sponsor: Alios Biopharma Inc.
Locations: New Zealand
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir
‎Thursday, ‎October ‎01, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Interventions: Drug: AL-335; Drug: ACH-3102; Drug: Simeprevir
Sponsor: Alios Biopharma Inc.
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02569710

_________________________________________________________

Sponsor: Gilead Sciences

Locations: Japan

Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
‎Monday, ‎September ‎28, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: SOF; Drug: REB
Sponsors: Gilead Sciences; Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
_________________________________________________________

Sponsor: Gilead Sciences
Locations Japan
Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
‎Friday, ‎August ‎28, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF; Drug: COPE
Sponsors: Gilead Sciences; Chugai Pharmaceutical
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Locations: United States, Canada , Spain
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma
‎Monday, ‎July ‎20, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02504099

_________________________________________________________

Sponsor: AbbVie

Locations: United States, New York, France

Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
‎Thursday, ‎July ‎02, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02493855

_________________________________________________________

Sponsor: AbbVie

Locations: Australia, New Zealand, Spain, United Kingdom

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
‎Monday, ‎June ‎29, ‎2015, ‏‎12:00:00 PM
Conditions: HCV; Genotype 1a; Genotype 4; Chronic Kidney Disease; Hepatitis C; pegIFN; IFN
Interventions: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02487199

_________________________________________________________

Sponsor: Gilead Sciences
Locations: Egypt
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
‎Saturday, ‎June ‎27, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Interventions: Drug: LDV/SOF; Drug: RBV
Sponsor: Gilead Sciences
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02487030

_________________________________________________________

Sponsor: AbbVie

Locations: United States, Massachusetts

Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
‎Wednesday, ‎June ‎17, ‎2015, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
Interventions: Drug: ombitasvir/ABT-450/ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02476617

_________________________________________________________

Sponsor: AbbVie

Locations: United States, California, Colorado, Florida, Indiana, Louisiana, Massachusetts
New York, North Carolina, Ohio, Pennsylvania, Texas, Washington

Canada

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
‎Wednesday, ‎June ‎17, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ombitasvir; Drug: paritaprevir; Drug: ritonavir; Drug: dasabuvir; Drug: ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02486406

_________________________________________________________

Sponsor: University Health Network, Toronto

Locations: Canada, Ontario

Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT)
‎Friday, ‎June ‎05, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Viral Infection
Intervention: Drug: Sofosbuvir (SOF) and Ledipasvir (LDV)
Sponsor: University Health Network, Toronto
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02478229

_________________________________________________________

Sponsor: Janssen

Locations: Belgium

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
‎Wednesday, ‎April ‎15, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C, Chronic
Interventions: Drug: Simeprevir (SMV); Drug: Ledipasvir (LDV); Drug: Sofosbuvir (SOF)
Sponsor: Janssen Sciences Ireland UC
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02421211

_________________________________________________________

Sponsor: AbbVie

Locations: United States, Alabama, California, Colorado, Florida, North Carolina, Rhode Island Tennessee, Texas, Utah, Washington

A Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Sofosbuvir and RBV in DAA Treatment-experienced Adults With Chronic Hepatitis C Virus Infection
‎Monday, ‎February ‎02, ‎2015, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: Ombitasvir/ABT-450/r; Drug: Dasabuvir; Drug: Sofosbuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02356562

_________________________________________________________

Sponsor: Gilead Sciences

Locations: United States, California, Illinois, Louisiana, Michigan, New York, Texas

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
‎Monday, ‎January ‎26, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C Virus Infection
Intervention: Drug: LDV/SOF
Sponsor: Gilead Sciences
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02350569

_________________________________________________________

Sponsor: Merck

Locations: United States, California, Colorado, Florida, Georgia, Illinois, Michigan, New Jersey, New York, North Carolina, Oklahoma, Texas, Virginia, Wisconsin

Canada, Denmark, France, Germany, Israel, Italy, New Zealand
Efficacy and Safety of Grazoprevir (MK-5172) and MK-3682 With Elbasvir (MK-8742) or MK-8408 for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3 Infection (MK-3682-012)
‎Tuesday, ‎January ‎06, ‎2015, ‏‎12:00:00 PM

Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: MK-3682; Drug: Elbasvir; Drug: MK-8408; Drug: MK-3682B; Drug: RBV
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier:NCT02332720

_________________________________________________________

Sponsor: Merck

Locations: United States, California,Coronado,United States, District of Columbia, Florida,Georgia,
Maryland,New Jersey,New Mexico,New York,North Carolina,Oklahoma,Pennsylvania,
Texas,Virginia
Austria, France, Italy, Lithuania, Poland, Puerto Rico, United Kingdom

Efficacy and Safety of Grazoprevir (MK-5172) and MK-3682 With Elbasvir (MK-8742) or MK-8408 for Chronic Hepatitis C Genotype (GT) 1 and GT2 Infection (MK-3682-011)
‎Tuesday, ‎January ‎06, ‎2015, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir; Drug: MK-3682; Drug: Elbasvir; Drug: MK-8408; Drug: MK-3682B; Drug: Ribavirin
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02332707

_________________________________________________________

Sponsor: AbbVie

Locations: Australia, Canada, New Zealand, United Kingdom
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With and Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
‎Thursday, ‎November ‎13, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Virus Infection
Interventions: Drug: Ombitasvir/ABT-450/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02292719

_________________________________________________________

Sponsor: Merck

Locations: Vietnam

Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
‎Thursday, ‎September ‎25, ‎2014, ‏‎12:00:00 PM
Condition: Hepatitis C
Interventions: Drug: Grazoprevir/Elbasvir; Drug: Placebo
Sponsor: Merck Sharp & Dohme Corp.
Recruiting - verified February 2016
ClinicalTrials.gov Identifier: NCT02251990

_________________________________________________________

Sponsor: Bristol-Myers Squibb
Locations: Japan

Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C ‎Wednesday, ‎September ‎24, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C
Intervention:
Sponsor: Bristol-Myers Squibb
Recruiting - verified January 2016

Sponsor: AbbVie
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection

‎Thursday, ‎September ‎04, ‎2014, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus
Interventions: Drug: ABT-493; Drug: ABT-530; Drug: Ribavirin (RBV); Drug: ABT-493/ABT-530
Sponsor: AbbVie
Recruiting - verified February 2016
_________________________________________________________

Sponsor: AbbVie
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
‎Friday, ‎August ‎15, ‎2014, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: AbbVie
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
‎Thursday, ‎July ‎31, ‎2014, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
Interventions: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir; Drug: Ribavirin
Sponsor: AbbVie
Recruiting - verified January 2016
_________________________________________________________

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Locations: United States, Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New JerseyNew Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Washington
Puerto Rico
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
‎Thursday, ‎July ‎17, ‎2014, ‏‎12:00:00 PM
Condition: HIV Infections
Interventions: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier:NCT02194998

_________________________________________________________

Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)

Locations: United States, California, Colorado, Georgia, Illinois, Maryland, Massachusetts, Missouri, New York, North Carolina, Pennsylvania, Rhode Island, Texas

Puerto Rico

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection
‎Tuesday, ‎April ‎29, ‎2014, ‏‎12:00:00 PM
Conditions: HIV-1 Infection; Hepatitis
Interventions: Drug: Ribavirin; Drug: Sofosbuvir; Drug: Ledipasvir/Sofosbuvir
Sponsors: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting - verified January 2016
ClinicalTrials.gov Identifier: NCT02128217

_________________________________________________________

Sponsors: Centre hospitalier de l'Université de Montréal (CHUM); Canadian Institutes of Health Research (CIHR); Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Locations: Canada
Noninvasive Staging of Liver Fibrosis: MR vs Ultrasound
‎Monday, ‎January ‎20, ‎2014, ‏‎12:00:00 PM
Conditions: Hepatitis C; Hepatitis B; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
Intervention: Device: Transient elastography, acoustic radiation force impulse, magnetic resonance elastography
Sponsors: Centre hospitalier de l'Université de Montréal (CHUM); Canadian Institutes of Health Research (CIHR); Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Recruiting - verified January 2016

ClinicalTrials.gov Identifier: NCT02044523

Contacts
Contact: An Tang, MD, MSc 514-890-8000 ext 36400 an.tang@umontreal.ca
Contact: Assia Belblidia 514-890-8000 ext 34369 assia.belblidia.chum@ssss.gouv.qc.ca

Contact hcvnewdrugs@gmail.com

Helpful Links
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Liver Transplants
Fatty Liver Disease
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Possible Side Effects Of HCV Therapy
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HCV Newsletters
Premier Hepatitis C Websites

The above links offer data about interferon-free regimens approved to treat HCV, with learning activities, editorials, and tips from patient bloggers who understand the ups and downs of liver disease, in addition to a list of outstanding hepatitis C websites, blogs and support forums.

On Twitter
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading articles about the treatment and management of hepatitis C.

The controversy over expensive new drugs for hepatitis C
Link to research and news articles addressing the high cost of hepatitis C drugs; insurance restrictions - private insurers/Medicaid - and availability of generic versions/India, Egypt and other lower-income countries or through online "buyers clubs"

Latest Update Feb 12, 2019

Lancet Study:

Direct-acting antivirals reduce risk of premature mortality and liver cancer for people with chronic hepatitis C

These findings firmly counter those of a Cochrane review of direct-acting antiviral treatment trials that could neither confirm nor reject if direct-acting antivirals had an effect on long-term HCV-related morbidity and mortality. They also provide the best evidence to date to support guidance documents that recommend direct-acting antiviral treatment for all patients with chronic HCV infection.

The Controversy
Rebuttal over Cochrane Review of DAAs
A systematic review published by the Cochrane Collaboration suggested achieving SVR (cure) for patients using hepatitis C direct-acting antivirals (DAAs) doesn't correlate with any long term benefits. View each rebuttal and all ongoing media coverage.

Risk Of Developing Liver Cancer After HCV Treatment

Monday, June 6, 2016

June Hep C Newsletters - Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

Friday, May 27, 2016

EU regulators recommend approving Gilead's Epclusa® (Sofosbuvir/Velpatasvir) for All HCV Genotypes

Monday, May 23, 2016

The Future of Hep C Treatment

Saturday, April 16, 2016

Gilead's Sofosbuvir/Velpatasvir and SOF/VEL Plus GS-9857 at The International Liver CongressTM

Wednesday, March 16, 2016

HCV Next - Impact of Sustained Virologic Response in Hepatitis C Therapy

Wednesday, February 10, 2016

Feb 2016 Update: Upcoming and Recruiting Hepatitis C Clinical Trials