Update AbbVie's Glecaprevir/Pibrentasvir (G/P) Acheive High SVR12 Rates at 8 Wks Genotypes 1-6

Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C

Nov 11, 2016

- 97.5 percent of chronic HCV infected patients without cirrhosis and new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P
- Across the 8-week arms of three registrational studies, no patients discontinued treatment due to adverse events
- G/P is an investigational, pan-genotypic, once-daily, ribavirin-free regimen for the treatment of chronic HCV

NORTH CHICAGO, Ill., Nov. 11, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12 rates with 8 weeks of treatment with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) across all major chronic hepatitis C virus (HCV) genotypes. In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711).

These data are the first to be released from registrational studies in AbbVie's G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.

"The results we announced today bring us closer to providing a potential pan-genotypic, once-daily treatment option with 8 weeks of therapy for people living without cirrhosis and who are new to treatment," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "With our registrational program nearing completion, we're on track to submit our next generation, pan-genotypic regimen to regulatory authorities by the end of this year in the U.S. and early 2017 in the European Union and Japan."

These new top-line data comprise results from the 8-week arms of three registrational clinical trials evaluating the efficacy and safety of G/P – the ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) studies. Across the 8-week arms of all three studies, there were no discontinuations due to adverse events (AEs). The most common AEs, occurring at a rate greater than 10 percent across these arms were headache and fatigue; and there were no AEs in any study arm at a rate greater than 20 percent. No clinically relevant laboratory abnormalities, including ALT changes, were observed.

"Most patients living with HCV today have never been treated and have earlier stages of liver disease, which have not yet progressed to cirrhosis," said Stefan Zeuzem, M.D., study author and chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "Therefore, these initial data highlighting the SVR rates achieved in these HCV patients to date, with 8 weeks of treatment with the G/P regimen, are particularly promising."

Overview of preliminary results across the three studies:

Study Name	Patient Population	Treatment Duration	Treatment Regimen	SVR12 Rate
ENDURANCE-1	GT1 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN) , and patients co-infected with HIV-1	8 week	G/P	99% (n=348/351)
ENDURANCE-3	GT3 without cirrhosis, new to treatment	8 week	G/P	95% (n=149/157)
SURVEYOR-2 (Part 4)	GT2, 4, 5, 6 without cirrhosis, new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF)	8 week	G/P	97% (n=196/203)

G/P is an investigational, pan-genotypic regimen currently being evaluated in a registrational clinical development program, and its safety and efficacy have not been established. Additional data from the ENDURANCE-1 and SURVEYOR-2 (Part 4) studies will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About the ENDURANCE and SURVEYOR Studies
ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) are open-label, multicenter registrational studies evaluating the safety and efficacy of G/P across all major chronic HCV genotypes (GT1-6). The primary efficacy endpoint for all studies is SVR12.

ENDURANCE-1 is a randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT1 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN), including patients co-infected with HIV-1.

ENDURANCE-3 is a partially randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT3 chronic HCV infection without cirrhosis and new to treatment. The study has an additional active comparator arm of 12 weeks of sofosbuvir + daclatasvir (SOF+DCV). Additional data from study arms will be presented at an upcoming scientific congress.

SURVEYOR-2 (Part 4) is a single-arm study evaluating an 8 week treatment duration of G/P in patients with GT2, 4-6 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF).

About AbbVie's HCV Clinical Development Program
AbbVie's Glecaprevir/Pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.

G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

GLE was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

AbbVie's HCV Regimen glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) Receives FDA Breakthrough Therapy Designation

AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation
Sep 30, 2016

- Breakthrough Therapy Designation granted based on Phase 2 clinical data for genotype 1 (GT1) patients who failed previous therapy with direct-acting antivirals (DAAs)
- Currently in Phase 3 clinical trials, glecaprevir/pibrentasvir (G/P) is an investigational, pan-genotypic regimen being evaluated for the treatment of chronic hepatitis C virus (HCV) genotypes 1-6
- Breakthrough Therapy Designation is granted to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence that may demonstrate substantial improvement over existing therapies

NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.

The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.1

"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."

AbbVie will present new Phase 3 data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

About AbbVie's Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and clinical care of people with chronic HCV infection by investigating a pan-genotypic (genotypes 1-6) regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). G/P is currently in Phase 3 of clinical development.

AbbVie's investigational regimen includes glecaprevir (GLE), an NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor dosed once daily as three oral tablets.

GLE was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies.
http://www.fda.gov
Accessed September 1, 2016.

Investigative Combo ABT-493 plus ABT-530 - Succeeds Against Multiple HCV Genotypes

Novel Drug Combo Succeeds Against Multiple HCV Genotypes
by Ed Susman
Contributing Writer, MedPage Today

No cases of virologic failure observed with ABT-493 plus ABT-530

SAN DIEGO -- An investigative combination of two drugs helped patients infected with hepatitis C virus (HCV) across genotypes 1, 2, 3.4, 5 and 6 achieve sustained virologic responses, researchers reported here.

No cases of virologic failure were observed in the 8-week courses of ABT-493 plus ABT-530 in non-cirrhotic patients infected with genotypes 1, 2 and 3, and no virologic failures were observed among patients with genotypes 4, 5 and 6 who were treated in a 12-week course, according to Tarek Hassanein, MD, of the Southern California GI and Liver Centers/UC San Diego Health System, David Wyles, MD, of the University of California San Diego, and colleagues.

In multiple presentations at the annual Digestive Disease Week (DDW), they described preliminary studies using the pangenotypic agents against the 6 different genotypes of HCV.

The only patients across the studies who failed to achieve a sustained virologic response at 12 weeks (SVR12) -- the standard defined as a function cure of the disease -- were three individuals who failed to complete their regimens. All of them, however, had no quantitative level of circulating virus at the time they left the study, the researchers reported.

During a DDW press conference, Kimberly Brown, MD, of Henry Ford Hospital in Detroit, noted that ABT-493 plus ABT-450 were "able to achieve very similar outcomes with the 8-week regimen as compared with 12 weeks of therapy. And in a third study, they were able to treat more difficult genotypes 4, 5 and 6 with their 12-week therapy with excellent outcomes."

The studies "highlight the advances in safety and tolerability as well as the cure rates for these therapies," she said.

ABT-493 is a pangenotypic NS3/4A protease inhibitor which was paired with ABT-530, a pangenotypic NS5a inhibitor. The regimens did not contain either ribavirin or interferon, which up to 5 years ago were considered mainstays of HCV treatment, but have taken a bit of a backseat to more effective, better tolerated treatments.

For genotypes 1 and 2, the researchers enrolled non-cirrhotic treatment-naïve patients or pegylated interferon/ribavirin treatment-experienced non-responders who received once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotype 3, the researchers enrolled treatment-naïve patients without cirrhosis and treated them with a once-daily ABT-493 dose of 300 mg plus ABT-530 at a dose of 120 mg for 8 weeks.

For genotypes 4, 5 and 6, the researchers enrolled treatment-naïve or pegylated interferon/ribavirin treatment-experienced patients who were treated with once-daily ABT-493 at a dose of 300 mg plus ABT-530 at a dose of 120 mg for 12 weeks.

Hassanein reported that in 34 patients diagnosed with genotype 1, 33 patients achieved an SVR12 after 8 weeks of treated with the investigative agents. In the modified intention-to-treat protocol, 33 of 33 patients achieved SVR12.

Also, in 54 patients diagnosed with genotype 2, 53 patients achieved an SVR12 after 8 weeks of treatment with the once-daily regimen, and in the modified intention-to-treat protocol, all achieved SVR12.

Wyles reported that in 29 patients diagnosed with genotype 3, 28 patients achieved an SVR12 after 8 weeks of treatment, and in the modified intention-to-treat protocol, all patients achieved SVR12.

In 11 patients diagnosed with genotype 4, all patients achieved an SVR12 after a 12-week treatment regimen, Hassanein stated.

One patient diagnosed with genotype 5 achieved an SVR12 after the 12-week regimen, and in 22 patients diagnosed with genotype 6, all achieved an SVR12 after the 12-week regimen, he said.

"Based on these findings, and those in patients with hepatitis C virus genotype 1, 2 and 3 infection, phase III studies are evaluating ABT-493 and ABT-530 in patient with and without cirrhosis across all 6 major hepatitis C virus genotypes, including 8-week duration treatments," Hassanein said.

Wyles and Hassanein reported few adverse events in the patients, with none discontinuing the trials due to adverse drug reactions. One patient left the study because he found blood draws intolerable. One patient was removed from the study due to advanced adenocarcinoma, not related to the drugs, Hassanein said. One person was lost to follow-up after 6 weeks of treatment.

"Over the past 10 years, we have made huge strides in the area of hepatitis C, a disease which really impacts...3.5 million people in this country," Brown stated. "With this research, there is greater understanding of the genome and several proteins in the virus and that has led to several developments, which now means we have the opportunity to cure more than 95% of these patients."

"In particular, researchers have been looking at direct-acting agents, which target specific proteins within the virus, disrupting viral replication," she added. "With these advances, investigators are now looking to see if we can shorten therapies. We have gone from treatment periods that have lasted nearly a year for patients with fairly significant side effects to...the majority of treatment paradigms [lasting] 12 weeks with very minimal side effects."

The studies were supported and funded by AbbVie. The company participated in the interpretation of data, review, and approval of the content.

Hassanein disclosed relevant relationships with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb (BMS), Eisai, Gilead Sciences, Ikaria, Janssen, La Jolla Pharmaceuticals, Merck, Mochida, NGM BioPharmaceuticals, Obalon, Roche, Ocera, Sundise, Salix, Taigen, Takeda, Tobria, Vertex, Vital Therapies, and Baxter.

Wyles disclosed relevant relationships with AbbVie, BMS, Gilead, Merck, Tacere Therapeutics, and Janssen.
Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Primary Source
Digestive Disease WeekSource Reference: Poordad F, et al "High SVR rates with the combination of ABT-493 + ABT-530 for 8 weeks in non-cirrhotic patients with HCV genotype 1 or 2 infection" DDW 2016; Abstract 752.

Secondary Source
Digestive Disease WeekSource Reference: Gane E, et al "SURVEYOR-1: 100% Svr12 and favorable safety of Abt-493 + Abt-530 administered for 12 weeks in non-cirrhotic patients with genotypes 4, 5, or 6 infection (Surveyor-I)" DDW 2016; Abstract 755.

Additional Source
Digestive Disease WeekSource Reference: Muir A, et al "High SVR Rates with ABT-493 + ABT-530 co-administered for 8 weeks in non-cirrhotic patients with HCV genotype 3 infection" DDW 2016; Abstract 753.

ABT-493 and ABT-530 gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

Related: View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

AbbVie Press Release
AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress
- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

Today At The International Liver Congress™

Phase 2 data show treatment efficacy in 'difficult-to-cure' hepatitis C patients

Investigational oral combination hepatitis C (HCV) treatment gets 1 step closer to offering HCV genotype 3 patients an effective therapeutic option

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: A Hepatitis C (HCV) drug currently under investigation, ABT-493 and ABT-530, which is an all-oral once-daily antiviral treatment, helped HCV genotype 3 patients with heavily scarred livers and no previous treatment history to achieve a 100% sustained virologic response after receiving the treatment for 12 weeks (SVR12).

Additional data from this study, also presented at The International Liver CongressTM today in Barcelona, Spain, show that 97% of patients with the same HCV genotype, but without scarred livers, achieved SVR12 after eight weeks on the same treatment without ribavirin (RBV).

As treatments for HCV have evolved, genotype 3 patients have become the most difficult subgroup of patients to cure.1 Although there have been recent advances in direct-acting antiviral therapies for HCV genotype 1, genotype 3 remains a challenge and is a highly prevalent strain of the infection globally, with a particularly high concentration of cases in Asia.1

The current standard of care for HCV genotype 3 is the nucleotide polymerase inhibitor sofosbuvir with weight-based RBV for 24 weeks. This recommendation comes from the Valence study where high SVR rates were seen in those who had no previous HCV treatment history, without or with scarring of the liver, known as cirrhosis (93% and 92%, respectively). However, treatment-experienced genotype 3 cirrhotic patients experienced a lower SVR rate of 60%.2

"We are pleased to see the efficacy of this two direct-acting antiviral investigational, pan-genotypic regimen has been validated for treatment-naïve Hepatitis C genotype 3 patients - with 100% of cirrhotic patients treated for 12 weeks and 97% of non-cirrhotic patients treated for eight weeks achieving sustained virologic response at 12 weeks post treatment," said Dr Paul Kwo from Indiana University School of Medicine, Indianapolis, US and one of the lead study authors. "Clinical trials are ongoing to evaluate the safety and efficacy of the investigational treatment, and we are now focusing on a larger cohort of HCV genotype 3 patients, including treatment-experienced patients."

In the international Phase 2 clinical trial, two study arms enrolled 24 cirrhotic patients each, none who had previously been treated for HCV infection. In the two patient groups taking the investigational combination treatment ABT-493 and ABT-530 with and without once-daily RBV, all achieved SVR12 after 12 weeks on treatment. No patient discontinued the study or experienced virologic failure.

In another trial treatment arm that focused on non-cirrhotic patients, 29 genotype 3-infected patients were enrolled. SVR12 was achieved by 97% (28/29) of patients with no patient experiencing virologic failure. The most common side effects were the same across both studies, including headache, and fatigue.

"These data mark another step forward in continued research efforts to address the unmet medical need among HCV patients," said Professor Frank Tacke, EASL Governing Board member. "We will be watching with close interest to see whether similar efficacy levels can be achieved for treatment-experienced genotype 3 HCV patients - a group known for being hard to cure."

###

About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ takes place from April 13 - 17, 2016, at the Fira Barcelona Gran Via, Barcelona, Spain.

About EASL

Since EASL's foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European Association with international influence, with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

Contact

For more information, please contact the ILC Press Office at:

Email: ILCpressoffice@ruderfinn.co.uk
Telephone: +44 (0)7841 009 252

Onsite location reference

Late-breaker session, Hall 6.0
Saturday 16 April, 16:00 - 18:00
Presenter: Paul Kwo, United States
Abstract: LB01, 100% SVR4 with ABT-493 and ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis

Viral hepatitis C (2), Hall 6.0
Saturday 16 April, 11:30 - 13:30
Presenter: Andrew Muir, United States
Abstract: PS098, High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection

Author disclosures of interest

Paul Kwo - Advisory board: Abbott, Abbvie, BMS, Gilead, Merck, Janssen. Grant support: Abbvie, BMS, Gilead, Janssen, Merck

Andrew Muir - Research grants: AbbVie, Achilion, BMS, Gilead, GSK, Hologic, Intercept, Janssen, Merck, NGM Biopharm, Roche. Educational activities: Salix. Consulting services: AbbVie, Achilion, BMS, Gilead, Inovio Pharmaceuticals, Intercept, Janssen, Lumena, Merck, Portola Pharmaceuticals, Regulus Therapeutics, Salix, Shire Pharmaceuticals, Theravance.

References

1 US National Library of MedicineNational Institutes of Health. Review article: HCV genotype 3 - the new treatment challenge. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24612116. Last accessed: March 2016.
2 The Hepatitis C Trust. Genotype 3: One of the Remaining Challenges for Hepatitis C. Available from: http://www.hepctrust.org.uk/news/may-2015/genotype-3-one-remaining-challenges-hepatitis-c. Last accessed: March 2016.

Generic direct-acting antivirals for hepatitis C virus infection Presented at International Liver Congress

Low-cost generic direct-acting antiviral treatment for hep C is equivalent to branded formulations

New data indicate that generics are a feasible alternative to support access to direct-acting antiviral treatment for hepatitis C sufferers

European Association for the Study of the Liver

April 16, 2016, Barcelona, Spain: Data presented today demonstrates that generic direct-acting antivirals (DAAs) are as effective and safe as branded treatments to cure Hepatitis C.

The summary results presented today at The International Liver Congress™ 2016 in Barcelona, Spain, showed high sustained virologic response (SVR) after treatment with generic sofosbuvir, ledipasvir, daclatasvir and ribavirin, confirming clinical efficacy equivalent to outcomes seen in Phase 3 clinical trials of branded combination treatments.

The high costs of branded DAAs prevent access to treatment in many countries.1 Generic DAAs are being mass-produced and are available for less than 1% of the retail price of their branded counterparts. Medication costing $94,000 per person in the US can currently be obtained for less than $1,000 as a generic, and a 12 week course of treatment could be produced for as little as $200 in the future.1

"Our interim data suggests a potential solution for Hepatitis C patients in areas where treatment access has been restricted as a result of the high prices demanded for branded treatment," said Dr James Freeman, of GP2U Telehealth, Hobart, Australia and lead author of the study. "At the price level of generic direct-acting antivirals, treating the entire global Hepatitis C epidemic could be financially feasible. Furthermore, if a patient is cured of Hepatitis C, there is evidence for improved survival, and lower risks of liver cancer and liver cirrhosis and cured patients could return to work, delivering further economic benefits to society."

In this study, people with HCV legally imported low-cost generic treatment to cure their infection. The study included people treated in Australia, USA, UK, Canada, Europe, SE Asia and Africa.

Generic DAAs were first evaluated for quality in Australia, using high precision liquid chromatography, nuclear magnetic resonance and mass spectroscopy. Patients were assessed pre-treatment, during treatment, and then at weeks 4 (SVR4) and 12 (SVR12) following the end of treatment. The objective of the analysis was to assess the efficacy and safety of generic DAAs legally imported for each patient's personal use.

The interim results show that for genotype 1 the overall SVR rate was 95%. Treatment with generic sofosbuvir and ledipsavir led to SVR4 rates of 93% and treatment with generic sofosbuvir and daclatasvir led to SVR4 rates of 97%.

"Across all genotypes, the SVR rate was 94% after treatment with generic DAAs. This indicates that generic DAAs can deliver the same success rates as branded equivalents, but at a price which is 1/100th of the current cost," explained Dr James Freeman.

"There is a clear role for generic treatments such as these for people with Hepatitis C across the world. The implications of increased availability of these drugs could be enormous, presenting more people with the possibility of a 'cure' for what is often a debilitating condition," said Professor Laurent Castera, EASL Secretary General.

Low-cost generic hepatitis C drugs match branded products in viral response
 Keith Alcorn
Generic versions of direct-acting antivirals purchased from China and India by people unable to obtain treatment in their own countries were just as effective and safe as the branded products, a study
Continue reading....

Study shows generics pose safe, economic option for patients with HCV
April 16, 2016
BARCELONA — Generic direct-acting antivirals for hepatitis C virus infection presented a similar biochemical makeup and sustained virological… “In this interim analysis, legally imported generic DAAs led to high SVR rates,” James Freeman, MD, executive director, GP2U Telehealth, Australia, said during a press conference. “A generic cure for hepatitis C is available now for $1,000 and works as expected. … Not in the future, but right now.”

Freeman explained that this endeavor began with one patient asking for assistance in obtaining a generic DAA as, at the time, only Olysio (simeprevir, Janssen) was available in Australia. He chose to assist the patient and test the generics to ensure safety. That patient went on to achieve SVR with the generic medication.

“The news leaked and one became a dozen,” Freeman said
Continue Reading...

View Todays Meeting Coverage @ Healio

ABT-493, ABT-530 produce high SVR4 rates in HCV genotype 3
BARCELONA — In this exclusive video interview at International Liver Congress, Paul Y. Kwo, MD, professor of medicine and director of liver transplantation at Indiana University, and HCV Next Editorial Board member, discusses results from the two SURVEYOR studies investigating the safety and efficacy of pangenotypic agents ABT-493 and ABT-530 in patients with hepatitis C virus genotype 3 infection with and without cirrhosis.

“We are clearly in need of different strategies for these individuals so the genotype 3 population can get the same benefits as the other [genotype patients],” Kwo told HCV Next.

Lean-NAFLD patients with large waist circumference linked to worse metabolic profile
April 16, 2016
BARCELONA — New data presented during the International Liver Congress showed patients with nonalcoholic fatty liver disease and a large waist…
   
Lower SVR rates, more death with DAA therapy in high MELD setting
April 16, 2016
BARCELONA — Physicians need to counsel patients with hepatitis C virus and MELD score higher than 18 prior to treatment with direct-acting…

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Fibroscan improves multiple scoring systems' risk stratification for PBC
April 16, 2016
BARCELONA — Adding liver stiffness measurement through Fibroscan to Globe and UK-PBC risk scores — two high-performance scoring systems…

AbbVie ABT-493 and ABT-530 For Genotypes 1-6: New Phase 2 Data Presented At The International Liver Congress

AbbVie Presents New Phase 2 Data for Investigational, Once-Daily, Ribavirin-Free, Pan-Genotypic Regimen of ABT-493 and ABT-530 for Hepatitis C Genotypes 1-6

Apr 16, 2016

- 97-98 percent SVR12 achieved with eight weeks of ABT-493 and ABT-530 in genotypes 1-3 hepatitis C virus patients without cirrhosis in SURVEYOR-1 and 2 studies(1,2)
- 100 percent SVR12 achieved with 12 weeks of treatment in difficult-to-treat genotype 3 patients with compensated cirrhosis (Child-Pugh A) new to therapy (3)
- 100 percent SVR12 achieved with 12 weeks of treatment in genotypes 4-6 patients without cirrhosis; eight-week duration investigated in this ongoing study (4)

BARCELONA, April 16, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that with eight weeks of treatment, 97-98 percent of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR₁₂).^1,2 Results for GT1 (n=33/34), GT2 (n=53/54) and treatment-naïve GT3 (n=28/29) patients were based on an Intent-to-Treat (ITT) analysis.^1,2 Additionally, 100 percent (n=34/34) of genotype 4-6 (GT4-6) chronic HCV infected patients without cirrhosis achieved SVR₁₂ with 12 weeks of treatment.⁴ These new data from the Phase 2 SURVEYOR-1 and SURVEYOR-2 studies will be presented at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

"These results move us closer to our ultimate goal of providing a treatment option for as many hepatitis C patients as possible. We will continue to examine our investigational, pan-genotypic regimen through our dedicated clinical trial program, including an eight-week duration across all genotypes," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie.
In separate late-breaking data from the SURVEYOR-2 study, 100 percent of GT3 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A) new to therapy achieved SVR₁₂ with 12 weeks of treatment both with and without RBV (n=24/24 in each arm).³ No patients discontinued treatment due to adverse events.³ Data in GT3 chronic HCV infected patients with and without cirrhosis were featured in the official ILC 2016 press program.

"The recent evolution in hepatitis C treatment has resulted in high cure rates for many patients with specific genotypes, but there remain distinct areas of unmet need," said Paul Kwo, M.D., professor of medicine at the Indiana University School of Medicine. "These new data show us the potential of ABT-493 and ABT-530 in genotype 3 patients new to therapy even with the added complication of compensated cirrhosis."

In a pooled analysis of 531 patients across both SURVEYOR studies, of five treatment regimens of ABT-493 and ABT-530 evaluated, the most commonly reported adverse events were fatigue (18 percent), headache (17 percent), nausea (13 percent) and diarrhea (10 percent).⁵ Three patients across all study arms evaluated to date, two of whom received RBV, discontinued study drugs early due to adverse events.⁵

Overview of SURVEYOR-1 and SURVEYOR-2 Clinical Data Presented at ILC:
Patient Profile/Study	Patient number (n)/ Patient Population	Duration of Treatment	Treatment Regimen	SVR12 Rates ITT*
GT1 Non-cirrhotic1 SURVEYOR-1	n=34 Treatment-naïve=85% pegIFN/RBV treatment experienced=15%	8 weeks	ABT-493 (300mg) + ABT-530 (120mg) once daily	97% (n=33/34)
GT2 Non-cirrhotic1 SURVEYOR-2	n=54 Treatment-naïve=87% pegIFN/RBV treatment experienced=13%	8 weeks	ABT-493 (300mg) + ABT-530 (120mg) once daily	98% (n=53/54)
GT3 Non-cirrhotic2 SURVEYOR-2	n=29 Treatment-naïve =100%	8 weeks	ABT-493 (300mg) + ABT-530 (120mg) once daily	97% (n=28/29)
GT3 Cirrhotic3 (Child-Pugh A)  SURVEYOR-2	n=24 Treatment-naïve= 100%	12 weeks	ABT-493 (300mg) + ABT-530 (120mg) without RBV once daily	100% (n=24/24)
	n=24 Treatment-naïve=100%	12 weeks	ABT-493 (300mg) + ABT-530 (120mg) +  RBV (800mg) once daily	100% (n=24/24)
GT 4,5,6 Non-cirrhotic4 SURVEYOR-1	n=34 (GT4=22; GT5=1; GT6=11) Treatment-naïve=85% pegIFN/RBV treatment experienced=15%	12 weeks	ABT-493 (300mg) + ABT-530 (120mg) once daily	100% (n=34/34)

*	Intent-to-treat (ITT) population is defined as all patients who received at least one dose of the study drugs

About SURVEYOR-1^1,4,5
SURVEYOR-1 is an ongoing Phase 2 two-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with and without RBV, for eight to 12 weeks, in cirrhotic and non-cirrhotic adult genotype 1 patients, and non-cirrhotic adult patients with genotypes 4, 5 or 6 chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responder).

About SURVEYOR-2^1,2,3,5
SURVEYOR-2 is an ongoing Phase 2, four-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without RBV, in adult patients with genotypes 2, 3, 4, 5 or 6 chronic HCV infection who were new to therapy or had failed previous treatment with pegylated interferon (pegIFN)/RBV.
The primary endpoint of both studies is the percentage of subjects achieving SVR₁₂.
Safety and efficacy data for Part 1 of the studies were presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

About pooled safety analysis of SURVEYOR-1 and SURVEYOR-2⁵
531 patients were included in this safety analysis: 26 percent GT1, 24 percent GT2, 43 percent GT3, and 6 percent with GT4, 5 or 6 infection. Patients across genotypes received ABT-493/ABT-530 at five doses: 300/120mg (n=258), 300/120mg with RBV (n=27), 200/120mg (n=121), 200/120mg with RBV (n=56), and 200/40mg (n=69).

About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment for 12 weeks. An eight-week treatment duration with ABT-493 and ABT-530 will be investigated across all genotypes in our comprehensive Phase 2/Phase 3 clinical trial program, which focuses on areas of ongoing need in HCV.
AbbVie's investigational regimen includes 300mg ABT-493, an NS3/4A protease inhibitor, and 120mg ABT-530, an NS5A inhibitor.
ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

¹ Poordad, F et al. High SVR Rates with the Combination of ABT-493 + ABT-530 for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 1 or 2 Infection. Poster presentation #SAT-157; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
² Muir, A et al. High SVR Rates with ABT-493 + ABT-530 Co-Administered for 8 Weeks in Non-Cirrhotic Patients with HCV Genotype 3 Infection. Oral presentation #PS098; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
³ Kwo, P et al. 100% SVR₁₂ with ABT-493 And ABT-530 with or without Ribavirin in Treatment-Naïve HCV Genotype 3-Infected Patients with Cirrhosis; Late Breaker presentation #LB01; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016
⁴ Gane, E et al. 100% SVR₄ and Favorable Safety of ABT-493 + ABT-530 Administered for 12 Weeks in Non-Cirrhotic Patients with Genotypes 4,5, or 6 Infection (SURVEYOR-I). Poster presentation #SAT-137; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.
⁵ Kwo, P et al. Safety of ABT-493 and ABT-530 Co-Administered in Patients with HCV Genotype 1-6 Infection: Results From the SURVEYOR-I and SURVEYOR-II Studies; Poster presentation #SAT-239; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 2016.

SOURCE AbbVie

AbbVie's Investigational Regimen ABT-493 and ABT-530 Shows High SVR In HCV Genotype 1 Patients Who Failed Previous Therapy

AbbVie's Investigational, Pan-Genotypic Regimen of ABT-493 and ABT-530 Shows High SVR Rates in Genotype 1 Hepatitis C Patients Who Failed Previous Therapy with Direct-Acting Antivirals
Apr 15, 2016

- 95 percent of patients achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with and without RBV in GT1 chronic HCV infected patients without cirrhosis who failed previous therapy with DAAs in a modified intent-to-treat analysis
- 91 percent achieved SVR12 with RBV in the primary intent-to-treat analysis; 86 percent achieved SVR12 without RBV

BARCELONA, April 15, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that 91 percent (n=20/22) of genotype 1 (GT1) chronic hepatitis C virus (HCV) infected patients who failed previous therapy with direct-acting antivirals (DAAs) achieved SVR12 with 12 weeks of ABT-493 and ABT-530 with ribavirin (RBV) in the primary intent-to-treat analysis. Additionally, 86 percent (n=19/22) of GT1 patients who received ABT-493 and ABT-530 without RBV, achieved SVR12.1 SVR12 was achieved in 95 percent of patients with and without RBV (n=20/21, n=19/20; respectively) in a modified intent-to-treat analysis, excluding patients who did not achieve SVR for reasons other than virologic failure.

The results were evaluated in the ongoing MAGELLAN-1 study of AbbVie's once-daily, investigational, pan-genotypic regimen of co-formulated ABT-493 (300mg) and ABT-530 (120mg) for the retreatment of non-cirrhotic patients with GT1 chronic HCV who have failed previous therapy with DAAs. These data will be presented today at The International Liver Congress™ (ILC) 2016 in Barcelona, Spain.

"Retreatment options for those patients who have previously failed therapy are limited, and present a particular challenge for treating physicians," said Fred Poordad, M.D., vice president of academic and clinical affairs at The Texas Liver Institute in San Antonio. "The high SVR rates seen in the ongoing MAGELLAN-1 study are significant as they show promise in addressing this particular clinical challenge."

No patients discontinued treatment due to adverse events, and two patients experienced virologic failure, one from each arm.1 The most common adverse events (?10 percent of patients overall; n=44) were headache (30 percent), fatigue (27 percent) and nausea (20 percent).1

"While high virologic cure rates have been demonstrated in clinical studies with current DAA regimens, we recognize that not all patients achieve a cure," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "Through our ongoing clinical development program, we are striving to give HCV patients a potential option for retreatment."

About MAGELLAN-11
MAGELLAN-1 is an ongoing Phase 2, randomized, open-label multicenter study to evaluate the efficacy, safety and pharmacokinetics of ABT-493 and ABT-530, with and without RBV, in adults with GT1 and genotypes 4-6 chronic HCV infection who failed a prior DAA-containing therapy.

In Part 1 of the study, 50 GT1 patients without cirrhosis who previously failed therapy containing a protease inhibitor and/or NS5A inhibitor, with or without a NS5B polymerase inhibitor, were randomized to receive once-daily ABT-493 and ABT-530 at doses of 200/80mg (Arm A), 300/120mg with 800mg RBV (Arm B), or 300/120mg without RBV (Arm C), for 12 weeks. The primary efficacy endpoint was SVR12. Patients who failed previous treatment for reasons other than breakthrough or relapse were excluded. Deep sequencing (Illumina MiSeq) revealed pre-existing resistance-associated variants (RAVs) in 41 patients (82 percent), 15 in NS3, 10 in NS5A, and 16 with RAVs in both targets. Data presented at ILC 2016 were based on an analysis of the intent-to-treat population.

Data from the first six patients enrolled in Arm A (once-daily ABT-493 and ABT-530 at doses of 200/80mg) showed 100 percent achieved SVR12. Additional patients were enrolled and received study drug at the higher doses of the combination, which will be used in Phase 3 clinical trials, 300/120mg ABT-493/ABT-530 with and without 800mg RBV. There were no grade 3 or 4 laboratory abnormalities.

Part 2 of the study is underway to examine once-daily ABT-493 (300mg) and ABT-530 (120mg) without RBV in a larger group of DAA treatment-experienced patients, including those with compensated cirrhosis and in genotypes 4-6.

About AbbVie's HCV Clinical Development Program
AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment for 12 weeks. An eight-week treatment duration with ABT-493 and ABT-530 will be investigated across all genotypes in our comprehensive Phase 2/Phase 3 clinical trial program, which focuses on areas of ongoing need in HCV.

AbbVie's investigational regimen includes 300mg ABT-493, an NS3/4A protease inhibitor, and 120mg ABT-530, an NS5A inhibitor.

ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Poordad, F et al. High Efficacy of ABT-493 and ABT-530 in HCV Genotype 1 Infected Patients Who Have Failed Direct-Acting Antiviral-Containing Regimens: The MAGELLAN-I Study. Oral presentation #GS11; presented at The International Liver Congress™ (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 13-17, 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