Tag Archives: hepatitis c treatments

Gilead Receives Health Canada Approval for VOSEVI™, the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment

Please note:  VOSEVI is available to eligible patients in Canada but is not yet covered by BC PharmaCare (or any provincial plans).  VOSEVI is included in Gilead’s Momentum Patient Support Program (information, including contact information, is available below and here).

See the Hep C Treatment Diagram on the left hand side of this page (homepage has 2 versions) for a picture of Canada’s drug approval system and where hep C treatments are at in it.  VOSEVI is at Step 3 and will be progressing through the approval process.  That takes time.  VOSEVI will be added to the pipeline diagram the week of August 21 2017.  Please check back.

________________________________________________________________________

Gilead Receives Approval in Canada for VOSEVI™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-treatment of Certain Patients with Chronic Hepatitis C Virus (HCV) Infection

VOSEVI is the First Once-Daily, Single Tablet HCV Regimen for Re-Treatment, and Completes Gilead’s Portfolio of Sofosbuvir-Based HCV Direct-Acting Antiviral Treatments

MISSISSAUGA, ON, Aug. 17, 2017 /CNW/ – Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance for VOSEVI™ (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a pan-genotypic single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1, 2, 3 or 4 previously treated with sofosbuvir-containing regimen without an NS5A inhibitor.  The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies that evaluated 12 weeks of VOSEVI in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis.

“HCV treatment has been transformed by effective direct-acting antiviral regimens, allowing health care providers the opportunity to cure many patients.  However, for those patients who have failed with prior therapy, there remains an unmet clinical need for an effective and well-tolerated option,” said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta.  “VOSEVI Phase 3 clinical studies have resulted in high cure rates among patients who were not previously cured with several widely-prescribed DAA regimens, providing physicians with an important new therapeutic option that could offer hope for their hardest-to-cure patients.”

VOSEVI is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV infection, with the convenience associated with once-daily single-tablet regimens.  Since 2013, Gilead has brought to market four HCV treatments, including three single-tablet regimens. To date, more than an estimated 1.5 million patients worldwide have been prescribed sofosbuvir-based regimens.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Kennet Brysting, General Manager, Gilead Canada. “The approval of VOSEVI in Canada completes our HCV portfolio and this will enable the company to commit to collaborative partnerships that will help drive progress towards the goal of eliminating HCV in Canada by 2030.”

The approval of VOSEVI is supported by Phase 3 data from the POLARIS-1 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3, 4, 5 or 6 infection with or without compensated cirrhosis who had failed prior treatment with an NS5A inhibitor-containing regimen, as well as Phase 3 data from the POLARIS-4 study evaluating 12 weeks of treatment among adults with HCV genotype 1, 2, 3 or 4 infection with or without compensated cirrhosis who had failed prior treatment with a DAA-containing regimen that did not include an NS5A inhibitor.  In these populations across the two studies, 431 of the 445 patients treated with VOSEVI (97%) achieved the primary endpoint of SVR12, defined as maintaining undetectable viral load 12 weeks after completing therapy.

The most common adverse events (≥10 per cent of patients) among patients who received VOSEVI were headache, fatigue, diarrhea and nausea. The proportion of subjects who permanently discontinued treatment due to adverse events was 0.2 per cent for subjects who received VOSEVI for 12 weeks.

“As Canada moves forward with its World Health Organization commitment to eliminate hepatitis C by 2030, it is important for all patients to have the opportunity to access a cure, regardless if they are new to treatment, or they have failed a previous therapy,” said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital.  “Treatment should be an option for everyone, including to those still seeking a cure.  The CLF is pleased to see that additional effective therapies are available, and are becoming more accessible to all patients, regardless of where someone lives, or their ability to pay.”

Patient Support Program
To assist eligible HCV patients in Canada with access to VOSEVI, Gilead Canada has added VOSEVI to the Gilead Momentum Support Program™, which provides information to patients and healthcare providers to help facilitate patient access to medication.  For more information regarding the Momentum Support Program in Canada, please call 1-855-447-7977.

Important Safety Information
The VOSEVI Product Monograph has a SERIOUS WARNINGS AND PRECAUTIONS BOX REGARDING THE RISKS OF HEPATITIS B VIRUS (HBV) REACTIVATION IN HCV/HBV CO-INFECTED PATIENTS.  For further details, please see the Canadian Product Monograph at www.gilead.ca.

Contraindications
VOSEVI is contraindicated with the following drugs products: dabigatran etexilate, phenobarbital, phenytoin, rifampin, rosuvastatin.  VOSEVI is also contraindicated with the herbal product, St. John’s wort.

Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with VOSEVI 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. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. 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.

Drug Interactions
Coadministration of VOSEVI is not recommended with carbamazepine, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, efavirenz, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir and/or voxilaprevir, and/or the other agent.

For additional important safety information for VOSEVI, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph at www.gilead.ca.

About Gilead Sciences
Gilead Sciences, Inc. (Gilead) 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.  Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2006.

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 physicians may not see the benefits of prescribing VOSEVI for the treatment of adults with chronic HCV infection. 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, 2017, 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.

Canadian Product Monograph for VOSEVI, including the SERIOUS WARNINGS and PRECAUTIONS,
is available at www.gilead.ca.

VOSEVI is a 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.

SOURCE Gilead Sciences, Inc.

 

 

 

 

Our Top 2016 Hepatitis C Treatment Posts as Clicked by You

Our top 2016 hepatitis C treatment posts as clicked by you are as follows:

Our Top 2016 Hepatitis C Treatment Posts as Clicked by YouThe Top 5 Blog Posts Read in 2016

The Top 5 Facebook Posts that Received the Most Reactions/Clicks in 2016

The Subjects of the Top 5 Tweets Posted in 2016

The Top Email Subjects Received by the Hepatitis C Treatment Information Project in 2016

  • I am thinking about starting treatment and am wondering if you can answer the following questions?
  • I am thinking about starting treatment and am wondering about BC PharmaCare’s liver fibrosis stage F2 or greater treatment eligibility cut off.

May 2017 be a year just as full of exciting hep C headlines and developments as 2016 was. Happy New Year from all of us at the Pacific Hepatitis C Network!

Two BC based Clinical Trials Examined at the Liver Meeting

Two BC based Clinical Trials Examined at the Liver MeetingThis post examines two BC based clinical trials BC for hep C treatments that were presented at the Liver Meeting 2016 earlier this month.

Clinical Trial Abstract #60 – Impact of drug use and opioid substitution therapy on hepatitis C reinfection: The BC Hepatitis Testers Cohort by Nazrul Islam, et al.

Summary: This clinical trial identified the risk factors that may lead to hep C reinfection by looking at those tested for the virus in BC between 1990-2013. It looked at data about their medical visits, hospitalizations, and prescription drugs.  Those who were able to clear the virus on their own were included in this study. The study’s results showed that 11.8% of those who cleared the virus on their own were reinfected within the study’s 19 year time period. This rate was higher in this group than in those who had cleared the virus through treatment. However, this group also had a higher proportion of people who recently injected drugs. Using injected drugs made the risk of reinfection higher, where as, using opioid substitution therapy (OST) reduced the hep C reinfection risk. Also, being younger was seen to increase one’s of reinfection risk, as well as, being co-infected with HIV.  Whereas, being female and being infected with hep B lowered one’s chances of reinfection. From these findings, the study concluded that treatment should be combined with harm reduction programs.

Clinical Trial Abstract #175 – The impact of sustained virological response to HCV infection on long term risk of hepatocellular carcinoma: The BC Hepatitis Testers Cohort by Naveed Z. Janjua, et al.

Summary: The risk of hepatocellular carcinoma (HCC), the most common type of liver cancer, after being cured of hep C in North America hasn’t been looked at in depth. This study assessed the effect of sustained virologic response (hep C cure) on the risk of HCC among a large Canadian population base, by examining the same patient database as the above clinical trial. RESULTS: It found that the risk of HCC was higher in those who weren’t cured than those who were (1.1/1000 person-yr(PY) in the SVR group and 7.2/1000 PY in the no-SVR group). It found that the risk of developing HCC was higher in those with liver cirrhosis, who were older, male, had hep C genotype 3 vs 1, and drank alcohol. The HCC incidence post treatment increase was steeper in the no-SVR vs the SVR group, but that SVR (cure) doesn’t eliminate the risk of HCC.

 The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held November 11th – 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, hosted the meeting and, as always, it was exciting.

More information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

The 2016 Liver Meeting by 2 Attending Blog Writers

2016 Liver Meeting via Attending Blog WritersAttending the Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, this year are not only researchers and physicians, but also a number of different blog writers.  The below is some of what these writers have been hearing and writing about.

2016 Liver Meeting Highlights being Written about by Two Attending Blog Writers

By Lucinda K. Porter, RN

Summary: A general description of the Liver Meeting 2016. “There were quite a few presentations on fatty liver diseases (FLD) such as non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). FLDs are rapidly overtaking hepatitis C as the most prevalent liver threat.”

Summary: A post about two of Porter’s favorite conference posters, Abstract #868 Safety and Tolerability of Direct Acting Antiviral Agents (DAAs) Used in Usual Clinical Practice: HCV-TARGET International Consortium, by Michael W. Fried, et al., and Abstract #911 Alcohol Use and Hepatitis C Virus Treatment Outcomes Among 15,151 Patients Receiving Direct Antiviral Agents, by Judith Tsui, et al. Editorial comments included.

Summary: A post highlighting Abstract # LB-15 Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients With HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis Following an 8-Week Treatment Duration(SURVEYOR-II, Part 4), by Tarek Hassanein, et al., and Abstract #831 Hepatitis C (HCV) Virologic Outcomes in Veterans Taking Ledipasvir/Sofosbuvir With Concomitant Acid Suppressing Medication – Austin Chan, et al. Editorial comments included.

By HIVandHepatitis.com

Summary: The hep C treatment Zepatier (grazoprevir/elbasvir) and Sovaldi (sofosbuvir) without ribavirin cured 96% of previously untreated and 97% of treatment-experienced people with hep C genotype 3 and liver cirrhosis, matching rates seen in easier-to-treat patient groups.

Summary: Direct-acting antiviral treatments have real-world rates similarly found in clinical trials, without major differences between treatment regimens.

Summary: Being cured of hepatitis C with direct-acting antiviral treatment doesn’t increase one’s risk of developing hepatocellular carcinoma (HCC) and may reduce it. (Canadian Study)

More information about the Liver Meeting or information about these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part1), on the American Association for the Study of Liver Diseases (AASLD)’s website, or by clicking the links listed above.

Live Stream Sessions from The Liver Meeting 2016

Three Live Stream Sessions from The Liver Meeting 2016Three Live Stream Sessions on Tuesday, November 15, 2016 @ 11:30 am to 1:00 pm ET (8:30 am to 10 am PT)

Can’t make it to The Liver Meeting this year? Get the latest updates on hepatitis treatment and clinical hepatology from the meeting in Boston, from your home or office.

The live stream for The Liver Meeting sessions below can be viewed via the LiverLearning® website or the LiverLearning® app for Android and iOS devices. You must register in order to watch the live stream on Tuesday, November 15. There is no charge for registration.

Three Live Stream Sessions

Hepatitis Debrief
11:30 am -12:00 pm ET
Speaker: Robert S. Brown, MD, MPH, FAASLD

This session provides a synthesis of new data on the treatment of viral hepatitis presented at The Liver Meeting.

Schiff State-of-the-Art Lecture
12:00 pm -12:30 pm ET
Speaker: Anna S. Lok, MD, FAASLD

This lecture will provide a vision for the global elimination of hepatitis B and strategies to reach that goal by examining the burden of hepatitis B infection and the disparity in prevalence across different parts of the world. Programs preventing hepatitis B infection, available treatment options in chronic hepatitis B, their limitations and novel therapies will also be discussed.

Clinical Hepatology Debrief
12:30 pm -1:00 pm ET
Speaker: Arun J. Sanyal, MD, FAASLD

This newly added session is designed to complement the highly-regarded, Hepatitis Debrief, and will review key clinical highlights from the meeting.

Access the Live Stream Sessions after The Liver Meeting

In addition to watching the sessions live on Tuesday, November 15, as a registered attendee of the live stream you can access the session recording on demand through December 31, 2016. AASLD members have access to content on LiverLearning® all year round.

The Liver Meeting 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

*The content of this blog post was taken from AASLD’s http://www.aasld.org/events-professional-development/live-stream-sessions

The Liver Meeting 2016 Hep C Abstract Highlights (Part2)

Liver Meeting 2016 Hep C Abstract HighlightsThe Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

Hep C Abstract Highlights to be Presented at The Liver Meeting 2016 (Part 2)

  • Eight weeks treatment duration with Ledipasvir/Sofosbuvir (LDV/SOF) is effective for appropriately selected patients with genotype 1 Hepatitis C virus (HCV) infection: an analysis of multiple real world cohorts totaling >6,500 patients, by Vinay Sundaram, et al. (LB-16)

Summary: Current studies are limited by lack of uniform data regarding fibrosis stage or risk factors for relapse when it comes to 8 weeks of treatments with LDV/SOF (Harvoni).  Looking at past records, the research team determined the effectiveness of 8 weeks of treatment (SVR rates >95% in selected patients), examined variables associated with relapse, and compared the efficacy of 8 weeks with 12 weeks of therapy.  The results were in the 90s for those >65 years, HIV co-infected, Caucasian and African-American, fibrosis stages of 0-3, and genotype 1a and 1b.

  • Hepatitis B Reactivation Associated with Direct Acting Antiviral Therapy for Hepatitis C: A Review of Spontaneous Post-Marketing Cases, by Susan J. Bersoff-Matcha, et al. (LB-17)

Summary: There have been recent published cases of hepatitis B virus reactivation (HBV-R) in patients with HCV/HBV coinfection. Before DAAs, this is often seen with immunosuppression, although, DAAs don’t suppress immune response. Therefore, the purpose of this evaluation was to assess spontaneous reports of HBV-R with DAA treatment. The conclusion was that it does happen and that further study is needed into the reasons for it and how to stop it from occurring.

  • Retreatment with sofosbuvir + grazoprevir + elbasvir + ribavirin of patients with Hepatitis C virus Genotype 1 or 4 with RASs at failure of a sofosbuvir + ledipasvir or + daclatasvir or + simeprevir regimen (ANRS HC34 REVENGE study), by Victor de Ledinghen, et al. (LB-18)

Summary: The best treatment regimen for such patients who have already tried but failed treatment is still unknown. This study evaluated sofosbuvir + grazoprevir + elbasvir + ribavirin, taken for 16 weeks vs 24 wks in patients with NS5A or NS3 resistance-associated substitutions (RASs), when treatment failed. SVR4 was achieved by 16/17 patients. The finding suggested that “…retreating patients who failed a DAA-based regimen with NS5A/NS3 RASs with the combination of SOF + GZR + EBV + RBV for 16 weeks is efficacious and represent an interesting option. Safety will need to be monitored cautiously for this combination.”

  • Reduction in Liver Transplant Wait-Listing in the Era of Direct Acting Anti-Viral Therapy, by Jennifer A. Flemming, et al. (LB-23)

Summary: The study analyzed trends in liver transplant wait-lists to explore the potential impact of effective medical therapy on wait-list registration. The findings found that wait-lists have reminded the same for those with hep B but the number of those waiting for livers due to hep C has decreased by over 30% in the era of DAA therapy. Further reductions of wait-lists may result from increased testing, linkage to care, and access to DAA treatment.

More information about this meeting or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part1) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)

The Liver Meeting 2016 Hep C Abstract Highlights (Part1)The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, will be held November 11th to the 15th. Last year’s meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. This year, Boston, Massachusetts, will be hosting the meeting and, as always, the meeting promises to be exciting.

Hepatitis C Treatment Topics to be Presented at The Liver Meeting 2016 (Part I)

  • GS-4997, an Inhibitor of Apoptosis Signal-Regulating Kinase (ASK1), Alone or in Combination with Simtuzumab for the Treatment of Nonalcoholic Steatohepatitis (NASH): A Randomized, Phase 2 Trial, by Rohit Loomba, et al. (LB-3)

Summary: “ASK1 is a serine threonine kinase that promotes hepatic inflammation and fibrosis in the setting of oxidative stress. Our aim was to describe the preliminary efficacy of GS-4997, a selective inhibitor of ASK1, alone or in combination with simtuzumab (SIM), in patients with NASH and moderate to severe liver fibrosis.” (Loomba, et al.) This study found that a 24-week course of GS-4997 reduced liver fibrosis and lowered hepatic stiffness in patients with NASH and moderate to severe fibrosis.

  • EXPEDITION-IV: Safety and Efficacy of GLE/PIB in Adults with renal impairment and Chronic Hepatitis C Virus Genotype 1 – 6 Infection, by Edward J. Gane, et al. (LB-11)

Summary: Currently, severe renal impairment still limits treatment options for those with hepatitis C. This study showed that a fixed dose of GLE/PIB (glecaprevir/pibrentasvir) taken once  a day for 12 weeks was well tolerated by patients with severe renal impairment, without any serious side effects. 99% of patients achieving SVR4, hep C cure.

  • A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study, by Ira M. Jacobson, et al. (LB-12)

Summary: This study compared treatment with sofosbuvir/velpatasvir/voxilaprevir for 8 weeks with treatment with sofosbuvir/velpatasvir (brandname Epclusa) for 12 weeks in patients with genotype 1-6 hepatitis C, who had or didn’t have liver cirrhosis, and who hadn’t previously been treated with a direct-acting antiviral agent (DAA). The most common side effect were headache, fatigue, diarrhea and nausea while taking SOF/VEL, and diarrhea and nausea while taking SOF/VEL/VOX.
Clinical Trial Results:

SVR4 % Total GT1 GT2 GT3 GT4 GT5 GT6 Other
SOF/VEL/VOX 8 Weeks 96 (482/ 501) 95 (221/ 233) 97 (61/ 63) 100 (92/ 92) 94 (17/ 18) 94 100 (30/ 30) 100 (2/2)
SOF/VEL 12 Weeks 98 (432/ 440) 99 (229/ 232) 100 (53/ 53) 97 (86/ 89) 96 (55/ 57) 100 (9/9)
  • A Novel Single Daily Fixed Dose Combination of Sofosbuvir 400 mg + Ribavirin 1000mg + EGCG400 mg is Superior to the Standard of Care as an Anti-Viral and Safer Causing less Hemolysis in Patients with Chronic Hepatitis C, by Gamal Shiha, et al. (LB-14)

Summary: Sofosbuvir has improved hep C treatments and outcomes, however, it is extremely costly and there is a risk of selecting viral escape mutants so a new combination, focusing on other steps in the infection process, may be better. Therefore, EHCV (Catvira) formulation composed of sofosbuvir / ribavirin / epigallocatechin gallate 400 mg (EGCG) is being developed. SVR 12 and SVR 24 for EHCV (Catvira) show results similar to those reached by the current standard of care, but with a much faster rate of viral load decline, for both treatment experienced and treatment naive genotype 4 hep C patients.

  • Glecaprevir/Pibrentasvir Demonstrates High SVR Rates in Patients with HCV Genotype 2, 4, 5, or 6 Infection without Cirrhosis Following an 8-Week Treatment Duration (SURVEYOR-II, Part 4), by Tarek I. Hassanein, et al. (LB-15)

Summary: The hepatitis C virus genotypes (GTs) 2, 4, 5 and 6 are everywhere and together make up approximately 23% of global hep C infections. With these genotypes being so widespread, it is important to have treatments and improving treatments for them as well. In previous phase 2 studies, SVR12 rates of 98% and 100% were achieved following treatment with GLE/PIB for 8 weeks in GT2 infected patients or 12 weeks in GT 4-6 infected patients. This study, SURVEYOR-II Part 4, looked at the safety and efficacy of 8-week GLE/PIB treatment in patients with GT4-6 infection, and a larger group of GT2-infected patients.  The study’s results were as follows:

SVR4 % Total GT2 GT4 GT5 GT6
GLE/PIB 8 Weeks 98 97 (141/145) 98 (45/46) 100 (2/2) 100 (10/10)

Lastly, more information about The Liver Meeting 2016 or these and other studies can be found in our blog post The Liver Meeting 2016 Hep C Abstract Highlights (Part2) or on the American Association for the Study of Liver Diseases (AASLD)’s website.

2015 Hepatitis C Drug Pipeline Highlights

2015 Hepatitis C Drug Pipeline HighlightsA lot happened in 2015 within the hepatitis C drug pipeline. Some treatments sought approval to be used in Canada and other treatments sought to be listed on PharmaCare’s formulary. The following highlights just some of their 2015 milestones:

2015 Hepatitis C Drug Pipeline Highlights

January
February
March
May
June
July
August
September
October
November

Have we missed any events in our list of 2015 hepatitis C drug pipeline highlights that you feel should be included? Send us an email and we may update this post.

Liver Meeting 2015 Highlights

Liver Meeting 2015 HighlightsThe American Association for the Study of Liver Diseases (AASLD) held its 66th annual meeting, The Liver Meeting 2015 (#Liver15), November 13th – November 17th. The meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases. The below is some of what they discussed and some of what has gone viral.

Hepatitis C Highlights from the 2015 Liver Meeting

AASLD issued a statement about hepatitis C that:

  • Endorsed treating patients with hep C as the standard of care instead of waiting for liver disease to develop;
  • Endorsed hepatitis C treatment that can prevent the progression of liver disease;

And argued that:

  • Inaction is harmful to patients;
  • Failure to treat leads to other health problems;
  • Access to treatment is the most effective way to eliminate the virus.

The full AASLD news release can be found at Leading Liver Doctors: Hepatitis C Patients Must Be Treated.

Hepatitis C Subjects Garnering Attention

Advocacy
Prevention
Treatment

Clinical Trial Results Garnering Attention

Clinical trial results were presented by researchers working to understand hep C and help treat a wider range of patients easier and faster. Our blog post covering some of these clinical trials results in more detail has been posted and can be found at Liver Meeting 2015 Clinical Trial Highlights.

The Liver Meeting 2015 Abstracts and Other Resources

The AASLD’s Liver Meeting 2016 will be in Boston.

Information presented at The Liver Meeting can be found online in easy-to-use versions so that you can find the information that may become the meeting’s highlights for you. Explore on your own or use PHCN’s Hepatitis C Treatment Information Project / email for direction.

References:

Liver Meeting 2015 Clinical Trial Highlights

The Liver MeetingThe American Association for the Study of Liver Diseases (AASLD) held its 66th annual meeting, The Liver Meeting 2015 (#Liver15), November 13th – November 17th. The meeting drew more than 9,500 international hepatologists and hepatology health professionals to San Francisco to discuss the latest treatments and research for liver diseases.

Some of the meeting’s highlights have been posted in our Liver Meeting 2015 Highlights blog post. In addition, some of the clinical trial results that were part of the meeting are presented below.

Some Clinical Trial Result Highlights that were Presented at the 2015 Liver Meeting

 

Patients
Treatment Regimen
Duration in Weeks
SVR
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for
12 Weeks in Naïve and Experienced Genotype 1, 2, 4,
5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2)
Genotype 1, 2, 4, 5, 6 Hepatitis C (GT 1, 2, 4, 5, 6 HCV); with and without cirrhosis; 740 patients Sofosbuvir/Velpatasvir 12 SVR12 99% Overall (GT1 98% GT2 100% GT4 100% GT5 97% GT6 100%)
Placebo Similar adverse effects
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis GT2 Sofosbuvir/Velpatasvir 12 SVR12 99%
Sofosbuvir + ribavirin (RBV) SVR12 94%
GT3 Sofosbuvir/Velpatasvir 12 SVR12 95%
Sofosbuvir + RBV 24 SVR12 80%
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
GT 1, 2,
3, 4, 6 HCV; with decompensated liver
disease; 267 patients (Patients with prior liver transplant or
hepatocellular carcinoma were excluded)
Sofosbuvir/Velpatasvir 12 SVR12 83% Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
Sofosbuvir/Velpatasvir + RBV SVR12 94% Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
Sofosbuvir/Velpatasvir 24 SVR24 85% Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)
SURVEYOR-I and SURVEYOR-II: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection (Ongoing Phase 2 clinical studies. Part 1 results of the SURVEYOR-II were presented at AASLD)
GT 1 HCV; without compensated cirrhosis; treatment naive or did not respond to pegylated interferon + RBV (PR) ABT-493 (200mg) + ABT-530 (120mg) 12 SVR12 100%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 97%
ABT-493 (300mg) + ABT-530 (120mg) 8
GT 2 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 96%
ABT-493 (200mg) + ABT-530 (120mg) SVR12 100%
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily
GT 3 HCV; without compensated cirrhosis; treatment naive or did not respond to PR ABT-493 (300mg) + ABT-530 (120mg) 12 SVR12 93%
ABT-493 (200mg) + ABT-530 (120mg)
ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily SVR12 94%
ABT-493 (200mg) + ABT-530 (40mg) SVR12 83%
ALLY-3+ Phase 3 Study: All-Oral Treatment With Daclatasvir (DCV) Plus Sofosbuvir (SOF) Plus Ribavirin (RBV) for 12 or 16 Weeks in HCV Genotype (GT) 3-Infected Patients With Advanced Fibrosis or Cirrhosis (Abstract LB-3)
GT 3 HCV; treatment-naive or treatment-experienced with advanced fibrosis or cirrhosis. Patients were randomized 1:1 to receive 12 weeks vs 16 weeks of DCV + SOF + RBV DCV + SOF + RBV 12 SVR4 88% Overall (83% in those with cirrhosis, 100%
in those with advanced fibrosis)
16 SVR4* 96% (94% with cirrhosis, 100% in those with advanced fibrosis)
*The AASLD Abstracts states, “DCV+SOF+RBV for 12 or 16 weeks achieved high SVR4 rates of 88% and 96%, respectively…”.
An Integrated Analysis of 402 Compensated Cirrhotic Patients With HCV Genotype (GT) 1, 4 or 6 Infection Treated With Grazoprevir/Elbasvir (Abstract 42, pg 23)
GT 1, 4, 6 HCV; treatment-naive with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir 12 SVR12 90%
Grazoprevir/Elbasvir + RBV SVR12 98%
GT 1, 4, 6 HCV; treatment-experienced with compensated liver cirrhosis (Child-Pugh class A) Grazoprevir/Elbasvir SVR12 89%
Grazoprevir/Elbasvir + RBV SVR12 91%
GT 1, 4, 6 HCV; treatment-experienced Grazoprevir/Elbasvir 16 or 18 SVR12 94%
Grazoprevir/Elbasvir + RBV SVR12 100%
C-CREST-1 & 2, Part A: Phase 2, Randomized, Open-Label Clinical Trials of the Efficacy and Safety of Grazoprevir and MK-3682 (NS5B Polymerase Inhibitor) with Either Elbasvir or MK-8408 (NS5A Inhibitor) in Patients with Chronic HCV GT1, 2 or 3 Infection (Abstract LB-15)
Population* G+E + MK-3682 300mg Grazoprevir
+ Elbasvir (G+E)
+ MK-3682
450mg
Grazoprevir
+ MK-8408
+ MK-3682
300mg
Grazoprevir
+ MK-8408
+ MK-3682
450mg
GT 1 HCV 100%** 100% 100% 91%
GT 2 HCV 69% 60% 71% 94%
GT 3 HCV 90% 86% 95% 91%
*Treatment-naive without liver cirrhosis; **SVR12, following 8 weeks of treatment
Osiris: Simeprevir in Combination with Sofosbuvir in Genotype 4 Infected HCV Patients In Egypt
GT 4 HCV, without liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 8 SVR12 75%
GT 4 HCV, with liver cirrhosis, treatment naïve and treatment experienced Simeprevir + Sofosbuvir 12 SVR12 100%

The American Association for the Study of Liver Diseases’ Liver Meeting 2016 will be in Boston.

Additional information presented at The Liver Meeting can be found online in easy-to-use versions and in our Liver Meeting 2015 Highlights blog post so that you can find the information that may become the meeting’s highlights for you. Explore on your own or use PHCN’s Hepatitis C Treatment Information Project / email us for direction.