All posts by Hep C TIP

Strategies to Address Reimbursement Restrictions

Strategies to address reimbursement restrictionsClick here to view a recording of the February 6th webinar Strategies to address reimbursement restrictions for Hep C treatment: Lessons from Australia.

In collaboration with CanHepC, CTAC, and The Kirby Institute in Australia, CATIE organized this webinar to look at strategies to address Canada’s current restrictive and inconsistent approach to direct-acting antiviral (DAA) access and the lessons we can learn from the Australian model.

Learn from experts like Alison Marshall and Greg Dore of Australia’s The Kirby Institute; and Helen Tyrell of Hepatitis Australia. Listen to a discussion between Adam Cook of CTAC and Action Hepatitis Canada’s Community Organizer, Zoe Dodd.

 

Glecaprevir/Pibrentasvir Granted Priority Review

Glecaprevir/Pibrentasvir Priority Review GrantedAbbVie, the developer of glecaprevir (ABT-493) / pibrentasvir (ABT-530), has submitted a New Drug Submission to Health Canada for the treatment of chronic hepatitis C and has been granted a priority review for it. This means that it will receive a priority review from Health Canada.*

A couple of weeks ago, the same hepatitis C treatment received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to Health Canada as a short term, eight week, treatment, made up of a once-daily three pill regimen. The treatment is for patients with chronic hepatitis C virus (HCV) genotypes 1-6, all major genotypes, without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A).

Glecaprevir/pibrentasvir is intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease and those not cured with previous direct acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Submission to Health Canada can be found here.

Sampling of Phase III Clinical Trials for Glecaprevir / Pibrentasvir:

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
ENDURANCE-1 GT1 without cirrhosis, new to treatment or not cured with previous treatment 8 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
12 weeks
ENDURANCE-2 GT2 without cirrhosis, new to treatment or not cured with previous treatment 12 weeks G/P vs Placebo 99%
ENDURANCE-3 GT3 without cirrhosis (NC), new to treatment (TN), treatment experienced (TE) 12 weeks G/P Ongoing
12 weeks SOF + DCV
8 weeks G/P 95%
ENDURANCE-4 GT4-6 NC, TN, TE 12 weeks G/P GT4 99%, GT5 100%, GT6 100%
SURVEYOR-2 (Part 3) GT3 TN, TE 12 weeks G/P 91%
Compensated cirrhosis (CC), TE 16 weeks 96%
GT3 TN 12 weeks G/P 98%
GT3 TE 16 weeks 96%
SURVEYOR-2 (Part 4) GT2, GT4-6 NC, TN, TE 8 weeks G/P GT2 98%, GT4 93%, GT5 100%, GT6 90%
EXPEDITION-4 CKD4/5, GT1-6, +/- CC 12 weeks G/P 98%
EXPEDITION-1 GT1, 2, 4-6 CC, TN, and TE 12 weeks G/P Ongoing
CERTAIN-1 GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 weeks G/P 99%
12 weeks Technivie 100%
MAGELLAN-1 (Part 2) GT1, 4, 6 +/- liver cirrhosis, DAA treatment experienced 12 weeks G/P + RBV Ongoing
16 weeks G/P – RBV
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“HCV patients with severe chronic kidney disease present a complex challenge for physicians to treat. This is particularly true in those with genotype 2 and 3 infection, and those with cirrhosis,” said Dr. Curtis Cooper, Director of the Regional Hepatitis Program at the Ottawa Hospital. “Recent clinical trial results are a positive development in AbbVie’s investigation of the G/P regimen for patients with chronic kidney disease, who currently have limited HCV treatment options.”

*For more information about the drug approval system in Canada please see Approval Process.

Treatment Access Webinar February 6th at 12-1:30pm

Treatment Access Webinar February 6th at 12-1:30pmClick here for more information and to register for the webinar on February 6th at 12-1:30pm PST.

In collaboration with CanHepC, CTAC, and the Kirby Institute in Australia, CATIE is organizing a webinar looking at strategies to address Canada’s current restrictive and inconsistent approach to direct-acting antiviral (DAA) access and lessons we can learn from the Australian model.

Register now and learn from experts such as Alison Marshall and Greg Dore of Australia’s The Kirby Institute; and Helen Tyrell of Hepatitis Australia. Engage in discussion with Adam Cook of CTAC and Action Hepatitis Canada; Community Organizer Zoe Dodd.

Glecaprevir/Pibrentasvir Submitted to the US FDA

Glecaprevir/Pibrentasvir Submission to the FDAA New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) late last year for glecaprevir/pibrentasvir, a hepatitis C treatment against all of the virus’s major genotypes. This application was submitted after the FDA grated glecaprevir/pibrentasvir a Breakthrough Therapy Designation (BTD) for the treatment of patients with hep C genotype 1 who were not cured with prior DAA therapies last September. It also came just weeks after a New Drug Application was submitted for sofosbuvir/velpatasvir/voxilaprevir, another hep C treatment.

There has been no word as to when glecaprevir/pibrentasvir will be submitted for approval in Canada.

Glecaprevir/Pibrentasvir

Glecaprevir/pibrentasvir was submitted to the FDA as a once-daily three pill regimen for the treatment of patients with chronic hepatitis C virus (HCV). The treatment is taken without pegylated interferon or ribavirin. It has achieved high SVR/cure rates in patients with health concerns that limit hep C treatment options, such as those with severe chronic kidney disease. In as little as 12 weeks, it has also been effective for those historically difficult to treat, such as those not cured by other direct-acting antiviral treatment.

Additional information and AbbVie’s press release about their New Drug Application to the U.S. FDA can be found here.

Sampling of Phase III Clinical Trials

Clinical Trial Patients Treatment Duration Treatment Regimen SVR12*
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 weeks Glecaprevir / Pibrentasvir (G/P) once daily 99%
ENDURANCE-3 GT3 without cirrhosis, never been treated G/P 95%
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) G/P 97%
*In clinical trials for hepatitis C virus (HCV) infection treatments, the goal is to cure/achieve SVR (sustained viral response)/reduce the virus so that it can’t be detected in the blood and liver disease from hep C is stopped. A SVR12 is an HCV viral load that has remained undetectable for 12 weeks after treatment, indicating a cure.
**Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon.

Common Side Effects Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

“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.

2016 Highlights of a Local Hepatitis C Advocate

2016 Highlights of a Local Hepatitis C AdvocateHepatitis C advocates are essential to bettering the lives of those living with hep C. As we begin 2017, the Hepatitis C Treatment Information Project wanted to look back and highlight some of the 2016 work of Daryl Luster, one of our hep C advocates.

The following is a collection of 2016 articles, events, and resources that Daryl Luster, hep C advocate and president of PHCN, was a part of:

February 11th, 2016

Daryl Luster wrote an editorial about the price of hepatitis C direct-acting antiviral treatments.

February 25 – 28th
The Canadian Network on Hepatitis C’s 5th Canadian Symposium on Hepatitis C Virus

The Canadian Network on Hepatitis C‘s 5th Canadian Symposium on Hepatitis C Virus took place in Montreal, in 2016. It gathered international experts, including Daryl, together to discuss hep C research into topics such as: treatment, immune response, antiviral resistance, HIV co-infected, and hepatitis C prevention and management.

May 11th
14th Annual Genomics Forum – “Global Impacts of Genomics”

This one-day scientific forum brought researchers and collaborators from all of BC’s life sciences sectors together to share information and discuss opportunities for future collaborations. Daryl took part in the event’s afternoon and panel session about global health and spoke about patients, the nexus of healthcare and research.

April 24th

Daryl Luster wrote an opinion piece that was published by The Vancouver Sun about hepatitis C globally and in BC. It spelt out the importance of testing baby boomers and the neurological and gastrointestinal issues that may be caused by the virus.

July 27th, 2016

Daryl Luster wrote an opinion piece that was published by The Vancouver Sun about hepatitis C globally and in BC. It spelt out the importance of testing baby boomers and the neurological and gastrointestinal issues that may be caused by the virus.

October 18-19th
Action Hepatitis Canada BC Regional Meeting

In our continuing commitment to Action Hepatitis Canada (AHC) and in his role on the steering committee and executive with AHC, Daryl was involved with hosting the meetings in BC. These meetings were part of a cross-Canada series of regional meetings in support of member organizations and the hepatitis community.

October 24th

Daryl Luster wrote an editorial about the newness of hepatitis C direct-acting antiviral treatments and the need to cure whole patients instead of just achieving sustained viral responses.

November 15th

Daryl Luster met with BC NDP MLA Shane Simpson. They spoke about the landscape of hepatitis C in BC, local testing shortfalls, and hep C treatments and cures.

December 1st
World AIDS Day Rally in Vancouver

On this year’s World AIDS Day the hep C and HIV communities stood in solidarity and honoured those they have lost and celebrated the contributions made by community based organizations here, across Canada, and the world. Daryl made a speech urging the Public Health Agency of Canada to rethink the decisions made to grants for HIV and HCV organizations.

Thank you Daryl and all of the hep C advocates who worked so hard in 2016 to speak up for those living with hepatitis C!

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!

Grazoprevir and Elbasvir at the Liver Meeting 2016

Grazoprevir and Elbasvir at the Liver Meeting 2016As we begin to look back on 2016, this post highlights some of the presentations that took place at the Liver Meeting 2016 about the hep C treatments grazoprevir and elbasvir.

Grazoprevir and Elbasvir

  • #74C-ISLE: Grazoprevir/Elbasvir plus Sofosbuvir in Treatment- naïve and Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or 16 weeks
Treatment Naive Treatment Experienced
Arm 1, 8 weeks + RBV Arm 2, 12 weeks without RBV Arm 3, 12 weeks without RBV Arm 4, 12 weeks with RBV Arm 5, 16 weeks without RBV
Treatment Week 4 87% 74% 71% 88% 71%
Treatment Week 8 100% 100% 100% 100% 100%
  • #76Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naive Subjects with Chronic HCV GT 1, GT 4 and GT 6 Infection (C-CORAL): A Phase III Randomized Multinational Clinical Trial

Summary: Hepatitis C contributes significantly to the overall liver disease burden in the Asia Pacific region and Russia where the seroprevalence rates vary from 1-5% and genotype (GT) 1b accounts for about half of infections. Conclusion: A 12-week regimen of EBR/GZR is effective and well-tolerated in GT1 and GT4-infected, treatment-naive patients in the Asia Pacific/Russia region.

Genotype SVR12 Rate
Overall (232/250) 92.8%
GT1a (23/26) 88.5%
GT1b (185/187) 98.9%
GT4 (2/2) 100%
GT6 (22/35) 62.9%
  • #110Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B of C-CREST-1 & 2)

Summary: Treatment was generally well tolerated, with no cardiac or renal safety signals seen. One GT1-infected patient died due to a study drug-unrelated bacterial sepsis The most common side effects, in >5% of all patients, were fatigue, headache, and nausea.

Patients SVR8/12 Rate
126 GT1-infected patients who recieved 8 or 12 weeks of treatment 100%
85 patients (46 GT1a/39 GT1b) who received 12 weeks of therapy 100%
  • #112High Sustained Virologic Response (SVR) Rates in Patients with Chronic HCV GT1, 2 or 3 Infection Following 16 Weeks of MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of Therapy (Part C of C-CREST-1 & 2)

Summary: To evaluate a retreatment regimen for patients who had failed therapy with a 3-drug direct-acting antiviral (DAA) combination: MK-3682, an NS5B polymerase inhibitor, grazoprevir, an NS3/4A protease inhibitor, and either elbasvir or MK-8408, which are NS5A inhibitors. All of the patients achieved SVR. The most common (>10%) side effects were headache, fatigue, nausea, rash, pruritus, insomnia, decreased hemoglobin, and cough.

  • #193Safety and Efficacy of the Fixed-Dose Combination Regimen of MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients with Chronic HCV GT1 Infection who Previously Failed a Direct-acting Antiviral Regimen (C-SURGE)

Summary: Patients who have failed an NS5A-containing DAA treatment regimen (Harvoni or Zepatier) are an unmet medical need because there isn’t enough data to guide physicians in their management. This study found that the treatment MK-3682/Grazoprevir/MK-8408 did well.

Arm Proportion of Patients with HCV RNA <15 IU/mL
Treatment Week 4 Treatment Week 8
16 weeks + RBV 39/42 (93%) 35/35 (100%)
24 weeks without RBV 44/49 (90%) 38/38 (100%)

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.

Possible Softening of Liver Fibrosis Stage F1> Treatment Requirement

Possible Softening of Liver Fibrosis Stage F1> Treatment RequirementThe Pacific Hepatitis C Network has received reports that at least one Canadian assistance program offered by a pharmaceutical company is working with patients, on a case-by-case basis, to treat those with liver fibrosis stage F1. The status quo, requiring a liver fibrosis stage F2 or higher to access hep C treatment, in Canada may be changing and the Pacific Hepatitis C Network applauds this possible change.

If you have hepatitis C and are interested in treatment, please talk to your healthcare provider about it and keep regular tabs on your liver’s health.

Liver Fibrosis

Liver fibrosis is the early stage of liver scarring. It happens when a liver tries to heal itself and in the process creates scar tissue that can’t do the work of normal liver cells. Fibrosis doesn’t cause symptoms but can lead to portal hypertension or liver cirrhosis. A liver biopsy is used to diagnosis it. Fibrosis can be stopped and some of the changes reversed if the underlying condition is treated.

Liver Fibrosis Stages

There are five stages of liver fibrosis, stage 0 to stage 4 (stage F1-F4). Stage 0 means a liver is normal and doesn’t have fibrosis. Stage 4 is liver cirrhosis. Currently, BC PharmaCare requires a patient to have liver fibrosis stage 2 or higher in order to possibly qualify for hep C treatment coverage. At stage 2, one may still not know that their liver is damaged and may not experience liver failure symptoms such as yellow skin or eyes or abdominal pain.

More information about liver fibrosis and liver cirrhosis can be found in Understanding Cirrhosis of the Liver: First steps for the newly diagnosed, an easy-to-read resource that was put together by CATIE and the Canadian Association of Hepatology Nurses.

New Drug Application Submitted for Sofosbuvir/Velpatasvir/Voxilaprevir

New Drug Application Submitted to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir~ A New Drug Application has been submitted to the FDA. If Approved, Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Would Be the First Once-Daily Single Tablet Regimen Available as a Treatment Resorted to when Preferred Therapies have been Tried, or a Salvage Treatment,  for Patients with Hep C Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors ~

The creator of the hepatitis C treatment SOF/VEL/VOX, Gilead, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the hep C treatment. SOF/VEL/VOX has been submitted as an once-daily single pill regimen for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients.

The Data Submitted in the New Drug Application (NDA)

The data submitted in the NDA, see below, supports the use of the regimen for 12 weeks in DAA treatment experienced patients with genotype 1 to 6 hep C who have or don’t have liver cirrhosis.

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 455 patients, including those who failed prior treatment with an NS5A-containing regimen, 41 percent (172/415) had cirrhosis 1-6 12 weeks SOF/VEL/VOX 96%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/VOX 97%
SOF/VEL 90%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/VOX 95%
12 weeks SOF/VEL 98%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/VOX 96%
12 weeks SOF/VEL 96%

Patients treated with SOF/VEL/VOX for 12 or 8 weeks experienced side effects similar to those treated with placebos. The most common side effects from SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

No news on or how the treatment may be submitted to Health Canada.

More Information

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.

The PHCN‘s News in Review Newsletter (06/12/16)

The PHCN‘s News in Review Newsletter (06/12/16)Welcome to the Pacific Hepatitis C Network (PHCN)‘s second Hepatitis C News in Review Newsletter. This is where we review all of the major current issues and events around hepatitis C and hep C treatments. It is an email that includes links to our recent blog posts—including links to blog posts about Public Health Agency of Canada funding.

HEALTH CANADA SUMMARY SAFETY REVIEW – DAAs – ASSESSING THE POTENTIAL RISK OF HEPATITIS B VIRUS REACTIVATION

Please click here for more information.

WHAT WOMEN WITH HEPATITIS C EXPERIENCE NEEDS TO BE IMPROVED NOW

“Although our research on the experience of diagnosis was undertaken prior to the present major advances of interferon-free HCV treatment, which have given new hope of speedy and less burdensome treatment, these new treatments alone will not solve the burden of HCV.” (Mitchell, et al. 2016)

Therefore, it is still critical to examine how women with hepatitis C are cared for and then strive to improve that care. The findings of a new study, published in a recent issue of the Canadian Journal of Nursing Research, are interesting and a good start. Click here to read more.

HEPATITIS C ADVOCACY HIGHLIGHTS

Recently the Public Health Agency of Canada (PHAC) announced that community-based projects that lost funding in the October changes to the HIV and Hepatitis C Community Action Fund‘s Letter of Intent (LOI) funding process will now, on a case-by-case basis, have transitional project funding until March 31, 2018. Click here for more information.

On December 1st, World AIDS Day, the HIV and HCV communities stood together in solidarity with organizations who were denied funding going forward as part of the changes to the PHAC Community Action Fund LOI process. More information about the rally is here.

Daryl Luster was at the World AIDS Day rally and wrote and gave a speech entitled: We Have Not Abandoned the Principles or Communities We Serve, Neither Should PHAC.

In addition, November began with Daryl meeting with BC NDP MLA Shane Simpson. They spoke about the landscape of hepatitis C in BC, local testing shortfalls, and hep C treatments and cures. See a picture here.

HEP C HIGHLIGHTS FROM THE CANADIAN DRUG APPROVAL PIPELINE AND THE LIVER MEETING 2016

The Liver Meeting 2016, the American Association for the Study of Liver Diseases (AASLD)‘s 67th annual meeting, was held last month. Exciting and important hep C clinical results were presented. Some of these highlights can be found in the following posts:

For more information about the topics in this newsletter, please click on the links, visit PHCN’s Hepatitis C Treatment Information Project, or email us.