All posts by Hep C TIP

CROI 2017 Hep C Highlights Part I

CROI 2017 Hep C Highlights Part ICROI 2017

The Conference on Retroviruses and Opportunistic Infections (CROI), an annual preeminent HIV research meeting, was held in Seattle, Washington, February 13-16 this year. CROI gathers scientists researching epidemiology and biology of human retroviruses and associated diseases to discuss their findings.

This blog post is a collection of HIV/HCV highlights that were presented. Please scroll down and click on the subjects that interest you.

Interesting Meeting Abstracts about HIV/HCV Coinfection

More information about The Conference on Retroviruses and Opportunistic Infections (CROI), or these and other studies can be found in our blog post CROI 2017 Hep C Highlights Part II or on the conference’s website.

Ontario Drug Benefit Program Funding Hepatitis C Drugs

Ontario Drug Benefit Program Funding Hepatitis C Drugs“The criteria for coverage of hepatitis C treatments is being expanded in a phased approach. Coverage will be further extended to all patients regardless of severity of disease or genotype within the next 12 months.” –Ontario Public Drug Programs

“We look forward to the day that all criteria are lifted and all people living with hep C can access treatment, regardless of disease and genotype.” -Pacific Hepatitis C Network

Reposted from Ontario Public Drug Program Dated February 21, 2017

Effective February 28, 2017, the following hepatitis C drug products will be funded under the Ontario Drug Benefit (ODB) Program for eligible ODB recipients for the treatment of hepatitis C.

• Harvoni (ledipasvir/sofosbuvir)
• Sovaldi (sofosbuvir)
• Epclusa (sofosbuvir/velpatasvir)
• Zepatier (elbasvir/grazoprevir)
• Daklinza (daclatasvir)
• Sunvepra (asunaprevir)
• Ibavyr (ribavirin)

The above drugs will be listed on the ODB Formulary/Comparative Drug Index (Formulary) as Limited Use (LU) benefits.

Health care providers are advised to refer to the Formulary for information about the specific reimbursement criteria applicable to each of the funded hepatitis C drugs.

The range of funded hepatitis C drug products will enable funding consideration for patients with most of the common or mixed genotypes in Ontario when the specified criteria are met.

The full details of the LU criteria will be also be posted in the February 2017 monthly Formulary update at:

www.health.gov.on.ca/en/pro/programs/drugs/odbf_eformulary.aspx

For more information, refer to the Frequently Asked Questions (FAQs) for healthcare providers and patients.

Additional Information:
For pharmacies:
Please call ODB Pharmacy Help Desk at: 1-800-668-6641

For all other Health Care Providers and the Public:
Please call ServiceOntario, Infoline at 1-866- 532- 3161 TTY 1-800-387 -5559. In Toronto, TTY 416- 327 -4282

PHCN’s Statement about the Successful Negotiations for 3 New Hepatitis C Treatments

PHCN's Statement about the Successful Negotiations for 3 New Hepatitis C Treatments‘No One Left Behind!’

Pacific Hepatitis C Network (PHCN) is very happy to learn that effective March 21, an extensive list of hepatitis C treatments will be available through BC PharmaCare – at far better prices than they previously had been. The high cost of hepatitis C treatment has effectively restricted the numbers of people living with hepatitis C who could access treatment.

Even with lower prices, those restrictions will remain in place until next year. Come March 2018, those restrictions (requiring a liver fibrosis stage of F2 or greater) will be lifted and hepatitis C treatment will be available to any person living with hepatitis C in BC, “regardless of the type and severity of their disease”.

The Province, via the Ministry of Health, co-led the negotiations for new, affordable prices and we at PHCN are both proud of that fact and sincerely grateful. We hope the same for new, hep C drugs that are currently in development and that improve even more on cure rates, tolerability, length of treatment, and treating more than one HCV genotype.

And with these new developments, our work continues! Now is the time to identify and address the barriers still in place that keep those living with hep C from accessing care and treatment: low levels of primary care provider awareness of hep C and treatments; believes about who deserves treatment and who doesn’t; patient education and outreach to those who were diagnosed years ago but are not engaged in care for their hep C. Stigma can and does underlay many of those barriers and must be addressed.

PHCN applauds the ushering in of the first critical step by BC’s Ministry of Health and we urge continued vigilance and collective planning and action to ensure ’No One Left Behind!’ when it comes to hepatitis C care and treatment in BC.

More information can be found here.

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C Treatments

BC Ministry of Health Press Release: More Patients to Benefit from Hepatitis C TreatmentsCopied and Pasted from BC Ministry of Health on February 21, 2017.

Thousands of British Columbians living with hepatitis C will have better access to treatment as a result of successful negotiations brokered by the pan-Canadian Pharmaceutical Alliance (pCPA).

“This agreement changes the landscape for hepatitis C patients living in B.C.,” said Health Minister Terry Lake. “Not only are there four new treatment options for what is now a curable virus, but the savings that were negotiated will allow us to cover treatment options for all hepatitis C patients – rather than just those in more advanced stages of the disease.”

British Columbia and Ontario co-led the negotiations with the drug manufacturers on behalf of the pCPA. The alliance helps provinces and territories leverage their collective buying power and negotiate better prices for new drugs.

The collaborative effort resulted in a significant cost savings to drug plans for participating provinces and territories. The agreement also allows access to treatment for all eligible patients in a fiscally sustainable manner. Prices and terms for this negotiation are confidential.

The list cost to the health system for hepatitis C treatment has ranged from $45,000 to over $100,000 per patient, depending on the drug and disease progression.

Agreements with the pCPA were reached with Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada to provide several hepatitis C drugs at an improved cost:

  • Daklinza (daclatasvir) – new
  • Epclusa (sofosbuvir/velpatasvir) – new
  • Harvoni (ledipasvir/sofosbuvir)
  • Sovaldi (sofosbuvir)
  • Sunvepra (asunaprevir) – new
  • Zepatier (elbasvir/grazoprevir) – new

PharmaCare is expanding the criteria in March 2017 to provide coverage to more patients living with hepatitis C. Physicians can apply for coverage of the new drugs on behalf of their patients on or around March 21, 2017. Starting in 2018-19, PharmaCare will provide coverage for any British Columbian living with chronic hepatitis C, regardless of the type or severity of their disease.

Up to 75,000 British Columbians are estimated to be living with hepatitis C. Approximately 24% of those exposed to the virus are able to clear it on their own. However, when left untreated, it can cause serious complications such as liver failure and liver cancer. The new modern hepatitis C therapies are highly effective, with the ability to clear the virus at rates over 95%.

If untreated, hepatitis C virus infection can be a life-threatening communicable disease. Risk and harm reduction practices are strongly encouraged for those who may be at higher risk for re-acquiring the virus after successful treatment, including people who inject drugs, men who have sex with men, and commercial sex workers.

Hepatitis C is the most-frequent cause of premature death among reportable infectious diseases in North America, and has become the most-frequent cause of premature death among people living with both hepatitis C and HIV.

Quick Facts:

  • Hepatitis C is a serious, communicable disease that is spread through direct contact with the blood of a person living with the virus. Symptoms may include fatigue, jaundice, abdominal pain and joint pain. In some people, it can cause liver damage (cirrhosis) or liver cancer.
  • Up to 75,000 people are estimated to be living with hepatitis C in British Columbia. However, many people with the virus have no symptoms. About one-quarter of people living with hepatitis C do not know they have it.
  • About one-quarter of people with hepatitis C do not need treatment, as their body fights off the infection.
  • Once someone is successfully treated and cured of hepatitis C infection, they are no longer able to pass the disease on to others.
  • Currently, there is no vaccine to prevent hepatitis C infection.
  • From March 2015 to December 2016, PharmaCare coverage was provided to about 3,800 people in B.C. for medication used to treat chronic hepatitis C.

Learn More:

For more information on the pan-Canadian Pharmaceutical Alliance:
http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance

For more information about B.C.’s PharmaCare program:
http://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents

Successful Negotiations for Three New Hepatitis C Treatments

Successful Negotiations for Three New Hepatitis C TreatmentsDirectly copied statement from the pan-Canadian Pharmaceutical Alliance

TORONTO, Feb. 21, 2017 /CNW/ – On behalf of participating federal, provincial and territorial public drug plans, the pan-Canadian Pharmaceutical Alliance (pCPA) has concluded successful negotiations with three drug manufacturers to help jurisdictions expand access to publicly funded medications for the treatment of chronic hepatitis C.

Hepatitis C is a communicable liver disease that is caused by an infection with the hepatitis C virus. Seventy-five per cent of people who have contracted hepatitis C cannot spontaneously clear the virus. This leads to chronic hepatitis C infection. Although many of the estimated 250,000 infected Canadians may have no symptoms for decades, if left untreated, chronic hepatitis C can lead to serious complications such as liver failure and liver cancer.

Just a few years ago, hepatitis C patients took a combination of pills and injections for almost a year and these earlier drugs had lower rates of treatment success. Today’s newer therapies are more effective, available in oral form and require substantially shorter durations of treatment.

These benefits, however, come at a substantial cost. Depending on the drug and disease progression, the list cost for hepatitis C treatments ranged from $45,000 to over $100,000 per patient. Although these costs were made more affordable with previous agreements, the funding of hepatitis C treatments has resulted in significant cost pressures.

Recently, multiple products have become available, creating a more competitive environment for hepatitis C treatment price negotiations.

The pCPA’s approach to hepatitis C treatment negotiations was guided by the following:

  • goal of providing treatment for patients regardless of genotype and disease severity
  • financial affordability and sustainability
  • a fair approach in negotiating value among multiple drugs and manufacturers.

Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada were able to reach an agreement through the pCPA to provide hepatitis C drugs at an improved cost. These agreements will help increase publicly funded access for most patients with hepatitis C.

As with all pCPA drug negotiations, individual participating jurisdictions will be responsible for implementing changes under their respective public drug plans.

SOURCE Pan Canadian Pharmaceutical Alliance (pCPA)

For further information: For more information (media): David Jensen, Ministry of Health and Long-Term Care, 416-314-6197

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.

What’s Been Recently Published About Hep C (December/January)

What's Been Recently Published About Hep CThe following highlights a variety of December/January published studies, articles, and press releases about hepatitis C and hepatitis C treatments.

Alimentry Pharmacology & Therapeutis (January 2017)

Summary: This study looked at the effectiveness and predictors of taking pegylated interferon with ribavirin (PR) and patients taking sofosbuvir (SOF) and PR. SVR ranged from 80.9% in the PR group to 96.1% in PR+SOF treated patients. Treatment-experienced patients with cirrhosis showed a suboptimal SVR of 68% for SOF+RBV but a high SVR of 90–95% for Daklinza+SOF±RBV. The safety analysis showed more adverse events and a stronger decline of haemoglobin for RBV based regimens.

Summary: This study looked at the effectiveness and predictors of taking sofosbuvir and ribavirin for 6 months versus taking the treatment sofosbuvir with pegylated interferon with ribavirin for 3 months. Group one achieved a 94% cure rate. In group two 78.7% achieved SVR. These results were similar to those achieved in other clinical trials.

Hepatology (December 2016)

Summary: Combining different DAAs with a variety of mechanisms may help shorten required treatment durations. This study aimed to find the treatment combination promising the best results the fastest. The study gave patients elbasvir/grazoprevir and sofosbuvir for 4-12 weeks. Patients being retreated were given the compound with ribavirin for 12 weeks. Cure rates were as follows:

Patients Treatment Weeks SVR
Without liver cirrhosis hep C genotype 1 4 32%
6 87%
With liver cirrhosis hep C genotype 1 4 80%
6 81%
Without liver cirrhosis hep C genotype 3 6 93%
8 100%
With liver cirrhosis hep C genotype 3 12 83%

The Lancet (December 2016/January 2017)

Summary: This clinical trial looked at the safety and effectiveness of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated anti-miR-122 oligonucleotide. The trial showed that RG-101 could achieve SVR after 4 weeks of treatment.

Recent Press Releases by Pharmaceutical Companies

Patients Treatment Weeks Treatment SVR
GT1 without cirrhosis, some with the resistance-associated Y93H virus variant 8 Glecaprevir / Pibrentasvir 99%
12

Technivie

100%

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.