Tag Archives: ZEPATIER

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.

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

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.

Victrelis (boceprevir) Voluntarily Discontinued

Victrelis (boceprevir) Voluntarily DiscontinuedVictrelis (boceprevir) and Victrelis Triple (Victrelis + pegylated interferon with ribavirin) were officially voluntarily discontinued in Canada yesterday, March 31st, 2016.

Victrelis, combined with pegylated interferon and ribavirin, was a first generation direct-acting antiviral hepatitis C treatment for adult patients with compensated liver disease, who were previously untreated or who had failed treatment. It was approved for use by Health Canada in July 2011.

In 2011, the standard treatment for all hepatitis C genotypes was the combination of pegylated interferon and ribavirin, taken for a year. Scrolling through PHCN’s blog post archive, there is a 2011 blog post about Victrelis and Incivek, another treatment that was approved that same year. In the blog post the new treatments were hailed as “important breakthroughs in the treatment of hepatitis C.”

Five years later, the decision to discontinue Victrelis was not based on safety or efficacy findings, but was based on scientific advancements, changes in treatment practices, and a decreased demand for the hep C treatment.

According to Merck, the treatment’s developer, it is believed that no one in Canada is still taking Victrelis. However, if more information about Victrelis or its discontinuance is required, one can still contact the Merck Care Program at 1-866-872-5773–although, the program is probably fielding less calls about Victrelis these days than it is about Merck’s new hepatitis C treatment, Zepatier*. The Hepatitis C Treatment Information Project certainly is.

*Zepatier is a new hep C treatment being developed by Victrelis’ creator, Merck. Zepatier is an all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for hep C genotype 1, 3, or 4. The treatment is currently being reviewed for BC PharmaCare coverage. Please click this link for more information about the BC PharmaCare review. It is not too late to include your voice.

Input Requested for Zepatier’s BC PharmaCare Review

Input Requested for Zepatier's BC PharmaCare ReviewZepatier’s BC PharmaCare Review Questionnaires (Once on the page, scroll down until you see a colourful table.)

Zepatier (elbasvir – grazoprevir) is being considered for BC PharmaCare coverage. As part of this process, BC PharmaCare has given BC patients, caregivers, and patient groups the opportunity to become a part of this drug review and share their opinions and perspectives with the decision makers.

If you are interested in grabbing this opportunity to voice your opinions, the link above will take you to the questionnaires. The link will also take you to BC PharmaCare’s Drug Information sheet and to information about BC PharmaCare’s approval process.

The questionnaires will ONLY remain open until MIDNIGHT ON Wednesday April 20, 2016.

Adding Your Voice to the BC PharmaCare Coverage Review for Zepatier

If you answer yes to any of the following questions, you can give your input:

Zepatier (elbasvir – grazoprevir)

Zepatier is a Health Canada approved, all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for hep C genotype 1, 3, or 4. The treatment can be prescribed with or without ribavirin and with or without Sovaldi. It has a high cure rate.

Links to Additional Information about Zepatier

For more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Take the time to voice your opinion and help advocate for a better tomorrow!

Add Your Voice for Zepatier

Add Your Voice for ZepatierAdd your voice. Zepatier will soon be considered for BC PharmaCare coverage. Therefore, your input may soon be sought.

Tentatively, patient and caregiver input into Zepatier’s approval process will be requested from Wednesday March 23, 2016 to MIDNIGHT ON Wednesday April 20, 2016.

How to Add Your Voice to the BC PharmaCare Coverage Review for Zepatier

If you are a BC resident and answer yes to any of the following questions, you can give your input into whether or not the treatment should be covered by BC PharmaCare:

Please note that PharmaCare’s questionnaire for Zepatier input tentatively wont be available for another week. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Zepatier in Canada

Zepatier is an approved all-oral, short-course (8, 12, or 16 weeks), interferon-free treatment for genotypes 1, 3, or 4 hep C. It can be taken with or without ribavirin and with or without Sovaldi.

Links to Additional Zepatier Information

For more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Recent Updates to Patient Support Programs

Recent Updates to Patient Support ProgramsPharmaceutical Company Patient Support Programs

Pharmaceutical companies have financial assistance programs for people undergoing their specific treatments. Two of these assistance programs have been updated to include two new hep C treatments, Technivie and Zepatier. These treatments are available for use in Canada but are not currently covered by PharmaCare.

For more information about these programs, call the numbers provided or talk with your healthcare provider about eligibility requirements.

AbbVie Care
Canadians prescribed Technivie can request to be enrolled in AbbVie Care. The program is designed to provide a wide range of customized services including reimbursement assistance, education, and ongoing disease management support. AbbVie Care will not only support people living with hepatitis C throughout their treatment but healthcare professionals as well. For more information, contact your doctor, nurse, or call the program at: 1-844-471-2273.

Merck Care Program
For those who are prescribed Zepatier, Merck has Merck Care Program. For more information, contact your doctor, nurse, or call the program at: 1-866-872-5773.

A list of all of the pharmaceutical company patient support programs can be found at Pharmaceutical Company Assistance Programs.

Zepatier Receives FDA Approval

Zepatier Receives FDA ApprovalZepatier (pronounced ZEP-ah-teer), taken with or without ribavirin, was approved by the U.S. Food and Drug Administration (FDA) yesterday for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4 and little or no liver damage (Child-Pugh A).

Yesterday’s Press Releases about Zepatier’s FDA Approval

Zepatier

Zepatier is an all-oral, short-course (12 or 16 weeks), interferon-free hep C treatment that can be taken with or without ribavirin. The treatment is a pill taken once-daily that is made up of two direct-acting antivirals, grazoprevir and elbasvir.

In clinical trials, Zepatier (with or without ribavirin) cured an overall 94% – 97% of patients with hep C genotype 1, and 97% – 100% of hep C genotype 4 patients.

Zepatier in Canada

On January 22nd, Health Canada approved Zepatier for use in Canada for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring). In Canada, it was approved for use with or without ribavirin and with or without Sovaldi.

More information about Zepatier in Canada can be found at Zepatier Approved in Canada or by visiting PHCN’s Hepatitis C Treatment Information Project.

Zepatier Approved in Canada

ZepatierZepatier (grazoprevir / elbasvir) is now an approved hepatitis C treatment in Canada! Health Canada has granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring).

When Zepatier will be prescribed to patients, the treatment’s regimen will depend on the genotype/type of hepatitis C virus one has, whether or not one has liver cirrhosis, and one’s treatment history (whether or not treatment has already been tried without success).

See Zepatier (grazoprevir / elbasvir) Facts for more information about Zepatier.

What a Notice of Compliance (NOC) Means for Zepatier

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance, a doctor may prescribe it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Zepatier (grazoprevir / elbasvir), or any other new and emerging hep C treatments, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Zepatier (grazoprevir / elbasvir) Facts

Zepatier (grazoprevir / elbasvir)*This Zepatier (grazoprevir / elbasvir) treatment facts sheet was updated January 21, 2016. It was originally put together in October 2015, while CADTH was seeking input for it from patient groups. This sheet is made up of Canadian treatment details. We will keep you updated as the treatment proceeds through the Canadian drug approval process.

Zepatier (grazoprevir / elbasvir)

Targeted Genotypes: 1, 3, 4

Treatment Description: Zepatier (grazoprevir / elbasvir) is made up of two direct-acting antivirals. Grazoprevir is a NS3/4A protease inhibitor. It works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. Elbasvir is a NS5A inhibitor. It blocks a virus protein, NS5A, that the virus needs to reproduce and for various stages of infection.

The treatment has been studied with ribavirin and Sovaldi (sofosbuvir) for multiple hep C genotypes and in patients with difficult-to-treat conditions, such as HIV/HCV co-infection and advanced chronic kidney disease.

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 90% – 98%

Daily Dose: 1 pill of Zepatier at the same time every day +/- Sovaldi +/- ribavirin
Zepatier can be taken with or without food.

Possible Length of Treatment:  8 – 16 weeks

Without Ribavirin:

Patients Weeks
With hep C genotype 1 or 4 who have never tried treatment or have tried treatment with peginterferon and ribavirin (PR) but relapsed 12
With hep C genotype 1 who has tried treatment with a protease inhibitor but relapsed 12
With hep C genotype 1b who has never tried treatment and doesn’t have liver cirrhosis 8
With hep C genotype 1b who has tried treatment with peginterferon or PR but experienced on-treatment virologic failures 12

With Ribavirin:

Patients Weeks
With hep C genotype 1a who has tried treatment with peginterferon (PI) or with peginterferon and ribavirin (PR) but experienced on-treatment virologic failures 16
With hep C genotype 4 who have tried treatment with PR but experienced on-treatment virologic failures 16

With Sovaldi:

Patients Weeks
With hep C genotype 3 who have never tried treatment 12

Availability:  Zepatier is approved for use in Canada

Common Side Effects Reported During Clinical Trials:

  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Trouble sleeping

If you experience any side effects listed or not listed here, contact your healthcare professional.

Usage Warning: Do not take Zepatier if you have moderate or severe liver problems (Child-Pugh B or C). Tell your doctor about any medication (over the counter, prescribed, or recreational) you are taking before taking Zepatier.

See our Sovaldi and ribavirin pages for more information about their possible side effects and usage warnings.

Co-infected with HIV:  Same dose and length of treatment required. Tell your doctor about any medication (over the counter or prescribed) you are taking before taking Zepatier.

More Information:

Sampling of Phase II/III Clinical Trials for Zepatier:

Clinical Trial Patients Treatment Regimen Duration in Weeks
SVR12*
C-EDGE (looked at treatment-naive, treatment experienced and HIV co-infected patients) GT 1, 4, 6 treatment naive with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 97%, GT1a 92%, GT1b 99%, GT4 100%, GT6 80%
GT 1, 4, 6 HIV/HCV co-infected with (C) or without cirrhosis (NC) ZEPATIER 12 95% (total) NC 94%, C 100%, GT1a 94%, GT1b 96%, GT4 96%, GT6 100%
GT 1, 4, 6 treatment- experienced with or without cirrhosis ZEPATIER +/- Ribavirin (RBV) 16 92% (- RBV total), GT1a 94%, GT1b 96%, GT4 60%, GT6 75%
97% (+ RBV total), GT1a 95%, GT1b 100%, GT4 100%, GT6 100%
C-SALVAGE (looked at retreat duration)
GT 1, previously failed with PR + a DAA**, with or without cirrhosis ZEPATIER + RBV 12 96% (total)
94% (cirrhosis)
C-SURFER (still ongoing) GT 1, treatment-naïve and patients who failed pegylated interferon, with or without cirrhosis, chronic kidney disease stages 4 or 5 ZEPATIER 12 99%
*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.

**The direct antiviral agents listed were Incivek (telaprevir), Victrelis (boceprevir), and Galexos (simeprevir).