Tag Archives: Elbasvir

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.

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.

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.

Thank you for Your Input

grazoprevir / elbasvirThank you to all of you who completed PHCN’s grazoprevir / elbasvir patient input survey and the earlier Technivie  patient input survey. Thank you also for sharing them with others. It was truly an honour to read your responses and to use them to write the patient group input report for the Canadian Agency for Drugs and Technologies in Health (CADTH) on your behalf.

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The patient input about grazoprevir / elbasvir was sent in this morning. We now wait to hear the outcome of the treatment submissions.

The Hepatitis C Treatment Information Project will keep you apprised of any news and is here to answer any questions you may have.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

Grazoprevir / Elbasvir CTAC Patient Input Group Webinar

CTAC Patient Input Group WebinarOn November 2 @ 11am PST / 1pm EST, the Canadian Treatment Action Council (CTAC) will be hosting a CTAC Patient Input Group Webinar about the exciting new hep C treatment grazoprevir / elbasvir.

The patient input survey that will follow CTAC’s grazoprevir / elbasvir webinar is different from PHCN’s patient input survey or PHCN’s loved ones / caregivers survey. Please consider filling out the PHCN survey that was created for you as well as CTAC’s survey.

Registration for the CTAC webinar is required to attend
. Click here to register or for more information about the webinar.

About the Canadian Treatment Action Council (CTAC)

CTAC is a Canadian non-governmental organization led by and for people living with HIV and HIV/HCV co-infection. Since 1996, they have been working to secure and ensure equitable, affordable, and timely access to treatment and care and support for people in Canada living with HIV and HIV/HCV co-infection.

Grazoprevir / Elbasvir Patient Input Surveys

Grazoprevir / Elbasvir Survey DotTake this survey if you are living with hep C/if you have had hep C.

Take this survey if you are a caregiver or loved one of someone who is living with hep C/had hep C.

Grazoprevir / elbasvir information is here.

The survey links will only remain open until November 4th so please complete a survey and share the survey links with others ASAP.

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently seeking patient input for grazoprevir / elbasvir and, therefore, the Pacific Hep C Network (PHCN) needs your thoughts, opinions, and experiences for our patient group input report.

PHCN’s Grazoprevir / Elbasvir Patient Input Surveys

There are two PHCN Input Surveys

The first survey was written for those with hep C or those who have had hep C. It includes 14 questions, some multiple choice, and is divided into 4 sections. The most important of these sections are ‘Section 2 of 4: Your Expectations of grazoprevir / elbasvir’ and ‘Section 3 of 4: Your Experience with grazoprevir / elbasvir’, if you have been treated with grazoprevir / elbasvir. If you haven’t taken grazoprevir / elbasvir, the survey lets you skip this section.

The second survey was written for loved ones or caregivers of those living with hep C/have had hep C. It includes 7 questions divided into 2 sections.

If the surveys don’t focus on something you would like to add, please use a textbox and include it as one of your answers. Some of the questions require answers but others were written to, hopefully, help you share your experiences or voice your opinion.

Survey responses are anonymous (we don’t know your name or other information about you). The information gathered will be used as part of a patient group input report for CADTH. By completing the survey you accept that PHCN can use the information gathered by it in our patient group input report for CADTH.

The survey links will only remain open until November 4th so please complete a survey and share the survey links with others ASAP.

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about grazoprevir / elbasvir.

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

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).

Grazoprevir/Elbasvir Announcement

Grazoprevir/elbasvirYesterday the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for the hep C treatment grazoprevir/elbasvir, developed by Merck.

About Grazoprevir/Elbasvir

Grazoprevir/elbasvir is a once-daily, single-pill hep C treatment made up of grazoprevir, a NS3/4A protease inhibitor, and elbasvir, a NS5A inhibitor. It is being tested on patients with difficult-to-treat conditions such as HIV/HCV co-infection, advanced chronic kidney disease, or advanced liver cirrhosis or inherited blood disorder.

In April, the Food and Drug Administration (FDA) in America gave the treatment Breakthrough Therapy designation to treat patients with hep C genotype 1 with end stage renal disease on hemodialysis, and patients with hep C genotype 4 or 6. The Breakthrough Therapy designation helps fast-track treatments through the American drug approval process when they treat serious diseases and their clinical trial results show that the drug may be a large improvement over existing therapies.

In Canada, Health Canada is currently reviewing the treatment. It has not been approved for use yet.

Additional grazoprevir/elbasvir information can be found on the Hepatitis C Treatment Information Project’s Hep C Drug Pipeline Treatments and Clinical Trial Results pages.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way.

They help ensure that patients and their loved ones can be a part of the drug review process!