Tag Archives: CADTH

Drug Pipeline

Sofosbuvir/Velpatasvir CTAC Webinar

Sofosbuvir/Velpatasvir CTAC Patient Group Input WebinarThis Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Following the webinar, there will be a survey to collect information that will help them write a patient input report for sofosbuvir/velpatasvir’s Common Drug Review. CTAC’s sofosbuvir/velpatasvir survey is different from PHCN’s patient input survey or PHCN’s loved ones/caregivers survey. Please consider filling out the still available 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 and for more information about the webinar.

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.

Patient Group Input Reports Requested by CADTH’s Common Drug Reviews

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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.

 Sofosbuvir/Velpatasvir

Sofosbuvir/velpatasvir is an all-pill, short-course (sometimes only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Drug Pipeline

Take this survey. Sofosbuvir / Velpatasvir Input Requested.

The above survey links will only remain open until April 27th, 2016, so please complete a survey and share the survey links with others ASAP.

The Drug Approval Process is Seeking Patient and Caregiver Input

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently reviewing the hep C treatment sofosbuvir / velpatasvir. As part of their review, they are seeking patient and caregiver input about hep C and hep C treatments from Canadian patient groups. Therefore, we, the Pacific Hep C Network (PHCN), are seeking your thoughts, opinions, and experiences for our patient group input report.

More information about CADTH and patient group reports is below.

PHCN’s Sofosbuvir / Velpatasvir 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 Sofosbuvir / Velpatasvir’ and Take this survey. Sofosbuvir / Velpatasvir Input Requested.‘Section 3 of 4: Your Experience with Sofosbuvir / Velpatasvir’, if you have been treated with sofosbuvir / velpatasvir. If you haven’t taken sofosbuvir / velpatasvir, 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 and 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 the sofosbuvir / velpatasvir 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 April 27th, so please complete a survey and share the survey links with others ASAP.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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 are a part of the drug review process!

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about sofosbuvir / velpatasvir.

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

Drug Pipeline

Sofosbuvir / Velpatasvir is up for Review

Sofosbuvir / Velpatasvir is up for ReviewSofosbuvir / velpatasvir is up for review. This morning the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for sofosbuvir / velpatasvir. Sofosbuvir / velpatasvir is an all-pill, short-course, interferon-free treatment for those with chronic hepatitis C, genotype 1, 2, 4, 5, or 6.

Please keep your eyes open for a blog post with more information about sofosbuvir / velpatasvir and a link to PHCN’s patient input survey. They will be finalized and sent out in the next few days.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then 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 are a part of the drug review process!

Please email or visit the Hepatitis C Treatment Information Project for more information about sofosbuvir / velpatasvir or any other hep C treatment.

Drug Pipeline

Canadian Public Drug Plans Request Answers

Canadian Public Drug Plans Request AnswersSubmit Your Answers to the Following 2 Questions BY EMAIL

OR

Submit Your Answers to the Following 2 Questions BY ONLINE QUESTIONNAIRE

Only submit your answers once. Submit your answers before February 12, 2016.

Our Request

We are asking that you take a moment to send us your answers to the two questions below and any other information that may help us with this request for patient input.

CADTH’s Request for Patient Input

The public drug plans that seek advice from CADTH’s Canadian Drug Expert Committee (CDEC), such as BC PharmaCare, have requested guidance about aligning two sets of recommendations for four hepatitis C treatments (Daklinza, Harvoni, Holkira Pak, and Sovaldi). The two sets of recommendations that the drug plans want aligned are CADTH’s therapeutic review on drugs for hepatitis C and CDEC Final Recommendation for the four hepatitis C treatments. (More information about the four CDEC final recommendations is below.)

The response to this request may result in changes to the current CDEC recommendations or new CDEC Records of Advice for these treatments.

Therefore, the CDEC has asked for patient input about the four hep C treatments, specifically answers to the following two questions:

  • Question 1: “Is there anything the CADTH review team should be aware or reminded of, when updating individual recommendations for Harvoni, Holkira Pak, Sovaldi and/or Daklinza?”
  • Question 2: “How do patients or how do you view hep C treatments that require ribavirin?”

Question 2 has been asked due to mixed feelings regarding ribavirin that have been expressed by hep C organizations. Some groups have reported that patients regard ribavirin as an intolerable treatment that is just as bad as interferon, whereas others see it as “tolerable and acceptable, if only barely and temporarily.”

Therefore, how do you feel about ribavirin? Would ribavirin as part of a hepatitis C treatment make you hesitant about that treatment? Would you take ribavirin if it increased your chances of a hep C cure? What information would influence whether you would take ribavirin or not?

Summaries of the CDEC Final Recommendations for Daklinza, Harvoni, Holkira Pak, and Solvaldi

Treatment Targeted Genotypes Recommended Criteria Suggested Conditions for Coverage
Daklinza in combination with Sovaldi*

(CDEC Final Recom-mendation Published Sept 21, 2015)

 1, 2, 3
  • Treatment
    experienced patients
    without cirrhosis who have not responded to
    pegylated
    -interferon plus ribavirin (PR).
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Drug plan cost of a treatment course with daclatasvir plus sofosbuvir should not exceed the drug plan cost of a treatment course with sofosbuvir plus ribavirin.
Harvoni*

(CDEC Final Recom-mendation Published Feb 18, 2015)

 1
  • A fibrosis stage of F2 or higher
  • Prescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Substantially reduced price
Holkira Pak*

(CDEC Final Recom-mendation Published May 21, 2015 and updated July 22, 2015)

 1
  • A fibrosis stage of F2 or higher
  • Pescribing restricted to hepatologists and physicians with experience treating patients with hepatitis C
  • Price should not exceed the drug plan costs of other interferon-free hep C treatments
Sovaldi + Pegylated Interferon with Ribavirin (PR)

(CDEC Final Recom-mendation Published Aug 18, 2014)

 1
  • A fibrosis stage of F2, F3, or F4
  • Have never been treated
  • Funding should not exceed a duration of 12 weeks for the treatment of patients with
    genotype 1 or 2 hep C and 24 weeks for the treatment of patients with genotype 3 hep C
  • Reduced price
Sovaldi + Ribavirin (RBV)*

(CDEC Final Recom-mendation Published Aug 18, 2014)

 2
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
3
  • A fibrosis stage of F2, F3, or F4
  • Previous treatment experience with PR or a medical contraindication to PR
*These treatments have possible pegylated interferon and/or ribavirin free options. Click their links for more information about the treatments. Our Basic Hep C Treatment Terms page also has more information about terms some may not be familiar with. Our Comparing Hep C Treatments page has additional information about the treatments except for Daklinza in combination with Sovaldi.
Request for Advice Regarding CDEC Recommendations for Hepatitis C Drugs

About CADTH

Within the Canadian drug approval process, Health Canada evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

About CADTH’s Canadian Drug Expert Committee (CDEC)

CADTH’s CDEC is an advisory board made up of experts and public members (for a lay perspective) that makes recommendations to the publicly funded drug plans about what and what not to cover and how to cover it.

Please email [email protected] for more information about this CDEC request.

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

Drug Pipeline

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.

Drug Pipeline

New Hep C Treatment Recommendations

New Hep C Treatment RecommendationsThere is excitement over CADTH’s new hepatitis C treatment recommendations report, CADTH Therapeutic Review, Drugs for Chronic Hepatitis C Infection: Recommendations Report, by the Canadian Drug Expert Committee (CDEC).

The report comes after Canadian patient groups, such as PHCN, CTAC,  and Action Hepatitis Canada (AHC), were asked to provide feedback to a draft of the recommendations this summer.

Action Hepatitis Canada has written about the new report and is very pleased that patient groups were asked for input, as are we, and that recommendations are in line with some of their feedback. For example, AHC highlighted the first recommendation which reads:

Recommendation 1: CDEC recommends that all patients with CHC infection should be considered for treatment, regardless of fibrosis score. Given the potential impact on health system sustainability of treating all patients with CHC infection on a first-come basis, priority for treatment should be given to patients with more severe disease.

Recommendation 4 stood out for us as the insufficient evidence seemed surprising. It reads:

Recommendation 4: CDEC considered there to be insufficient evidence to make a recommendation for patients with CHC genotype 5 or 6 infection.

Hep C Treatment Recommendations 2, 3, and 5 are as follows:

Recommendation Targeted Patients Preferred Treatment
2 Those with genotype 1 (GT1) hepatitis C who have never tried treatment (treatment naive) regardless of liver cirrhosis stage Harvoni or Holkira Pak +/- ribavirin for same duration as approved by Health Canada
Those with GT1 hep C who have tried treatment (treatment experienced) regardless of cirrhosis stage Pegylated interferon + ribavirin (PR) for same duration as approved by Health Canada
3 GT2
Sovaldi + ribavirin (12 weeks)
Those with GT3 hep C without cirrhosis Daklinza + Sovaldi (12 weeks)
Those with GT3 hep C with cirrhosis Sovaldi + ribavirin (12 weeks)
Those with GT4 hep C who are treatment naive and don’t have liver cirrhosis Sovaldi + PR (12 weeks)
Those with GT4 hep C who are treatment experienced or have liver cirrhosis regardless of treatment history Insufficient evidence to make a recommendation
5 Those with GT1 hep C who have already tried
a protease inhibitor-PR regimen regardless of cirrhosis stage		 Harvoni
Treatment experienced with an all-oral DAA treatment Insufficient evidence to make a recommendation

Recommended condition for all patients being treated for hep C: Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C. The report also includes recommendations for liver transplant recipients starting on page 22.
For more information, please see the full report, visit PHCN’s Hepatitis C Treatment Information Project, or email us.
Drug Pipeline

Journal Articles Since the Liver Meeting

journalWriting about the hep C research presented at the Liver Meeting 2015 in November started us wondering about what has been published since the meeting. Thus, the following highlights some recent* journal articles and press releases about hep C.

Canadian Medical Association Journal (CMAJ) (December 2015)

  • Federal inmates treated for hep C drop 29% by Paul Christopher Webster (Early release date: November 2, 2015)

Summary: Due to budget cuts, high hep C treatment costs, and an increasing inmate population, the number of inmates in treatment has declined.

  • What’s next for the Liberals on health? by Lauren Vogel

Summary: Upcoming health decisions in Canada will center around: a new health accord to replace the lapsed 2004 Health Accord, PharmaCare, assisted death and marijuana, health promotion, indigenous health, foreign aid and refugee health. [This was included in this blog in hopes of helping hep C advocates.]

The Lancet (November 2015)

  • Profile: British Columbia Centre for Excellence in HIV/AIDS by Tony Kirby

Summary: In 1992, the British Columbia Centre for Excellence in HIV/AIDS opened in Vancouver. It has worked against HIV/AIDS and now, with help from BC’s provincial government, will also work against HCV.

  • Prevalence of HIV, hepatitis B, and hepatitis C in people with severe mental illness: a systematic review and meta-analysis by Elizabeth Hughes, et al.

Summary: A review done to estimate the frequency of blood-borne viral infection in people with serious mental illness.

Hepatology (December 2015)

  • Hepatology highlights by Jean-Francois Dufour The hepatitis C studies that were highlighted by Dufour are:

HCV: Direct-Acting Antiviral Agents Against Vertical Transmission by Tomi T Kanninen, et al.

Summary: Those pregnant can not be prescribed ribavirin and, although the risk is small (2%-10%), can pass HCV onto their babies. This article examines the possibility of  treating pregnant women to eliminate any chance of virus transmission, as recent literature has shown success for those with hep B, and states that more research in this should be collected.

Antibodies to an interfering epitope in hepatitis C virus E2 can mask vaccine-induced neutralizing activity by Alla Kachko, et al.

Summary: So far, a vaccine against HCV remains just a  goal. This article highlights one of the difficulties faced in developing a HCV vaccine and hypothesizes “…that the proximity of the two epitopes [epitopes 1 and 2] leads to physical interference among the antibodies. Epitopes selected for a vaccine should not be in close proximity.” (Dufour)

  • Treatment of hepatitis C virus–associated mixed cryoglobulinemia with direct-acting antiviral agents by Meghan Sise, et al.

Summary: The research team compared cure rates of two hep C treatments, Sovaldi-based regimens and historical controls treated with pegylated interferon and ribavirin (PR), in those with mixed cryoglobulinemia syndrome (MCS). Conclusion: The Sovaldi-based regimens decreased the cryoglobulin levels in 89% of patients, 83% achieved SVR12 (cure). Only 10% of those treated with PR achieved SVR12 and 50% had to stop treatment due to side effects.

Liver International (December 2015)

  • Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study by Donald M. Jensen, et al.

    Summary: Study examined the combinations of setrobuvir (a DAA non-nucleoside inhibitor), danoprevir (a ritonavir-boosted protease inhibitor), and ribavirin, with or without the nucleoside inhibitor mericitabine in hep C genotype 1 patients. The 3 DAAs plus ribavirin combination was found to be safe and effective for hep C genotype 1 patients who have never tried treatment.

CADTH (November 2015)

  • CADTH Therapeutic Review, Drugs for Chronic Hepatitis C Infection: Recommendations Report

Press Releases by Pharmaceutical Companies (International)

  • AbbVie Announces FDA Acceptance of New Drug Application for a Once-Daily Formulation of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) to Treat Genotype 1 Chronic Hepatitis C Virus Infection
  • European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C

*This post concentrated on literature published between November 18th and December 12th, 2015.

Drug Pipeline

Zepatier (grazoprevir / elbasvir) Facts

*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:

  • Health Canada’s Summary Basis of Decision (SBD) documents that provide information related to the original authorization of a product.

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).
Drug Pipeline

Final Recommendation for Daklinza (daclatasvir)

Daklinza (daclatasvir)Daklinza (generic name daclatasvir), developed by Bristol-Myers Sqibb, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

The Canadian Drug Expert Committee (CDEC) Final Recommendation is important within the Canadian drug approval process as it is sent to the provinces and territories to help them decide on PharmaCare coverage.

The CDEC’s Final Recommendation advocates for Daklinzain combination with Sovaldi (sofosbuvir) to be listed as a treatment for adults with chronic hepatitis C genotype 1, 2, or 3 if the following criteria is met:
Clinical Criteria
  • Treatment experienced patients without cirrhosis who have not responded to pegylated interferon with ribavirin (PR).
    The report highlighted that this does not mean that patients who haven’t been treated, are treatment-naive, should be treated with pegylated interferon with ribavirin (PR) first.
Conditions

  • Treatment should be started by hepatologists or physicians experienced with treating chronic hep C.

  • Drug plans should not pay more for Daklinza than they do for Sovaldi (sofosbuvir) plus ribavirin.

Reasons for the Daklinza Recommendations

  1. The clinical trial ALLY-3 results showed high rates of sustained virologic response (SVR12), cure, for treatment experienced patients with chronic hep C genotype 3.

  2. The manufacturer’s pharmacoeconomic evaluation showed that Daklinza plus Sovaldi was a cost-effective option, when it was compared with 24 weeks of Sovaldi plus ribavirin for patients with hep C genotype 3 who are treatment experienced and don’t have liver cirrhosis. However, Daklinza plus Sovaldi was not a cost-effective option for patients with hep C genotype 3 who are treatment naive and/or have cirrhosis.

Reported Research Gaps
  • There aren’t any comparisons between Daklinza and sofosbuvir and the other hep C direct-acting antivirals that are currently used in Canada.
  • There is limited data on patients who have cirrhosis, are co-infected with other diseases, such as AIDS, or who have been treated with other hep C direct-acting antivirals but who weren’t cured.
Other Highlighted Information
  • Four groups responded to CADTH’s call for input from patient groups. This input successfully explained what it’s like to have hep C, what stigma surrounds hep C, what side effects are like, and the importance of having access to inferferon free/low toxicity treatments with shorter treatment durations and no drug interactions.
Daklinza (daclatasvir)

Daklinza is approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.

Daklinza with Sovaldi is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

Drug Pipeline

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!