Tag Archives: asunaprevir

Sunvepra (Asunaprevir) Final Recommendation Sent to PharmaCare Plans

Sunvepra (asunaprevir) Final RecommendationSunvepra (generic name asunaprevir), developed by Bristol-Myers Sqibb, passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation for it.

The Canadian Drug Expert Committee Final Recommendation is important within the Canadian drug approval process as it’s sent to the provinces and territories to help them decide on how they want to cover the treatment through their PharmaCare plans.

The CDEC Final Recommendation for Sunvepra (asunaprevir) when combined with Daklinza (daclatasvir)

The CDEC advocates that Sunvepra, in combination with Daklinza (daclatasvir), be listed by drug plans as a treatment for adults with chronic hepatitis C genotype 1b and with Daklinza, pegylated interferon, and ribavirin, for patients with hep C genotype 1 or 4, if the following criteria/conditions are met:

Recommended Clinical Criteria
  • None listed. This is the first CDEC report for a hep C treatment to not recommend that the treatment only be covered for patients who have a liver fibrosis stage of F2 or higher–this is a great omission.
Recommended Conditions
  • Drug plans should save money when comparing this treatment’s cost to the cheapest hep C treatment alternative.
  • Treatment should be started by hepatologists or physicians experienced with treating chronic hepatitis C.

Reasons for the Above Sunvepra Recommendations
  1. A review of clinical trial results suggests that Sunvepra’s treatment response rates are comparable to success/cure rates of other interferon-free hep C treatments. However, it was noted that there are no trial results with direct comparisons to other treatments already covered by public drug programs. This has also been noted in CDEC recommendations for other hep C treatments.

  2. “There is uncertainty regarding the cost-effectiveness of ASV [Sunvepra] combination regimens…” when they are compared with other hepatitis C treatments.(CDEC)
Noted Discussion Points
  • Efficacy of these Sunvepra-based treatment combinations for patients with decompensated liver disease, hepatitis B, or HIV coinfection, malignancy, or recent drug use, remains uncertain. However, the current data indicates that Daklinza + Sunvepra is effective and safe for all of these patients.
  • The CDEC believes that there will be “limited use” of pegylated interferon with ribavirin-based treatments when there are interferon-free treatments available.
  • Further research into patients infected with hepatitis C with L31 or Y93 HCV NS5A-resistant variant at baseline is needed. (CDEC)

The Canadian Drug Expert Committee’s Final Recommendation for Sunvepra can be found here.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed with other hepatitis C treatments/direct-acting antivirals (DAAs). It is a treatment for patients with chronic hepatitis C genotype 1 or 4.

Sunvepra, in combination with Daklinza, peginterferon, and ribavirin, has been tested on those with hep C genotype 1 or 4 who were non-responders (patients who tried treatment but it failed to achieve SVR/a cure) with great results. The cure rate when treating patients with hep C genotype 1 is 93.2%. The cure rate when treating patients with hep C genotype 4 is 100%. (Health Canada)

Lastly, doctors are able to prescribe Sunvepra to patients, but the hepatitis C treatment isn’t covered by PharmaCare yet.

Your Voice Requested for Sunvepra’s BC PharmaCare Review

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

Sunvepra (asunaprevir) is being considered for BC PharmaCare coverage. As part of this process, BC patients, caregivers, and patient groups have 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 June 15, 2016.

Adding Your Voice to the BC PharmaCare Coverage Review for Sunvepra

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

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/’cure’) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

Links to Additional Information about Sunvepra

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!

Sunvepra (asunaprevir) Facts

Sunvepra (asunaprevir) FactsSunvepra (generic name asunaprevir) is being considered for BC PharmaCare coverage. As part of this process, BC patients, caregivers, and patient groups have the opportunity to become a part of this drug review and share their opinions and perspectives with the decision makers.

The below treatment fact sheet was designed to give you more information about Sunvepra (asunaprevir). and to encourage you to submit your opinions about the hep C treatment and other treatments.

Sunvepra (asunaprevir) Facts

BC PharmaCare is considering Sunvepra as a treatment for the hep C genotype 1, 1b, or 4 infection.

Treatment Description: Sunvepra is a NS3/4A protease inhibitor that works by blocking a viral enzyme (protease) that enables the hep C virus to survive and replicate in host cells. It works in combination with other treatments, such as Daklinza (daclatasvir).

  • Sunvepra +
  • Daklinza +/-
  • Pegylated interferon with ribavirin

Approximate Sustained Viral Response (SVR)/”Cure Rate”: 

  • 90.6% in treatment-naïve patients
  • 82.4% in prior non-responders to pegylated interferon with ribavirin patients (hard to treat patients)
  • 82.6% in pegylated interferon intolerant/ineligible patients (hard to treat patients)
  • 93.2%-95.5% in patients with hep C genotype 1
  • 100% in patients with hep C genotype 4 (Health Canada)

Daily Dose:
Sunvepra is taken orally twice daily

Genotype Treatment Usual Dose
1b Sunvepra with Daklinza Twice daily with Daklinza taken once daily
1 or 4 Sunvepra with Daklinza and peginterferon and ribavirin Twice daily with Daklinza taken once daily, peginterferon taken once weekly, ribavirin twice daily

Possible Length of Treatment: 24 weeks

HCV/HIV Co-infection: The safety and efficacy of Sunvepra have not been studied in HCV patients co-infected with HIV.

Common Side Effects of Sunvepra with Daklinza Reported in Clinical Trials:

  • Headache
  • Tiredness (fatigue)

Drugs Sunvepra Should Not Be Taken With:

  • Dependent on the cytochrome P450 enzyme 2D6 (CYP2D6) for clearance and for which elevated plasma concentrations are associated with serious health issues.
  • Moderate or strong inducers and inhibitors of CYP3A.
  • Strong inhibitors of organic anion transporting polypeptide (OATP) 1B1 or 2B1.

Please see Sunvepra’s product monograph for more information.

Sampling of Clinical Trials for Sunvepra with Daklinza:

Clinical Trial Patients Treatment Regimen SVR12*
HALLMARK QUAD GT 1 prior non-responders (partial and null responders) Sunvepra + Daklinza + Pegylated Interferon with Ribavirin 93.2%
GT 4 prior non-responders (partial and null responders) 100%
HALLMARK-DUAL GT 1b treatment naive Sunvepra + Daklinza 90%
GT 1b pegylated interferon with ribavirin (PR) non responder 82%
GT 1b PR ineligible/intolerant 82%
GT 1b with cirrhosis 84%
GT 1b without cirrhosis 85%
*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.

Additional Resources about Sunvepra with Daklinza:

The above resources were used to create this treatment fact sheet.

Please email or visit the Hepatitis C Treatment Information Project for more information about Sunvepra, Daklinza, or any other hep C treatment.

Another Step Towards Approval for Sunvepra

Another Step Towards Approval for SunvepraSunvepra (asunaprevir) will soon be considered for BC PharmaCare coverage. Therefore, your input will again soon be sought.

Tentatively, patient and caregiver input into Sunvepra’s approval process will be requested from Wednesday May 18, 2016 to MIDNIGHT ON Wednesday June 15, 2016.

How to Add Your Voice to the BC PharmaCare Coverage Review for Sunvepra (asunaprevir)

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 Sunvepra (asunaprevir) input tentatively wont be available for another two weeks. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/’cure’) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

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

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the CADTH Common Drug Review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted on March 15th, 2016.

Sunvepra (asunaprevir) Approved in Canada

Sunvepra (asunaprevir) Approved in CanadaSunvepra (asunaprevir) has been approved as a hepatitis C treatment in Canada!* Health Canada granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C, genotype 1 or 4, in adult patients with compensated liver disease, including liver cirrhosis (liver scarring).

Health Canada has stated that Sunvepra is to be taken in combination with other hep C direct-acting antivirals/treatments. It has also stated that:

  • Treatment with Sunvepra should be initiated and monitored by a physician experienced in treating hep C.
  • Sunvepra must not be administered by itself.
  • Treatment length depends on the viral genotype and subtype.
  • Sunvepra has not been studied in treatment experienced patients who have tried to treat their hep C already with a treatment regimen that included Sunvepra or other hep C protease inhibitors.
  • Sunvepra should not be taken by those with moderate or severe hepatic impairment (Child-Pugh B or C, score 7 or greater) and by patients with decompensated liver disease.

For more information, please see Sunvepra’s product monograph, available through Health Canada, or Health Canada’s Summary Basis of Decision (SBD) document for Sunvepra.

What a Notice of Compliance (NOC) Means for Sunvepra (asunaprevir)

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).

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/cure) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted in early 2016.

Advance Notice for Sunvepra and Daklinza 2

Sunvepra and DaklinzaSunvepra (asunaprevir) and Daklinza (daclatasvir)** will soon be considered for BC PharmaCare coverage. Therefore, your input will soon be sought.

Tentatively, patient and caregiver input into Sunvepra and Daklinza’s approval process will be requested from Wednesday July 22, 2015 to MIDNIGHT on Wednesday August 19, 2015.

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 treatments should be covered by PharmaCare:

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

Additional information about Sunvepra (asunaprevir) and Daklinza (daclatasvir) can be found at Asunaprevir and Daclatasvir Advance, a blog post written in January when the Canadian Agency for Drugs and Technologies in Health (CADTH) began reviewing the treatments.

The Canadian Treatment Action Council (CTAC) also has a webinar, created in February 2015, that explains Sunvepra (asunaprevir) and Daklinza (daclatasvir). It includes much more information.

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

**Sunvepra (asunaprevir) and Daklinza (daclatasvir) have not yet received Notices of Compliance from Health Canada. They still can not be bought in Canada and are still being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Click here for more information about the drug approval process.

Advance Notice for Sunvepra and Daklinza

Sunvepra and DaklinzaThe Hepatitis C Treatment Information Project just received an advance notification from BC’s Ministry of Health that Sunvepra (asunaprevir) and Daklinza (daclatasvir)** will soon be considered for BC PharmaCare coverage. The tentative dates for input into this process are from Wednesday June 17, 2015 to midnight on Wednesday July 15, 2015*.

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 treatments should be covered by PharmaCare:

  1. Do you have hep C?
  2. Are you a caregiver to someone who has hep C?
  3. Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

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

Additional information about Sunvepra (asunaprevir) and Daklinza (daclatasvir) can be found at Asunaprevir and Daclatasvir Advance, a blog post written in January when the Canadian Agency for Drugs and Technologies in Health (CADTH) began reviewing the treatments.

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

*This process for Sunvepra (asunaprevir) and Daklinza (daclatasvir) has been rescheduled by BC PharmaCare until possibly the end of July. Please see  Advance Notice for Sunvepra and Daklinza 2 for more information

**Sunvepra (asunaprevir) and Daklinza (daclatasvir) have not yet received Notices of Compliance from Health Canada. They still can not be bought in Canada and are still being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Click here for more information about the drug approval process.

Asunaprevir and Daclatasvir Reports Complete

Asunaprevir and Daclatasvir SurveyThe asunaprevir and daclatasvir reports were sent in last week. We now wait to hear the outcome of the submissions. Thank you to all of you who completed PHCN’s Asunaprevir and Daclatasvir Survey and shared it with others. All of the responses made writing the patient group input reports on your behalf, a relatively simple task.

The patient group input reports requested by the Canadian Agency for Drugs and Technologies in Health (CADTH) are an important step towards getting new treatments for hep C more widely available in Canada and BC. They allow patients to have a say in the drug approval process.

The Hepatitis C Treatment Information Project will keep you apprised of any developments and is full of information about asunaprevir and daclatasvir.

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

Asunaprevir and Daclatasvir Survey Work Ahead

Asunaprevir and Daclatasvir Survey LogoTake this survey if you are living with hep C or if you have had hep C.

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

Survey participants with hep C or living with/caring for someone with hep C needed immediately! The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you.

CADTH is currently seeking 2 patient group input reports, one for asunaprevir and the other for daclatasvir; both treatments are being developed by Bristol-Myers Squibb. Thus, the Pacific Hep C Network (PHCN) needs your thoughts, opinions, and experiences for our reports.

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 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 you can be a part of the process!

Once again, PHCN’s patient input survey has been redesigned to, hopefully, help you easily voice your opinions and share your experiences.

There are now two PHCN input surveys. The first survey was written for those with hep C or those who have had hep C. It includes 22 questions, mostly multiple choice, and is divided into 4 sections. The most important of these sections  are ‘Section 2 of 4: Your Expectations of Asunaprevir and Daclatasvir’ and ‘Section 3 of 4: Your Experience with Asunaprevir and/or Daclatasvir’, if you have experience with asunaprevir and/or daclatasvir.

The second survey was written for loved ones or caregivers of those living with hep C / have had hep C. It includes 8 questions divided into 2 sections.

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 the last week of February, so please get your surveys in early and share the survey links with others ASAP.

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

Please email the Hepatitis C Treatment Information Project for more information about the surveys or visit PHCN’s Hepatitis C Treatment Information Project for more information about asunaprevir and daclatasvir.

Asunaprevir and Daclatasvir Advance

Asunaprevir and Daclatasvir Advance Check MarkThe Canadian Agency for Drugs and Technologies in Health (CADTH) announced last week that they had received notices of pending Common Drug Review submissions from Bristol-Myers Squibb for asunaprevir and daclatasvir, two of their hep C treatments.

Within their announcement, CADTH also stated that the patient group input reports for these two potential treatments are due in early March.

For asunaprevir and daclatasvir, this means a new step has been reached on their way through the drug approval process towards approval. For you, it means an opportunity to have your voices and stories heard is imminent!

As a precursor to that, the Hepatitis C Treatment Information Project has put together the following treatment summary. The following treatment summary includes information not only about asunaprevir and daclatasvir, but also about beclabuvir. Beclabuvir is another Bristol-Myers Squibb direct-acting antiviral making its way through the hep C drug pipeline. We included it in this summary as all three drugs have been studied together in a number of different clinical trials.

The Hepatitis C Treatment Information Project’s Hep C Treatment page includes more information about direct-acting antivirals (DAAs).

Asunaprevir, Daclatasvir, and Beclabuvir

  • Asunaprevir (a NS3/4A protease inhibitor. It impairs the activity of a protein called NS3 that is used by HCV)
  • Daclatasvir (a NS5A inhibitor. It impairs the protein NS5A, a protein that plays a role in hep C RNA replication)
  • Beclabuvir (a non-nucleoside NS5B polymerase inhibitor. It impairs the protein NS5B)

Possible Daily Dose: 1 pill once or twice daily +/- ribavirin

SVR: 82 – 100%

Length of Treatment: 12 weeks or 24 weeks

Common Side Effects: Some people in clinical trials reported headache, diarrhea, fatigue, and/or nausea.

Sampling of Phase III Clinical Trial Results:

Clinical Trial Patients Treatment Regimen SVR12/24*
ALLY-3 (12 weeks) GT 3 Treatment-naive Daclatasvir + Sovaldi** 90%
GT 3 Treatment-experienced*** with compensated cirrhosis (except those who had already tried NS5A inhibitors) 86%
UNITY-1 (12 weeks)  GT 1 Treatment-naive without cirrhosis GT 1a Daclatasvir / Asunaprevir / Beclabuvir 90%
GT 1b 98%
GT 1 Treatment-experienced without cirrhosis GT 1a Daclatasvir / Asunaprevir / Beclabuvir 85%
GT 1b 100%
UNITY-2 (12 weeks)  GT 1 Treatment-naive with compensated cirrhosis Daclatasvir / Asunaprevir / Beclabuvir + Ribavirin 98%
Daclatasvir / Asunaprevir / Beclabuvir 93%
GT 1 Treatment-experienced with compensated cirrhosis Daclatasvir / Asunaprevir / Beclabuvir + Ribavirin 93%
Daclatasvir / Asunaprevir / Beclabuvir 87%
Collapsing these groups, 90% of all patients who received daclatasvir / asunaprevir / beclabuvir alone and 96% who used daclatasvir / asunaprevir / beclabuvir plus ribavirin were cured.
HALLMARK- Dual (24 weeks) GT 1b Treatment-naive Daclatasvir + Asunaprevir 90%
GT 1b Peginterferon/ribavirin non-responder 82%
GT 1b Peginterferon/ribavirin ineligible/intolerant 82%
GT 1b Cirrhotic 84%
GT 1b Non-cirrhotic 85%
*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. SVR12 or SVR24 means that the treatments can achieve this response after 12 or 24 weeks of therapy.
**Sovaldi is being developed by Gilead Science.
***Treatment-experienced means that the patients who took part in this trial had already unsuccessfully tried to cure their HCV with pegylated interferon (pegIFN)

Sampling of Phase III Clinical Trials Still Ongoing:

Clinical Trial Patients Treatment Regimen SVR12/24
ALLY-2 (12 weeks) Any GT, HCV/HIV coinfection, Treatment-naive, Treatment-experienced Daclatasvir + Sovaldi (once daily) 97% (high SVR regardless of treatment experience, GT, cirrhosis). No alteration of HIV meds required. Completion Date was Feb 2015.
UNITY-3 (12 weeks) GT 1b Treatment-naive non-cirrhotic Daclatasvir / Asunaprevir / Beclabuvir Estimated Study Completion Date: Sept 2015
ALLY-1 (12 weeks) Any Genotype (GT), With cirrhosis who have already received a liver transplant Daclatasvir + Sovaldi + Ribavirin Estimated Study Completion Date: Oct 2015

ClinicalTrials.gov lists additional clinical trials involving daclatasvir and asunaprevir. The website is pretty user-friendly.

More information about daclatasvir, asunaprevir, and other emerging hep C treatments can also be found at PHCN’s Hepatitis C Treatment Information Project or by emailing hepctip@pacifichepc.org.

Please keep an eye out for the coming patient input survey.