Tag Archives: asunaprevir

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.