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.

Project Update

sq_experiencesThe Hepatitis C Treatment Information Project’s drug pipeline diagram has been updated twice in the past couple of weeks, the Hep C Drug Pipeline page has exploded with the help of easy to read tables, and our Financial Support page now lists a brand-new assistance program, AbbVie Care, for patients and health care professionals.

Pay the Hepatitis C Treatment Information Project a visit for more information about currently approved hep C treatments in BC–there have been recent changes. The project also has information on emerging treatments, the drug approval process in Canada and BC, and financial support programs.

You can also email us your questions about hep C treatments.

PHCN’s Hepatitis C Treatment Information Project is a source of information that doesn’t post a ‘site last modified date’ because it is truly forever changing!

Response to Treatment by Prevention Article

sq_trialsThe Globe and Mail article: B.C. medical researchers offer treatment by prevention for hepatitis C

PHCN recognizes treatment as prevention (TasP) as the strategy of choice for people who use injection/inhalation drugs, who, as a group, have the highest rate of new HCV infections. Treatment as prevention is an approach tailored to meet their specific health needs and we both support and advocate for that approach in all communities of the province.

That idea – specific approaches designed to meet the needs of specific populations – is what is critical in the drive to cure individuals and eradicate hepatitis C in BC.

The gap right now is a clearly thought-out and articulated strategy for reaching out to baby boomers, immigrant populations, and Aboriginal people, and engaging them in care, treatment, and support for hepatitis C. The other half of this picture is the health care system and providers within it. What is the strategy to build capacity – system and providers – to meet this urgent and acute population health demand?

A Hep C Advocate’s 2014

Luster-Daryl-2015As we have just rung in 2015, the Hepatitis C Treatment Information Project wanted to look back and highlight some of the 2014 work of one of our hep C advocates.

The following is a collection of 2014 articles and resources that Daryl Luster, hep C advocate and president of PHCN,  was a part of:

January 13  –  CADTH Letter  (Canadian Agency for Drugs and Technologies in Health)

February 19  –  Daryl Luster and the work of Pacific Hep C Network  (PHCN)

May 30  –  Highly effective new drugs for hepatitis C jostle for market share: No provincial health system covers the medications, but lobbying is already underway to make sure they do  (Vancouver Sun)

July 17  –  Vancouver Resident Raises Awareness for World Hepatitis Day  (Hello Vancity)

July 21  –  Note to Editor: World Hepatitis Day is a time to rethink the future impact of untreated Hepatitis C in Alberta  (iStockAnalyst.com)

July 25  –  Richmondite Spreads Hep C Awareness  (Richmond News)

August 1  –  Hep Stories: Daryl Luster  (hepmag.com)

October 1  –  Hepc.bull Mention and Pictures on Page 5  (hepc.bull)

October 8  –  ‘If you have money, you’ll live. If you don’t, you’ll die’: B.C.’s Hepatitis C sufferers hope for fast drug approval  (The Province)

November 5 – 6  –  Virology Education  (1st International Hepatitis Cure & Eradication Meeting)

November 13  –  Bristol-Myers Squibb Announces High Cure Rates for Genotype 3 Hepatitis C Using Combination of Daclatasvir and Sofosbuvir in ALLY-3 Trial  (Bristol-Myers Squibb)

November 25  –  Richmond Centre for Disability Empower Series  (Richmond Centre for Disability)

December  –  Hepc.bull Mention and Pictures on Page 4  (hepc.bull)

We also wanted to wish you all a happy new year! May the coming year bring new treatments, medical breakthroughs, and hope.

HOLKIRA PAK Approval

holkira pak trialsThis morning Health Canada approved AbbVie’s HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir and dasabuvir) for the treatment of patients with chronic genotype 1 hep C, including those with cirrhosis.

HOLKIRA PAK is an all-oral, short-course, interferon-free treatment. It can be taken with or without ribavirin (RBV).

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hep C patients, and 98 percent of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of discontinuation due to adverse reactions were low (0.2 percent).

The recommended treatment regimens and durations for HOLKIRA PAK are:

Patient

Treatment

Duration

Genotype 1a, without cirrhosis HOLKIRA PAK + ribavirin 12 weeks
Genotype 1b, without cirrhosis HOLKIRA PAK 12 weeks
Genotypes 1a and 1b, with cirrhosis HOLKIRA PAK + ribavirin 12 weeks*
*24 weeks of HOLKIRA PAK + ribavirin is recommended for patients with genotype 1a-infection with cirrhosis who have had a previous null response to pegylated interferon (pegIFN) and ribavirin.
Note: HOLKIRA PAK with ribavirin is recommended in patients with an unknown genotype 1 subtype or with mixed genotype

 

An honour

sq_trialsThank you to all of you who completed PHCN’s Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir survey and shared it 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.

You can find a slightly shortened version of the report on PHCN’s Resources page.

The report was sent in this morning. We now wait to hear the outcome of the treatment’s submission. The Hepatitis C Treatment Information Project will keep you apprised of any news.

PHCN’s Hepatitis C Treatment Information Project is a source of information that doesn’t post a ‘site last modified date’ because it is truly forever changing. Pay it a visit for more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, resources to help in getting ready for treatment, or just to try to figure out what pages have been newly added in the last week or two! You can also email us your questions about hep C treatments.

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

MLA’s luncheon

sq_experiencesOn November 18th, the PHCN hosted Honourable Terry Lake, BC Minister of Health, and 15 other BC Government MLAs at a MLA’s luncheon in Victoria. Speeches were made about hepatitis C and the policy changes needed to ensure that more people in BC get tested, treated, and cured of hepatitis C.

Daryl Luster, PHCN Board President, described his experience with hepatitis C—beginning to feel ill, 3 years of tests and worsening symptoms, an ‘accidental’ hepatitis C diagnosis, and a fortunate clinical trial where Daryl, after a fairly debilitating round of new and old hep C treatments, cleared the virus. Daryl spoke of how he wanted to spare other hep C patients the experience of worsening symptoms and not being able to find help for far too long. He made a promise then to work hard to see changes that would make it easier for anyone with hepatitis C to get tested, treated, and cured.

Dr. Mel Krajden, Director of BC Hepatitis Services at the BC Centre for Disease Control (BCCDC), presented as well. Dr. Krajden spoke to the different groups of people with hep C—baby boomers, people who use injection drugs, immigrant populations, and aboriginal communities—and about how each group has specific needs. He said that while the Treatment as Prevention is a good approach for reaching and engaging people who are marginalized, other strategies are required. For instance, for baby boomers, he recommends a ‘Test, Triage, and Treat’ approach.

We spoke to the need for new treatments to be listed with PharmaCare with no unnecessary restrictions as soon as possible. We urged the government to seize the opportunity to be leaders in the fight to eradicate hepatitis C—a very real possibility.

Health Minister Lake spoke to the government’s commitment to addressing viral hepatitis and the ongoing negotiations with pharmaceutical companies for new drug prices. The Ministry of Health sees great value in the ‘Treatment as Prevention’ approach.

We hope that the government also sees that different populations have different needs and we want to be smart and strategic in how needs are met!

In addition, Daryl and Dr. Mel Krajden also met with political staff in Minister Lake’s office as well as with Ministry of Health staff in the Population and Public Health branch to discuss these same issues.

Stay tuned for more Hep C TIP Advocacy News!