Category Archives: Drug Pipeline

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!

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.

Canadian Treatment Action Council Webinar

sq_trialsOn December 10th @ 11am PST / 2pm EST, the Canadian Treatment Action Council (CTAC) will be hosting an informative webinar with a survey to follow about the hep C treatment ombitasvir/paritaprevir/ritonavir and dasabuvir. The treatment is currently undergoing a CADTH Common Drug Review (CDR), which is now collecting patient input.

The survey that will follow the Canadian Treatment Action Council webinar is different from PHCN’s patient input survey. Please consider filling out both surveys.

Registration for the webinar is required
. Email Adam Cook to register to attend or to get more information about the webinar.

More information about ombitasvir/paritaprevir/ritonavir and dasabuvir can be found at Hep C TIP News or PHCN’s Hepatitis C Treatment Information Project.

Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir

sq_drugsAs there seems to be a lot happening around ombitasvir / paritaprevir / ritonavir and dasabuvir (known in Canada as Holkira Pak and Viekira Pak in the USA), with CADTH seeking patient group input reports and PHCN putting out a call for patient input and survey participants, the Hepatitis C Treatment Information Project has put together the following treatment summary:

OMBITASVIR / PARITAPREVIR / RITONAVIR & DASABUVIR (HOLKIRA PAK)
Maker: AbbVie

3 DAA Co-formulated Drugs for Genotype 1:

  • Ombitasvir / paritaprevir / ritonavir +
  • Dasabuvir +/-
  • Ribavirin (RBV)

Adult Daily Doses:  4 pills per day +/- ribavirin

  • Ombitasvir / paritaprevir / ritonavir: 2 pills in the morning
  • Dasabuvir: 1 pill in the morning and 1 pill in the evening
  • Ribavirin (RBV): 1 pill in the morning and 1 pill in the evening

Length of Treatment:

12 or 24 weeks

Summary of Phase III Clinical Trial Results:

Clinical Trial Patients Treatment Regimen SVR12*
PEARL-II(12 weeks) Genotype 1bTreatment-experienced AbbVie regimen + RBV 97%(85/88)
AbbVie regimen only 100%(91/91)
PEARL-III(12 weeks) Genotype 1bTreatment-naive AbbVie regimen + RBV 99%(209/210)
AbbVie regimen only 99%(207/209)
PEARL-IV(12 weeks) Genotype 1aTreatment-naive AbbVie regimen + RBV 97%(97/100)
AbbVie regimen only 90%(185/205)
TURQUOISE-II(12 & 24 weeks) Genotype 1Treatment-naive & treatment-experienced with

compensated cirrhosis

AbbVie regimen + RBV, 12 weeks 92% (191/208)
AbbVie regimen + RBV, 24 weeks 96%(165/172)
SAPPHIRE-I(12 weeks) Genotype 1Treatment-naive AbbVie regimen + RBV 96%(455/473)
SAPPHIRE-II(12 weeks) Genotype 1 treatment-experienced AbbVie regimen + RBV 96%(286/297)

*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.

Side Effects:

During the clinical trials, some reported side effects including headaches, fatigue, itchy skin, nausea, insomnia, and/or diarrhea. Headaches and fatigue were reported similarly by those taking the AbbVie regimen without ribavirin (RBV) and those taking it with ribavirin (RBV).

PHCN’s Ombitasvir / Paritaprevir / Ritonavir and Dasabuvir Survey

Please email hepctip@pacifichepc.org for more information about the survey or visit PHCN’s Hepatitis C Treatment Information Project for more information about ombitasvir / paritaprevir / ritonavir and dasabuvir and the different hep C treatments within the drug approval process.

Take this Survey

ombitasvir / paritaprevir / ritonavir and dasabuvir (HOLKIRA PAK) Survey Logo

Take this survey.

Survey participants with hep C or living with/caring for someone with hep C wholesale mlb jerseys needed immediately!

The LEDIPASVIR/SOFOSBUVIR Canadian Agency for Drugs and Technologies in Health (CADTH) is currently seeking patient group input reports for ombitasvir / paritaprevir Copyright / ritonavir and dasabuvir (HOLKIRA PAK), developed by AbbVie. Thus, Pacific Hepatitis C Network (PHCN) needs your help for our report.

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 be a part of this process!

The survey is newly la redesigned and includes 33 questions, mostly multiple choice, that are divided into five sections. cheap jerseys The sections that don’t needed pertain to you, such as the section about your experience with ombitasvir / paritaprevir / ritonavir and dasabuvir (HOLKIRA PAK) if you’ve never taken this hep C treatment, can be easily skipped. Those living with/caring for Managing someone with hep Simeprevir C are only asked to complete eight questions.

Survey responses are anonymous (we wholesale jerseys don’t for know your name or Истребитель 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 лиц use the information gathered by it in our patient group input report for CADTH.

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

Please email hepctip@pacifichepc.org for more information about the survey or visit PHCN’s Hepatitis C Treatment Information Project for more information about ombitasvir / paritaprevir / ritonavir and dasabuvir (HOLKIRA PAK) and the different hep C treatments within the drug pipeline.

PharmaCare Approves Simeprevir PegIFN/RBV Combination

sq_checkJanssen Inc.’s simeprevir, brand name Galexos, in combination with peginterferon/ribavirin was V110 just approved by BC’s PharmaCare for the treatment of chronic hepatitis C genotype 1 in patients with or without Notice compensated cirrhosis and who have:

  • never tried to treat their wholesale nfl jerseys hepatitis C
    OR
  • tried treatment but the virus came back
    OR
  • tried treatment but weren’t cured

AND

Who Post have ALL of the following:

  • Lab-confirmed hepatitis C genotype 1
  • A prescription for the treatment from a qualified healthcare provider
  • Detectable levels of hep C in the last 6 months
  • Recent lab-confirmation of NS3 Q80K polymorphism negative for patients with hep C genotype 1a cheap jerseys subtype or genotype 1 with indeterminate subtype. Retesting is required is for all those who had their genotype tested before May 1, 2012.
  • A liver fibrosis stage F2 or greater

BUT

Who have NOT been or ARE NOT being cheap nfl jerseys treated with a LEDIPASVIR/SOFOSBUVIR protease inhibitor.

Please ask your wholesale jerseys healthcare provider for more information about simeprevir (Galexos) in combination with peginterferon/ribavirin (PegIFN/RBV) and about other hep C cheap mlb jerseys treatments.

For more Survey information about currently Bro approved hep C treatments in BC, emerging treatments, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

Notice of Compliance for ledipasvir/sofosbuvir

sq_drugsGilead Sciences, Inc. announced yesterday that Health Canada has issued a Notice of Compliance for ledipasvir/sofosbuvir (Harvoni), the first ?irketleri once-daily single tablet regimen for the treatment of chronic hepatitis C genotype Dr.SiLnT 1 infection in adults. The technical tablet combines wholesale NFL jerseys the NS5A inhibitor ledipasvir with the Wholesale Miami Dolphins Jerseys nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi) cheap NFL jerseys for a 8, 12, or 24 week treatment duration.

The press release programa that Gilead Sciences posted TAKERS! regarding this ledipasvir/sofosbuvir development also includes information about Gilead’s Momentum Support Program in wholesale jerseys Canada.

For more information about currently approved hep C treatments in BC, new and Winter, emerging drugs, ASAP! the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.