URGENT! Patient and Caregiver Input Request: We Need to Hear your Voice!
Patient and Caregiver input is requested by CADTH on AbbVie’s BRAND NEW (not yet for sale in Canada!) combo of glecaprevir and pibrentasvir (G/P) for Genotypes 1-6. AbbVie’s G/P combo is pan-genotypic (works for all genotypes). Check out the background information in links below to see the results that have been achieved in clinical trials to date. You will see that the cure rates across all genotypes are high: (98%+ in most of the trials).
The G/P combination is particularly interesting because it focuses on areas of unmet medical need of patients, such as those who are GT3 with cirrhosis, those with chronic kidney disease (CKD) or renal impairment, and those who have failed treatment with one of the newer hepatitis C drugs (DAAs). It also may be an alternative to consider for anyone with or without cirrhosis.
Clinical trials tested G/P in 2300 patients in 27 countries. The G/P combo is being given priority review status by Health Canada and CADTH is advising the Canadian Drug Expert Committee about this combo. Check out the links below and then give us your feedback to the 10 short questions about whether (or not) you’d like to see the G/P combo recommended for inclusion on Canada’s drug formularies, and why. You have until June 15th 2017 to tell us what you think. We’ll include your views in our submission to CADTH.
A (short) questionnaire for patients and caregivers to submit to Patient Group HepCBC.
HepCBC will put all the responses together and submit them to CADTH as part of our opinion as to whether we think AbbVie’s G/P combo should be recommended as a hepatitis C treatment.
A – Be sure to read background info first.
- SHORT SUMMARY: http://hepcbc.ca/wp-content/uploads/2017/05/HepCBC_OnePageFactSheet_AbbVie-GP.pdf
- HepCTip SUMMARY (Pacific Hep C Network): http://www.hepctip.ca/drug-pipeline-2/glecaprevir-pibrentasvir-granted-review/
- ABBVIE NEWS RELEASE: http://hepcbc.ca/2017/02/01/health-canada-grants-priority-review-abbvies-investigational-regimen-glecaprevirpibrentasvir-gp-treatment-chronic-hepatitis-c-major-genotypes-gt1-6/
- LONGER RESEARCH RESULTS: http://www.natap.org/2017/EASL/EASL_10.htm
B – Read the 10 short questions below.
C – Put your answers into the Body of an email OR email with a Word file attachment. Email to this spam-free address: <office.hepcbc(at)gmail.com> BEFORE MIDNIGHT on June 15th 2017.
THE 10 QUESTIONS:
(1) Disclose any possible conflicts of interest such as financial support from the pharmaceutical industry [e.g., educational or research grants, honouraria, gifts, and salary], as well as affiliations or personal or commercial relationships with drug manufacturers or other interest groups.) The names of all manufacturers providing funding should be listed, not just the manufacturer of the drug under review. You can still answer the questions if you have a conflict of interest. We just need to know, that’s all. List here…
(2) ARE YOU SOMEONE WHO…
- has hepatitis C?
- had hepatitis C but was cured?
- is or has been a caregiver of someone with hepatitis C? If you are a patient’s CAREGIVER, please identify as such here, and fill out the questions to the best of your ability from your own point of view.
If so please tell us which of the above.
If not, tell why you are interested in the glecaprevir/pibrentasvir combo.
(3) DAILY LIFE:
Describe how hepatitis C affects (or did affect) your day-to-day life. You don’t have to spend too much time on this as we have lots of this data from past submissions, but if you want, please feel free to share as much as you’d like.
(4) OTHER TREATMENT(S):
Have you ever taken (or are you now taking) another treatment for hepatitis C?
When did you take it, how long did your treatment last, and did you experience any adverse events (side-effects)? If so, how serious were they? Please list all of the drugs or treatments and tell us about your experience with each treatment.
(5) BEING A CAREGIVER OR HAVING A CAREGIVER:
If you look after someone who has hepatitis C or have someone looking after you because you suffer from hepatitis C, how does being a caregiver affect you or your caregiver’s life? What difficulties do caregivers face?
(6) ABOUT YOU…
What is your age and gender, your degree of liver damage (or cirrhosis) if known, or co-infections? How many years have you had hepatitis C (if known) and when were you diagnosed? What genotype are you? Did you achieve an SVR (cure)? and if so how long ago did this happen?
(7) HAVE YOU EVER TAKEN glecaprevir/pibrentasvir?
If so, when, and how long did your treatment with glecaprevir/pibrentasvir last? Was it successful?
Did you experience any adverse events (side-effects) with glecaprevir/pibrentasvir? If so, how serious were they?
(8) ACCESS PROBLEMS:
Have you experienced difficulty in accessing all-oral hepatitis C treatment due to it not being covered by BC Pharmacare or because you did not meet the criteria for treatment? If so, explain what you did about this and how this experience affected your life. CADTH will consider financial hardships as possible barriers to treatment.
(9) WHAT DO YOU HOPE THE NEW DRUG WILL BE ABLE TO DO?
Please tell us why you believe glecaprevir/pibrentasvir should be an approved treatment in Canada.
Why should glecaprevir/pibrentasvir be available for hepatitis C patients (or why not)? You can answer this question whether you have used the drug in a clinical trial or even if you have not used the drug, but think it should be made available (or not).
(10) ANYTHING YOU WANT TO ADD? (optional)
Thanks! Now please…
D – Put your answers into the Body of an email OR email with a Word file attachment. Email to this spam-free address: <office.hepcbc(at)gmail.com> BEFORE MIDNIGHT June 15th 2017.
You will receive a thank-you email from us acknowledging your submission soon (not automatic – we are real people [volunteers]) on this end!!).