Patient Input Is Requested by CADTH on Gilead’s Combo of Sofosbuvir and Velpatasvir for Genotypes 1, 3 and 4

This page is an archive. Its content may no longer be accurate and was last updated on the original publication date. It is intended for reference and as a historical record only. For hep C questions, call Help4Hep BC at 1-888-411-7578.

We want to hear your voice!

Patient input is requested by CADTH on Gilead’s combo of sofosbuvir and velpatasvir for genotypes 1, 3 and 4.  ANYONE AFFECTED BY HEPATITIS C CAN SUBMIT; it doesn’t matter which genotype you are, or if you haven’t had any experience with this new treatment. Gilead’s combo is pan-genotypic (works for all genotypes).  Check out the background information below to see the results from clinical trials to date. You will see that the cure rates across all genotypes are high: 95%+ in many of the trials.

The combo is being given priority review status by the FDA (in the US) and CADTH is advising and recommending on this combination to the Canadian Drug Expert Committee.  Check out the links below and then give us your feedback on whether you’d like to see the combo recommended for inclusion on drug formularies.  You have until May 8, 2016 to let us know what you think.  We’ll include your views in our submission to CADTH.

A 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 this combination of drugs should be recommended as a hepatitis C treatment.

DIRECTIONS:

A – Be sure to read background info first at:

B – Read the 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 DOT hepcbc AT gmail DOT com BEFORE MIDNIGHT on May 8, 2016.

D – Both PATIENTS and/or their CAREGIVERS may submit.  If you are a patient’s CAREGIVER, please identify as such (in Question 2) and fill out the questions to the best of your ability from your own point of view.

 

THE QUESTIONS:

  • 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 so please tell us which of the above.
If not, tell why you are interested in the sofosbuvir/velpatasvir 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 you 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 SVR (cure)? and if so how long ago did this happen?

 

(7) HAVE YOU EVER TAKEN Sofosbuvir/Velpatasvir?
If so, when, and how long did your treatment with sofosbuvir/velpatasvir last?  Was it successful?
Did you experience any adverse events (side-effects) with sofosbuvir/velpatasvir? If so, how serious were they?

 

 (8) ACCESS PROBLEMS:
Have you experienced difficulty in accessing all oral hepatitis C treatment due to their 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.

 

(9) WHAT DO YOU HOPE THE NEW DRUG WILL BE ABLE TO DO?
Please tell us why you believe sofosbuvir/velpatasvir should be an approved treatment in Canada.
Why should sofosbuvir/velpatasvir 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).

 

Thanks! Now please…

Put your answers into the Body of an email OR email with a Word file attachment. Email to this spam-free address: office DOT hepcbc AT gmail DOT com BEFORE MIDNIGHT May 8, 2016.

You will receive a thank-you email from us acknowledging your submission soon (not automatic – we are real people [volunteers]) on this end!!)