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YOUR HELP IS URGENTLY NEEDED! (Canadians and Non-Canadians Welcome to Participate). Input Needed Before August 15, 2017.
Did you or someone you love fail treatment with one of the new interferon-free “DAAs”? Worried about “treatment-resistant” hepatitis C viruses developing? Here’s a new treatment that could help solve these problems. If you are a patient (current or former) or caregiver with an opinion on whether a treatment like this should (or shouldn’t) get approved in Canada, we really want to hear your voice!
Patient input has been requested on Gilead’s “pan-genotypic” combo of sofosbuvir+velpatasvir+voxilaprevir (brand name “Vosevi”) for re-treatment of patients with hepatitis C, genotypes 1-6. HepCBC presents patient and caregiver input to federal and provincial agencies that approve new drugs, and we need your SHORT survey results before August 15th. Even Non-Canadians are welcome to complete our survey!
What’s new or special about this drug?
Gilead’s combo is another “one pill a day” treatment that’s been developed to treat hepatitis C sufferers of ANY GENOTYPE who have previously failed treatment with the new Direct Acting Antivirals (DAAs), specifically those who failed treatment with an NS5A inhibitor. Alternatively it is for those with Genotypes 1a or 3 who failed a previous treatment like Sovaldi, which used sofosbuvir but didn’t use an NS5A inhibitor. It has been used in patients with compensated cirrhosis.
Although the new all oral DAAs have been hugely successful in curing many people with hepatitis C, and boast cure rates of 95%+, this still means a few patients unfortunately fail treatment. This is tragic for these patients, but also means they are still able to infect others, and that “treatment-resistant” viruses could develop in their bodies and, if they engage in risky activities, spread to the wider population.
For those patients, Vosevi could offer an effective option since 96% of HCV+ people who take Vosevi get cured (cure is defined as being virus-free 12 weeks after treatment finishes). The combo has achieved good results in patients without cirrhosis or with compensated cirrhosis.
The combo was recently approved by the FDA (in the US), and now CADTH (Canadian federal agency that approves drugs for sale) is advising and recommending on this combination to the Canadian Drug Expert Committee. CADTH has requested patient and caregiver input from HepCBC. See all of HepCBC’s previous hepatitis C treatment reviews to government since 2011 HERE.
Here is what you can do to help
Check out one or two of the links below, and complete the questionnaire about whether you’d like to see the combo recommended for inclusion on drug formularies, and why.
DEADLINE: August 15th 2017 to email your questionnaire results to this (spam-free) HepCBC address: <office DOT hepcbc AT gmail DOT com>. THANKS!
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Questionnaire for Patients and Caregivers to submit to Patient Group
DIRECTIONS:
A – It’s good (but not required) to read a little background info first. If time, check out 1 or 2 of these links:
EASL (2017): Treatment With SOF/VEL or SOF/VEL/VOX Is Well Tolerated and Results in High SVR12 in Genotype 1-6 HCV-Infected Patients With Minimal Fibrosis: a Retrospective Analysis of the ASTRAL and POLARIS Clinical Studies – (04/21/17)
GILEAD PRESS RELEASE (2017): http://www.gilead.com/news/press-releases/2017/7/us-food-and-drug-administration-approves-gileads-vosevi-sofosbuvirvelpatasvirvoxilaprevir-for-retreatment-of-adults-with-chronic-hepatitis-c-virus
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 August 15th 2017.
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:
(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 below…
(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+voxilaprevir 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 the combo of sofosbuvir+velpatasvir +voxilaprevir?
If so, when, and how long did your treatment with sofosbuvir+velpatasvir+voxilaprevir last? Was it successful?
Did you experience any adverse events (side-effects) with sofosbuvir+velpatasvir+voxilaprevir? 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 other health insurance), not being affordable, 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+voxilaprevir should (or shouldn’t) be an approved treatment in Canada.
Why should sofosbuvir+velpatasvir+voxilaprevir 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.
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 August 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!!)