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URGENT BC Patient and Caregiver Input Request: We need to hear your voice! Patient and Caregiver input is requested by BC PharmaCare on Gilead’s combo of sofosbuvir, velpatasvir, and voxilaprevir (SOF-VEL-VOX or Vosevi™) for Genotypes 1-6.
Check out the background information in links below to see the results that have been achieved in clinical trials to date.
- Gilead’s “SOF-VEL-VOX” combo is pan-genotypic (works for all genotypes).
- One pill per day for 12 weeks, very few if any side-effects.
- Cure rates across all genotypes are almost 100%, similar to other DAAs.
- Pricing has continued to decline somewhat for this hep C treatment, though it still is higher than the 8-week AbbVie treatment glecaprevi+pibrentasvir (all genotypes, treatment-naïve) and Merck’s elbasvir+grazoprevir (w/o ribavirin, in GT1b).
- The “SOF-VEL-VOX” combination focuses on re-treating 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 (compensated) cirrhosis.
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 “SOF-VEL-VOX” combo recommended for inclusion in British Columbia’s “PharmaCare” drug formulary, and why. You have until 11:55 pm on Wednesday, December 13, 2017 to tell us what you think. We’ll include your views in our submission to BC PharmaCare.
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A (short) questionnaire for patients and caregivers to submit to Patient Group HepCBC.
HepCBC will put all the responses together and submit them to BC Pharmacare as part of our opinion as to whether we think Gilead’s “SOF-VEL-VOX” combo should be covered by PharmaCare for hepatitis C treatment.
DIRECTIONS:
A – Be sure to read the 1-page background summary here (and more if you have time):
- 1-PAGE BACKGROUND SUMMARY: http://hepcbc.bchep.org/wp-content/uploads/2017/12/VOSEVI_1_page_info_sheet_BCPharmaCare.pdf
- BC PharmaCare Drug Information Sheet: https://www2.gov.bc.ca/assets/gov/health/health-drug-coverage/pharmacare/sofosbuvir-velpatasvir-voxilaprevir-3547-info.pdf (Note they give the public input closing date as Dec. 15th but HepCBC requires you to email yours to us by 11:55 pm on Wednesday, December 13th, thanks!)
- News of Canadian approval: http://www.newswire.ca/news-releases/gilead-receives-approval-in-canada-for-vosevi-sofosbuvirvelpatasvirvoxilaprevir-for-re-treatment-of-certain-patients-with-chronic-hepatitis-c-virus-hcv-infection-640869053.html
- LONGER RESEARCH RESULTS: The Safety and Tolerability of SOF/VEL/VOX for 8 or 12 Weeks in >1000 Patients Treated in the POLARIS-1, POLARIS-2, POLARIS-3, and POLARIS-4 Studies: an Integrated Analysis, via URL: http://natap.org/2017/EASL/EASL_64.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 11:55 pm on Wednesday, December 13, 2017.
THE 10 QUESTIONS:
(1) CONFLICTS of INTEREST
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. You can also add your CAREGIVER input separately through https://survey.health.gov.bc.ca/TakeSurvey.aspx?SurveyID=8lKL3p7M
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 caregivers face?
(6) ABOUT YOU…
What is your age and gender, your degree of liver damage (or cirrhosis) if known, or co-infections? Do you suffer from other medical conditions? 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/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 because you could not afford it, or 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 be covered by BC PharmaCare (or not).
Why should sofosbuvir/velpatasvir/voxilaprevir be covered by BC PharmaCare 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 11:55 pm om Wednesday, December 13th 2017.
You will receive a thank-you email from us acknowledging your submission soon (not automatic – we are real people [volunteers]) on this end!!)