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On October 1, 2013 the Canadian Agency for Drugs and Technologies in Health (CADTH) released a call for patient input into Gilead Science’s new HCV drug, SOFOSBUVIR. In order to prepare our Patient Group submission by CADTH’s October 23rd (noon, PST) deadline, HepCBC is ASKING for INPUT from HCV+ people and caregivers from throughout Canada, by Sunday, October 20th (midnight, PST).
CLICK HERE to ADD YOUR VOICE to HepCBC’s group submission which will help determine whether this new treatment should be available in Canada. You may wish to read below for more information about sofosbuvir and how it compares with other hepatitis C drugs.
This application is to use sofosbuvir for any hepatitis C genotype (1a or 1b, 2, 3, 4, 5, 6). In other words it is ‘pan-genotypic’. Like telaprevir and boceprevir (current Standard of Care for genotypes 1a or 1b), and simeprevir (also currently under CADTH review), sofosbuvir will also be used in a ‘Triple Therapy’ . Sofosbuvir will be used in combination with pegylated interferon and ribavirin for genotypes 1a, 1b, 4,5, and 6. Those with genotypes 2 or 3 will only have to take it with ribavirin, so it is Interferon-Free for them.
Duration of therapy will be 12 weeks, regardless of patient’s history or early response to the medication. In other words, it is NOT a ‘Response-Guided Therapy’. The adverse events (side-effects) of adding sofosbuvir are considered trivial, though patients still must put up with the well-documented side-effects of ribavirin and (except for those with genotypes 2 and 3), pegylated interferon.
Cutting the treatment time down to 12 weeks should help decrease adverse events. Those with compensated cirrhosis have an 80% chance of achieving a sustained viral response (SVR, sometimes called ‘a cure’) with sofosbuvir, while the general SVR rate for sofosbuvir is 90%. Only one sofosbuvir pill per day is taken, and there are no requirements to take it with food.
An excellent “Sofosbuvir Education Seminar” with slides, led by Dr. Paul Marotta, is available at this address: http://cc.readytalk.com/play?
Enter your name, email address, phone number (and optional company name) in the spaces provided. Press SUBMIT.
Read more about its safety, efficacy, etc. HERE. (http://www.prnewswire.com/news-releases/data-from-phase-3-studies-of-gileads-sofosbuvir-for-hepatitis-c-to-be-presented-at-48th-annual-easl-meeting-findings-published-online-today-in-the-new-england-journal-of-medicine-204301831.html)
Sofosbuvir will need an NOC (Notice of Compliance) clearance from Health Canada as well. Once CADTH recommends a prescription drug (in this case roughly projected sometime in early 2014), it is then up to the provincial governments to decide if and how their health insurance plans will cover the drug. HepCBC will make a British Columbia “Your Voice” group submission, and individuals will also be able to send personal submissions at that point. BC Pharmacare typically takes up to 6 months to complete post-CADTH approvals.
HepCBC confidentially collects data from HCV+ people and their caregivers through our support groups, website and email mailing list. If you are not on our mailing list yet, sign up HERE. While we welcome sofosbuvir to the arsenal of available or soon-to-be-available HCV treatments, it should be noted that numerous other drugs are also in the pipeline which will offer interferon-free and ribavirin-free options in the next couple years. It is an encouraging time for hepatitis C treatment, though the high cost of all of these drugs will continue to be a big challenge, particularly for the poor – even in the developed world – and for most patients in the developing world.
CLICK HERE to ADD YOUR VOICE to HepCBC’s group submission now.