We want as many people as possible living with HIV and hepatitis C to have their voices heard by drug regulators.
New drugs are submitted by manufacturers to Health Canada for a Notice of Compliance (NOC). Following the satisfactory review of a submission, an NOC is issued to a manufacturer to signify compliance with Food and Drug Regulations.
In a separate process the Canadian Agency for Drugs and Technologies in Health (CADTH) puts out a call to all patient groups to submit input regarding the drug seeking a NOC. CTAC regularly contributes to the CADTH Common Drug Review Patient Input process for a number of HIV and hepatitis C drugs. The experiences and feedback from patients are key in informing the recommendations CADTH makes to publicly funded drug plans throughout Canada.
To sign up for notifications about future patient input consultations please email firstname.lastname@example.org.
Drawing on our years of experience we have created CTAC’s Guide to Patient Input: Patients Shaping Treatment Choices for anyone who would like to take part in, or organize, patient input. You can read and download the guide in English and in French.
This consultation is about a new drug to treat HIV-1 infection, cabotegravir, and the new 2-drug combination cabotegravir/rilpivirine. To take part please click here to fill out a brief survey by 4th September 2019.
Cabotegravir (CAB), manufactured by ViiV Healthcare, is an HIV-1 integrase strand transfer inhibitor. Its composition is oral (30 mg tablet), and long-acting IM injection (200 mg/mL). Rilpivirine (RPV), which is marketed as EDURANT, is an HIV-1 non-nucleoside reverse transcriptase inhibitor. Its composition is oral (25 mg tablet), and long-acting IM injection (300 mg/mL).
For those living with HIV, long-acting injectables, created using extended-release drug formulations, present a possible alternative to taking medication on a daily basis.
2 large studies have been completed using the new 2 drug combination cabotegravir/rilpivirine (CAB + RIV). The ATLAS Study compared participants on CAB + RPV (an oral regimen transitioning to a monthly injection regimen) to participants remaining on their current antiretroviral regimen (CAR). It found:
· A monthly CAB + RPV injection was non-inferior to current three-drug oral regimens at 48 weeks for maintaining viral suppression.
· There was low virologic failure rates in both groups (1%).
· CAB + RPV injection site reactions were mostly short-lived with few associated discontinuations.
· Serious adverse events were infrequent for both groups.
· Patient views regarding the long-acting injectable were positive. Of 308 participants in the CAB + RPV arm of the study, 86% preferred the long-acting injectable versus 2% who preferred staying on their oral therapies.
All participants in the FLAIR Study were initially treatment-naive and then given the daily oral combination TRIUMEQ (dolutegravir/abacavir/lamivudine-DTG/ABC/3TC) for 20 weeks. Then, participants were split into 2 groups to compare those taking CAB + RPV (a monthly injection regimen) to those remaining on the oral combination TRIUMEQ. The study found: · A monthly CAB + RPV injection was non-inferior to continued use of the oral combination.
· There was low virologic failure rates in both groups (1.4% vs 1.1%).
· CAB + RPV injection site reactions were common but not severe and most (88%) resolved themselves within seven days and were associated with few discontinuations.
· Patient views regarding the long-acting injectable were positive. Of 283 participants in the CAB + RPV arm of the study 91% preferred the long-acting injectable compared to 1% who preferred daily oral therapy.
Patient input has been a central part of our work for many years.
We are often the only organization to hold national patient input sessions about new HIV medications under review for submission to CADTH under the Common Drug Review process, and one of three for HCV medications under review. In June 2015 CTAC was recognized by CADTH as one of the most active patient groups in Canada, being one of only 17 groups to have provided more than five patient input submissions since 2010.
Since the Common Drug Review (CDR) began accepting patient input submissions in 2010, CTAC has contributed to 30 assessments for HIV and hepatitis C drugs. CTAC has usually been the sole group to contribute patient input to reviews of new HIV drugs and also contributed to CADTH’s Therapeutic Review of all hepatitis C drugs.
The 30 assessments that CTAC has contributed to are listed in the table below, RFA means Request for Advice, which is a re-examination of an assessment to allow the expert committee to respond to a question from the public drug plans.
Holkira Pak RFA