Tag Archives: AbbVie 2D–GT4

CTAC Patient Input Group Webinar

ombitasvir/paritaprevir/ritonavirOn September 21 @ 8am PST / 11am EDT, the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the upcoming hep C treatment AbbVie 2D – GT4 (ombitasvir / paritaprevir / ritonavir). The treatment is about to undergo a CADTH Common Drug Review (CDR), which is now collecting patient input.

The patient input survey that will follow CTAC’s webinar is different from PHCN’s patient input survey or PHCN’s loved ones / caregivers survey. Please consider filling out the PHCN survey that was created for you as well as CTAC’s survey.

Registration for the CTAC webinar is required
. Click here to register or for more information about the webinar.

About the Canadian Treatment Action Council (CTAC)

CTAC is a Canadian non-governmental organization led by and for people living with HIV and HIV/HCV co-infection. Since 1996, they have been working to secure and ensure equitable, affordable, and timely access to treatment and care and support for people in Canada living with HIV and HIV/HCV co-infection.

Survey Takers Are Required

AbbVie 2D–GT4 Survey DotTake this survey if you are living with hep C/if you have had hep C. This survey is open to everyone who has or had hep C. It doesn’t discriminate based on hep C genotype.

Take this survey if you are a caregiver or loved one of someone who is living with hep C/had hep C.

AbbVie 2D–GT4 (ombitasvir / paritaprevir / ritonavir) information is here.

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently seeking patient input for AbbVie 2D–GT4 (ombitasvir / paritaprevir / ritonavir) and, therefore, the Pacific Hep C Network (PHCN) needs your thoughts, opinions, and experiences for our patient group input report.

CADTH Patient Group Input Reports

The patient group input reports requested by CADTH are an important step towards getting new treatments for hep C more widely available in Canada and BC.

The reports help ensure that health outcomes and issues important to patients are incorporated into the Common Drug Review process in a formal and meaningful way. They help ensure that you can be a part of the process!

PHCN’s Patient Input Surveys

Once again, PHCN’s patient input survey has been redesigned to, hopefully, help you easily voice your opinions and share your experiences.

There are two PHCN Input Surveys

The first survey was written for those with hep C or those who have had hep C. It includes 14 questions, some multiple choice, and is divided into 4 sections. The most important of these sections are ‘Section 2 of 4: Your Expectations of AbbVie 2D–GT4 (ombitasvir/ paritaprevir/ ritonavir)’ and ‘Section 3 of 4: Your Experience with AbbVie 2D–GT4’, if you have been treated with AbbVie 2D-GT4. If you haven’t taken AbbVie 2D–GT4, the survey lets you skip this section.

The second survey was written for loved ones or caregivers of those living with hep C/have had hep C. It includes 7 questions divided into 2 sections.

If the surveys don’t focus on something you would like to add, please use a textbox and include it as one of your answers. Some of the questions require answers but others were written to, hopefully, help you share your experiences or voice your opinion.

Survey responses are anonymous (we don’t know your name or other information about you). The information gathered will be used as part of a patient group input report for CADTH. By completing the survey you accept that PHCN can use the information gathered by it in our patient group input report for CADTH.

The survey links will only remain open until September 21st, so please complete a survey and share the survey links with others ASAP/before the September rush.

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about AbbVie 2D–GT4 (ombitasvir / paritaprevir / ritonavir).

Thank you for taking the time to voice your opinion and help advocate for a better tomorrow.

Technivie (Ombitasvir / Paritaprevir / Ritonavir) Facts

TechnivieTechnivie (Ombitasvir / Paritaprevir / Ritonavir)

Technivie Background: Hepatitis C genotype 4 only accounts for about 13% of global hep C infections and isn’t as common in Canada as it is in the Middle East and Africa. However, due to increased travel and immigration, the population who have hep C genotype 4 and who live in high-income countries  is growing.

Currently, those in BC with hep C genotype 4 have two treatment options. The first treatment option is pegylated interferon and ribavirin. It is covered by BC’s PharmaCare for genotype 4, but only has a SVR, or “cure rate”, of up to 65% as a genotype 4 treatment. It is a treatment known for poor tolerability, multiple side effects, and high rates of patients deciding to stop treatment early.

The second treatment option for those with hep C genotype 4 is Sovaldi in combination with pegylated interferon and ribavirin. This option is more successful, however, it isn’t covered by BC’s PharmaCare for genotype 4 and it includes pegylated interferon with ribavirin and its side effects.

Therefore, AbbVie, the creator of Technivie (ombitasvir / paritaprevir / ritonavir), is working to add a new treatment option to BC PharmaCare’s formulary.* This new treatment option, Technivie, has been approved for use by Health Canada and the FDA in the States.***

Targeted HCV Genotype:  4

Targeted Patients: Those without liver problems, or with Child-Pughs A, who have never tried hep C treatment or have previously tried peginterferon and ribavirin but weren’t cured by it. Those who have not had a severe skin rash after taking ritonavir.

Generic Name:  Ombitasvir / paritaprevir / ritonavir

Treatment Description:  Technivie is made up of 2 direct acting antivirals (ombitasvir and paritaprevir) and ritonavir, a booster for paritaprevir. It is taken without interferon.

  • Ombitasvir / paritaprevir / ritonavir +
  • Ribavirin

Approximate Sustained Viral Response / Cure Rate:  100% with ribavirin, 91% without ribavirin

Daily Dose:  2 pills taken once in the morning with food + ribavirin taken once in the morning and once at night

Length of Treatment:  12 weeks

The Most Common Side Effects Reported During Technivie Clinical Trials:

  • Insomnia
  • Nausea
  • Tiredness (fatigue)
  • Weakness (asthenia)

No one in the Pearl-I clinical trial discontinued treatment because of side effects.

Availability:  Technivie is approved for use in Canada

Clinical Trials for Technivie:

Clinical Trial Patients Treatment Regimen SVR12
PEARL-I* (12 weeks) Genotype (GT) 4 treatment naive, without cirrhosis Technivie 91%
Technivie + Ribavirin 100%
GT4 treatment experienced without cirrhosis Technivie + Ribavirin 100%
AGATE-I** (12, 16, or 24 weeks) This randomized study evaluates the safety and efficacy of Technivie with ribavirin in adults with hep C genotype 4 and cirrhosis who are treatment naive or treatment experienced. The study opened in October 2014. Ongoing but not recruiting
AGATE-II This study evaluates the efficacy and safety of Technivie with ribavirin in those with hep C genotype 4 Ongoing in Egypt
*Pearl-I was a trial which looked at hep C genotype 1 and 4, treatment-naive and -experienced patients. This trial didn’t include those with cirrhosis or a ribavirin free treatment option for those who were treatment experienced.
**In the Agate-I clinical trial treatment experienced patients had already been treated with Sovaldi in combination with pegylated interferon and ribavirin or Sovaldi with ribavirin.

More information about this and other emerging hep C treatments can be found at PHCN’s Hepatitis C Treatment Information Project or by emailing hepctip@pacifichepc.org.

*Technivie is currently approved for use in Canada and is being reviewed for BC PharmaCare coverage. (January 20, 2016)

**The Hepatitis C Treatment Information Project has a hep C treatment vocabulary page that defines words that are commonly used when  hep C treatment is discussed.

***The background information was from CATIE’s TreatmentUpdate 202 (March/April 2014): Simeprevir + interferon + ribavirin in HCV genotype 4 infection, World Federation of Science Journalists’ Hepatitis C: A Worldwide Health Story, FDA News Release: FDA approves Technivie for treatment of chronic hepatitis C genotype 4, Official Technivie, and ‘Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial’ published by The Lancet, March 31, 2015.