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 +
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:
- Tiredness (fatigue)
- Weakness (asthenia)
No one in the Pearl-I clinical trial discontinued treatment because of side effects.
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.
*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.