Tag Archives: ombitasvir

Advocacy, Drug Pipeline

Technivie and BC PharmaCare

Technivie and BC PharmaCareTechnivie, the hepatitis C treatment, was approved for use in Canada in October 2015 and then later went on to pursue approval for BC PharmaCare coverage in January 2016. However, negotiations that may have led to BC PharmaCare coverage being granted in the near future were closed as an agreement couldn’t be reached between AbbVie and pCPA at this time.

Technivie is still an approved hepatitis C genotype 4 treatment in Canada. For more information about this, please contact the AbbVie Care program at: 1-844-471-2273.

Technivie (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.

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.

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.

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

Thank you to all of those who wrote in for Technivie’s patient input reports that were sent to CADTH and BC PharmaCare. Thank you also to those who worked to develop Technivie, a treatment for hepatitis C genotype 4. Thank you for working in hopes of a better tomorrow for those with hepatitis C genotype 4.

Advocacy, Drug Pipeline

Holkira Pak and BC PharmaCare

Holkira Pak and BC PharmaCareThe hepatitis C treatment Holkira Pak was approved for use in Canada in March 2015 and then was later approved for BC PharmaCare coverage in July  2015. Although Holkira Pak is still approved for use in Canada and has an amazingly high cure rate, as of March 23, 2017, BC PharmaCare has decided not to approve new requests for coverage.

For patients whose coverage was approved before March 23, 2017, BC PharmaCare will continue coverage until their current Special Authority expires. For more information about this change, please contact your doctor, nurse, or call the AbbVie Care program at: 1-844-471-2273.

From all of the BC residents who were able to access Holkira Pak and, therefore, may have been cured of the hepatitis C virus, we would like to thank all of the people who work within the hepatitis C approval pipeline who made their recovery possible.

Holkira Pak

Treatment Description: Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

  • Ombitasvir / Paritaprevir / Ritonavir +/-
  • Ribavirin

Daily Dose: 4 pills +/- ribavirin pills

Sustained Viral Response (SVR)/”Cure Rate”: 95 – 100% with ribavirin

Usage Warning: Holkira Pak should not be taken with/by the following:

  • Those with moderate to severe liver impairment (Child-Pughs B and C);
  • Ethinyl estradiol-containing medicines (such as some birth control products);
  • Drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations;
  • Strong CYP2C8 inhibitors and inducers;
  • Moderate or strong inducers of CYP3A;
  • Recreational drugs.

Length of Treatment:

Genotype Previously Treated Cirrhosis Treatment # of Weeks
1a Yes or No No 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV* 12
1b Yes or No No 2 pills once daily + 1 pill twice daily 12
1a/1b No Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 12
1a Yes Yes 2 pills once daily + 1 pill twice daily + 1 pill twice daily of RBV 24**
*RBV stands for ribavirin. Holkira Pak with ribavirin is recommended for patients with an unknown genotype 1 subtype or with mixed genotype.
**24 weeks of Holkira Pak + ribavirin is recommended for patients with genotype 1a infection with cirrhosis who previously didn’t respond to pegylated interferon and ribavirin (PR).

Common Side Effects Reported in Clinical Trials:

  • Can’t sleep (insomnia)
  • Diarrhea
  • Headache
  • Itchiness
  • Nausea
  • Tiredness
Drug Pipeline

BC PharmaCare Coverage Review for Technivie

Advanced Notice of BC PharmaCare Coverage Review for TechnivieTechnivie will soon be considered for BC PharmaCare coverage. Therefore, your input will soon be sought.

Tentatively, patient and caregiver input into Technivie’s approval process will be requested from Wednesday January 20, 2016 to Wednesday February 17, 2016 AT MIDNIGHT.

How to Add Your Voice to the BC PharmaCare Coverage Review for Technivie

If you are a BC resident and answer yes to any of the following questions, you can give your input into whether or not the treatment should be covered by BC PharmaCare:

Please note that PharmaCare’s questionnaire for Technivie input tentatively wont be available for another two weeks. The Hepatitis C Treatment Information Project will follow this development and keep you updated.

Technivie

Information about Technivie can be found at Technivie (Ombitasvir / Paritaprevir / Ritonavir) Facts or in CTAC’s Technivie Youtube video.

For more information, please contact BC PharmaCare’s Your Voice or the Hepatitis C Treatment Information Project.

Drug Pipeline, Uncategorized

Technivie Now Approved for Use

TechnivieTechnivie (ombitasvir/paritaprevir/ritonavir) with ribavirin  is now an approved hepatitis C treatment in Canada!

Health Canada has granted the treatment Technivie with ribavirin a Notice of Compliance (NOC) for treating adult patients with chronic hep C genotype 4 without cirrhosis and who have never tried treatment or who have previously been treated with pegylated interferon and ribavirin.

A Notice of Compliance

Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance a doctor may prescribe it – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Technivie (ombitasvir/paritaprevir/ritonavir), or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Drug Pipeline

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.

Advocacy, Drug Pipeline

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.

Drug Pipeline

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.

Drug Pipeline

Ombitasvir/ paritaprevir/ ritonavir Announcement

Ombitasvir/ paritaprevir/ ritonavirThis morning the Canadian Agency for Drugs and Technologies in Health (CADTH) sent out notice that they are currently seeking patient group input for Technivie (ombitasvir/ paritaprevir/ ritonavir). Technivie is an interferon-free treatment for hepatitis C genotype 4 infections.

Please keep your eyes open for a blog post with more information about Technivie (ombitasvir/ paritaprevir/ ritonavir) and a link to PHCN’s patient input survey. They will be finalized and sent out in the next few weeks.

About Patient Group Input Reports Requested by CADTH

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. The Common Drug Review (CDR) by CADTH then assesses the treatment’s clinical and cost-effectiveness as it compares to other treatments.

During Common Drug Reviews, CADTH requests patient input reports. These patient input 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 patients and their loved ones can be a part of the drug review process!

Please email or visit the Hepatitis C Treatment Information Project for more information about Technivie (ombitasvir/ paritaprevir/ ritonavir) or any other hep C treatment.

Drug Pipeline, Uncategorized

PharmaCare Covers Holkira Pak

Holkira Pak and BC PharmaCareVancouver, B.C. – (July 28th, 2015) – On World Hepatitis Day, Pacific Hepatitis C Network (PHCN) welcomed the B.C. Ministry of Health’s announcement that it will provide coverage for a new hepatitis C virus (HCV) treatment, Holkira Pak.

The hepatitis C virus is considered one of the most serious public health issues facing Canadians, causing more years of life lost than any other infectious disease in the country. In B.C. alone, for example, there are about 80,000 people currently living with hepatitis C.

Therefore, “the Pacific Hepatitis C Network applauds the addition of new treatments like Holkira Pak to the PharmaCare formulary here in B.C.,” said Daryl Luster, president of the board of the Pacific Hepatitis C Network. “I can say with great certainty that lives will be saved, and the quality of life for thousands of people living with hepatitis C, and their families will be impacted in the most positive of ways due to this action by the Government of British Columbia.”

Holkira Pak is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-pill, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

Holkira Pak is the third new hepatitis C drug to be covered by BC’s PharmaCare this year. The other two treatments covered were Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

For more information about Holkira Pak, please visit PHCN’s Hepatitis C Treatment Information Project or email.

The B.C. Ministry of Health’s Holkira Pak Press Release can be found at: https://news.gov.bc.ca/releases/2015HLTH0053-001186

Holkira Pak

Drug Pipeline

Holkira Pak Recommendations

Holkira PakHolkira Pak (generic name: ombitasvir/paritaprevir/ritonavir and dasabuvir), developed by AbbVie, just passed its Common Drug Review with the release of the Canadian Drug Expert Committee (CDEC) Final Recommendation.

Within the Canadian drug approval process, Health Canada first evaluates a drug’s safety, clinical effectiveness, and its manufacturing process. After which, a Common Drug Review (CDR) by the Canadian Agency for Drugs and Technologies in Health (CADTH) compares the drug’s clinical and cost-effectiveness to those of other treatments. This assessment report is then sent to the provinces and territories to help them decide on coverage.

The CDEC’s Final Recommendation advocates for Holkira Pak to be listed as a treatment for adults with genotype 1 hep C if the following criteria is met:
Clinical Criteria
Conditions
  • Treatment should be started by physicians experienced with treating chronic hep C.
  • Drug plans should not pay more for Holkira Pak than they do for other hep C interferon-free treatments.
Reasons for the Holkira Pak Recommendations
  1. 6 randomized clinical trials (Sapphire I, Sapphira II, Pearl II, Pearl III, Pearl IV, and Turquoise II) showing that treatment with Holkira Pak, with or without ribavirin (RBV), achieved high rates of SVR12 (cure at 12 weeks) for both those who have and those who haven’t already tried treatment.
  2. Holkira Pak’s results (quality-adjusted life years) and costs are similar to other hep C treatments, such as Harvoni. Provinces will have to consider drug plan and health care system sustainability when deciding whether or not to cover newly available expensive hep C treatments.
  3. CDEC couldn’t evaluate the cost-effectiveness of Holkira Pak according to liver fibrosis stage due to limitations in the manufacture’s pharmacoeconomic evaluation.
Other Reported Discussion Points
  • Holkira Pak may offer a greater range of therapeutic options to some patients, but it requires more pills be taken than Harvoni.
  • There may be a greater chance of drug interactions while taking Holkira Pak than while taking Harvoni.
  • A phase 2 clinical trial (TURQUOISE I) tested hep C patients co-infected with HIV with 12 or 24 weeks of Holkira Pak and ribavirin (RBV). SVR12 rates were 93.5% and 90.6% for the 12 and 24 week groups.
Reported Research Gaps
  • There isn’t a comparison between Holkira Pak and Harvoni.
  • The consequences of reinfection following treatment with hep C direct-acting antiviral require further study.
Holkira Pak

Holkira Pak (ombitasvir/paritaprevir/ritonavir and dasabuvir) is a treatment for patients with chronic genotype 1 hep C, including those with cirrhosis. It is an all-oral, short-course, interferon-free treatment that can be taken with or without ribavirin.

In Phase 3 clinical trials, Holkira Pak (with or without ribavirin) cured an overall 97% of genotype 1 hep C patients, and 98% of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of treatment discontinuation due to adverse reactions were low (0.2%).

For more information about Holkira Pak, CADTH,  or any other new and emerging hep C drug, please visit PHCN’s Hepatitis C Treatment Information Project or email.