Tag Archives: Velpatasvir

Drug Pipeline

Sofosbuvir/Velpatasvir CTAC Webinar

Sofosbuvir/Velpatasvir CTAC Patient Group Input WebinarThis Monday, May 2nd, from 11 AM to 12 PM (PDT/in BC) / 2 PM to 3 PM (EDT/in Ontario), the Canadian Treatment Action Council (CTAC) will be hosting a webinar about the exciting new hep C treatment sofosbuvir/velpatasvir.

Following the webinar, there will be a survey to collect information that will help them write a patient input report for sofosbuvir/velpatasvir’s Common Drug Review. CTAC’s sofosbuvir/velpatasvir survey is different from PHCN’s patient input survey or PHCN’s loved ones/caregivers survey. Please consider filling out the still available PHCN survey that was created for you as well as CTAC’s survey.

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

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.

Patient Group Input Reports Requested by CADTH’s Common Drug Reviews

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.

 Sofosbuvir/Velpatasvir

Sofosbuvir/velpatasvir is an all-pill, short-course (sometimes only 8 weeks), interferon-free treatment that can be taken with or without ribavirin. In Phase 3 clinical trials, sofosbuvir/velpatasvir (with or without ribavirin) cured an overall 99% of those with genotype 1, 2, 4, 5, or 6 hep C and was found to be well tolerated by patients.

“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

Drug Pipeline

In the Final Steps of the Canadian Drug Approval Pipeline

In the Final Steps of the Canadian Drug Approval PipelineCurrently, there are a couple of hepatitis C treatments making their way through the final steps of the Canadian drug approval pipeline. The following table was created to highlight these treatments and highlight the ways that you may be able to include your voice in their approval process.

Hepatitis C Treatments in the Final Steps of the Canadian Drug Approval Pipeline

Technivie (ombitasvir, paritaprevir, ritonavir) +/- Ribavirin (RBV) Sovaldi (sofosbuvir) + Daklinza (daclatasvir) +/- RBV Sofosbuvir / Velpatasvir +/- RBV Zepatier (elbasvir / grazoprevir) +/- RBV Zepatier (elbasvir / grazoprevir) + Sovaldi (sofosbuvir)
Treatment Drug Classes NS5A Inhibitor, NS3/4A Protease Inhibitor, and Ritonavir, a booster for paritaprevir Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor Nucleotide NS5B Polymerase Inhibitor, NS5A Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor NS5A Inhibitor, NS3/4A Protease Inhibitor, Nucleotide NS5B Polymerase Inhibitor
Steps in Canadian Drug Approval Pipeline Step 5 – Provincial Review Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review Step 4 – Common Drug Review by CADTH / Step 5 – Provincial Review
Currently Seeking Patient Input No No Yes Yes Yes
Genotype (GT) Health Canada has Approved it for 4 1, 2, 3 This treatment has just begun the Canadian review process. Clinical trials have examined it on hep C genotypes 1-6. 1, 3, 4 3
Under BC PharmaCare Review for Genotype 4 Genotype 1, 2 or 3 without RBV, Genotype 2 or 3 with RBV Genotype 1, 3, 4 with or without RBV 3
Approximate SVR (Approx Rate of Cure) 90% without RBV, 100% with RBV 90 – 100% 94 – 100% 93 – 100% 91 – 100%
May Require PR* No
May Not Require RBV
 Yes
Daily Pills 1 +/- twice daily RBV 2 +/- twice daily RBV 1 +/- twice daily RBV 1 +/- twice daily RBV 2 once daily
Possible Weeks of Treatment 12 12 or 24 8, 12, or 24 8, 12, or 16 12
Limited Most Common Side Effects**  (Ribavirin can affect side effects)
  • Headache
  • Insomnia
  • Nausea
  • Tiredness
  • Weakness (asthenia)
  • Diarrhea
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Anemia
  • Headache
  • Nausea
  • Tiredness (fatigue)
  • Headache
  • Nausea
  • Tiredness (fatigue)
Drug Warnings (Healthcare providers, patient assistance programs, and/or online product monographs, links below, have more information)

Technivie is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Technivie should not be taken while taking: ethinyl estradiol-containing medicines, drugs that are sensitive cytochrome P450 (CYP) 3A substrates and for which elevated plasma concentrations are associated with serious adverse reactions, strong CYP2C8 inhibitors and inducers, moderate or strong inducers of CYP3A.

 Sovaldi is not for patients taking amiodarone. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness. Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Zepatier is not for patients with moderate to severe liver impairment (Child-Pughs B and C). Zepatier is contraindicated with organic anion transporting polypeptide 1B (OATP1B) inhibitors, strong inducers of cytochrome P450 3A (CYP3A), and efavirenz.

Patients taking amiodarone should not take Sovaldi (sofosbuvir) in any combination.
General Hep C Treatment Usage Warning Do not take treatments while taking recreational drugs or over-the-counter drugs, such as St. John’s wort, without first talking with your healthcare provider as they may interact with each other. Tell your doctor if you may be or may become pregnant. The safety and efficacy of most of these treatments in children less than 18 years of age has not been established.
Patient Assistance Program Contact Information AbbVie Care 1-844-471-2273 Bristol-Myers Squibb Canada’s CLAIRE Program 1-844-HCV-2559 Gilead’s Momentum Patient Assistance Program 1-855-447- 7977 Merck Care Program 1-866-872-5773
Information by Health Canada Technivie Daklinza Zepatier
Information about HCV / HIV Co-infection Technivie (by CATIE) Daklinza (by CATIE)

Sovaldi / Velpatasvir (by hepmag)

 Zepatier (by CATIE)
*PR stands for pegylated interferon with ribavirin. It may be combined with other drugs for the treatment of hep C. RBV stands for ribavirin. **If patients experience treatment side effects, they are usually not severe enough to stop treatment. 

—

Information was gathered from Health Canada’s Drug and Health Products sheets, BC PharmaCare Drug Information sheets,  CATIE, hepmag, product monographs, and the Hepatitis C Treatment Information Project within the past week.

Drug Pipeline

Take this survey. Sofosbuvir / Velpatasvir Input Requested.

The above survey links will only remain open until April 27th, 2016, so please complete a survey and share the survey links with others ASAP.

The Drug Approval Process is Seeking Patient and Caregiver Input

The Canadian Agency for Drugs and Technologies in Health (CADTH) wants to hear from you! They are currently reviewing the hep C treatment sofosbuvir / velpatasvir. As part of their review, they are seeking patient and caregiver input about hep C and hep C treatments from Canadian patient groups. Therefore, we, the Pacific Hep C Network (PHCN), are seeking your thoughts, opinions, and experiences for our patient group input report.

More information about CADTH and patient group reports is below.

PHCN’s Sofosbuvir / Velpatasvir Patient Input Surveys

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 Sofosbuvir / Velpatasvir’ and Take this survey. Sofosbuvir / Velpatasvir Input Requested.‘Section 3 of 4: Your Experience with Sofosbuvir / Velpatasvir’, if you have been treated with sofosbuvir / velpatasvir. If you haven’t taken sofosbuvir / velpatasvir, 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 and 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 the sofosbuvir / velpatasvir 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 April 27th, so please complete a survey and share the survey links with others ASAP.

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 are a part of the drug review process!

Email the Hepatitis C Treatment Information Project for more information about the surveys or for more information about sofosbuvir / velpatasvir.

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

Drug Pipeline

Sofosbuvir / Velpatasvir Fact Sheet

Sofosbuvir / Velpatasvir Facts SheetThe below treatment fact sheet was designed to give you more information about sofosbuvir / velpatasvir and to encourage you to help us, PHCN, with our sofosbuvir / velpatasvir patient group input report for CADTH. The fact sheet was put together in hopes that you will help us advocate on behalf of those with hep C and their loved ones.

Sofosbuvir / velpatasvir, an exciting new hepatitis C treatment, is currently being reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH). Therefore,  CADTH is seeking patient input about hep C, hep C treatments, and  sofosbuvir / velpatasvir.

PHCN’s Sofosbuvir / Velpatasvir Surveys

  • Take this survey if you are living with hep C/if you have had hep C.

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

Sofosbuvir / Velpatasvir Facts

Genotypes Tested Against: 1 – 6

Treatment Description: Sofosbuvir / velpatasvir is made up of two direct-acting antivirals, sofosbuvir and velpatasvir. Sofosbuvir (brand name Sovaldi) is a nucleotide NS5B polymerase inhibitor that “…targets the hep C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information (RNA) to block the virus from multiplying.” (Gilead)

Velpatasvir is a pan-genotypic NS5A inhibitor that blocks a virus protein, NS5A, that the hep C virus needs for reproducing and various stages of infection.

Approximate Sustained Viral Response (SVR)/”Cure Rate”:  94 – 100%

Daily Dose:  1 pill +/- ribavirin

Possible Length of Treatment:  8, 12, or 24 weeks

Common Side Effects Reported in Clinical Trials: 

  • Headache
  • Nausea
  • Tiredness (fatigue)

Usage Warning: Do not take sofosbuvir in any combination while taking Amiodarone or with bradycardia.

Step in Drug Approval Pipeline:  Step 4 – Common Drug Review by CADTH

 Availability:  Not approved for use in Canada

Sampling of Phase II/III Clinical Trials for Sofosbuvir / Velpatasvir:

Patients
Treatment Regimen
Duration in Weeks
SVR12
ASTRAL-1: A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naïve and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without cirrhosis (Abstract LB-2 from AASLD’s Liver Meeting 2015)
Genotype (GT) 1, 2, 4, 5, 6 Hepatitis C with and without cirrhosis; 740 patients Sofosbuvir / Velpatasvir (SOF/VEL)
 12 Overall: 99% (618/624)

GT1: 98% (323/328)

GT2: 100% (104/104)

GT4: 100% (116/116)

GT5: 97% (34/35)

GT6: 100% (41/41)
Placebo 116 patients received placebo, experienced similar adverse effects, SVR12 0%
ASTRAL-2 and ASTRAL-3: Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
GT 2, 3 HCV; treatment naive and treatment experienced; including patients with compensated cirrhosis GT2 14% with cirrhosis SOF/VEL 12 99% (133/134)
Sofosbuvir + ribavirin (RBV) 94% (124/132)
GT3 30% with cirrhosis SOF/VEL 12 95% (264/277)
Sofosbuvir + RBV 24 80% (221/275)
ASTRAL-4: Sofosbuvir/Velpatasvir Fixed Dose Combination for the Treatment Of HCV in Patients with Decompensated Liver Disease
Genotypes 1-6 All with Child-Pugh class B (decompensated) cirrhosis SOF/VEL 12 83% (75/90) Overall (GT1 88% GT2 100% GT3 50% GT4 100%)
SOF/VEL + RBV 94% (82/87) Overall (GT1 95% GT2 100% GT3 84% GT4 100%)
SOF/VEL 24 86% (77/90) Overall (GT1 91% GT2 75% GT3 50% GT4 100% GT6 100%)

Additional Facts about Sofosbuvir / Velpatasvir can be Found in the Following Resources:

Please email or visit the Hepatitis C Treatment Information Project for more information about Sofosbuvir / Velpatasvir or any other hep C treatment.