Tag Archives: Sofosbuvir / Velpatasvir

Pan-Genotypic Hepatitis C Treatments: The Basics

Pan-Genotypic Hepatitis C Treatments: The BasicsHepatitis C Genotypes

Based on its genetic (RNA) makeup, the hepatitis C virus has different types/variations/strains. These types are referred to as genotypes.

There are six common hep C genotypes, with several different subtypes, identified throughout the world. The most common hep C genotype in Canada is known as the hepatitis C virus genotype 1 (HCV GT1 or just GT1).

A person can become infected with more than one of these genotypes, so prevention (following the basic rules for staying healthy) and harm reduction are always important. Knowing one’s hep C genotype is also important as it affects the type of treatment prescribed, the treatment’s duration, and the treatment’s success.

Hepatitis C Genotypes and Hep C Treatment

The type of hep C infection one has doesn’t determine how bad their hep C symptoms may be. For example, having genotype 1 hep C doesn’t mean that a person will experience less hep C symptoms than someone with genotype 2 hep C. However, hep C genotypes do effect a treatment’s possible success and its side effects. Therefore, each hep C genotype has its own treatments and set of treatment lengths that work best against it.

Pan-Genotypic Hepatitis C Treatments

However, there are now pan-genotypic hep C treatments in the Canadian approval process that are able to treat all virus genotypes. These new treatments are important as they have the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explained, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

Possible Pan-Genotypic Hepatitis C Treatments in Development or the Approval Process

Treatments*
Epclusa (sofosbuvir / velpatasvir)
Glecaprevir / Pibrentasvir
Sofosbuvir / Velpatasvir + Voxilaprevir
AL-335 + Odalasvir (ACHN-3102) + Simeprevir
*An additional name for the drug glecaprevir is ABT-493. An additional name for pibrentasvir is ABT-530. An additional name for voxilaprevir is GS-9857. Epclusa is the only one so far to be approved for use in Canada.

Interesting Online Articles and Resources

Is Epclusa soon-to-be considered for BC PharmaCare coverage?

Epclusa soon-to-be considered for BC PharmaCare coverage?YES. The Hepatitis C Treatment Information Project just received an advance notification from BC’s Ministry of Health that the hepatitis C treatment Epclusa (generic name sofosbuvir / velpatasvir) will soon be considered for BC PharmaCare coverage.

Wednesday August 24, 2016 to MIDNIGHT ON Wednesday September 21, 2016 is tentatively when input will be sought.

Submitting Input to BC PharmaCare about Hepatitis C Treatments and Epclusa

The BC PharmaCare approval process seeks input from patients and caregivers or loved ones of those who have or have had hepatitis C. If you are a BC resident and answer YES to any of the following questions, you can complete a questionnaire and send BC PharmaCare your input into whether or not they should cover Epclusa:

  1. Do you have hep C?
  2. Are you a caregiver to someone who has hep C?
  3. Does your patient group represent patients who have hep C AND have you registered with PharmaCare to give input? (Learn more about registering your organization).

Please note that PharmaCare’s questionnaire for Epclusa input wont tentatively be available for another two weeks. The Hepatitis C Treatment Information Project will send the questionnaire’s link out when BC PharmaCare makes it available.

Epclusa

Epclusa is the first pan-genotypic hepatitis C treatment to be approved for use in Canada against all six hep C virus types. A pan-genotypic treatment is a treatment able to cure all six of the hep C virus types with high success rates against all six.

More Information about Epclusa

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

Global and CTV News Report that Health Canada has Approved Epclusa

Global and CTV News Reports Health Canada Approved EpclusaGlobal News and CTV News are reporting that Health Canada has approved the hepatitis C treatment sofosbuvir / velpatasvir (American brand name Epclusa) for use in Canada. If this news is correct, Health Canada has just approved the first hep C treatment that can cure all 6 hep C virus types with high success rates!

A treatment able to cure all virus types is amazing as it has the power to make hep C treatment much easier than it is now. As Dr. Jordan Feld, a liver specialist at Toronto Western Hospital, explains, a treatment that can be used for every virus type “…eliminates the need for [virus type/genotype] testing, which often delayed treatment and can be difficult to access for those living in rural or remote regions of the country….” (Ubelacker, The Canadian Press)

News Reports Remain Unverified

The Hepatitis C Treatment Information Project tried to double check that this treatment has indeed been approved, and approved as the articles have said. However, we were unable to reach Gilead, the treatment’s developer, and Health Canada before this blog post was published. This failure to reach the two parties was probably because it was early evening in BC and so passed business hours in the East when this post was written.

We will follow this story and share additional information as it becomes available.

Sofosbuvir / Velpatasvir

Description: Sofosbuvir / velpatasvir is a short-course, interferon-free, hepatitis C treatment that can be prescribed with or without ribavirin. It is one pill taken once a day.

Treatment Lengths Approved in America:

  • 12 weeks for patients without liver cirrhosis and patients with compensated liver cirrhosis (Child-Pugh A)
  • 12 weeks for patients with more serious  liver cirrhosis (Child-Pugh B or C) when it is combined with ribavirin.

Most Common Side Effects when Treatment is Taken Without Ribavirin:

  • Headache
  • Fatigue (Tiredness)

Most Common Side Effects when Treatment is Taken With Ribavirin:

  • Fatigue (Tiredness)
  • Anemia
  • Nausea
  • Headache
  • Insomnia (Can’t sleep)
  • Diarrhea

Clinical Trial Results for Sofosbuvir / Velpatasvir

In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with  moderate to severe liver cirrhosis.

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

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

Sofosbuvir / Velpatasvir Facts

Genotypes Tested Against1 – 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.