Tag Archives: FDA

New Drug Application Submitted for Sofosbuvir/Velpatasvir/Voxilaprevir

New Drug Application Submitted to FDA for Sofosbuvir/Velpatasvir/Voxilaprevir~ A New Drug Application has been submitted to the FDA. If Approved, Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Would Be the First Once-Daily Single Tablet Regimen Available as a Treatment Resorted to when Preferred Therapies have been Tried, or a Salvage Treatment,  for Patients with Hep C Genotype 1-6 Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors ~

The creator of the hepatitis C treatment SOF/VEL/VOX, Gilead, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the hep C treatment. SOF/VEL/VOX has been submitted as an once-daily single pill regimen for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients.

The Data Submitted in the New Drug Application (NDA)

The data submitted in the NDA, see below, supports the use of the regimen for 12 weeks in DAA treatment experienced patients with genotype 1 to 6 hep C who have or don’t have liver cirrhosis.

Clinical Trial Patients Genotype Duration Treatment SVR12
POLARIS-1 455 patients, including those who failed prior treatment with an NS5A-containing regimen, 41 percent (172/415) had cirrhosis 1-6 12 weeks SOF/VEL/VOX 96%
Placebo 0%
POLARIS-4 DAA-experienced (No NS5A inhibitor), 46 percent (153/333) had cirrhosis 1-4 12 weeks SOF/VEL/VOX 97%
SOF/VEL 90%
POLARIS-2 DAA-naive, 18 percent (174/941) had cirrhosis 1-6 8 weeks SOF/VEL/VOX 95%
12 weeks SOF/VEL 98%
POLARIS-3 DAA-naive, All had cirrhosis 3 8 weeks SOF/VEL/VOX 96%
12 weeks SOF/VEL 96%

Patients treated with SOF/VEL/VOX for 12 or 8 weeks experienced side effects similar to those treated with placebos. The most common side effects from SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.

No news on or how the treatment may be submitted to Health Canada.

More Information

“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead.

Viekira XR Received US FDA Approval

Viekira XR Received U.S. FDA ApprovalViekira XR has been FDA approved in America. Viekira XR is an extended-release version of the hepatitis C treatment Viekira Pak (American brand name Viekira Pak / Canadian brand name Holkira Pak). This extended-release version is for patients with chronic genotype 1 hepatitis C, including those with compensated cirrhosis (Child-Pugh A). The treatment includes 3 pills, taken daily with food, that may or may not be combined with ribavirin. It may be prescribed for 12 or 24 weeks of therapy.

An extended-release therapy is a treatment made up of pills that were created to slowly release over time. This slow release gives the drugs more time to work and may allow the levels of the drugs in the body to be more consistent than they may be with other treatment types. This may help lower side effects.

For more information about this FDA approval or about the hepatitis C treatment, please see the press release by AbbVie, the developer of Viekira Pak/Holkira Pak and Viekira XR.

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

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)

U.S. FDA Approved Epclusa (Sofosbuvir/Velpatasvir)Epclusa (sofosbuvir / velpatasvir), the first hepatitis C treatment able to cure six types of the hep C virus with high success rates against all of the six types, has been approved for use in America for all of those six types!

The hep C treatment sofosbuvir / velpatasvir (American brand name Epclusa) was approved by the U.S. Food and Drug Administration (FDA) yesterday. It was approved for the treatment of adult patients with a chronic hepatitis C virus infection, genotype 1, 2, 3, 4, 5, or 6. This approval means that it can be prescribed to those with or without liver cirrhosis and can be prescribed with or without the drug ribavirin (prescribed with ribavirin for patients with liver cirrhosis, Child-Pugh B or C).

Yesterday’s Press Releases about Sofosbuvir / Velpatasvir’s FDA Approval

Sofosbuvir / Velpatasvir (American Brand Name Epclusa)

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

It is the first once daily pill treatment for patients with hep C genotype 2 and 3, without the need for ribavirin.

Approved for in the States: Epclusa taken for 12 weeks was approved in patients without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with more serious  liver cirrhosis (Child-Pugh B or C).

Common Side Effects: The most common side effects of sofosbuvir / velpatasvir are headache and fatigue. However, If it is combined with ribavirin, patients may experience side effects from the ribavirin.

Sofosbuvir / Velpatasvir in Canada

Sofosbuvir / velpatasvir isn’t approved for use in Canada yet.

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,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.

U.S. FDA Approved Harvoni for More Patients

U.S. FDA Approved Harvoni for More PatientsIn the U.S,. the FDA approved Harvoni for more hep C patients today. Harvoni (ledipasvir/sofosbuvir), a FDA approved hepatitis C treatment, was also FDA approved to treat patients with advanced liver disease. The treatment was approved to be prescribed with ribavirin for 12 weeks for patients with:

  • Hep C genotypes 1 or 4 who are liver transplant recipients and who have compensated cirrhosis (Child-Pugh A) or don’t have cirrhosis;
  • Hep C genotype 1 with decompensated cirrhosis (Child-Pugh B or C), including those who have had liver transplants.

See today’s press release for more information about Harvoni in the U.S., the FDA approval, clinical trial results, and safety information for Harvoni (ledipasvir/sofosbuvir).

Harvoni in Canada

Harvoni is an all-oral (one pill daily), short-course (8 – 24 weeks), interferon-free, ribavirin-free, treatment for patients with chronic hep C genotype 1, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 93% of the patients who have been treated with Harvoni. Harvoni is listed by Canadian pharmacare programs. More information about the hep C treatment can be found here.

U.S. FDA Approves Expanded Use of Daklinza

U.S. FDA Approves Expanded Use of DaklinzaIn the U.S., Daklinza (daclatasvir) plus Sovaldi (sofosbuvir), a FDA approved hepatitis C treatment for those with hep C genotype 3, is now also FDA approved to treat hep C genotype 1 or 3 patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of hep C. The treatment is approved to be prescribed on its own or combined with ribavirin.

See yesterday’s press release for more information about the FDA approval, suggested treatment lengths, and clinical trial results for Daklinza and Sovaldi.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” said Chris Boerner, Head of U.S. Commercial, Bristol-Myers Squibb, in the company’s press release.

Daklinza in Canada

In Canada, Daklinza was approved for use with Sovaldi last August. Daklinza with Sovaldi, when prescribed in Canada, is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment for patients with chronic hep C genotype 1, 2, or 3, who have or don’t have liver cirrhosis. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.

FDA Holkira Pak and Technivie Warning

Holkira Pak and TechnivieThe U.S. Food and Drug Administration (FDA) sent out a warning yesterday that the hepatitis C treatments Holkira Pak and Technivie “can cause serious liver injury mostly in patients with underlying advanced liver disease.”

As a result, the FDA is requiring that the two hep C treatments add information about this safety risk to their labels in the States and are advising patients taking these treatments to speak to their health care provider immediately if they experience signs of liver damage.

Signs of liver damage can be fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools.

The FDA does not advise patients to stop treatment without talking to their health care provider first as this may result in drug resistance to hep C treatments.

The complete FDA safety announcement can be found on the FDA’s website.

OCTOBER 23 UPDATE / CLARIFICATION:

All drugs and health products have benefits and risks. Although medical treatments are carefully tested before they are allowed to be used, some reactions become evident only after the drug is being used by the general population. Health care systems monitor drugs closely after they are approved for use and change labels and send out warnings when need be.

The American label change was a result of this and possibly the treatments being prescribed to patients with cirrhosis with Child Pugh Scores of B or C. Health Canada’s website states that the treatments are only approved for those with a Child Pugh Score of A (5-6), as: “The safety and efficacy of Holkira Pak have not been established in HCV-infected patients with moderate (Child-Pugh B) or severe hepatic impairment (Child-Pugh C). Therefore, Holkira Pak should not be used in these patients.”