Tag Archives: FDA Approval

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.

Zepatier Receives FDA Approval

Zepatier Receives FDA ApprovalZepatier (pronounced ZEP-ah-teer), taken with or without ribavirin, was approved by the U.S. Food and Drug Administration (FDA) yesterday for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4 and little or no liver damage (Child-Pugh A).

Yesterday’s Press Releases about Zepatier’s FDA Approval

Zepatier

Zepatier is an all-oral, short-course (12 or 16 weeks), interferon-free hep C treatment that can be taken with or without ribavirin. The treatment is a pill taken once-daily that is made up of two direct-acting antivirals, grazoprevir and elbasvir.

In clinical trials, Zepatier (with or without ribavirin) cured an overall 94% – 97% of patients with hep C genotype 1, and 97% – 100% of hep C genotype 4 patients.

Zepatier in Canada

On January 22nd, Health Canada approved Zepatier for use in Canada for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring). In Canada, it was approved for use with or without ribavirin and with or without Sovaldi.

More information about Zepatier in Canada can be found at Zepatier Approved in Canada or by visiting PHCN’s Hepatitis C Treatment Information Project.