Seven FDA developments since last World Hepatitis Day

World Hepatitis Day is July 28. To acknowledge how far treatment and the drug pipeline for hepatitis C and other strands of the virus infection has come, Healio.com/Hepatology created a list of drugs and regimens that have been approved by the FDA or are in the pipeline to treat the infection from the past year.

FDA approves Daklinza for chronic hepatitis C genotype 3 infections

Daklinza (daclatasvir, Bristol-Myers Squibb) is the first drug to demonstrate safety and efficacy in genotype 3 HCV infections without requiring co-administration of interferon or ribavirin, two FDA-approved drugs used for the treatment of HCV infections. Read more.

FDA approves Technivie for HCV genotype 4

Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie) was approved for use with ribavirin for the treatment of adults with hepatitis C virus genotype 4 infection without cirrhosis and is the first drug to be found both safe and effective in this patient population without the addition of interferon. Read more.

FDA grants fast track designation for HDV inhibitor

Eiger BioPharmaceuticals was granted fast track designation by the FDA for lonafarnib in combination with Norvir (ritonavir, AbbVie) for treatment of hepatitis delta virus infection.

Lonafarnib, an orally active agent that targets farnesyltransferase, inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply, according to a press release. A phase 2 trial is currently underway to evaluate the drug when used in combination with Norvir. Read more.

FDA grants new breakthrough therapy designations for grazoprevir/elbasvir

After rescinding breakthrough designation earlier this year, the FDA re-established two new designations for an oral combination tablet of grazoprevir/elbasvir for the treatment of chronic hepatitis C virus infection. The new breakthrough designations for grazoprevir and elbasvir (MK-5172, MK-8742; Merck) are geared towards treating patients with chronic HCV genotype 1 with end-stage renal disease on hemodialysis and patients with chronic HCV genotype 4. Read more.

FDA approves Viekira Pak for treatment of HCV

The FDA approved Viekira Pak, a treatment for patients with hepatitis C virus genotype 1 infection, including those with cirrhosis.

The regimen, which is a combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, (AbbVie) previously received the FDA’s breakthrough therapy designation and can be used with or without ribavirin, but is not recommended for patients with decompensated cirrhosis. Read more.

FDA approves Olysio to be used with Sovaldi for HCV genotype 1

The FDA has approved changes to the Olysio (simeprevir, Janssen Therapeutics) label reflecting that it can be used in combination with Sovaldi (sofosbuvir, Gilead Sciences) to treat patients with chronic hepatitis C virus genotype 1 infection. Olysio should be administered in combination with either pegylated interferon alfa and ribavirin or sofosbuvir for the treatment of genotype 1. Read more.

FDA approves Harvoni for HCV treatment

Using the breakthrough therapy designation, the FDA approved the first combination pill for treatment of chronic hepatitis C virus genotype 1 that does not require interferon or ribavirin for administration.

With Harvoni (ledipasvir/sofosbuvir, Gilead Sciences), treatment-naive participants showed a 94% sustained virologic response rate after 8 weeks of treatment and a 96% SVR rate after 12 weeks. Treatment-naive patients with and without cirrhosis showed a 99% SVR rate after 12 weeks. Among treatment-experienced participants with and without cirrhosis, ribavirin did not improve response rates in any of the trials. Read more.