New and Noteworthy
Harvoni (ledipasvir + sofosbuvir) approved by Health Canada
In October, Health Canada approved the hepatitis C medication Harvoni (ledipasvir + sofosbuvir) for people over the age of 18 with genotype 1 hepatitis C virus. In clinical trials, the cure rate for this combination was 94% to 100%.
Ledipasvir and sofosbuvir are both direct-acting antiviral (DAA) medications. This group of medications attacks the ability of a virus to make copies of itself. Ledipasvir and sofosbuvir are co-formulated into one tablet that is taken once per day.
Treatment for 12 weeks is recommended for people without severe liver damage (cirrhosis) and people with cirrhosis who have never been treated before (treatment naïve). People who have previously been treated and not cured and who have cirrhosis are recommended to take Harvoni for 24 weeks. (pharmaceutical-business-review.com, October 2014, in English)
Simeprevir added to provincial formularies in B.C. and Saskatchewan
B.C. and Saskatchewan have added the Hep C medication simeprevir (Galexos), taken in combination with peg-interferon and ribavirin, for people with genotype 1 hepatitis C virus to their provincial formularies. When a medication is listed on a provincial formulary this means that people who are approved for a particular treatment are able to have the costs of treatment covered.
Some of the eligibility requirements for being approved for simeprevir in B.C. or Saskatchewan include:
- Not having been previously treated with telaprevir (Incivek) or boceprevir (Victrelis)
- Having a moderate to severe amount of liver damage (F2 or higher)
- Not having the Q80K mutation if a person has the genotype 1a hepatitis C virus (this mutation reduces the chance of being cured when treated with simeprevir)
Hep C treatment showed high cure rates for people with liver failure
Harvoni (ledipasvir + sofosbuvir) and ribavirin taken for 12 weeks cured 87% of participants with genotype 1 virus and with liver failure (liver decompensation), reported researchers at the American Association for the Study of Liver Diseases (AASLD) Meeting in Boston.
Liver decompensation is the most advanced stage of liver disease. People at this stage may experience abdominal fluid build-up (ascites), bleeding from veins in the esophagus and stomach, internal infection and brain impairment (hepatic encephalopathy).
People with decompensated cirrhosis are generally considered to be too sick to take interferon-based treatment.
In this late-stage clinical trial, 108 people with genotype 1 or 4 hepatitis C virus took ribavirin plus once-daily Harvoni for 12 or 24 weeks. The majority of the participants had genotype 1 virus with only four participants having genotype 4 virus.
Researchers reported that:
- 87% of participants treated for 12 weeks were cured
- 89% of participants treated for 24 weeks were cured
- Two participants with genotype 4 virus were cured and two were lost to follow-up
Almost all participants experienced side effects and one-quarter experienced serious side effects.
“Ledipasvir + sofosbuvir plus ribavirin for 12 weeks resulted in a high sustained virological response rate at 12 weeks in hepatitis C patients with genotype 1 and 4 and advanced liver disease,” reported the researchers. (HIVandhepatitis.com, November 2014, in English)