FDA green-lights treatment for all types of Hepatitis C
The FDA has approved a new drug called Epclusa which doctors can prescribe for their adult patients with chronic hepatitis C virus – all six major forms (including with and without cirrhosis). It is a fixed-dose combination tablet that contains sofosbuvir – approved in 2013 – as well as new drug velpatasvir. Epclusa can be used in combination with the drug ribavirin for patients who have moderate to severe cirrhosis (also known as decompensated cirrhosis). “This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research Dr. Edward Cox said in a press release.
As you are probably aware of, being a doctor and whatnot, hepatitis C is a virus (HCV) that causes liver inflammation and can result in decreased liver function or liver failure. At least six different HCV genotypes exist – distinct genetic strains of the virus. Knowing the genotype helps you establish treatment protocols and determine the length of treatment.
· About 75% of Americans have genotype 1.
· 20% to 25% have genotypes 2 or 3.
· Small numbers of patients are infected with genotypes 4, 5 or 6.
· According to the CDC, HCV infection becomes chronic in 75% to 85% of cases.
· Patients with chronic hepatitis C may endure complications for years, including bleeding, jaundice, fluid accumulation in the abdomen, infections, liver cancer and death.
Three Phase III clinical trials of 1,558 subjects without cirrhosis or with compensated (mild) cirrhosis were conducted to determine the safety and effectiveness of Epclusa. The results showed that 95% to 99% of patients who were administered the drug had no traces of the virus in their blood 12 weeks after treatment ended, indicating that the infection had been cured. Additionally, the safety and effectiveness were assessed in a clinical trial of 267 patients with decompensated (moderate to severe) cirrhosis, of which 87 were given Epclusa with ribavirin for 12 weeks; 94% of these subjects had virus in their blood 12 weeks after treatment ended.
Common side effects of the drug included headache and fatigue. Epclusa has warning for healthcare providers that “serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.” Therefore, you should not co-administer amiodarone with Epclusa. There is an additional warning that certain drugs may decrease the amount of Epclusa in the blood and thus reduce its effectiveness. Something else that might reduce its efficacy is not being able to afford it – it goes for $890 a pop. Thankfully, you and your patients can help offset the costs by resorting to Discount Medical Supplies for all your other medical supply needs.