FDA Approves New Drug for All Strains of Hepatitis C

FDA Approves New Drug for All Strains of Hepatitis C

The FDA has approved a new drug to treat all forms of Hepatitis C. The new pill, Epclusa, from Gilead Sciences, has been approved to treat patients in all stages of the disease. Patients without liver damage can use the drug alone, while those with moderate to advanced cirrhosis of the liver are being advised to use it in tandem with ribavirin, an established antiviral drug.

Hepatitis C is a virus that slowly affects and declines the function of the liver. There are 6 different strains of Hepatitis C, however, the new drug has been approved to treat people with all strains. Existing drugs for Hepatitis C are specifically for the different strains and stages of the disease, making management and tailoring the prescription much easier for both patients and doctors.

Epclusa combines a new drug with Sovaldi, an older drug previously used to treat the condition. It comes in pill form and is taken daily. The FDA reports that it treated an average of 95 percent of patients in three months during the clinical trial.

In one clinical trial, 1,558 patients with mild or no cirrhosis of the liver took the medication daily for 12 weeks. 95-99 percent of them had no virus detected in their blood at the end of trial. Eighty-seven patients with severe liver damage took Epclusa in combination with ribavirin and 94 percent of them were virus-free after the 12 weeks.

The drug also carries very few side effects, with most patients reporting headaches and fatigue in conjunction with the pill.

Although the drug may seem like a huge breakthrough in the treatment of Hepatitis C, it may end up being cost-prohibitive for many patients. A 12-week course, which is the standard time for treatment, costs $74,760, with a steep price tag of $890 per pill. Gilead’s previous pills used to treat Hepatitis C also run at a high cost, with Harvoni priced at $1,125 per pill and Sovaldi with a price tag of around $1,000 per pill.

Due to the cost, only around 3 percent of Medicaid patients are actually receiving these drugs.


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