Hepatitis C Drug From Merck Approved by FDA

Hepatitis C (HCV) is an infection of the liver that causes inflammation. It is spread through contact with the blood of an infected person, and transmission is often via sharing needles, or unsanitary medical procedures and transfusions. According to Healthline, about 3.2 million Americans are affected by hepatitis C.

But there is good news for hepatitis C patients, as the pharmaceutical company, Merck's new once-a-day pill has been given the stamp of approval by the U.S. Food and Drug Administration (FDA), The Salt Lake Tribune reports. In fact, the FDA confirmed that Merck may begin marketing the drug called Zepatier for patients who have the liver-affecting virus. Zepatier is a combination of elbasvir and grazoprevir, which combats the drug in a two-punch pattern.

Merck's Zepatier has been approved by the FDA for the treatment of hepatitis C genotype 1, which is the most common type of hepatitis in the U.S., and genotype 4, one of the least common types.

According to ABC News, a clinical trial was done on 1,373 patients with or without liver cirrhosis, for 12 weeks. Results showed that after three months of treatment, 94% of patients with genotype 1 and 97% to 100% of those who had genotype 4 had no detectable hepatitis viruses in their blood, which implied that they had been cured. However, the consumption of Zepatier showed side effects such as fatigue, headache, nausea, and problems with liver function.

In terms of price point, Merck also said that the drug will cost $54,600 for a 12-week treatment program, which they believe all within the range of what is currently the net prices competitors are receiving from clients. This still stands as good news for patients, as an introduction of a new drug will mean a stiffer competition and hopefully lowered prices for hepatitis C drugmakers.

Meanwhile, NPR reports that California has been billed $387.5 million by private health plans because of the high prices of hepatitis C treatments in Medi-Cal from July 2014 to November 2015, covering for 3,624 patients who received such treatments. Charles Bacchi, president of industry trade group California Association of Health Plans is concerned that the high prices of hepatitis C drugs are eating up the budget for a wider array of medical services.

"In order for taxpayers of the state of California to afford to provide people the necessary treatments, we have to have drug pricing society can afford to pay," Bacchi said. Around 237,000 patients in Medi-Cal are affected by hepatitis C. With the arrival of Zepatier, people are hoping for more competitive and affordable hepatitis C drugs in the near future.