Hepatitis C Treatment by Johnson & Johnson Wins FDA Nod

Hepatitis C Drug

A Hepatitis C treatment by Johnson & Johnson won FDA approval Friday. The drug, known as Olysio, aims to eliminate chronic Hepatitis C infection from the body.

Hepatitis C is a liver-destroying virus that afflicts anywhere between 2.7 to 3.9 million Americans. Unlike Hepatitis A and Hepatitis B, there is no vaccine for Hepatitis C. The number of cases is increasing each year as the blood-borne disease is responsible for nearly 15,000 deaths annually. It is also the cause of liver cancer in many.

Hepatitis C infection is five times more commonly found in individuals born between 1945 and 1965. Needle-sharing and intercourse with an infected person are attributed to the large number of cases in this age group. Also, before 1992, blood transfusions were not tested, helping the disease spread further.

The normal pathways of contracting Hepatitis C are needle-sharing, needlestick injuries in health care settings, and being born to mother infected with Hepatitis C. Less frequently, Hepatitis C is spread through sharing personal items, like razors and toothbrushes, or having sexual contact with an infected individual.

Symptoms of Hepatitis C may not appear for years, leaving the liver damaged. Some symptoms may include: abdominal pain, dark urine and jaundice (yellow coloring of skin and eyes).

Johnson & Johnson is one of several companies working on a Hepatitis C treatment. Medivir, Gilead Sciences Inc., and Bristol-Myers Squibb Co. are also developing drugs to treat the infection.

Johnson & Johnson’s Olysio belongs to a family of drugs known as protease inhibitors. The drug blocks a critical protein that the Hepatitis C virus needs in order to reproduce. However, Olysio by itself would not be an effective treatment. Rather, Olysio would be taken along with the regular cocktail of long-established drugs to treat chronic Hepatitis C and advanced liver disease.

For the past two decades, Hepatitis C treatment has consisted of a year-long regimen of injections and pills. The drug cocktail consists of two antiviral drugs known as  ribavirin and interferon-alpha. This combination of drugs causes flu-like side effects like nausea, diarrhea and muscle ache. In 2011, Merck and Vertex Pharmaceuticals added some new drugs to the mix that reduced the treatment period and improved the cure rates up to 75 percent. According to studies submitted to the FDA, Olysio’s cure rate is 80 percent in patients who have not been treated for Hepatitis C prior to the Olysio trial – a slight improvement over the previous drug mix.

Most importantly, however, is that Olysio reduces the time period patients have to take the traditional drug combo by half. Most patients will only need to suffer the unpleasant side effects for about six months, instead of the traditional one year, with the help of Olysio.

“The FDA approval of Olysio is an important milestone for people living with chronic hepatitis C as it means that patients have a new treatment option with the potential to cure this challenging disease,” stated Douglas Dieterich, M.D. of Mount Sinai School of Medicine and Olysio clinical trial investigator.

Over the course of five clinical trials with over 2,000 patients, Olysio was tested for safety and efficacy.

The FDA panel also cited how the new Hepatitis C treatment from Johnson & Johnson would make patients’ lives much easier with its one-a-day dose. The current treatment  requires taking 12 pills from Merck or six pills from Vertex daily.

By Fatema Biviji

ABC News 

Nature World News

Centers for Disease Control and Protection