FDA Approves of New Treatment For Hepatitis C by Maria Sanchez

Over 3 million Americans have Hepatitis C, an infection that affects the liver. Hepatitis means inflammation of the liver. There are many causes of hepatitis. For example, drinking too much alcohol, various drugs and chemicals, and also several different viruses can cause hepatitis.

Hepatitis C is a virus which is carried in the bloodstream to the liver. It can then affect and damage your liver. However, this virus can also affect other parts of the body, including the digestive system, the immune system and the brain.

There are six types of hepatitis C viruses, which all have different genes. These different types are called genotypes and they are numbered 1 to 6. Different types respond differently to treatment.

Past treatments were arduous and only 70% effective. However, a new drug option may now make patients’ lives much more manageable.

Janssen Therapeutics, Division of Janssen Products, announced that the U.S. Food and Drug Administration (FDA) has approved Olysio (Simeprevir). This antiviral treatment (combined with interferon and ribavirin treatment to interfere with viral replication within hosts cells) could mean a new beginning for Hepatitis C patients.

Olysio may benefit patients with Chronic Hepatitis C, including those who are treatment naïve (for example, a person with HIV who has never taken HIV drugs.) or who have failed prior interferon-based therapy.

Olysio works by blocking the viral protease enzyme that enables the hepatitis C virus (HCV) to replicate in host cells.

Hepatitis C patients are excited about this recently FDA-approved treatment option that promises to be all in all, gentler and more effective than previous therapies.

“We want to get it as soon as possible,” says Russell Myers, a client with Harlem United and a peer mentor. “I want to live, just like everybody else.”

Simeprevir has proven to have a high curing rate. There are also less pills to take on a daily basis.

It has less side effects and has a shorter duration of therapy. A responding patient would last 12 weeks with Olysio and 24 weeks with interferon and ribavirin. A previously non-responding patient would last 12 weeks taking Olysio and another 48-week period with interferon and ribavirin.

However, Simeprevir, like most drugs, has its downsides. For years, researchers have attempted to create a treatment that was interferon-free. Unfortunately, Hepatitis C patients must continue to use interferon and ribavirin treatment for a full 48 weeks to get the long term effects of Simeprevir.

“Given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments,” said Douglas Dieterich, M.D., Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, and Olysio clinical trial investigator. “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.”


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