In October 2014, the Food and Drug Administration awarded approval to drug developer Gilead Sciences for a revolutionary pill: Harvoni, the first complete treatment for Hepatitis C that involves taking only one dose of one medication a day.

Some studies reportedly show that Harvoni can bring about a complete cure in approximately 90 percent of patients infected with Hepatitis C in as little as 8 to 12 weeks, along with shortened duration of treatment and few of the side effects that commonly accompany HCV treatments.

Unfortunately, some people that suffer from Hepatitis C have been unable to gain access to Harvoni.  With a hefty price tag of approximately $1,125 per pill, or approximately $94,500 for a 12-week course of treatment (some discounting has since occurred for insurers; read more about Harvoni pricing here), the drug has remained out of reach for some insureds.  While Harvoni would likely be considered medically necessary by many physicians treating patients with Hepatitis C, some insurance plans have refused to cover the drug in some cases.  (Read more about Harvoni insurance denials here.)

Some of these denials have resulted in lawsuits.

At Vinas & Deluca, we are monitoring the progress of the Harvoni matter and would be happy to speak with anyone who feels they have been wrongfully denied Harvoni medication.

Here are some basics about Hepatitis C and Harvoni.

• What is Hepatitis C? Hepatitis C is a contagious viral liver disease. The CDC estimates that approximately 75 to 85 percent of cases result in chronic infection that can lead to cirrhosis of the liver and liver cancer.
• What are the symptoms of Hepatitis C? Many people newly infected with Hep C have no symptoms or mild ones that do not always prompt immediate medical attention, such as fever, fatigue, abdominal pain, loss of appetite, dark urine, and nausea. Chronic HCV infection can be particularly insidious, causing slowly progressing chronic liver disease that manifests no signs or symptoms for decades.
• What is Harvoni? Harvoni is a pill containing two drugs, both of which directly interfere with replication of the Hepatitis C virus. One drug, sofosbuvir (which Gilead sells under the brand name Sovaldi), has been on the market since late 2013. The second drug is the newly developed ledipasvir.
• What makes Harvoni remarkable? Harvoni is revolutionary for HCV sufferers, first and foremost for its efficacy rates (which reportedly range from 94 to 99 percent for complete cure) and minimal treatment duration period (people who have never received HCV treatment generally undergo 12 weeks; approximately 40 percent of people are eligible for an 8-week regimen).
• Plus: Harvoni is also the first all-in-one pill for HCV treatment, meaning patients oftentimes do not need to pay for other complementary medications.  They just take one medication, once a day. This makes Harvoni the first approved drug that does not require pairing with interferon or ribavirin, two drugs also used to treat HCV infection that come with major, often debilitating side effects, including flu-like symptoms and depression.