Harvoni Is Here: The Once-a-Day, Single Hep C Pill

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The Hepatitis C community has been waiting a long time for a miracle – and Harvoni nearly fits the bill. Approved on October 10, 2014, Harvoni became the first Hepatitis C drug approved by the U.S. Food and Drug Administration (FDA) that does not require the patient to also take interferon or ribavirin. In the form of a once daily pill, Harvoni seems to be the medication many struggling with this infectious disease had been hoping for.

Of course, it shouldn’t be surprising that a drug with such fanfare comes with a steep price tag.

The U.S. Centers for Disease Control and Prevention estimate that more than 3 million Americans have chronic Hepatitis C, and most don’t know they have it. Part of its insidious nature, the Hepatitis C virus can linger for decades before presenting any symptoms. When issues such as jaundice and fatigue do arise, the liver has often incurred years of progressive damage. If undetected and untreated, Hepatitis C may lead to liver scarring, cirrhosis, liver cancer or liver failure.

Interferon and ribavirin were the standard of care for Hepatitis C for many years, but their high incidence of severe side effects has transformed them into dreaded drugs. Besides their cure rate being about 50 percent or lower, many patients complained that interferon and ribavirin’s side effects – including nausea, diarrhea, itchy skin rashes, insomnia and severe depression – were worse than the disease itself.

Highly effective Hepatitis C treatments with minimal side effects have been in the works for decades. Anticipation of better treatment options has led many infected with this virus to pass on treatment until safer drugs with a high cure rate become available.

Harvoni’s Predecessor

Known by the brand name Sovaldi, sofosbuvir was approved by the FDA in December of 2013 in combination with:

• ribavirin to treat patients with Hepatitis C genotypes 2 and 3
• pegylated interferon and ribavirin for treatment-naive patients with Hepatitis C genotypes 1 and 4

Although Sovaldi boasts high cure rates (over 90 percent) with a relatively low incidence of side effects, it has two undesirable traits:

1. Combinations – Sovaldi must be combined with ribavirin and possibly interferon, two drugs associated with potentially severe side effects.
2. Cost – In the U.S., Sovaldi costs approximately $1,000 per pill, bringing a one-month supply to $30,000. Most treatment regimens involve three to four months of Sovaldi – plus the cost of the ribavirin and interferon.

Harvoni

Harvoni is a combination of two medications by Gilead: ledipasvir and sofosbuvir. Containing 90 mg of ledipasvir and 400 mg of sofosbuvir, this once daily pill is taken orally with or without food.

Harvoni is officially the first interferon-free and ribavirin-free treatment for those with Hepatitis C genotype 1, the most common strain in North America. Without adding any other medications, Harvoni claims over a 90 percent cure rate.

Different treatment lengths have been advised for different groups:

• 2 months – Treatment-naïve patients without cirrhosis who have a baseline Hepatitis C RNA level less than 6 million IU/mL
• 3 months – Treatment-naïve patients with or without cirrhosis AND treatment-experienced patients without cirrhosis
• 6 months – Treatment-experienced patients with cirrhosis

Harvoni’s Drawbacks

The side effects of Harvoni pale in comparison to those associated with interferon or ribavirin. Nonetheless, all potent medications have drawbacks:

• Interactions – Harvoni may interact with rifampin (a drug typically prescribed for tuberculosis) and St. John’s Wort (an herb commonly used for depression and anxiety).
• Side Effects – During a three-month regimen of Harvoni, the most commonly reported side effects were fatigue (13 percent) and headache (14 percent). Less common side effects included nausea (7 percent), diarrhea (3 percent) and insomnia (5 percent).
• Cost – The wholesale list price of Harvoni is $1,125 per pill. That means a two-month supply is approximately $63,000, a three-month supply is $94,500 and a six-month supply is $189,000.

Financial Help

Patients and physicians have already begun the arduous task of requesting insurance companies to approve Harvoni’s expense. Sadly, many who could benefit from this one-pill-a-day Hepatitis C treatment will find themselves ineligible – at least on the first few tries. Healthcare advocates suggest working with a compassionate physician to help submit repeated authorization requests.

If you are unable to obtain Harvoni, Gilead has a patient assistance program for eligible Hepatitis C patients:

• who do not have insurance
• who are underinsured
• who otherwise need financial assistance to pay for or obtain access to Harvoni

Information regarding their patient assistance program can be found by going to Gilead’s website, clicking on the Responsibility tab on the top, then clicking on U.S. Patient Access on the left hand side, then clicking on SupportPath™ for Sovaldi and Harvoni in the center. In addition, they can be contacted directly by phone at 1-855-769-7284.

Harvoni appears to be the latest and greatest development for Hepatitis C sufferers – one oral pill each day with few side effects that offers a 90 percent success rate is really here. If there is a way to overcome this drug’s price tag, it could be the beginning of the end of the Hepatitis C virus.