Harvoni as a Miracle Drug

by Jeremy Winograd on July 26, 2017

Hepatitis C drug

July 28 is World Hepatitis Day. No, not “Hepatitis Awareness Day” or “Cure Hepatitis Day” or even “#hepatitisistheworstday.” It’s a bit curiously worded, isn’t it? It’s almost as if we are supposed to celebrate the disease itself, as we would celebrate, say, National Milk Chocolate Day (which just so happens to fall on the same day and is unquestionably worth celebrating). But perhaps the nomenclature is sort of appropriate – after all, thanks to recent pharmaceutical developments, the most common and deadly form of viral hepatitis, Hepatitis C, has become something of an underdog when considered against current treatment options and can only prevail when rooted for en masse.

Not that Hepatitis C (HCV) isn’t still a major public health threat. Per estimates, upwards of 130 million people worldwide suffer from HCV. However, the actual infection rate may be even higher, which can be attributed to acute cases that sometimes resolve without intervention, as well as the fact that many people don’t know they have chronic HCV until years, even decades, after they are initially infected, which is how long it takes for serious outcomes like liver cirrhosis and cancer to develop. What’s more, although HCV rates have dropped significantly overall over the last 30 years, the CDC reports that new incidences nearly tripled between 2010 and 2015, with HCV-related deaths in the U.S. reaching a record high in 2014. This trend is likely the result of the nationwide opioid epidemic, as HCV infection is most commonly associated with fluid sharing resulting from intravenous drug use.

But thanks to Harvoni, a drug that received FDA approval in 2014 for HCV treatment, an HCV diagnosis is no longer nearly as scary as it once was. It’s no exaggeration to call Harvoni, a combination pill manufactured by the U.S.-based biopharmaceutical developer Gilead, a miracle drug. Here’s what you need to know about it.

How effective is it?

Comprising ledipasvir and sofobuvir, Harvoni achieved a seemingly impossible 94% cure rate during clinical trials. Imagine a drug for cancer or HIV that outright cured 94% of patients, no caveats necessary. There would be parades in the streets! And those parades would be absurdly well-attended by all the people who would have otherwise died from potentially fatal diseases! That is the kind of amazing success we’re talking about with Harvoni. Basically, even if HCV infection rates continue to increase, the long-term health effects associated with the disease could soon become concerns of the past.

Are there any negatives?

The same number milk chocolate has: zero. It’s as easy to take as your morning vitamins – just ingest the oral tablet once a day, with or without food, for 12 weeks (or as many as 24 for patients who have already developed liver cirrhosis), and voila! No more HCV. Even better, there are minimal to no side effects – just some mild fatigue, headaches, or nausea in a relatively small percentage of patients. This contrasts with pre-Harvoni forms of HCV treatment, which offered difficult delivery options, such as self-injections, and severe side effects, from hair loss to mood changes, all while having a fraction of the effectiveness.

Is it affordable?

Herein lies the catch. A full 12-week Harvoni regimen costs about $95,000 in the U.S. That’s obviously well beyond most Americans’ capacity to afford out of pocket, and there are currently no generics or comparably effective alternatives available on the market. But while some insurers don’t offer much assistance in paying for it—including Medicaid, which covers the drug’s cost for as few as 1% or less of enrollees in some states—many do, so check with your insurance to see if it’s covered. Furthermore, Gilead offers co-pay coupons and other forms of financial assistance to some applicants that can reduce out-of-pocket costs and help put the miracle drug within reach.

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