5 minute read.
This is the most definitive article on HARVONI® (generic Harvoni) in 2021.
Before we dive deep in to Harvoni.
We’ll ask the following questions:
What is Harvoni?
What is Harvoni used to treat?
Why is treatment with Harvoni important?
What came before treatment with Harvoni?
When and where did Harvoni come from?
Who discovered Harvoni?
How much does Harvoni cost?
What is Harvoni?
Harvoni is a prescription drug to treat hepatitis C.
The pronunciation of Harvoni is Har·vo·ni | \ här-ˈvō-nē.
The ingredients of Harvoni (generic Harvoni):
- ledipasvir 90mg and.
- sofosbuvir 400mg.
What is Harvoni used to treat?
Acute hepatitis C is a candidate for treatment with Harvoni.
Also, chronic hepatitis C.
Acute and chronic hepatitis C scars the liver, this is called cirrhosis.
There are two types of cirrhosis when discussing hepatitis C:
- Compensated cirrhosis – no symptoms of liver scarring
- Decompensated cirrhosis – symptoms from severe liver scarring
Treatment with Harvoni for compensated cirrhosis is one tablet a day for 84 days.
While, decompensated cirrhosis requires Harvoni and ribavirin for 12 to 24 weeks.
Usually, patients with decompensated cirrhosis may opt for a liver transplant.
Only, if the condition continues to rapidly decline.
However, Harvoni treatment for hepatitis C has been effective.
Successful hep C treatment with Harvoni is in the range of 95% to 99%.
Why is treatment with Harvoni important?
We know that Harvoni treats hepatitis C.
Before, our grandparents (in the US) would die of hepatitis C.
Remember, hepatitis C (hep C or HCV) is a highly infectious disease.
Its a public health hazard.
Hep C kills approximately 15,000 people every year in the US.
In Europe, hepatitis C virus kills 86,000 every year, according to WHO.
Approximately 2% of the EU (European Union) population has hepatitis C.
Majority of these hepatitis C infections are in Eastern Europe and Central Asia.
Globally hepatitis C kills approximately 400,000 people.
We believe the numbers could be much higher.
Statistics in developing countries like China or India are not that reliable.
Same goes for data from South America, Africa, Middle East and Oceania.
We just know, hepatitis C is a killer.
Today, with the help of new hepatitis C treatments (drugs), hep C can be cured.
What came before treatment with Harvoni?
Hepatitis C treatment(s) prior to Harvoni were not effective.
The standard treatments available were:
1. Pegylated-Interferon-Alfa (injection)
2. with ribavirin (ribavirin)
Success rate of the combination of pegylated-inteferon-alfa with ribavirin varied.
Most hep c patients couldn’t handle the very harsh side effects of this treatment.
Compliance rate was very low.
Before Harvoni was made available to the public.
Sovaldi (sofosbuvir 400mg) came out in 2013.
Like Harvoni, Sovaldi treats chronic hepatitis C.
Sovaldi is a drug to treat hepatitis C.
It was discovered in 2007.
The person behind the drug discovery was Dr. Michael Sofia.
Not until 2012, did Sovaldi get approval from the FDA.
Our government is very strict with the drug approval process.
Sovaldi had to go through many clinical trials.
Only then it was made available to the public for hep C treatment.
Hepatitis C treatment prior to Harvoni were not effective.
The standard treatments available were:
1. Pegylated-Interferon-Alfa (injection)
2. with ribavirin (ribavirin)
Success rate of the combination of pegylated-inteferon-alfa with ribavirin varied.
Most hep c patients couldn’t handle the very harsh side effects of this treatment.
Compliance rate was very low.
Sovaldi replaced those difficult injections with tablets.
The main ingredient of Sovaldi is sofosbuvir 400mg.
Sofosbuvir pronunciation is so·fos·bu·vir | \ sō-ˈfäs-bu̇-ˌvir.
Its once a day tablet (taken by mouth) for 84 days for most cases.
The hepatitis C virus genotypes it cures are 1, 2, 3 or 4.
Genotypes 5, 6 or 7 can also be cured with sofosbuvir combinations of:
1. ledipasvir
2. velpatasvir
3. simeprevir
4. daclatasvir
5. peylated-interferon-alfa
6. ribavirin
These combination of sofosbuvir can cure hepatitis C.
All known hepatitis C virus genotypes.
Yes, it is a miracle.
Harvoni was approved by the FDA in 2015.
FDA approved Sovaldi in 2014.
Sovaldi cost $1,100 for one tablet.
That was too pricey for the US market.
There were many protests.
Some leaned towards riots.
People with hepatitis C were not happy.
They wanted the government to put a price cap on Sovaldi.
Public requests or demands were not in step with law makers.
“Big Pharma” is very well established in the halls of congress.
Lobbyists from pharmaceutical companies shower political parties with cash.
Approximately, $303.63 million dollars in 2020.
The price of Sovaldi didn’t budge.
84 days (12 weeks) of Sovaldi cost $84,000.
For 168 days (24 weeks) of treatment cost $168,000.
Price of Sovaldi did not budge.
Protests highlighted hepatitis C as a highly infectious disease.
That was about it.
The bad part was how media portrayed hep C.
It was a IV drug users disease.
That didn’t help with public sentiment.
36.3% of baby boomers have hepatitis C. (recipients of blood that was not screened)
Throughout the country, state health systems went berzerk.
By law, whoever was under their (state’s) care, they had to treat them.
One problem.
State health budgets could not absorb the costs.
While the manufacturer of Sovaldi, Gilead Sciences, was increasing their revenue.
States health care systems were going bust.
As a society we were questioning our healthcare system.
Unfortunately, nothing changed.
Almost expected.
Sovaldi (sofosbuvir 400mg) made $10.3 billion in 2013.
Gilead Sciences made $44 billion in three years with only two drugs:
1. Sovaldi (sofosbuvir)
2. Harvoni (ledipasvir and sofosbuvir)
Yes, Gilead Sciences was the darling of Wall Street that year.
Their CFO, Robin Washington, retires in 2020.
We are sure a very good retirement.
Not to poke at Robin, its our institution.
Its our American way of life.
We built it and so we must live with it.
Unless there are other options. (more on that later)
Many Americans and foreigners are looking for affordable treatment.
Treatment with Harvoni can be affordable.
In 2019, Gilead Sciences released their generic Harvoni:
Ledipasvir 90mg and sofosbuvir 400mg.
Generic Harvoni cost $24,000 for 12 weeks hepatitis C treatment.
24 weeks would run you $48,000.
A lot better than $168,000 back in 2014.
I guess things are getting better.
Now, what if you can’t afford $24,000 for three months.
Or $48,000 for six months of hep c treatment.
Insurance can help out.
Often times, you pay half the price, $12,000.
Not bad.
GoodRx has a price range of $5,456 to $11,720 for one bottle.
That is 28 tablets per bottle of generic Harvoni (ledipasvir /sofosbuvir).
Most people need three bottles.
84 tablets to clear the virus.
While some require 6 bottles and 168 tablets.
Treatment with Harvoni has a cure rate of 95% to 99%.
Insurance approval for Harvoni was considerably lower.
Only 15% of were approved for Harvoni.
Those not approved, just had to wait.
Their liver has to be a F3 or F4 fibrosis stage.
Only then Harvoni may be considered for treatment.