The title of this article is not a typo! That is what it is, one pill for you to swallow each day would cost you USD 1,000 (or RM 3,796). And you need to swallow that “magic” pill for 24 weeks to be “cured.” That’s a total of RM 637,728 — anyone would like to make a try?

Let us share with you this story.

YL is a 54-year-old lady. She was diagnosed with hepatitis C, Type 3, subtype 3a. Her blood test results on 5 May 2015 are as follows:

Total bilirubin	0.9
Alkaline phosphatase	79
ALT	107
AST	112
GGT	108
Lactate dehydrogenase	366
Alpha fetoprotein	23

YL was offered two options.

1.  Interferon injection. The treatment would last 24 weeks. Each treatment would cost about RM 800 and the injection can be done at home by yourself. However, the doctor said interferon injection is not encouraged because TL’s liver is already hardened.

2. TL may want to try taking a new drug called Harvonis or Sovaldi. That would cost about half a million ringgit for a 24-week treatment. According to TL’s son a 12-week treatment cost USD 80,000.

But the question to ask is: Can this new drug that the doctor suggested,  cure her hepatitis C? The answer was: It’s a new drug.

Comments

This is the first time that we ever heard of Harvonis or Sovaldi. So this is a good experience for us to learn more. Let’s google Harvoni and Sovaldi and let’s see what we can find.

First, let’s start with the USA-FDA website and read what it says about Harvoni and Sovaldi. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm

6 December 2013: FDA approves Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).

Sovaldi must be given in combination with other antiviral medications and should not be used alone. Sovaldi is usually given with ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) with or without peginterferon alfa (Pegasys, PegIntron).

Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV.

The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response — SVR), suggesting a participant’s HCV infection has been cured.

October 10, 2014:  FDA approves first combination pill Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm

Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR.

Beware of Side Effects

The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.

The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. http://www.fda.gov/Drugs/DrugSafety/ucm439484.htm

Here it goes, according to the above, your virus would disappear within 12 or 24 weeks — that is if you have half a million ringgit to gamble with.

More info from the internet ….

Activists Challenge Gilead’s Patents on Costly Hepatitis C Drug Sovaldi

http://www.newsweek.com/activists-challenge-gileads-patents-costly-hepatitis-c-drug-sovaldi-334768

A group of doctors and patient advocates are putting pressure on Gilead Sciences—maker of Sovaldi, the $1,000-a-day drug for hepatitis C—to release its patents. The Initiative for Medicines, Access & Knowledge (I-MAK), a U.S. nonprofit advocating for improved access to affordable medications, has filed challenges this week against the company in Argentina, Brazil, China, Russia and Ukraine. The organization had previously filed similar patent challenges in Europe and China.

I-MAK said Gilead’s move toward worldwide patents for sofosbuvir (the generic term for Sovaldi) would prevent millions of people from getting the treatment. A full course of the drug for one patient can cost up to $84,000 over 12 weeks of treatment.

The organization argues that the cost of the drug, approved by the U.S. Food and Drug Administration in December 2013, is prohibitive to most patients.

China Rejects Patent Application Of Gilead For $1,000 A Day Hepatitis C Drug Sovaldi http://www.techtimes.com/articles/62222/20150621/china-rejects-patent-application-of-gilead-for-1-000-a-day-hepatitis-c-drug-sovaldi.htm

China has rejected a patent application related to Gilead Sciences’ controversial hepatitis C drug Sovaldi, an advocacy group said, saying that this could pave way for other countries rejecting the patent for the top-selling drug

Gilead has drawn fire for its exorbitant price of $1,000 per pill.

Despite its prices, Sovaldi’s cure rate was over 90 percent, sparking outrage among various patients, government officials and insurers. Gilead has also started to market another hepatitis C drug known as Harvoni, which costs up to $94,500 for a 12-week treatment.

Since it has come under fire because of the price of its drug, the California-based company has agreed to sell Sovaldi at lower prices in 91 developing counties.  The deal that the company offered is however criticized because middle-income countries were not included.

If you don’t have that kind of money, GO for Generic (USD 10 = USD 1,000!)

$10 Copy of Gilead Blockbuster Sovaldi Appears in Bangladesh http://www.bloomberg.com/news/articles/2015-03-08/-10-copy-of-gilead-s-blockbuster-sovaldi-appears-in-bangladesh

$10 version of Sovaldi, the Gilead Sciences Inc. hepatitis C treatment that sells for $1,000 a pill in the U.S., is now available in Bangladesh and could make its way to other parts of the world where the U.S. company doesn’t have patents.

Incepta Pharmaceuticals Ltd. doesn’t have a license from Gilead and its version was launched last month, said Managing Director Abdul Muktadir. The company also aims to sell the drug overseas, including to parts of Southeast Asia and Africa.

Under a World Trade Organization agreement, Bangladesh, as one of the world’s least developed countries, doesn’t have to protect pharmaceutical patents.

Hyderabad-based Natco Pharma Ltd., one of Gilead’s licensees, launched its generic sofosbuvir in Nepal this month. Natco in a statement Monday said it had priced its generic medicine at 19,900 rupees ($318) for a bottle of 28 tablets in Nepal.

The All Important Question: Will you be cured? 

The sustained virologic response (SVR) has become the best indication of successful therapy for HCV infection; SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL 6 months after therapy is completed.

Several studies have addressed HCV infection recurrence after antiviral therapy–induced SVR. The rate of late relapse, defined as reappearance of serum HCV RNA, is extremely low, with the majority of studies showing 0%–1%. Two preliminary studies, from Egypt and Italy showed late relapse rates of 9% and 10%, respectively. http://cid.oxfordjournals.org/content/52/7/889.long

HCV infection is curable. In clinical trials, roughly 95 percent of those who took the newest medications were cured. When HCV treatment is working, the virus will become undetectable in the blood within four to 12 weeks and will remain that way throughout treatment. People are considered cured when they have achieved a continuation of this undetectable status for 12 to 24 weeks after completing therapy. The chances of HCV returning after 24 weeks of remaining clear of the virus are nearly zero.  http://www.hepmag.com/articles/2512_18755.shtml

SVR is the closest you’ll get to “a cure” for hepatitis. … suppress the virus to undetectable levels for an extended period of time. In clinical language, this is called a “sustained virologic response. It means that during the six months after you complete treatment, there is no detectable hepatitis C virus in your blood. Studies have shown that with a six-month SVR  relapse occurred in only 1-2% of patients. So, for every 100 people who finished treatment and attained SVR, the virus will return in only 2 of them. However, for these people, the virus never really left. The medicine was able to eliminate most of the virus (so much that medical tests couldn’t detect it), but after treatment ended, for whatever reason the virus was able to continue replicating itself. http://hepatitis.about.com/od/treatment/f/SVR.htm

Decide for yourself if you can be cured by this medication!

If the virus cannot be detected in your blood, does that mean it is gone forever?

What if just a few are left behind and remain undetected. Sometime later it will multiply and become a problem again?