Why being treated for Hepatitis C feels like pregnancy - Harvoni side effects

While you're expecting...

I would like to say that getting cured of Hepatitis C is like expecting a child - you are literally creating life within yourself. 

Not being Hepatitis C positive pretty much prevents me from having a real-life experience of how it feels to be treated with the new Gilead blockbusters Harvoni and Sovaldi but judging from the side effects from their Phase III study and complaint from the patients, I feel confident I can relate to headaches and fatigue majority of patients are experiencing. 

Pregnancy

When you are pregnant, there are some very apparent signs. If you feel morning sickness, have to vomit from time to time and feel more light-headed than usual, chances are you are carrying the fruits of the seed of life - a child. 

Many mothers can attest that they knew they were pregnant even prior of taking the test due to such overwhelmingly obvious signs. 

Here's a rundown of pregnancy-related signs:

• Morning sickness
• Loss of energy, fatigue
• Dizziness
• Weight gain
• Stability of hormone levels is questionable

All in all, these symptoms are most predominant in the first trimester. So, after 3 months, you're pretty much off the hook if you're lucky.

Hepatitis C treatment

Pregnancy has an unusual amount of parallels with the modern Hepatitis C treatment. 

Only a few years ago, majority of Hepatitis C patients were treated with injections of interferon which was known to cause severe allergic reactions that resulted in headaches and fatigue among other side effects. I always thought being treated for a deadly disease that is responsible for 500,000 deaths in a year is worth the adverse effects of interferon. However, the treatment lasted for half a year and I can hardly imagine me being normal after half a year of constant however mild headaches. It literally messes up your life. 

In 2013, humanity (well, pharmaceutical giant Gilead Sciences) discovered a wonder drug for Hepatitis C. The newly discovered molecule sofosbuvir proved to be successful in more than 90% of patients who regained complete recovery (interferon cure rate was 50%). What is more, the treatment only lasts for 3 months, has less severe side effects and it consists of taking a pill - much more convenient than taking sticking yourself with a needle. 

Here are some Harvoni side effects:

• Headaches
• Fatigue
• Nausea
• Diarrhea
• Insomnia
• Weight gain (not explicitly found in Phase III drug studies but patients on Harvoni usually gain 10 pounds of more)

Comparing these side effects with the signs of early pregnancy, we see an uncanny resemblance. 

How frequent are Harvoni side effects?

Here is a nice infographic on how frequent Harvoni side effects are. This is based on results of Phase III studies by Gilead Sciences. I snatched the infographics from esofosbuvir, pretty much the most credible page on Harvoni and it's side effects.

In short, about 20% of people experience headaches and fatigue based on the clinical studies. However, if truth be told, majority of patients feel the lack of energy and occasional headaches due to Harvoni treatment. 

Harvoni and weight gain

What is surprising is that patients are experiencing some unwanted weight gain. "Harvoni regimen is a 3-months weight gain story," one of the Hepatitis C patients claimed. She gained 23 pounds while being treated successfully. The Hepatitis C (the thing that might kill you) is gone but the extra pounds are there to stay (and recently everybody is talking about how that can kill you as well).

When you think about it, though, the weight gain is pretty obvious consequence of the side effects. I've never met a person suffering from headaches and fatigue with a dire desire to cook for himself or herself a full nutritious meal. Usually in such a state we take the path of least resistance and get some snacks that can be eaten right of the couch cause 'Hey, I'm being cured of a deadly disease, I can treat myself a bit as well'.

Interestingly, eating more than usual is recommended for Hepatitis C patients on Harvoni. During treatment, the body creates antibodies and is actively fighting off the virus - and it needs extra energy to do so. There is a nice story about how Heather experienced the weight gain on Harvoni and used a fat diminishing program to start losing weight by burning fat in order to supply her body with the energy it needed.

Here is her  weight diary:

All in all, if you feel like you're pregnant, you're probably getting cured

These side effects are actually getting you an extra life. What I really love about the new Hepatitis C treatments is that they transformed Hepatitis C, one of the most deadly diseases known to man, to an easily treatable disease with a pill-a-day regimen and some mild side effects.

What I hate about it? Harvoni costs. Those pretty much translate into Gilead putting a gun to your head and asking you for $94,500 or they'll blow your brains out. This is the US price of Harvoni.

Gilead has managed to put a price on human life: And it's $94,500. 

But in the end, you have to give it to them - they managed to produce a drug that no-one else in the last 100 years of pharmaceutical industry could. It saves lives every day but,  on the other hand, the price also prevent lives from being saved. So there you have it, the blessings and evils of big pharma.

Is The New Hepatitis C Treatment worth a $94,500 price tag?

Wonder drug for Hepatitis C

Hepatitis C was a known lethal disease for which there was no effective cure. In 2013, a new line of treatment was discovered and approved to be used in the US by FDA. The wonder drug quickly became one of the best successful drugs in the world but at a steep price: patients had to pay more than $1000 for a single pill. And in order to get cured of Hepatitis C, the usual treatment takes 84 pills. You do the math.

Standard Interferon-based treatment

Of all the viral liver diseases, Hepatitis C stands out as the one that was for ages the hardest to treat. For Hepatitis A and B, for instance, we have effective vaccines available that prevent the virus ever accessing our liver and causing irreversible damage. Hepatitis C, however, is different and cannot be fought against by vaccine.

The standard treatment for liver patients before 2013 was quite unpleasant. It was based on interferon. Interferon is a substance that is regularly produced in a human body and works as a signaling molecule. In essence, it is a beacon in the human body that detected pathogens such as Hepatitis C virus and enables the immune response against it. Liver patients were given interferon intravenously on a daily basis. The additional interferon increased the ability of immune system to fight the virus in the liver. As surprisingly simple as this treatment might seem, there were some serious issues as far as patients are concerned.

·         Treatment had a success rate of about 50%.

·         Side effects included headaches and fatigue.

·         Patients had to inject themselves on a daily basis.

·         Treatment usually lasted for half a year.

Sticking yourself with a medical needle and having some headaches seems like a modest cost to pay for getting cured of a deadly disease. However, if you imagine having headaches for half a year while knowing that everything that is happening will only be successful in 50% of cases, you can see the problems Hepatitis C patients were facing.

Standard Hepatitis C treatment requires needle injections

New Hepatitis C treatment

It was not until December 2013 that the new line of antivirals arrived on the market. At first, Hepatitis C patients rejoiced and welcomed the new drugs that were based on the newly discovered antiviral molecule sofosbuvir.

There are some reasons why the new treatment was seen as such a success. Firstly, the cure rate is higher than 95% - in other words, the medicine works almost for everyone. Secondly, the new medicine is in the form of pills. There is no need for medical needles that are very unpopular. And thirdly, the standard treatment lasts only 12 weeks instead of half a year. The additional benefit is less frequent side effects.

The bottom line is pretty straightforward: Hepatitis C patients stumbled upon a wonder drug that will save their lives painlessly. Or will it?

While the effectiveness of the new medicines was much higher than that of the old interferon treatment, the price of the medicine went up even more. Interferon treatment was considered expensive because it cost a few $1000. Can you imagine what was the reaction of Hepatitis C patients when they found out that the price tag of new drugs is $94,500?

In the US majority of insurance companies do not cover the costs of the new treatment. Just imagine walking to a local pharmacy with $94,500 in your suitcase because you'll die if you don't get the medicine. It looks like a drug deal scene, and in all reality, it is exactly like it.

Would you pay $94,500 for life saving medicine?

Treatment cost in India is only $900 per treatment

Due to the extremely high price things escalated even further. People started wondering what kind of society we are since after finding a wonder drug for a deadly disease; we don't make it accessible to everybody in need of it. Insurance companies had a problem with the price as much as the patients. The price of Hepatitis C drugs might crumble the very health care system that is supposed to provide innovative medicines to the people.

Even the US government saw the problem. Since it is estimated that 3% of the 300 million US population are in need of such treatment, that means that the price of treating the 10 million patients alone was around 1000 billion dollars. That is a figure that can cause headaches for the US health care system.

American citizens are used to paying for their own medicines. However, in other developed countries such as Canada or Europe, patients are used to getting their drugs literally for free. It is the health care system that pays for the drugs. However, in the case of new Hepatitis C medicine, the high price threatened the health care systems themselves. One has to wonder, for example, how many people with other diseases can be treated for the price of treating a single Hepatitis C patient with the newly developed drugs. France was the first European country to negotiate successfully lower prices (around 40.000€ per 12-week treatment). The other European countries followed; nonetheless, the price of 40.000€ is still considered extremely high. Patients need to work and save for years to be able to afford the medicine that will save their liver.

There is a bright light at the end of the tunnel. Due to the issues raised about the high price of the new treatment, the pharmaceutical company producing the medicine decided to give licenses for the generic production of their pills in third world countries. In short, Indian pharmaceutical companies were given plans and permissions to produce the exact duplicates of the pills. This lowered the costs of treatment in more than 100 third world countries.

For instance, you can go to India and obtain Hepatitis C medicines for only $900 if you know what doctors to talk to and what distributors to contact. This is why more and more US and European patients are traveling to India and use our 'How to buy generic Hepatitis C drugs from India' manual as a guidebook. The step-by-step instructions and lists of doctors and pharmaceutical distributors in India that manual includes are vital for successfully obtaining the life-saving medicines that would cost $94,500 in the US.

Generic treatment in India cost 100 less than original in the US

Future of Hepatitis C treatment

The relationship between health insurance companies, pharmaceutical companies, and patients became much more intense in the wake of new liver medicines. Questions of 'How much is life worth in US dollars?' started to arise. Ethical and moral factors are intertwined with economic interests at the price of the patients.

The story of the new line of Hepatitis C drugs is not over. With more and more people seeking help in countries like India, the 'Hepatitis C tourism' is flourishing. On the other hand, health care systems around the world are tightening their wallets and working on new strategies of how to further reduce the extremely high prices of life-saving medicines. The question that is on everybody's mind is how the pharmaceutical producer will respond to patients traveling to India and spending only $900 for medicines that the original producer is selling for $94,500. Will they try to stop the loophole in the pharmaceutical market?

How to get Hepatitis C treatment from India

Because we get an amount of questions about how to buy generic Hepatitis C drugs in India, we have teamed up with Hepatitis C Society and prepared a manual to help all Hepatitis C patients who would rather spend $900 on the medicines than $94,500. The manual is available for a nominal price in order to cover the costs of the medical team of doctors and pharmacists that created the manual.

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