Harvoni: Ingredients, Side Effects, Cost, and Alternatives
Harvoni (by Gilead Sciences), the leading FDA approved hep C cure of today. It was first launched in October 2014 and approved by the FDA as a hepatitis C genotype 1 medication. The drug is a combination of ledipasvir (90 mg) and sofosbuvir (400 mg). The most outstanding benefit of this particular medication is the success rate of 93-99%.
Harvoni is an all-oral treatment for HCV which blocks the enzymes the virus needs in order to multiply. Depending on the situation, it can be used with other hepatitis C medications. It was this particular drug that really redefined the answer to the question is there a Hep C Cure? as it can treat the infection with a big chance of success even after prolonged exposure to the virus.
Of course, no matter how great the results of this Gilead Science’s product are, one must never forget that the hepatitis C virus is subject to unpredictable mutation. At the moment, scientists are aware of 7 HCV genotypes and each of them has sub-types of its own. The development of the virus in the body is affected by a great number of factors. Therefore, the treatment plan for each HCV type is different and must be determined on a case-to-case basis.
You also shouldn’t forget that Hepatitis C Symptoms are often overlooked. You shouldn’t count on their appearance to determine whether you’ve contracted the disease. If you believe yourself to be at risk, take the hep C antiviral blood test to check. The treatment should be started early to produce the best results and minimize liver damage.
Harvoni: History Overview
Harvoni was the first drug that allowed people suffering from genotype 1 HCV to receive treatment with only a single pill a day. Most importantly, it makes injections of interferon as well as ribavirin unnecessary, so the patient can avoid the negative side effects of these medications.
Another great advantage offered by this fixed-dose combination of ledipasvir and sofosbuvir is the fact that in many cases, the course of treatment only takes 12 weeks. This is a huge improvement over the average 24-48-week course for other medications. However, the length of the treatment still has to be determined on a case-to-case basis.
In November 2015 the FDA also approved Harvoni for the treatment of hepatitis C genotype 4, 5, and 6 as well as those suffering from HCV-HIV co-infection. In these cases, however, the drug may be combined with other medications as per the doctor’s judgment based on the patient’s condition. The drug has also been approved as a 24-week treatment for HCV genotype 1 patients suffering from cirrhosis.
In February 2016 the FDA has also extended Harvoni’s approval for liver transplant recipients suffering from hepatitis C genotype 1 and 4.
Despite its proven efficiency, the doctor may withhold from prescribing the fixed-dose ledipasvir and sofosbuvir combination based on certain factors that include but aren’t limited to:
- Type and sub-type of the HCV virus
- Treatment history
- Additional medications taken by the patient for different conditions
- Extent of the liver damage
- Liver transplant
Please note that even herbal supplements can affect one’s possible response to the medication. Therefore, it’s imperative to inform your doctor about any and all medications, drugs, supplements, vitamins, and herbs you take beforehand. It’s no less important to provide them with your full medical history.
Harvoni Side Effects
Despite its great efficiency, ledipasvir/sofosbuvir can have some negative side effects. However, they aren’t as detrimental than those of interferon-based therapies. The most common of them are:
- Fatigue (up to 18% of patients)
- Headache (up to 17% of patients)
- Diarrhea (up to 10% of patients)
- Sleep problems (up to 10% of patients)
It’s important to inform your doctor about any of the symptoms you experience and if they worsen.
In many cases, such minor side effects don’t require medical attention and aren’t considered a valid enough reason to abort the treatment. Your doctor will determine whether taking any steps is necessary based on your other symptoms and test results.
When ledipasvir and sofosbuvir are combined with ribavirin, the patients often develop side effects consistent with ribavirin. Their intensity increases only in a small number of cases.
An allergic reaction to Harvoni is extremely rare, however, this medication has an acute negative reaction when combined with any amiodarone-based heart medication. In some cases, combining these drugs can have fatal consequences.
If the medication (or any other reason) causes you to vomit within 5 hours after taking a pill, inform your doctor. You might need to take an extra dose. If this is a regular occurrence, you might need to be prescribed a different drug.
Before Taking a Fixed-Dose Combination of Sofosbuvir and Ledipasvir
There are many factors that affect the hepatitis C treatment plan prescribed by your doctor. To ensure you are safe when taking Harvoni, warn your health care provider if:
- You’ve experienced any other liver problems.
- You are currently suffering from HIV or AIDS.
- You have a heart rhythm problem or other heart issues and take amiodarone and/or its derivatives.
- You’ve suffered from some form of kidney disease or are on dialysis.
When your treatment requires combining Harvoni with ribavirin, you need to be very careful and ensure your doctor is aware of your full medical history. It’s not advised to use these hepatitis C medications for patients with a severe case of kidney disease as well as those suffering from hemoglobin blood cell disorders.
Pregnant women should avoid this hep C cure altogether before giving birth. Sofosbuvir and ledipasvir may have a wide range of negative effects on the fetus. The reaction to the medication is difficult to predict and the mother’s health might be endangered as well. Therefore, it’s best to postpone hepatitis C therapy until after birth.
Women are advised to use at least 2 forms of birth control when undergoing hep C treatment. At the moment, it’s unknown whether ledipasvir/sofosbuvir passes into breast milk. However, it’s advised that women avoid nursing when taking this drug.
Ledipasvir and Sofosbuvir with Other Medications
When taking a ledipasvir/sofosbuvir medication, you should avoid taking an antacid for at least 4 hours after your daily dose. As it’s advised to keep the level of the medication stable in the body, you should try to take Harvoni at the same time every day.
In case you’ve missed a dose, take the pill as soon as you remember it. If you’ve only remembered the next day, skip a dose completely. You should never exceed the daily dose, so don’t take two pills at once to ‘make up’ for the loss. You can use a variety of reminder apps to ensure you don’t miss your pill.
If you ingest more than the required dose of the medication by accident, seek medical assistance right away.
Drugs that interact with Harvoni include but aren’t limited to:
- John’s Wort
- Stomach acid reducers
- Tuberculosis medications
Be sure to inform your doctor if you are currently taking any of them. You also need to tell them whether you’ve taken any hepatitis C medications in the past.
Although Harvoni can be used as a part of an HCV-HIV treatment program, it interacts badly with some HIV drugs. In this situation, your health care provider must develop an individual treatment plan that will account for all your personal symptoms and needs.
Harvoni Efficiency and Resistance to the Drug
Clinical studies of Harvoni proved that the patient’s age, race, and gender have no bearing on the efficiency of the treatment. Please note that this medication should be used only by people over 18.
However, there are many other factors that affect your chances of curing HCV successfully. Due to what hepatitis C is, the disease is difficult to block as the virus copies itself incessantly. During this process it also mutates, which affects its resistance to the drug’s effects.
In many cases, even a patient with some measure of resistance can be cured of hepatitis C through the use of different anti-viral drugs combinations. However, this treatment will need to be closely monitored via regular tests.
Please note that a body develops resistance to the drug during the therapy. This means that you may not be able to use these hepatitis medications in the future should you contract the virus again. However, the resistance may fade on its own in a few months or last for years.
The Cost of Hep C Cure with Harvoni
It does seem that Harvoni is the best hep C cure currently available. However, this medication has one huge disadvantage. The cost of one course of this drug is over $90,000. It also may not be covered by Medicare and other health insurance plans. This makes the fixed-dose ledipasvir and sofosbuvir from Gilead Sciences unavailable to a large number of hep C patients who simply cannot afford this drug.
Harvoni in The News
Gilead Sciences, the manufacturer of Harvoni, came under fire when the product first hit the market. Accusations of price gouging and predatory pricing were made and continue to this day.
The cost of the brand name medication has all but put it out of reach for all but the rich.
Publicly funded research has contributed greatly to the development of this medication, and now the people that paid for the research are being asked to beg, borrow and steal to buy Harvoni for themselves!
USA and Canada have some of the highest standards of living in the world. In the USA, less than 66% of workers earn less than $41,500. The price of approximately $90,000 for the complete Harvoni treatment is equivalent to more than 3 years of one’s net income! Yet the pills cost mere dollars to make!
Gilead has recently spent over $100 million dollars in TV and magazine advertising in the USA. This has created a lot of interest and patients asking their doctors to prescribe the medication. But doctors are hesitant and patients shocked when they learn the cost can be as much as $94,500!
When you consider that sales of Harvoni have been over $15 Billion dollars US since it came on the market in late 2014, you see that $100 million in advertising is nothing.
In Massachusetts, The Attorney General has threatened legal action arising from unfair trade practices. Others are also in line to do the same.
In New York, the Attorney General’s office is investigating a number of insurance companies who are refusing to pay for Harvoni. It’s expected other states will follow suit.
In April of 2014, insurers in New York were ordered to pay for Harvoni, by the states Drug Utilization Review Board.
Many insurers are refusing to pay for the high cost. In some cases, only the very ill are receiving are being covered. Those whose livers seem to be okay for now, are being turned away.
Doctors are asking patients to hold out for cheaper alternatives that may come available, or put them on older treatments.
History shows that the manufacturer of any medication that charges an insane amount will always win in the end. Even if the price was controlled by government now, Gilead has made billions in profit. All at the expense of those who can least afford it.
Are There Any Alternatives to Harvoni?
Of course, patients who cannot afford the cost of this medication can resort to other available hepatitis C therapies. Those are used in both developing and developed countries. However, today people around the world have a better solution that allows them to avoid dangerous and less effective interferon-based treatments.
This alternative therapy is based on a generic Harvoni alternative. Like the drug itself, it also contains a fixed dose of ledipasvir and sofosbuvir, and has the same effect on the virus. The generic hepatitis C medicine costs around $700 per course.
Considering the transmission of hepatitis C and the fact that over 60% of patients suffering from it are ex-drug addicts and prison inmates, making the treatment more affordable means saving more lives.
If you are interested in buying our low priced, 100% risk free generic Harvoni (Ledipasvir Sofosbuvir) starting at just $699 for a full 12 weeks of treatment, visit our Shop page immediately!