what are post treatment effects of harvoni

Precautions

For a small number of people, Harvoni causes insomnia (trouble sleeping). This side effect also may get worse the longer you take the drug. Your doctor can suggest ways to improve your sleep if you have problems while taking Harvoni. Recently, warnings about mood changes like irritability or depression were added to the drug label.

What are the side effects of Harvoni?

In the open-label 1119 trial, Harvoni was administered for 12 weeks to 41 treatment-naïve or previously treated adult subjects with genotype 5 HCV infection, with or without cirrhosis. The overall SVR12 was 93% (38/41). SVR12 was similar based upon prior HCV treatment history and cirrhosis status.

What is the efficacy of Harvoni in the 1119 trial?

1 Take Harvoni exactly as your healthcare provider tells you to take it. ... 2 Do not stop taking Harvoni without first talking with your healthcare provider. 3 Take Harvoni tablets or oral pellets by mouth, with or without food. 4 It is important that you do not miss or skip doses of Harvoni during treatment. More items...

How should I take Harvoni?

Clinical and hepatic laboratory monitoring, as clinically indicated, is recommended for patients with decompensated cirrhosis receiving treatment with Harvoni and ribavirin [see Adverse Reactions (6.1)]. No specific antidote is available for overdose with Harvoni. If overdose occurs, the patient must be monitored for evidence of toxicity.

What is included in the monitoring of patients receiving Harvoni?

What are the long term effects of Harvoni?

One of the main side effects of Harvoni is tiredness. This tends to increase the longer you take the drug. Tiredness may be related to an interaction with other drugs that can slow your heart rate. If you feel tired while taking Harvoni, talk with your doctor about how you can increase your energy level.

How long does Harvoni stay in your system after treatment?

This means that nearly all people who took Harvoni achieved a sustained virologic response (SVR). SVR means that they had no virus detected in their body 12 weeks or longer after treatment ended.

Does Harvoni have any side effects?

Tiredness, headache, nausea, diarrhea, or difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.

What happens after treatment for hep C?

After you clear your hep C (being cured) you won't have any immunity to protect you from catching it again. You can lower your risk of catching hep C again by avoiding blood-to-blood contact with other people.

How do you feel after being cured from hep C?

Since hepatitis C doesn't always cause any symptoms, you may not feel any different after being cured. If you were experiencing symptoms — fatigue is the common one — you should start to feel stronger and more energetic, which should continue to improve after you finish treatment, says Massoud.

How long does it take to feel better after hep C treatment?

The healing process takes time, patience and effort. Most hep C patients report seeing treatment side effects subsiding within a few months or longer. Often it takes six months to a year to regain full energy and feel well. Some patients have reported side effects lingering for longer periods of time.

Does Harvoni make you gain weight?

Weight gain has not been reported as a side effect of Harvoni in clinical trials. However, some individuals on blog posts report gaining weight (from two to 12 pounds); however, this was temporary and easily lost once treatment with Harvoni finished.

Does Harvoni cause kidney damage?

Rarely, it can cause nausea, diarrhea and insomnia. We describe a case of cirrhosis of liver secondary to HCV and alcohol. The patient received Harvoni but 4 weeks after receiving Harvoni he became extremely fatigued and developed acute renal failure with elevated transaminases.

Can you drink alcohol while on Harvoni?

Can you drink alcohol while taking Harvoni? The answer from several leading organizations is: no. You should not drink alcohol while taking this drug. The HCV Advocate is a nonprofit support group that offers advice for hepatitis C patients.

Can hep C come back after Harvoni treatment?

It's possible, but rare, for hepatitis C infection to reappear after apparently successful treatment. Relapses usually occur in the first few months after blood testing to confirm that the virus is no longer detectable.

Does hep C treatment weaken your immune system?

Is my immune system weakened by the treatment? No. There is no evidence that hep C treatments affect your immune system or makes you more at risk of catching COVID. Hep C medications directly attack the hep C virus; they do not have any impact on your immune system.

How long do hep C antibodies stay in your system?

HCV antibodies can persist up to 20 years after resolution of clinical infection, suggesting that the virus and its antigens may persist, but at extremely low levels.

Do I need to follow a special diet while taking Harvoni?

No, there is no special diet required while you take Harvoni. However, if you experience nausea or stomach pain as a side effect of Harvoni, it may...

How long will Harvoni take to get rid of my hepatitis C?

Harvoni will start working right away to fight the virus. However, in order to get rid of hepatitis C, you will need to take Harvoni for the full l...

What is the cure rate for Harvoni?

The cure rate for Harvoni depends on certain aspects of your hepatitis C. This includes whether or not you have cirrhosis, what hepatitis C treatme...

Can hepatitis C come back after taking Harvoni?

If you take Harvoni every day as directed by your doctor and you maintain a healthy lifestyle, the virus shouldn’t return. However, it’s possible t...

What is a hepatitis C genotype?

There are six different strains, or types, of hepatitis C viruses that are known to infect people. These strains are called genotypes. Genotypes ar...

How long does Harvoni last?

Harvoni is a new medication for hepatitis C. It’s a single tablet taken once per day that contains two drugs: ledipasvir and sofosbuvir. When taken for 12 weeks, Harvoni cures most cases of hepatitis C.

Why do I feel tired when I take Harvoni?

If you feel tired while taking Harvoni, talk with your doctor about how you can increase your energy level. Some people have headaches when they take Harvoni. This side effect generally gets worse the longer you take the drug.

How long does it take for hepatitis C to cure?

Previous drug treatments for hepatitis C took longer and had lower cure rates. On average, treatment took two to four months with a cure rate of 50 to 80 percent. Harvoni cures 93 to 100 percent of patients in just 12 weeks. Harvoni causes few side effects compared with previous drugs.

How do you know if you're taking amiodarone?

These symptoms can include: feeling like you’re going to faint, or actually fainting. lightheadedness. tiredness. weakness. shortness of breath. chest pains. confusion or memory problems. If you have symptoms of bradycardia (even if you’re not taking amiodarone with Harvoni), call your doctor right away.

Is Harvoni safe for pregnant women?

Harvoni is a pregnancy Category B medication. This means there haven’t been enough studies done in pregnant women to confirm whether this drug is safe to use during pregnancy. Harvoni has been tested in pregnant lab animals (rats), but the results of those studies can’t always be applied to humans.

Can you take Harvoni if you have kidney disease?

If you have mild kidney disease, you should be able to take Harvoni without any problems. Your doctor will likely prescribe the normal dosage for you. But if you have severe kidney disease, your body may not be able to process the drug well. This could lead to increased amounts of the drug in your body, and increased risk of side effects.

Does Harvoni cause stomach problems?

Digestive system. Like many drugs, Harvoni can cause some stomach problems. A small number of patients have reported nausea and diarrhea while taking the drug. Like some other side effects, these tend to get a little worse the longer you take the drug.

What does the FDA say about long term side effects of Harvoni?

Are these side effects long lasting or they just last a few weeks or months after treatment.

What does the data suggest about harmful effects of Harvoni?

We have to look at all the data before we make the decision to take Harvoni.

Clinical Trials

Although there are some common side effects while taking Harvoni, many of the patients in the clinical trials were taking it with Ribavirin.

Headaches & Dizziness

Headaches are the most common side effect noted by patients who take Harvoni.

Physical Weakness & Fatigue

These are some of the most commonly reported effects that can be experienced.

Insomnia, Irritability & Depression

Depression is not very common, but has been reported during clinical trials.

Nausea & Diarrhea

Nausea and diarrhea are more common side effects of Harvoni, but it only affects about 3% to 7%. Rates of people who experience this tend to rise with longer treatments.

Why is it important to take Harvoni?

This is because following your treatment plan increases your chances of curing your hepatitis C (HCV). It also helps reduce your risk of the long-term effects of HCV, which include cirrhosis and liver cancer.

How long does it take for Harvoni to go away?

Most of these side effects may go away within a few days or a couple of weeks.

What is Harvoni used for?

Harvoni is FDA-approved to treat hepatitis C in adults with genotypes 1, 4, 5, or 6. It can also be used to treat children with these genotypes who are aged 12 and up or who weigh at least 77 pounds.

Is Harvoni the same as Zepatier?

Harvoni and Zepatier are similar medications and their effects on the body are alike. Therefore, they cause many of the same side effects. Below are some examples of their side effects.

Does Sovaldi have side effects?

Because of this, the side effects seen with Sovaldi treatment depend on the drug it’s used with. Common and serious side effects for Harvoni and Sovaldi are shown below. The Sovaldi side effects described are seen when Sovaldi is used with other hepatitis C drugs such as ribavirin and pegylated interferon.

Is Epclusa the same as Harvoni?

Harvoni and Epclusa are both drugs called direct-acting antivirals and have similar effects in the body. Because of this, they cause many of the same side effects. Below are some examples of these side effects.

Can Harvoni cause side effects?

Serious side effects from Harvoni aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

What is Harvoni used for?

Harvoni is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14)]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.

How many trials of Harvoni?

The efficacy and safety of Harvoni were evaluated in four trials in genotype 1 HCV mono-infected subjects including one trial exclusively in treatment-experienced subjects with compensated cirrhosis (Child-Pugh A); one trial in genotype 1 or 4 HCV/HIV-1 coinfected subjects; two trials in genotype 4, 5, or 6 HCV mono-infected subjects; two trials in genotype 1 or 4 HCV infected pretransplant subjects with decompensated cirrhosis (Child-Pugh B and C) or post-transplant with Metavir F0–F3 fibrosis, compensated cirrhosis, decompensated cirrhosis, or fibrosing cholestatic hepatitis (FCH); two trials in subjects with severe renal impairment (one of which included subjects requiring dialysis); and one trial in genotype 1 or 4 HCV pediatric subjects 3 years of age and older without cirrhosis or with compensated cirrhosis, as summarized in Table 10 [see Clinical Studies (14.2, 14.3, 14.4, 14.5, 14.6, and 14.7) ]:

What is the trial 0154?

Trial 0154 was an open-label clinical trial that evaluated 12 weeks of treatment with Harvoni in 18 treatment-naïve and treatment-experienced (subjects with prior exposure to an HCV NS5B polymerase inhibitor were excluded) genotype 1 HCV-infected adults with severe renal impairment not requiring dialysis. At baseline, two subjects (11%) had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0 to 39.6). The SVR rate was 100% (18/18).

What is the role of Ledipasvir in the replication of HCV?

Ledipasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.

How long does NS5A resistance-associated substitution persist?

NS5A resistance-associated substitutions for other NS5A inhibitors have been found to persist for >1 year in some patients. The long-term clinical impact of the emergence or persistence of virus containing ledipasvir or sofosbuvir resistance-associated substitutions is unknown.

How much Harvoni should I take?

Recommended Dosage in Adults. The recommended dosage of Harvoni in adults with genotype 1, 4, 5, or 6 HCV is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily with or without food [see Clinical Pharmacology (12.3)].

How many Harvoni tablets are in a bottle?

Each bottle contains 28 tablets (NDC 61958-1801-1), a silica gel desiccant and polyester coil, and is closed with a child-resistant closure.

Where was Mary Harvoni diagnosed with cancer?

She was referred to Siteman Cancer Center in St Louis, the diagnosis was a rapid cancer that had metastasized to the lungs, throat, spine hips pelvis, her body was ravaged with cancer. The cancer grew so rapid she was dead by July 28, 2019. Could Harvoni have been the cause, our family does not have a history of cancer.

Is liver cancer a Harvoni cancer?

Liver cancer is the only recognised Harvoni cancer to this date. I developed head and neck cancer 8 months after Harvoni. It is A viral related cancer. 8 months after I stopped taking Harvoni, 6 months after SVR my cure, I started having symptoms in my jaw, which was a secondary cancer site.