Treatment FAQ

harvoni treatment in patients who had interferon

by Prof. Charlene Schinner Published 3 years ago Updated 2 years ago
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Can Hep C come back after interferon treatment?

Combination therapy of interferon and ribavirin has traditionally been used to eradicate hepatitis C virus. The sustained virologic response achieved with interferon-related therapy is persistent, and late relapses after achieving sustained virologic response at 24 weeks using this therapy are reportedly rare (< 1%).

Is Harvoni an interferon?

HCV and Harvoni: Interferon-Free Many treatments for chronic hepatitis C virus (HCV) -- the blood-borne infectious disease that can lead to: chronic liver disease.

Who should not take Harvoni?

Harvoni in people with kidney disease: Harvoni can be used in people with mild or moderate kidney disease. It is not recommended for people with severe kidney disease (eGFR<30 mL/min/1.73 m2) or for people on dialysis.

Do they still use interferon for Hep C?

But today, interferons aren't typically prescribed to treat hepatitis C. In recent years, DAAs have become available, and they have a cure rate of up to 99 percent . These drugs require a shorter treatment time and typically have fewer side effects than interferons.

What does Harvoni do to your body?

Harvoni prevents the hepatitis C virus (HCV) from multiplying in the body. It is a single combination pill that is given by mouth once a day for 8, 12, or 24 weeks, depending upon your HCV status.

Is Harvoni an antiviral?

Harvoni is an antiviral medicine used to treat chronic hepatitis C. It contains the active substances sofosbuvir and ledipasvir. Harvoni has been approved within the NHS for treatment of Genotype 1. It has also been approved for people with Genotype 4 who have previously had treatment or who have compensated cirrhosis.

How long does Harvoni stay in your system?

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.

Can Harvoni treat cirrhosis of the liver?

Please see “Advanced Cirrhosis/Liver Transplant” tab for HARVONI treatment recommendations for these patients. *Advanced cirrhosis (decompensated) is when the liver is extensively scarred and can no longer do its job effectively....GenotypeWeeks of Treatment5126121 more row

Why does Harvoni make you tired?

Central nervous system. 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.

Does interferon cause liver damage?

Interferon beta is a well known cause of mild hepatic injury that occasionally can lead to severe liver injury with jaundice.

How long does interferon stay in your body?

Occurs within 1-2 hours of treatment, may last up to 24 hours (over time the intensity of these symptoms decreases depending on the dose, how it is given, and the schedule of administration). Fatigue , drowsiness. Low blood counts . Your white and red blood cells and platelets may temporarily decrease.

Does interferon suppress the immune system?

There are at least two types of interferon. Along with their antiviral properties, they have recently been shown to exert a suppressive effect on the humoral and cellular immune response; they affect both B and T lymphocytes.

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 did Shutts take interferon?

Shutts underwent the standard pre-Sovaldi treatment, interferon and ribavirin, but found it unbearable and asked his doctor to stop after 14 months. “I told them, ‘This is enough,’” he said. Although treatment had reduced his viral load to 500,000, it has now rebounded to 7 million, he said.

How much does Sovaldi cost?

The new medication costs $95,000 for a 12-week course of treatment. On the surface it appears even more expensive than Sovaldi, which costs $84,000 for a 12-week supply. Both medications have been proven to cure hepatitis C in a majority of people with genotype 1 hepatitis C within that time frame.

How did hepatitis C spread?

The disease could also have been spread via blood transfusions, as it was not even identified until 1989. For all of the above risk factors, baby boomers have been designated as especially at risk. The U.S. Centers for Disease Control and Prevention (CDC) has called for all people born between 1945 and 1965 to be tested for the virus. The CDC estimates that more than 3 million Americans have the disease, and most don’t know they have it. Hepatitis C can linger for decades before presenting symptoms such as jaundice and fatigue. If left untreated, it can cause cirrhosis, or scarring of the liver, and eventually death.

Is Harvoni the same as Sovaldi?

Harvoni is much less expensive than using Sovaldi with Olysio, Bernstein told Healthline. It is also about the same price as using Sovaldi with interferon and ribavirin. Get the Facts: Chronic Hepatitis C Symptoms, Diagnosis, and Treatment ».

Does Harvoni help with hepatitis C?

Harvoni Takes the Sting Out of Hepatitis C Treatment. For the first time, hepatitis C can be cured without interferon and ribavirin, which can cause fatigue and depression. Finally, there’s a medication to cure hepatitis C that doesn’t require use of the dreaded drugs interferon or ribavirin. , a once-daily tablet manufactured by Gilead Sciences.

Is there a drug that can cure hepatitis C?

Finally, there’s a medication to cure hepatitis C that doesn’t require use of the dreaded drugs interferon or ribavirin. , a once-daily tablet manufactured by Gilead Sciences. Harvoni is a combination medication that includes sofosbuvir (Sovaldi), another Gilead breakthrough treatment approved late last year, and ledipasvir, ...

Is Harvoni red tape worse than Sovaldi?

While the same access issues have arisen with Harvoni as with Sovaldi — pharmacy benefit managers and Medicaid programs telling patients they’re not sick enough for the medication — they don’t appear to be any worse, Bernstein told Healthline.

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.

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 interferons be used for hepatitis C?

For these reasons, today interferons aren’t typically used to treat hepatitis C.

Does Harvoni increase digoxin?

Taking Harvoni with digoxin (Lanoxin) can increase the amount of digoxin in your body. Digoxin levels that are too high can lead to dangerous side effects.

What are the side effects of ribavirin?

When this drug was studied with ribavirin, the most common side effects to this combination were consistent with known ribavirin side effects; frequency and severity of the expected side effects were not increased.

Does amiodarone cause bradycardia?

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with this drug . [ Ref]

Can ribavirin cause headaches?

The most common side effects in patients with HCV with compensated liver disease (with or without cirrhosis) and end-stage renal disease requiring dialysis were insomnia and headache. If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.

Is ribavirin discontinued?

Ribavirin was permanently discontinued in up to 19% of patients. Immunosuppressive agents were modified in up to 10% of liver transplant recipients (modified dose due to improved organ function in at least 7%). Very common (10% or more): Decreased hemoglobin (up to 39%)

Does Sofosbuvir go away?

Some side effects of ledipasvir / sofosbuvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Does Sofosbuvir cause side effects?

Side effects requiring immediate medical attention. Along with its needed effects, ledipasvir / sofosbuvir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking ledipasvir / ...

Is amiodarone a direct acting antiviral?

FDA. U.S. Food and Drug Administration "FDA Drug Safety Communicaation: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug.

What is the effect of interferons on HCV?

Interferons are natural cellular proteins that can have different actions in humans, e.g., direct antiviral effect, inhibition of cell growth and control of apoptosis, and promoting immune responses.8,34The effectiveness of IFN in HCV treatment can be significantly enhanced by the addition of RBV.6,7,35The combination results in higher SVR rates than does IFN monotherapy, even in patients with advanced liver disease or those who either did not respond or relapsed after completion of IFN therapy.5A significant advance in IFN therapy was the introduction of pegylated IFNs, which slow drug elimination, making it possible to maintain a stable serum concentration with once-weekly administration.36Two pegylated IFNs, PEG-IFN-α2a and PEG-IFN-α2b, are commercially available, and they have different pharmacokinetic properties. The duration of IFN-based therapy depends on a few factors, such as HCV genotypes and baseline viral loads. Currently, 24-week combination therapy is recommended for genotypes 2 and 3 patients and 48 weeks for genotypes 1 and 4. By monitoring HCV RNA levels at baseline and after treatment initiation, particularly at 4 and 12 weeks, the optimal duration of therapy can be further customized.37Careful studies of HCV kinetics during treatment may help the development in individualization and optimization of combination therapy.

How does IFN affect HCV?

To determine the mode of action of IFN-α against HCV, the viral load decline during the first two weeks of daily IFN-α2b treatment with doses of 5, 10, and 15 IU was analyzed using the above model.32If IFN acts solely by blocking new HCV infections (η>0 and ε=0), then HCV clearance and production would both continue at their pretreatment rate until infected cells begin to die. This would suggest a slow first phase decline. Moreover, it was shown that blocking de novo infection could not account for the strong dose dependence observed during the first day of therapy and for the slower viral decline after 2 days.32If the major effect of IFN is to block viral production (ε>0), then a rapid dose-dependent HCV RNA decline is expected after treatment initiation. Further, if blocking is not 100% (i.e., 0<ε<1), then model analysis showed that the viral decline will be biphasic. The slope of the first phase decline is determined by the viral clearance rate, c, and the drug efficacy, ε. The second phase decline reflects the loss rate of productively infected cells, δ, as well as the drug efficacy.32

How long does a pegylated IFN last?

Pegylated IFNs have a longer half-life (about 77 hours and 40 hours for PEG-IFN-α2a and PEG-IFN-α2b, respectively), better pharmacokinetic properties, and have yielded a better SVR rate in HCV patients than standard IFN.60-62Viral kinetic analysis has been performed to study the antiviral potency of pegylated IFNs.56,63The viral decay after treatment initiation is generally biphasic, with a rapid dose-dependent first phase decline and a second, slower phase decline, similar to the results with unmodified IFNs. The first and second phase declines are also faster in patients infected with HCV genotypes 2 and 3 than with genotype 1.

What are the components of the HCV life cycle?

The HCV life cycle (Fig. 4) starts with viral attachment, entry, and fusion, which involve both the HCV structural proteins and the receptor molecules at the surface of target cells. Two HCV envelope glycoproteins, E1 and E2, are essential for viral entry and fusion. A few cell surface molecules, such as CD81,82the human scavenger receptor class B type 1 (SR-B1),83claudin-1,84and other putative receptor molecules85have been proposed to mediate HCV binding or HCV binding and internalization. After fusion of the viral and cellular membranes, viral nucleocapsid releases a single-stranded, positive-sense genomic RNA into the cell cytoplasm. This genome serves as a messenger RNA (mRNA) for synthesis of a large polyprotein (HCV polyprotein translation). It can also be a template for HCV RNA replication, or be packaged as a new genome in a progeny virus particle. At least two host cellular peptidases, i.e., host signal peptidase and signal peptide peptidase, are required for processing of the HCV structural proteins from the HCV polyprotein.14A few viral enzymes, including the NS3-4A serine protease, are involved in the HCV polyprotein cleavage for generation of nonstructural proteins. This is followed by HCV RNA replication. The precise mechanism of HCV replication is largely unknown, but the process is thought to be semiconservative and asymmetric86: the positive-strand genome RNA serves as a template for the synthesis of a negative-strand intermediate; the negative-strand RNA then serves as a template to produce multiple nascent genomes. NS5B RNA-dependent RNA polymerase (RdRp), a product of the polyprotein cleavage, is thought to catalyze HCV RNA replication. The last step of the HCV life cycle is viral assembly and release. Although the HCV core protein can self-assemble to generate nucleocapsid-like particles and virus seems to be released into the extracellular milieu by exocytosis,14the exact mechanisms underlying HCV assembly and exportation are still poorly understood because of lack of appropriate study models. Inhibitors of different steps in the HCV life cycle (e.g., viral entry, RNA translation and post-translational processing, RNA replication, viral assembly and release) are currently at various stages of clinical development (see a recent review80).

How long does it take for a biphasic HCV RNA decline?

Before initiation of therapy, the viral load is at the set-point level. The first phase decline lowers HCV RNA levels 1-2 logs during the first 1-2 days of treatment. It is followed by a slower second phase viral decline during the subsequent weeks of therapy.

What are the three variables of the IFN- model?

The model includes three variables (Fig. 2): uninfected target cells (T), productively infected cells (I), and free virus (V). sand dare the recruitment rate and per capita death rate of uninfected target cells, respectively. Viral infection is assumed to occur at a rate proportional to the product of the densities of virus and target cells (the law of mass action), i.e., at rate βVT, where βis the infection rate constant. Productively infected cells are lost, by either natural death or immune attack, at rate δper cell. Virus is released from productively infected cells at rate pper cell and cleared at rate c. Lastly, IFN therapy is assumed to act by partially blocking viral production, with efficacy ε, and by reducing the infection rate, with efficacy η(Fig. 2), where εand ηare between 0 and 1. Before IFN therapy, both εand ηare 0. Once treatment is initiated, ε>0 or η>0 or both. The model is described by the following differential equations:

Does ribavirin decrease HCV?

When used as monotherapy, ribavirin results in either a transient initial decline or no decrease in HCV RNA level.70,71The addition of RBV to IFN-α, however, has dramatically improved the long-term outcome of therapy.6,7,35In some patients, RBV induced an increase in the slope of the second phase decline, whereas in other patients, it did not significantly affect the second phase, although it decreased the frequency of viral rebound observed when only pegylated IFN was administered.70In patients with a triphasic decline after treatment with IFN or pegylated IFN, administration of RBV seemed not to affect the first phase decline, but enhanced the third phase decline.29,31

How long does interferon treatment last?

Interferon treatment for hepatitis C would typically last 24–48 weeks (6–12 months). Interferons caused many long-term side effects partly because of this long treatment time.

What to do if you have side effects from interferon?

If you have these side effects and you’re concerned that they relate to your interferon exposure, call your doctor. They can assess you and determine if the interferons or something else is causing your symptoms.

How do interferons work?

For one, they change the way white blood cells destroy invading cells. This change triggers the body’s built-in immune response to fight viruses such as hepatitis C.

Why are interferons used with ribavirin?

Another reason for the long-term side effects was that interferons were often used with ribavirin to treat hepatitis C. Ribavirin further raised the risk of side effects.

What is the medication used to treat hepatitis C?

Interferons are medications that used to be standard treatments for hepatitis C.

What does interferon do to your immune system?

White blood cells fight infections as part of your immune system. Interferons can change the way white blood cells fight infection.

What to do if you have a thyroid problem after interferon?

Call your doctor if any of these symptoms occur after receiving interferon therapy. You may need replacement thyroid hormone if your thyroid isn’t producing enough, or treatment to reduce the activity of an overactive thyroid gland.

What is Harvoni used for?

Harvoni is an antiviral medicine used to treat adults and children from 3 years of age with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.

How many people have been infected with Harvoni?

Harvoni has been investigated in three main studies involving a total of around 2,000 adults infected with hepatitis C virus of genotype 1 whose liver function was normal. In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end ...

How long does Harvoni last?

In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients. Around 94% to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after treatment. Ribavirin was not needed for most patients.

What is the active substance in Harvoni?

The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply. Sofosbuvir blocks the action of a protein called NS5B RNA-dependent RNA polymerase, while ledipasvir targets a protein called NS5A.

How much Harvoni should I take a day?

For adults the recommended dose of Harvoni is one tablet containing 90 mg ledipasvir and 400 mg sofosbuvir once a day.

When did Harvoni get its marketing authorisation?

Harvoni received a marketing authorisation valid throughout the EU on 17 November 2014.

Is Harvoni safe for hepatitis C?

The Agency considered that treatment with Harvoni, with or without ribavirin, is highly effective for many patients with hepatitis C virus, including those who have had a liver transplant or who have compensated or decompensated cirrhosis. The side effects of Harvoni are manageable.

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