what is the proven data for epclusa treatment

Yes, Epclusa (sofosbuvir

and velpatasvir) can cure hepatitis C virus (HCV) in many patients and has a 98% overall cure rate in all 6 of the main types of hepatitis C. "Cure” means the Hep C virus is not detected in the blood when measured three months after treatment is completed.

Full Answer

How are the benefits and side effects of Epclusa evaluated?

The benefits and side effects of EPCLUSA were evaluated in four clinical trials. Each trial was designed differently. In Trial 1, patients randomly received either EPCLUSA or placebo pill for 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.

What is the recommended dosage of Epclusa?

The recommended dosage of Epclusa is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)]. One tablet of Epclusa contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1 shows the recommended treatment regimen and duration based on patient population.

Why was Epclusa approved by the FDA?

The FDA approved EPCLUSA based on evidence from four clinical trials of 1825 patients with chronic hepatitis C virus infection. In these trials, some patients were previously treated for hepatitis C and some were never treated before. Some patients had cirrhosis and some did not.

What is Epclusa (ribavirin)?

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C ( Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

What is the success rate of Epclusa?

Effectiveness: The cure rates are from 97% to 100% in those without cirrhosis or with compensated cirrhosis. Side effects: Most people don't experience significant side effects – but if they do the most common adverse reactions observed with treatment with Epclusa for 12 weeks are headache and fatigue.

What is the success rate of Hep C treatment?

Hepatitis C treatment can cure more than 90 percent of hepatitis C cases, but testing is a critical first step. It's estimated 40 percent of people with hepatitis C in the U.S. from 2015-2018 were unaware of their infection.

Can Epclusa help cirrhosis?

For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

What are the long term effects of Epclusa?

Does Epclusa have any long-term side effects? No, long-term side effects haven't been reported with Epclusa. However, hepatitis C can cause long-term harm to your liver, such as cirrhosis (liver scarring). This could last even after your hepatitis C is cured.

Can Epclusa cure hep C in 8 weeks?

An eight-week course of sofosbuvir/velpatasvir (Epclusa) cured almost all people with hepatitis C genotype 3 without cirrhosis receiving treatment alongside opioid substitution therapy through community pharmacies or prisons in the Greater Glasgow area, Alison Boyle of Gartnavel Hospital, Glasgow, reported at the 2018 ...

How long does it take for Epclusa to start working?

Epclusa starts working quickly in your body to stop hepatitis C virus from making more of itself. But not everyone may have the same experience with Epclusa. Ask your doctor how long it should take for Epclusa to work for you. In studies, many people taking Epclusa had cleared hepatitis C after 12 weeks of treatment.

Does Epclusa damage liver?

EPCLUSA can cause serious side effects, including: This may cause serious liver problems including liver failure and death.

Does Epclusa cause hair loss?

Hair loss. Hair loss didn't occur in clinical studies of Epclusa. Some people have reported losing hair during Epclusa treatment.

Can I drink coffee while taking Epclusa?

No interactions were found between caffeine and Epclusa. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.

Does brain fog go away after Hep C treatment?

The virus can cause problems such as brain fog, fatigue, and memory trouble. The good news: These cognitive problems can be reversed. Hepatitis C is known for damaging the liver, but that's not the only organ affected. It may also cause damage in the brain.

Can Epclusa cure hep C?

Official Answer. Yes, Epclusa (sofosbuvir and velpatasvir) can cure hepatitis C virus (HCV) in many patients and has a 98% overall cure rate in all 6 of the main types of hepatitis C.

Which is better Epclusa or Mavyret?

If you have liver disease, Epclusa may be a better treatment choice for you. Severe scarring of your liver. Mavyret isn't used for treating hepatitis C if you have severe cirrhosis. However, Epclusa can be used with the drug ribavirin for this purpose.

What is the difference between hepatitis B and C?

Some of the main differences between hepatitis B and C are: Hepatitis B virus can be prevented with a vaccine, but not hepatitis C. Hepatitis B and...

How long does Epclusa stay in your system?

Epclusa stays in your system approximately 3 days after the last dose.

How long is an Epclusa treatment?

Epclusa (sofosbuvir and velpatasvir) is given as a single daily pill for 12 weeks duration. With advanced liver disease (decompensated cirrhosis, C...

What is the best time of day to take Epclusa?

Epclusa can be taken either in the morning or the evening, but it is important to take it at approximately the same time each day. Most people find...

Does Epclusa work if you miss doses?

There is a chance that Epclusa may not work as well if you miss doses. Epclusa works by interfering with a protein and an enzyme needed by the hepa...

Does Epclusa cure Hep C, what is the success rate?

Epclusa has a 98% overall cure rate in all 6 of the main types of hepatitis C in patients without cirrhosis (a serious liver disease) or with compe...

How long did the EPCLUSA trial last?

In this trial, both patients and health care providers knew which treatment was given. The Trial 3, patients randomly received EPCLUSA for 12 weeks or the combination of two previously approved drugs called sofosbuvir and ribavirin for 24 weeks.

What are the side effects of epclua?

The most common side effects of EPCLUSA when used alone are headache and tiredness. The most common side effects of EPCLUSA when used with another approved HCV drug called ribavirin are tiredness, an emia, nausea, headache, difficulties sleeping and diarrhea. MORE INFO.

What is the drug for hepatitis C?

EPCLUSA is a drug for the treatment of adults who have a specific type of Hepatitis C virus (HCV) infection, called chronic Hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection. EPCLUSA is a combination of two anti-viral drugs: sofosbuvir (previously approved for HCV treatment) and velpatasvir (new drug for HCV).

What is a clinical trial?

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.#N#COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.#N#EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.#N#PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.#N#SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

Where were the cirrhosis trials conducted?

Some patients had cirrhosis and some did not. The trials were conducted in the United States, Puerto Rico, Canada, Europe, Australia, New Zealand and China. The figure below summarizes how many men and women were in the clinical trials. Figure 1.

What is a placebo pill?

PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial.

What is Epclusa tablet?

Epclusa is available as tablets or pellets for oral use. Each dosage form is available in two dose strengths: 400 mg/100 mg Tablets: pink, diamond-shaped, film-coated tablet debossed with "GSI" on one side and "7916" on the other side. Each tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir.

What are the side effects of Epclusa?

The most common side effects of Epclusa in adults and children 6 years of age and older include headache and tiredness. The most common side effects of Epclusa when used with ribavirin in adults with decompensated cirrhosis are tiredness, low red blood cells, nausea, headache, trouble sleeping, and diarrhea.

What is the ASTRAL 5 trial?

ASTRAL-5 was an open-label trial that evaluated 12 weeks of treatment with Epclusa in subjects with genotype 1, 2, 3, 4, 5, or 6 HCV infection who were coinfected with HIV-1. Subjects were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, raltegravir or elvitegravir/cobicistat.

What is Velpatasvir a drug?

Velpatasvir is an inhibitor of drug transporters P-gp, breast cancer resistance protein (BCRP), OATP1B1, OATP1B3, and OATP2B1. Coadministration of Epclusa with drugs that are substrates of these transporters may increase the exposure of such drugs.

What are the inducers of P-GP?

Inducers of P-gp and/or moderate to strong inducers of CYP2B6, CYP2 C8, or CYP3A4 (e.g., rifampin, St. John's wort, carbamazepine) may decrease plasma concentrations of sofosbuvir and/or velpatasvir, leading to reduced therapeutic effect of Epclusa [see Warnings and Precautions (5.3) and Drug Interactions (7.3)].

Does Epclusa affect milk production?

It is not known whether the components of Epclusa and its metabolites are present in human breast milk, affect human milk production, or have effects on the breastfed infant. The predominant circulating metabolite of sofosbuvir (GS-331007) was the primary component observed in the milk of lactating rats administered sofosbuvir, without effect on nursing pups. When administered to lactating rats, velpatasvir was detected in the milk of lactating rats and in the plasma of nursing pups without effects on the nursing pups [see Data].

Is Epclusa contraindicated with ribavirin?

Epclusa and ribavirin combination regimen is contraindicated in patients for whom ribavirin is contraindicated. Refer to the ribavirin prescribing information for a list of contraindications for ribavirin [see Dosage and Administration (2.2, 2.3, 2.4) ].

Who makes Epclusa?

Epclusa is manufactured and marketed by Gilead Sciences, Inc., of Foster City, California. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

What is the name of the drug that is used to treat HCV?

Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

What percentage of people with HCV have genotype 1?

Knowing the genotype helps inform treatment recommendations and the duration of treatment. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small numbers of patients are infected with genotypes 4, 5 or 6.

How many cases of HCV are chronic?

According to the Centers for Disease Control and Prevention, HCV infection becomes chronic in approximately 75 to 85 percent of cases. Patients who suffer from chronic HCV infection over many years may have complications, such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections, liver cancer and death.

Does Epclusa slow heart rate?

Epclusa carries a warning for patients and health care providers that serious slowing of the heart rate (symptomatic bradycardia) and cases requiring pacemaker intervention have been reported when amiodarone is used with sofosbuvir in combination with another HCV direct-acting antiviral.

Is Epclusa approved for cirrhosis?

Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin.

Can you take amiodarone with epclusa?

Co-administration of amiodarone with Epclusa is not recommended. Epclusa also carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood which could lead to reduced efficacy of Epclusa.

EPCLUSA can cause serious side effects, including

Hepatitis B virus reactivation: Before starting EPCLUSA treatment, your healthcare provider will do blood tests to check for hepatitis B infection. If you have ever had hepatitis B, the hepatitis B virus could become active again during and after treatment with EPCLUSA. This may cause serious liver problems including liver failure and death.

What should I tell my healthcare provider before taking EPCLUSA?

Tell your healthcare provider about all of your medical conditions, including if you have ever had hepatitis B infection, liver problems other than hepatitis C infection, or a liver transplant; if you have kidney problems or are on dialysis; if you have HIV; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed.

What are the possible side effects of EPCLUSA?

Slow heart rate (bradycardia): EPCLUSA, when taken with amiodarone (Cordarone ® , Nexterone ®, Pacerone® ), a medicine used to treat certain heart problems, may cause slow heart rate. In some cases slow heart rate has led to death or the need for a pacemaker when amiodarone is taken with medicines containing sofosbuvir.

What is EPCLUSA?

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1-6 infection with or without cirrhosis (compensated).

Can you swallow 400 mg of ribavirin?

Two 200 mg/50 mg tablets once daily can be used for patients who cannot swallow the 400 mg/100 mg tablet. The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.

Can you chew epcluse?

Do not chew EPCLUSA oral pellets to avoid a bitter aftertaste. EPCLUSA oral pellets can be taken directly in the mouth or with food (See Instructions for Use ). In pediatric patients less than 6 years of age, administer the oral pellets with food to increase tolerability related to palatability.

How many cure rates for Epclusa?

Bottom Line. Epclusa has a 98% overall cure rate in all 6 of the main types of hepatitis C in patients without cirrhosis (a serious liver disease) or with compensated cirrhosis (mild or no symptoms).

How many mg of epclusa is in a tablet?

Epclusa is an oral tablet taken once a day, with or without food. It comes in two strengths: 400 mg sofosbuvir/100 mg velpatasvir and 200 mg/50 mg tablets. Epclusa also comes as oral pellets (200 sofosbuvir/50 velpatasvir and 150/37.5 oral pellets) for use in children who cannot swallow tablets.

When was Epclusa approved?

Epclusa was first approved by the FDA in June of 2016. It is approved for use in adults and pediatric patients at least 3 years of age with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection. Epclusa is used with ribavirin in patients with advanced liver disease (decompensated cirrhosis).

What are the side effects of Epclusa?

The most common side effects of Epclusa in adults and children 6 years and older include headache and tiredness. When used with ribavirin in advanced liver disease in adults, common side effects also include anemia (not enough red blood cells), upset stomach (nausea), trouble sleeping, and diarrhea. In children less than 6 years old, vomiting and ...

Does Epclusa cure HCV?

Official Answer. Yes, Epclusa ( sofosbuvir and velpatasvir) can cure hepatitis C virus (HCV) in many patients and has a 98% overall cure rate in all 6 of the main types of hepatitis C. "Cure” means the Hep C virus is not detected in the blood when measured three months after treatment is completed. In studies, these cure rates were seen in patients ...

Can a child spit up epclusa?

Children under 6 years may vomit or spit up the medicine. This is not all the information you need to know about Epclusa for safe and effective use. Review the full Epclusa information here, and discuss this information with your doctor or other health care provider. References. Epclusa [product information].

Is Epclusa a ribavirin?

Epclusa is used with ribavirin in patients with advanced liver disease (decompensated cirrho sis). In August 2017, the FDA also approved Epclusa to treat chronic HCV in patients co-infected with HIV. Gilead Science's Epclusa is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment ...

How many cure rates for epclusa?

Epclusa has a 98% overall cure rate in patients with genotype 1-6 without cirrhosis (a serious liver disease) or with compensated cirrhosis (meaning you have cirrhosis, but with mild or no symptoms). "Cure” means the Hep C virus is not detected in the blood when measured three months after treatment is completed.

How much does Epclusa cost?

In some cases, this has resulted in severe and rapid liver disease, hepatic failure, and death. The cost of Epclusa is roughly $78,078 for a 12-week course of treatment. Your cost might vary based on insurance or manufacturer-provided discounts.

How does Velpatasvir work?

Velpatasvir works by interfering with a protein, called HCV NS5A that is needed by the virus to replicate itself. Sofosbuvir is a prodrug that is converted to its pharmacologically active form (GS-461203), which inhibits an RNA-dependent polymerase called HCV NS5B, which is also needed by the virus to replicate itself.

What is epclusa used for?

Epclusa is a fixed-dose combination medication containing velpatasvir and sofosbuvir that may be used to treat hepatitis C infection (HCV). Velpatasvir is a nucleotide analog polymerase inhibitor and sofosbuvir is a pan-genotypic NS5A inhibitor.

What are the side effects of Epclusa?

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include: Headache and tiredness are the most common side effects of Epclusa. Other side effects reported in more than 10% of people include anemia, diarrhea, insomnia, itching, ...

When to use Epclusa?

Upsides. Epclusa is approved for use in adults and children at least 3 years of age with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection. May be used with ribavirin in patients with advanced liver disease (decompensated cirrhosis).

Does Epclusa stop hepatitis C?

The ingredients in Epclusa initially greatly reduce and then completely stop the production of new copies of the hepatitis C virus. Epclusa belongs to the class of medicines known as hepatitis C antivirals. It may also be called a combination antiviral agent. 2.

How to contact EPCLUSA?

One way is by contacting EPCLUSA Support Path ®, where a program navigator can assist you with this and other insurance-related questions. Call EPCLUSA Support Path at 1-855-7-MYPATH (1-855-769-7284) and inform the EPCLUSA Support Path program navigator that you want to complete a benefits investigation.

What are the side effects of epclua?

The most common side effects of EPCLUSA include headache and tiredness. EPCLUSA can cause serious side effects, including Hepatitis B virus reactivation: Before starting EPCLUSA treatment, your healthcare provider will do blood tests to check for hepatitis B infection.

What is the name of the medication used to treat hepatitis C?

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C ( Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin. Speak with your Hep C Specialist to find out if EPCLUSA is right for you.

What is a protease inhibitor?

Protease inhibitors are a class of antiviral drugs used to treat Hep C and work by stopping the virus from replicating. Examples of drugs that are protease inhibitors are Incivek® (telaprevir) and Victrelis ® (boceprevir). Speak with your Hep C Specialist to find out if EPCLUSA is right for you.

Can you take epclua with food?

No additional medicines are required for the majority of patients. EPCLUSA is one pill, taken once daily, with or without food. EPCLUSA with ribavirin is recommended for certain patients with advanced cirrhosis (decompensated).

Does EPCLUSA work?

Even if your previous Hep C treatment was unsuccessful, EPCLUSA may work . In clinical studies, EPCLUSA was proven effective in treating chronic Hep C patients who had previously failed a peginterferon alfa- and ribavirin-based regimen, with or without a protease inhibitor.

How long does Epclusa last?

If you have failed a previous Hepatitis C treatment then you should seriously consider do the maximum Epclusa treatment period, which is generally considered to be 24 weeks. One of the reasons for this is because it is likely that the Hepatitis C virus in your body has developed some degree of resistance to treatment.

Why is it better to take Epclusa with food?

Why? Because having a small amount of food in the stomach will stimulate the stomach acids and assist in the absorption process. The Epclusa is absorbed in the stomach, through the stomach walls.

Where is Epclusa absorbed?

The Epclusa is absorbed in the stomach, through the stomach walls. Not a large amount of food, not a huge meal, because some of the Velpatasvir is going to get caught up in the mass of food. Also I would not suggest drinking a large amount of water right after taking your pill. For the same reason.

How much coffee should I drink a day with Epclusa?

One or two cups of coffee a day is not a problem but if you are drinking ten or more cups of coffee a day you should consider reducing this whilst taking Epclusa. The same applies to energy drinks containing high levels of caffeine.

Is epclusa a water soluble drug?

Understanding Epclusa. The first thing to understand when taking Epclusa is that Epclusa is two drugs, Sofosbuvir and Velpatasvir. Velpatasvir is not a water soluble chemical. That is to say it does not dissolve easily. Sofosbuvir is very soluble, Velpatasvir is not very soluble.

Does coffee affect epclusa?

Coffee and Epclusa. Coffee, or rather caffeine causes the body to produce CYP enzymes because the liver considers caffeine to be a toxin and wants to remove it. If you drink large amounts of coffee while doing treatment with Epclusa it is possible that this may effect treatment outcomes.

Is Velpatasvir soluble in stomach acid?

Sofosbuvir is very soluble, Velpatasvir is not very soluble. Velpatasvir relies heavily on the stomach acids to dissolve it and make it easy for the body to absorb. This is why you must never take antacids when you are taking Epclusa or any other substance that might neutralise your stomach acid.

Medical uses

Contraindications

• Who participated in the clinical trials?
  The FDA approved EPCLUSA based on evidence from four clinical trials of 1825 patients with chronic hepatitis C virus infection. In these trials, some patients were previously treated for hepatitis C and some were never treated before. Some patients had cirrhosis and some did not. …
• How were the trials designed?
  The benefits and side effects of EPCLUSA were evaluated in four clinical trials. Each trial was designed differently. In Trial 1, patients randomly received either EPCLUSA or placebo pill for 12 weeks. Neither the patients nor the health care providers knew which treatment was being give…

See more on fda.gov

Administration

Description

Pathophysiology

Management

• The recommended dosage of Epclusa is one tablet taken orally once daily with or without food [see Clinical Pharmacology (12.3)]. One tablet of Epclusa contains 400 mg of sofosbuvir and 100 mg of velpatasvir. Table 1 shows the recommended treatment regimen and duration based on patient population. For patients with HCV/HIV-1 coinfection, follow the ...

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Side effects

Symptoms

Interactions

Research

Prognosis

Adverse effects

Results

Safety

Pharmacology