ZEPATIER

ZEPATIER is a medication that requires a prescription and is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in adults and children who are at least 12 years old or weigh at least 66 pounds (30 kilograms). It can be taken with or without ribavirin.

You may experience tiredness, headache, or nausea. If any of these symptoms persist or worsen, please inform your doctor or pharmacist immediately. It is important to remember that this medication has been prescribed to you because your doctor has determined that the benefits outweigh the potential risks of side effects.

Symptoms to watch out for include pain or swelling in the upper right side of the stomach, along with nausea, vomiting, and loss of appetite. Other concerning signs include confusion, tiredness, and feeling light-headed. If you experience easy bruising or bleeding, vomiting blood, or have diarrhea with black or bloody stools, it is important to seek medical attention. Additionally, dark urine, clay-colored stools, or yellowing of the skin or eyes should not be ignored and should be evaluated by a healthcare professional.

DateArticleJan 28, 2016
Approval: FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4

Jul 28, 2015
Merck Announces FDA Acceptance of NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4 and 6 Infection

The United States’ health care system faces a significant drawback with these groundbreaking drugs due to their exorbitant costs. A single pill of Sovaldi is priced at around $1,000, resulting in a total expense of $84,000 for the twelve-week treatment. Similarly, Olysio is estimated to cost $23,600 per month of treatment.

If you have a history of hepatitis B, there is a possibility that the hepatitis B virus may reactivate while undergoing treatment with HARVONI. This can lead to severe liver complications, such as liver failure and even death. To ensure your safety, your healthcare provider will closely monitor you throughout your HARVONI treatment and afterwards.

Zepatier is a medication that combines Elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adults who have not received treatment before or who have previously been treated. It can be used in patients with or without compensated cirrhosis. Elbasvir is an NS5A inhibitor, while grazoprevir is an NS3/4A protease inhibitor.

ZEPATIER is a single tablet that combines two drugs, elbasvir and grazoprevir, in fixed doses of 50 mg and 100 mg respectively. It is recommended to take one tablet of ZEPATIER orally once a day, with or without food.

Harvoni is approved for individuals over 18 years old in the United States, regardless of their HIV status, who have hepatitis C genotypes 1, 4, 5, and 6.

Harvoni, a combination antiviral drug containing ledipasvir and sofosbuvir, is frequently prescribed for Hepatitis C. The price for a 28-pellet supply of Harvoni oral pellets (33.75 mg-150 mg) is approximately $33,179, but may vary depending on the pharmacy.

MAVYRET’s Wholesale Acquisition Cost (WAC), also known as the list price, is $13,200.00 per month as of January 2023. Please note that the WAC may not be the actual price paid by patients. To determine the cost of MAVYRET for you, please consult with your healthcare provider or pharmacist.

The cure rates for individuals treated with 16 weeks of Zepatier were 83% (5 out of 6) without the use of RBV and 100% (4 out of 4) with the use of RBV.

There are no known interactions between Zepatier and alcohol. Zepatier is prescribed to treat a long-lasting liver infection caused by specific types of the hepatitis C virus (HCV). However, it is important to note that consuming alcohol while having HCV can lead to liver complications.

The lifespan of individuals diagnosed with hepatitis C can vary, but they can still live for many years. However, a study conducted in 2014 revealed that on average, patients infected with the hepatitis C virus passed away 15 years earlier than those without the illness. Inflammation caused by hepatitis C leads to severe liver damage.

The prognosis of patients with advanced non-small cell lung cancer is negatively affected by hepatitis B virus infection, according to a study published in the Asian Pacific Journal of Cancer Prevention.

Direct acting antivirals currently being developed for clinical use include NS3-4A protease inhibitors. Two of these inhibitors, telaprevir and boceprevir, have recently been approved for the treatment of HCV genotype 1 infection when used in combination with pegylated interferon-?± and ribavirin. Additionally, there are nucleoside/nucleotide analogue and non-nucleoside inhibitors being studied as potential treatments.

As of the current press time, the price of Harvoni stands at $87,800, which reflects a $13,800 increase compared to the price in 2016. This price surge may be attributed to the remarkable efficacy of Harvoni, as it eliminates the need for further treatment once the 12- to 24-week supply is completed.

Hepatitis C has the potential to become a long-term condition, as acute infection often progresses to chronic infection. If left untreated, chronic hepatitis C can persist throughout a person’s lifetime. This can result in severe health complications such as liver damage, cirrhosis, liver cancer, and potentially even death.

Epclusa and Harvoni have comparable effectiveness, with reported cure rates of over 95-97% and 93-95% respectively.

The manufacturer of the medication trial treatment, Harvoni, was recently involved in a class action lawsuit.

Hepatitis D has the potential to manifest as either a brief, acute infection or a persistent, chronic infection. This disease can result in severe symptoms and significant health complications, including long-lasting liver damage and potential fatality.

The current direct-acting HCV oral treatments available, like Epclusa, have the ability to achieve a sustained virologic response (SVR). This means that the virus becomes undetectable and a cure is possible for 80% to 100% of patients, often within just 8 to 12 weeks of treatment.

Zepatier is a medication that is taken orally and contains a combination of two antiviral drugs, elbasvir and grazoprevir. It is specifically used to treat chronic hepatitis C, specifically genotypes 1 and 4.

Historically, HCV genotype 3 was known to be more challenging to treat compared to other genotypes. It has been linked to a higher incidence of complications such as fatty liver disease, fibrosis, hepatocellular carcinoma, and mortality.

Take one tablet of ZEPATIER once a day, either with or without food, as recommended by your doctor. The duration of your treatment will be determined by your doctor. Swallow the tablet whole, without chewing, crushing, or splitting it.

The most common genotype of HCV worldwide is genotype 1, accounting for 46% of cases. In North America, Europe, and Australia, the predominant subtypes are 1a and 1b. However, in Japan, subtype 1b is found in 73% of HCV-infected individuals.

The FDA approved the daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks to treat genotype 1 infection in treatment-naive patients, as demonstrated in ASTRAL-1. Other approved combinations include glecaprevir/pibrentasvir, elbasvir/grazoprevir, and ledipasvir/sofosbuvir.

For patients infected with genotype 1b who have not received treatment before and do not have cirrhosis, and for patients who have previously failed INF/RBV treatment, there are three equally effective treatment regimens available. The first regimen involves taking a daily fixed combination of Ledipasvir for 12 weeks. The second regimen involves taking a daily fixed-dose combination of Paritaprevir/Ritonavir/Ombitasvir, along with twice-daily Ribavirin for 12 weeks. The third regimen involves taking a daily fixed-dose combination of Paritaprevir/Ritonavir/Ombitasvir, along with once-daily Dasabuvir and twice-daily Ribavirin for 12 weeks.

The use of pegylated interferon, ribavirin, and sofosbuvir has shown effectiveness in treating HCV genotype 3 infection. A 12-week course of this combination resulted in an 83% overall sustained virologic response (SVR) rate in both cirrhotic and non-cirrhotic patients.

For adults with HCV genotype 2 (without cirrhosis), the initial treatment options are glecaprevir-pibrentasvir for 8 weeks or sofosbuvir-velpatasvir for 12 weeks.

Genotype 4 is the predominant HCV RNA genotype in Egypt, accounting for over 85% of all HCV cases in the country.

Methods for determining the genotype of HCV for diagnosis primarily involve sequencing the genomic nucleotide sequence or using kit-based assays with complementary probes to identify the genotype present in a specimen.

DAAs, also known as direct acting antivirals, are effective in inhibiting the replication of the hep C virus. Certain DAAs have shown promising results in treating all genotypes of hepatitis C.

ZEPATIER (Elbasvir/Grazoprevir) Tablets, 50 mg/100 mg, received FDA approval on January 28, 2016. This medication is indicated for the treatment of chronic HCV genotype 1 or 4 infection in adults.

Zepatier is a combination medication that includes two antiviral drugs, elbasvir and grazoprevir. It is commonly prescribed as a primary treatment for hepatitis C genotypes 1 and 4.

Merck, also known as MSD in Europe, stated in an email that during the European review for Zepatier, the European Medicines Agency identified issues with Merck’s third-party manufacturer, primarily related to insufficient record-keeping and the need for enhancements in their quality management systems.

ZEPATIER is approved for treating chronic hepatitis C (CHC) in patients aged 12 and above, including both adults and children weighing at least 30 kg. Please refer to sections 4.2, 4.4, and 5.1 for more information on dosage recommendations based on patient weight and age. For specific information on the effectiveness of ZEPATIER against different genotypes of the hepatitis C virus (HCV), please see sections 4.4 and 5.1.

The FDA approved Paxlovid for adults in 2023 after reviewing all the scientific evidence provided by Pfizer. This included data from a Phase 2/3 study, which demonstrated an 86% decrease in the risk of COVID-19-related hospitalization or death in patients who received Paxlovid within five days of experiencing symptoms.

The Food and Drug Administration has approved Remdesivir and ritonavir-boosted nirmatrelvir (Paxlovid) as antiviral agents for the treatment of COVID-19.

The FDA has granted approval for BIMZELX®, making it the first biologic to specifically target IL-17A and IL-17F. This medication is now available for adults who are dealing with moderate to severe plaque psoriasis.

Gilead (NASDAQ: GILD) has revealed its intention to introduce authorized generic editions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), the company’s primary treatments for chronic hepatitis C virus (HCV), in the United States. This will be carried out through a newly established subsidiary, Asegua Therapeutics LLC.

Symdeko (tezacaftor/ivacaftor) tablets were approved by the Food and Drug Administration (FDA) earlier this year for the treatment of specific cystic fibrosis (CF) patients aged 12 years and above.