Ledipasvir

Generic Name: Ledipasvir

Ledipasvir is a drug for the treatment of hepatitis C that was developed by Gilead Sciences. After completing Phase III clinical trials, on February 10, 2014 Gilead filed for U.S. approval of a ledipasvir/sofosbuvir fixed-dose combination tablet for genotype 1 hepatitis C. The ledipasvir/sofosbuvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without PEG-interferon or ribavirin.

Ledipasvir is an inhibitor of NS5A, a hepatitis C virus protein.

Data presented at the 20th Conference on Retroviruses and Opportunistic Infections in March 2013 showed that a triple regimen of the nucleotide analog inhibitor sofosbuvir, ledipasvir, and ribavirin produced a 12-week post-treatment sustained virological response (SVR12) rate of 100% for both treatment-naive patients and prior non-responders with HCV genotype 1. The sofosbuvir/ledipasvir coformulation is being tested with and without ribavirin. In February 2014 Gilead filed for United States Food and Drug Administration (FDA) approval of ledipasvir/sofosbuvir oral treatment, without interferon and ribavirin.

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Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in viral chain termination.

Ledipasvir is most commonly used in combination with sofosbuvir for treatment in chronic hepatitis C genotype 1 patients. This drug has been tested and shown efficacy in treatment-naive and treatment experienced patients.

Ledipasvir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • tiredness
  • headache
  • difficulty falling asleep or staying asleep
  • nausea
  • diarrhea
  • cough
  • dizziness
  • muscle pain
  • irritability

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency treatment:

  • rash
  • blisters
  • swelling of the face, arms, or legs
  • shortness of breath

Adult

Dosage Forms & Strengths

ledipasvir/sofosbuvir

tablet

  • 90mg/400mg

Hepatitis C Virus Infection

Indicated for adults with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 infection

1 tablet (90 mg/400 mg) PO qDay

Treatment duration

  • The following regimens also apply to HCV/HIV-1 coinfection
  • Genotype 1
    • Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks
    • Treatment-experienced without cirrhosis: 12 weeks
    • Treatment-experienced with compensated cirrhosis (Child-Pugh A): 24 weeks; may also consider adding daily weight-based ribavirin
    • Treatment-naïve and treatment-experienced with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation: 12 weeks in combination with ribavirin
  • Note:
    • 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pretreatment HCV RNA <6 million IU/mL
    • Treatment –experienced patients include those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor
    • Ledipasvir/sofosbuvir + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin; see ribavirin dosage recommendations below
    • In patients with decompensated cirrhosis, the starting dosage of ribavirin is 600 mg and can be titrated up to 1000 mg for patients <75 kg and 1200 mg for those ≥75 kg in two divided doses with food; if starting dosage of ribavirin is not well tolerated, reduce dosage as clinically indicated based on hemoglobin levels
    • Ribavirin dosage recommendations: The daily dosage of ribavirin is weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food
    • For further information on ribavirin dosing and dosage modifications, refer to the ribavirin prescribing information
  • Genotypes 1 or 4
    • Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A), including those who have undergone liver transplantation: 12 weeks in combination with ribavirin
  • Genotypes 4, 5, or 6
    • Treatment-naïve and treatment-experienced, without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks

Dosage Modifications

Renal impairment

  • Mild or moderate: No dosage adjustment required
  • Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

Hepatic impairment

  • Mild, moderate, or severe: No dosage adjustment required
  • Decompensated cirrhosis: Safety and efficacy not established

Pediatric

Dosage Forms & Strengths

ledipasvir/sofosbuvir

tablet

  • 90mg/400mg

Hepatitis C Virus Infection

Indicated for pediatric patients aged ≥12 yr or weighing at least 35 kg with hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis

<12 years or <35 kg: Safety and efficacy not established

≥12 years or weight ≥35 kg: 1 tablet (90mg/400mg) PO qDay

Treatment duration

  • The following regimens also apply to HCV/HIV-1 coinfection
  • Genotype 1
    • Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks
    • Treatment-experienced without cirrhosis: 12 weeks
    • Treatment-naïve and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A): 24 weeks
  • Genotypes 4, 5, or 6
    • Treatment-naïve and treatment experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A): 12 weeks

Dosage Modifications

Renal impairment

  • Mild or moderate: No dosage adjustment required
  • Severe (eGFR <30 mL/min/1.73 m²) or ESRD: No dosage recommendation can be given owing to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Amiodarone
  • Bosentan
  • Calcium Carbonate
  • Carbamazepine
  • Cimetidine
  • Dexlansoprazole
  • Digoxin
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Enzalutamide
  • Esomeprazole
  • Famotidine
  • Fosphenytoin
  • Lansoprazole
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Mitotane
  • Modafinil
  • Nafcillin
  • Nizatidine
  • Omeprazole
  • Oxcarbazepine
  • Pantoprazole
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Rabeprazole
  • Ranitidine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Rosuvastatin
  • Simeprevir
  • Sodium Bicarbonate
  • St John's Wort
  • Tenofovir Disoproxil Fumarate
  • Tipranavir
  • Topotecan

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

It is usually taken with or without food once daily. Take ledipasvir and sofosbuvir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ledipasvir and sofosbuvir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ledipasvir and sofosbuvir combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ledipasvir and sofosbuvir combination in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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